Anterion

K230897 · Heidelberg Engineering GmbH · OBO · Oct 11, 2023 · Ophthalmic

Device Facts

• Record ID: K230897
• Device Name: Anterion
• Applicant: Heidelberg Engineering GmbH
• Product Code: OBO · Ophthalmic
• Decision Date: Oct 11, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1570
• Device Class: Class 2

Intended Use

The ANTERION is a non-contact ophthalmic imaging and analysis device for the eye. It is intended for visualization and measurement of the anterior segment and measurement of the axial length. The analysis covers: - Cornea Thickness - Anterior Segment o Anterior chamber width, depth, volume and angle parameters o Lens Thickness - Axial Length

Device Story

ANTERION is a non-contact diagnostic imaging device using swept-source optical coherence tomography (SS-OCT) and an infrared (IR) camera. Operated by clinicians in a clinic setting, the device captures cross-sectional OCT images and en-face IR images of the eye. The system includes a motorized chin rest and joystick for patient alignment. Software applications (Imaging, Cornea, Cataract, Metrics) process raw scan data to provide automated measurements of corneal thickness, anterior chamber parameters (width, depth, volume, angle), lens thickness, and axial length. Output is displayed on a GUI for clinical review and surgical planning. The device integrates with a Medical Image Management and Processing System (MIMPS) like HEYEX 2/PACS. By providing precise anatomical measurements, the device assists in cataract surgery planning and anterior segment assessment, potentially improving diagnostic accuracy and surgical outcomes.

Clinical Evidence

Two prospective, observational studies (Protocol B-2018-3, B-2018-5) evaluated precision (repeatability/reproducibility) across 230+ participants. B-2018-3 compared ANTERION to CIRRUS HD-OCT 5000 in open/narrow angle eyes. B-2018-5 compared ANTERION to Pentacam AXL in normal, cataract, corneal abnormality, post-refractive, and pseudophakic/aphakic eyes. Primary endpoints were repeatability and reproducibility of anterior segment and biometry measurements (e.g., CCT, ACD, Axial Length). Results showed low CV% and SD across all parameters, demonstrating high precision. No adverse events reported.

Technological Characteristics

Swept-source OCT (1310 nm center wavelength); IR camera; motorized chin rest; joystick control. OCT axial resolution <10 μm; lateral resolution 30 μm/45 μm. Scan length 5-16.5 mm; A-scan rate 50,000 Hz. Connectivity via MIMPS (HEYEX 2/PACS). Biocompatibility per ISO 10993-5/18. Electrical safety per ANSI AAMI ES60601-1; EMC per IEC 60601-1-2. Laser safety per IEC 60825-1 and ANSI Z80.36.

Indications for Use

Indicated for visualization and measurement of the anterior segment and axial length in patients requiring ophthalmic imaging and analysis. No specific age or gender contraindications stated.

Regulatory Classification

Identification

An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.

Special Controls

*Classification.* Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

Predicate Devices

• ANTERION (K211817)

Reference Devices

• CIRRUS HD-OCT 5000 (K150977)
• Pentacam AXL (K152311)

Submission Summary (Full Text)

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October 11, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the full name. The full name of the agency is "U.S. Food & Drug Administration".

Heidelberg Engineering GmbH % Lena Sattler Consultant Orasi Consulting, LLC. 226 1st Street Bonita Springs, Florida 34134

Re: K230897

Trade/Device Name: Anterion Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO Dated: August 31, 2023 Received: August 31, 2023

Dear Lena Sattler:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Elvin Y. Ng-S

Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices

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Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K230897

Device Name ANTERION

Indications for Use (Describe)

The ANTERION is a non-contact ophthalmic imaging and analysis device for the eye. It is intended for visualization and measurement of the anterior segment and measurement of the axial length.

The analysis covers:

- · Cornea Thickness
- · Anterior Segment
- o Anterior chamber width, depth, volume and angle parameters
- o Lens Thickness
- · Axial Length

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/0 description: The image shows the logo for Heidelberg Engineering. The logo consists of two lines of text, with a red square on either side. The first line says "HEIDELBERG" and the second line says "ENGINEERING".

# 510(K) SUMMARY

## Date Prepared

October 10, 2023

## SPONSOR/510(K) OWNER/ MANUFACTURER

Heidelberg Engineering GmbH Max-Jarecki-Strasse 8 69115 Heidelberg, Germany +49 6221 / 64 63 0 Telephone: Facsimile: +49 6221 / 64 63 62 Email: [e-mail] Establishment Registration No.: 8043762

# OFFICIAL CONTACT PERSON

| Lena Sattler | |
|--------------------------|--------------------------|
| Orasi Consulting, LLC. | |
| 226 1st Street | |
| Bonita Springs, FL 34134 | |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| E-mail: | [e-mail] |

# COMMON/USUAL NAME

Optical Coherence Tomography

## PROPRIETARY OR TRADE NAMES

## ANTERION

## CLASSIFICATION INFORMATION

| Regulation Number: | 21 CFR 886.1570 |
|-----------------------|-------------------------------------|
| Classification name: | Ophthalmoscope |
| Device Class: | II |
| Common name: | Optical Coherence Tomography |
| Product Codes, Name: | OBO (Tomography, Optical Coherence) |
| Medical Specialty: | Ophthalmic |
| Classification Panel: | Ophthalmic Device Panel |

Heidelberg Engineering GmbH

Traditional 510(k): ANTERION Page 1 of 13

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Image /page/5/Picture/0 description: The image contains the logo for Heidelberg Engineering. The logo consists of two lines of text, with a red square on either side. The first line reads "HEIDELBERG" and the second line reads "ENGINEERING". The text is in a bold, sans-serif font.

# PREDICATE DEVICE

ANTERION (K211817), Heidelberg Engineering GmbH

# REFERENCE DEVICES

CIRRUS HD-OCT 5000 (K150977), Carl Zeiss Meditec Inc.

Pentacam AXL (K152311), Oculus Optikgerate GmbH

# INDICATIONS FOR USE

The ANTERION is a non-contact ophthalmic imaging and analysis device for the eye. It is intended for visualization and measurement of the anterior segment and the measurement of the axial length.

The analysis covers:

- Cornea thickness ●
- Anterior segment
- o Anterior chamber width, depth, volume, and angle parameters
- o Lens thickness
- Axial Length ●

# GENERAL DEVICE DESCRIPTION

The ANTERION is a diagnostic imaging device for the eye. The technology is based on swept-source optical coherence tomography (SS-OCT) technology. The device itself has two basic component groups:

- ANTERION Hardware (Imager/Base) with integrated forehead/ chin rest: The . hardware includes imaging hardware (e.g., laser, LEDs, optics, detectors, hardware for spatial encoding) as well as a touch screen.
- . ANTERION Software (V.1.2.4) (PC): The ANTERION Software includes the main user interface. The software allows for device control, such as selection of examination(s) and imaging parameter(s). The ANTERION software provides an interface for a Medical Image Management and Processing System.

The ANTERION hardware is separated in three parts: the Base (bottom part), the Imager (top part), and the Head Rest (forehead/chin rest).

For examinations, the patient places his/her head in the forehead/chin rest. The Head Rest is mechanically and electronically connected to the Base and controlled via a joystick. Placed within the stand are a stepper motor with additional mechanical parts Heidelberg Engineering GmbH Traditional 510(k): ANTERION

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### HEIDELE engineering

and a controller board, allowing the operator to move the motorized chin rest up or down for optimally positioning the patients' eye. An external fixation light is mounted at the forehead rest.

The Base mainly contains the power supply and PC connection of the device. In the Imager, the components for scanning, signal generation, and signal processing are contained.

The operator directly accesses two software modules, which are named AQM (acquisition module) and VWM (viewing module). The AQM allows selecting between examinations. The VWM shows acquired images, parameters, and reports.

The ANTERION device contains two imaging modalities, a scanning optical coherence tomography (OCT) modality and an infrared (IR) camera. The OCT modality allows for cross-sectional imaging and biometry, while the IR camera allows for en-face imaging of a patient's eye.

The ANTERION device provides four separate software applications (Apps) to acquire various imaging and measurements of the anterior segment of the eye: (1) the Imaging App (cleared under K211817), (2) the Cornea App, (3) the Cataract App and (4) the Metrics App. The Cornea App provides tomographic data and measurements paraments for the patient's individual corneal geometry and corneal characteristics. The Cornea App provides tomographic data and parameters, such as corneal curvature and thickness. The Cataract App provides key measurements for the cataract surgery planning, such as corneal thickness, anterior chamber depth and axial length. The Metrics App generates OCT images and scan parameters for the anterior chamber such as anterior chamber angle and volume. The four ANTERION Apps are locked/unlocked independently by a license mechanism for each App. The software implementation of these Apps is realized within the AQM and VWM.

This submission is to seek clearance for the Metrics App, Cataract App and Cornea App.

To function as intended, the ANTERION must be connected to a Medical Image Management and Processing system (MIMPS) with compatible interface. To date, HEYEX 2 / HEYEX PACS is the only available MIMPS with compatible interface.

# COMPARISON OF TECHNOLOGICAL CHARACTERISTICS BETWEEN THE SUBJECT AND THE PREDICATE DEVICE

The predicate ANTERION (K211817) and the subject ANTERION do not share identical technological characteristics. However, the differences in design are marginal and do not raise different questions of safety and effectiveness. The software of both devices, the predicate ANTERION (K211817) and the subject ANTERION, includes all available imaging functions (Imaging App, Cornea App, Cataract App, Metrics App) which are locked/ unlocked independently by a license mechanism for

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Traditional 510(k): ANTERION Page 3 of 13

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each App. The main difference between both devices is that the predicate ANTERION (K211817) only provides the Imaging App to the customer, and the other Apps were not made available for the customer. For the subject ANTERION, all software Apps are available which expand the indications for use of the device and allow measurements regarding the anterior segment. Regarding the OCT specifications, the subject device additionally provides a lateral resolution of 45 um which is specific for the Cornea App and therefore is not applicable for the predicate ANTERION. Only minor hardware changes regarding the assembling of the power supply, replacement of light sources and of the housing coating, were implemented for the subject device which have no impact on the technology and performance of the ANTERION.

| | SUBJECT DEVICE<br>ANTERION | PREDICATE DEVICE<br>ANTERION<br>(K211817) | DISCUSSION |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use/ Indications<br>for use | The ANTERION is a non-contact ophthalmic<br>imaging and analysis device<br>for the eye. It is intended<br>for visualization and<br>measurement of the<br>anterior segment and the<br>measurement of the axial<br>length.<br>The analysis covers:<br>• Cornea thickness<br>• Anterior segment<br>o Anterior chamber<br>width, depth,<br>volume, and angle<br>parameters<br>o Lens thickness<br>• Axial Length | The ANTERION is a non-contact ophthalmic<br>imaging and analysis<br>device for the eye. It is<br>intended for visualization<br>of the anterior segment. | Different:<br>Predicate device<br>is only for<br>imaging of the<br>anterior segment.<br>The subject<br>device provides<br>automated<br>measurements of<br>corneal<br>thickness,<br>anterior chamber<br>width, depth, and<br>volume, anterior<br>segment angle,<br>lens thickness<br>and vault, and<br>axial length; the<br>predicate device<br>does not provide<br>automated<br>measurements of<br>any anterior<br>segment<br>parameters. |
| Device classification name | Optical Coherence<br>Tomographer (OCT) | Optical Coherence<br>Tomographer (OCT) | Same |
| Main Technology | Swept Source OCT<br>Technology | Swept Source OCT<br>Technology | Same |
| Supporting Technologies | Infrared Camera | Infrared Camera | Same |
| OCT center wave length | 1310 nm | 1310 nm | Same |
| OCT axial resolution | <10 μm (tissue) | <10 μm (tissue) | Same |
| OCT lateral resolution | 30 μm, 45 μm | 30 μm | Similar:<br>45μm only for<br>Cornea App |
| Scan length | 5 - 16.5 mm | 5 - 16.5 mm | Same |

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| Number of A-Scans per B-<br>Scan | 256; 512; 768; 1024 | 256; 512; 768; 1024 | Same |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|------|
| A-scan rate | 50,000 Hz | 50,000 Hz | Same |
| Number of B- Scans | 1-65 | 1-65 | Same |
| Scan Pattern | Line, Volume, Arc, Radial | Line, Volume, Arc, Radial | Same |
| Scan Center | Adjustable | Adjustable | Same |
| Tracking | Available | Available | Same |
| Number of averaged Scans | 1; 2; 4; 8 | 1; 2; 4; 8 | Same |
| IR camera image size (px) | 768 x 576 | 768 x 576 | Same |
| Dilation of pupil required? | No | No | Same |
| Eye contact required? | No | No | Same |
| Fixation light | Internal, external | Internal, external | Same |
| Working position | Upright sitting position of<br>the patient, using chin rest | Upright sitting position of<br>the patient, using chin rest | Same |
| User Interface | Joystick for user to move and<br>align device, device has GUI<br>(Graphical user interface) for<br>display and analysis of data | Joystick for user to move and<br>align device, device has GUI<br>(Graphical user interface) for<br>display and analysis of data | Same |

# NON-CLINICAL PERFORMANCE TESTING

Software documentation was provided, and software verification and validation was conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

Documentation regarding cybersecurity was submitted as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" and an overall risk assessment regarding security and safety of the device was conducted due to ISO 14971:2019.

Laser safety testing for the light sources used in ANTERION was provided and showed that the requirements according to FDA recognized standards IEC-60825-1:2007 and ANSI Z80.36:2016 were fulfilled.

Bench verification testing was conducted to demonstrate OCT spatial performance, device sensitivity, depth attenuation and performance of auxiliary functions. The device met all pre-determined acceptance criteria.

Biocompatibility of the device was demonstrated by cytotoxicity testing and chemical analysis according to ISO 10993-5:2009 and ISO 10993-18:2005, respectively, and supported by biocompatibility assessment according to 10993-1:2018.

Tests for electrical safety (ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012) and electromagnetic compatibility (IEC 60601-1- 2 Edition 4.0 2014-02) were performed with the ANTERION device and passed the relevant requirements of the applied standards.

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Traditional 510(k): ANTERION Page 5 of 13

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# CLINICAL PERFORMANCE TESTING

Two prospective, observational clinical studies were conducted at a single clinical site in the United States to compare the clinical performance of the ANTERION Metrics App between the ANTERION and the CIRRUS HD-OCT 5000 devices (Protocol B-2018-3) and the clinical performance of the ANTERION Cataract and Metrics App between the ANTERION and the Pentacam AXL and a reading center (Protocol B-2018-5).

For Protocol B-2018-3, eligible participants age 22 or older were assigned to one of two sub-groups: 1) eyes with open angle (Group A), 2) eyes with narrow angle (Group B). Participants were excluded if they had active infection of inflammation in either eye, insufficient tear film or corneal reflex, rigid gas permeable (RGP) contact lens wear during the two weeks prior to the study visit, and/or soft CL wear within one hour of the study visit. A baseline eye examination that included manifest refraction, slit-lamp biomicroscopy, assessment of best-corrected visual acuity (BCVA), gonioscopy, tonometry, and cataract grading (where applicable) was performed to verify eligibility. One eye per participant was randomly selected as the study eye. Three ANTERION and three CIRRUS 5000 HD-OCT devices were used. These six instruments were paired with three operators to form three device-operator configurations. All participants were imaged repeatedly on all three configurations. Three replicates per acquisition type, per configuration were obtained from each participant. The order of imaging by configuration order, device order within configuration, and by acquisition type was randomized. Image quality was assessed by the operator after each acquisition. Manual correction of ANTERION segmentation and manual editing of the scleral spur and angle recess points were performed as needed. Image quality assessment of CIRRUS images was performed as consistent with the CIRRUS instructions for use. Repeatability and reproducibility of measurements was estimated using a two-way, random-effects analysis of variance (ANOVA) model. Agreement was characterized using Bland-Altman and Deming regression analyses.

30 participants were enrolled into Group A and 28 participants were enrolled into Group B. 29 Group A participants and 27 Group B participants completed the study. Data from 225 scans of 25 Group A participants and 234 scans of 27 Group B participants were included in precision analyses, respectively. Data from 27 Group A and 26 Group B participants were included in the agreement analyses, respectively. The mean age in the safety population was 45.6 ± 16.9 years overall (mean 37.1±12.7 years in Group A, 55.1±16.0 years in Group B). 68.4% (39/57) were women (60.0% [18/30] Group A, 77.8% [21/27] Group B). 44% (25/57) were Caucasian (50.0% [15/30] in Group A, 37.0% [10/27] in Group B), 21% (12/57) were Black/African American (16.7% [5/30] Group A, 25.9% [7/27] Group B), 22.8% (13/57) were Asian (30.0% [9/30] Group A, 14.8% [4/27] Group B). 28.1% (16/57) were Hispanic/Latino

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(16.7% [5/30] Group A, 40.7% [11/27] Group B). Demographics are similar for the Precision Analysis Population and the Agreement Analysis Population. There were no adverse events related to this study. Manual segmentation/extension of ANTERION images was performed on 21.8% (59/271) of scans of open-angle study eyes and 74.5% (181/243) of scans of narrow-angle study eyes.

The following quantitative parameters were evaluated:

- Spur-to-Spur Distance ●
- Angle-to-Angle Distance
- Scleral Spur Angle 500/750 [°] (nasal and temporal) ●
- Angle Opening Distance 500/750 [um] (nasal and temporal) ●
- Trabecular Iris Space Area 500/750 [mm2] (nasal and temporal) ●
- Anterior Chamber Angle 500/750 [°] (nasal and temporal) ●
- Lens Vault ●

ANTERION precision results are presented in the tables below:

| | | | TABLE 1 B-2018-3 REPEATABILITY AND REPRODUCIBILITY OF ANTERION PRECISION | | |
|----------------------------------------|--|--|--------------------------------------------------------------------------|--|--|
| ANALYSIS POPULATION OF OPEN ANGLE EYES | | | | | |

| Eye Population | # of | # of | | | Repeatability | | | Reproducibility | | |
|-------------------------|----------|-------|-----------|-------|---------------|--------|-------|-----------------|--------|--|
| Parameter | Subjects | Scans | Intercept | SD | Limit | CV% | SD | Limit | CV% | |
| Eye(s) with open angle | | | | | | | | | | |
| ACA 500 Nasal (°) | 25 | 225 | 41.876 | 2.892 | 8.098 | 6.906 | 3.772 | 10.561 | 9.007 | |
| ACA 750 Nasal (°) | 25 | 225 | 41.222 | 2.115 | 5.921 | 5.130 | 2.565 | 7.183 | 6.223 | |
| AOD 500 Nasal (mm) | 25 | 225 | 0.561 | 0.048 | 0.135 | 8.584 | 0.067 | 0.188 | 11.945 | |
| AOD 750 Nasal (mm) | 25 | 225 | 0.742 | 0.046 | 0.130 | 6.244 | 0.062 | 0.174 | 8.397 | |
| TISA 500 Nasal (mm²) | 25 | 225 | 0.195 | 0.017 | 0.047 | 8.665 | 0.022 | 0.063 | 11.463 | |
| TISA 750 Nasal (mm²) | 25 | 225 | 0.347 | 0.025 | 0.070 | 7.192 | 0.035 | 0.097 | 9.935 | |
| SSA 500 Nasal (°) | 25 | 225 | 46.956 | 3.143 | 8.799 | 6.693 | 4.297 | 12.032 | 9.152 | |
| SSA 750 Nasal (°) | 25 | 225 | 44.920 | 2.109 | 5.906 | 4.696 | 2.794 | 7.822 | 6.219 | |
| ACA 500 Temporal (°) | 25 | 225 | 44.391 | 3.145 | 8.807 | 7.086 | 3.937 | 11.023 | 8.869 | |
| ACA 750 Temporal (°) | 25 | 225 | 43.524 | 2.222 | 6.222 | 5.105 | 3.069 | 8.593 | 7.051 | |
| AOD 500 Temporal (mm) | 25 | 225 | 0.588 | 0.062 | 0.173 | 10.523 | 0.087 | 0.245 | 14.856 | |
| AOD 750 Temporal (mm) | 25 | 225 | 0.803 | 0.046 | 0.128 | 5.706 | 0.084 | 0.234 | 10.413 | |
| TISA 500 Temporal (mm²) | 25 | 225 | 0.201 | 0.021 | 0.060 | 10.622 | 0.032 | 0.089 | 15.746 | |
| TISA 750 Temporal (mm²) | 25 | 225 | 0.368 | 0.028 | 0.079 | 7.660 | 0.046 | 0.130 | 12.605 | |
| SSA 500 Temporal (°) | 25 | 225 | 48.867 | 2.811 | 7.871 | 5.753 | 4.458 | 12.483 | 9.124 | |
| SSA 750 Temporal (°) | 25 | 225 | 46.613 | 2.072 | 5.802 | 4.445 | 3.318 | 9.290 | 7.118 | |
| STS Distance (mm) | 25 | 225 | 11.920 | 0.051 | 0.143 | 0.428 | 0.072 | 0.201 | 0.602 | |
| ATA Distance (mm) | 25 | 225 | 12.009 | 0.060 | 0.167 | 0.497 | 0.065 | 0.181 | 0.539 | |
| Lens Vault (mm) | 25 | 225 | 0.072 | 0.026 | 0.072 | 35.515 | 0.032 | 0.091 | 45.011 | |

All statistics are estimated (REML) from two-way random-effect ANOVA model with random effects operator/device. eye and interaction between operator/device and eye.

Reproducibility SD = Square root of the operator/device variance, the interaction variance and the residual variance

Repeatability limit = 2.8 × Repeatability CV% = (Repeatability SD)/Intercept × 100%. Reproducibility limit = 2.8 x Reproducibility SD. Reproducibility CV% = (Reproducibility SD)/Intercept × 100%. ACA = Anterior Chamber Angle. AOD = Angle Opening Distance. TISA = Trabecular-Iris Space Area. SSA = Scleral Spur-Angle. STS Distance = Spur-to-Spur Distance. ATA Distance = Angle-to-Angle Distance.

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Traditional 510(k): ANTERION

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TABLE 2 B-2018-3 REPEATABILITY AND REPRODUCIBILITY OF ANTERION PRECISION ANALYSIS POPULATION OF NARROW ANGLE EYES

| Eye Population | # of | # of | | | Repeatability | | Reproducibility | | | |
|--------------------------|----------|-------|-----------|-------|---------------|--------|-----------------|--------|--------|--|
| Parameter | Subjects | Scans | Intercept | SD | Limit | CV% | SD | Limit | CV% | |
| Eye(s) with narrow angle | | | | | | | | | | |
| ACA 500 Nasal (°) | 26 | 234 | 15.722 | 2.631 | 7.367 | 16.735 | 3.145 | 8.806 | 20.004 | |
| ACA 750 Nasal (°) | 26 | 234 | 15.235 | 1.918 | 5.371 | 12.591 | 2.307 | 6.460 | 15.144 | |
| AOD 500 Nasal (mm) | 26 | 234 | 0.164 | 0.024 | 0.068 | 14.870 | 0.033 | 0.092 | 19.965 | |
| AOD 750 Nasal (mm) | 26 | 234 | 0.227 | 0.030 | 0.083 | 13.105 | 0.035 | 0.097 | 15.266 | |
| TISA 500 Nasal (mm²) | 26 | 233 | 0.059 | 0.010 | 0.027 | 16.181 | 0.012 | 0.033 | 20.102 | |
| TISA 750 Nasal (mm²) | 26 | 233 | 0.106 | 0.014 | 0.040 | 13.387 | 0.017 | 0.049 | 16.478 | |
| SSA 500 Nasal (°) | 26 | 234 | 18.145 | 2.728 | 7.640 | 15.037 | 3.569 | 9.993 | 19.668 | |
| SSA 750 Nasal (°) | 26 | 234 | 16.906 | 2.077 | 5.814 | 12.283 | 2.445 | 6.847 | 14.465 | |
| ACA 500 Temporal (°) | 26 | 234 | 15.145 | 2.621 | 7.340 | 17.308 | 3.404 | 9.531 | 22.475 | |
| ACA 750 Temporal (°) | 26 | 234 | 15.350 | 1.913 | 5.355 | 12.460 | 2.908 | 8.142 | 18.943 | |
| AOD 500 Temporal (mm) | 26 | 234 | 0.152 | 0.028 | 0.078 | 18.363 | 0.037 | 0.104 | 24.415 | |
| AOD 750 Temporal (mm) | 26 | 234 | 0.226 | 0.031 | 0.088 | 13.926 | 0.048 | 0.134 | 21.274 | |
| TISA 500 Temporal (mm²) | 26 | 233 | 0.058 | 0.009 | 0.026 | 16.316 | 0.012 | 0.033 | 20.448 | |
| TISA 750 Temporal (mm²) | 26 | 233 | 0.104 | 0.014 | 0.040 | 13.828 | 0.020 | 0.056 | 19.106 | |
| SSA 500 Temporal (°) | 26 | 234 | 16.949 | 2.883 | 8.073 | 17.010 | 3.951 | 11.062 | 23.309 | |
| SSA 750 Temporal (°) | 26 | 234 | 16.671 | 2.239 | 6.269 | 13.430 | 3.391 | 9.496 | 20.343 | |
| STS Distance (mm) | 26 | 234 | 11.870 | 0.061 | 0.170 | 0.511 | 0.079 | 0.220 | 0.662 | |
| ATA Distance (mm) | 26 | 234 | 11.994 | 0.085 | 0.237 | 0.706 | 0.095 | 0.267 | 0.795 | |
| 25 | 225 | 0.756 | 0.029 | 0.082 | 3.860 | 0.045 | 0.127 | 5.980 | | |

All statistics are estimated (REML) from two-way random-effect ANOVA model with random effects operator/device, eye and interaction between operator/device and eye.

Reproducibility SD = Square root of the operator/device variance, the interaction variance and the residual variance

Repeatability limit = 2.8 × Repeatability CV% = (Repeatability CV% = (Repeatability SD)/Intercept × 100%.

Reproducibility limit = 2.8 x Reproducibility SD. Reproducibility CV% = (Reproducibility SD)/Intercept x 100%.

ACA = Anterior Chamber Angle. AOD = Angle Opening Distance. TISA = Trabecular-Iris Space Area. SSA = Scleral Spur-Angle. STS Distance = Spur-to-Spur Distance. ATA Distance = Angle-to-Angle Distance.

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### ibelB SIMEETIL

For the second study B-2018-5, eligible participants age 22 or older were assigned to one of five sub-groups: 1) eyes with "normal anterior segment" (Group A), 2) eyes with cataract (Group B), 3) eyes with corneal abnormalities such as corneal ectasias (Group C), 4) eyes that were post-keratorefractive surgery (Group D), 5) pseudophakic/aphakic eyes (Group E). Exclusion criteria were similar to those described for Protocol B-2018-3. A baseline eye examination that included manifest refraction, slit-lamp biomicroscopy, assessment of best-corrected visual acuity (BCVA), tonometry, and cataract grading (where applicable) was performed to verify eligibility. One eye per participant was randomly selected as the study eye. Three ANTERION and three Pentacam AXL devices were used. These six instruments were paired with three operators to form three device-operator configurations. All participants were imaged repeatedly on all three configurations. Three replicates per acquisition type, per configuration were obtained from each participant. The order of imaging by configuration order, device order within configuration, and by acquisition type was randomized. Image quality was assessed by the operator after each acquisition. Manual correction of ANTERION segmentation was performed by an independent reading center and manual placement of the angle recess points were performed. Image quality assessment of Pentacam images was performed as consistent with the Pentacam's instructions for use. Repeatability and reproducibility of measurements was estimated using a two-way, random-effects analysis of variance (ANOVA) model. Agreement was characterized using Bland-Altman and Deming regression analyses.

176 participants were enrolled and 172 completed the study. In the safety population, there were 27 in Group A, 33 in Group B, 45 in Group C, 29 in Group D, and 41 in Group E. The mean age was 52.6 ± 18.8 years (range 23 to 87 years). The mean age in Group A was 36.1±10.4 years (range 23 to 59); Group B, 66.9±6.8 years (range 48 to 80); Group C, 41.4±14.7 years (range 23 to 71); Group D, 43.1±13.9 years (range 24 to 72); Group E, 70.8±12.5 years (range 30 to 87). 65.1% (114/175) were women (55.6% [15/27] in Group A; 72.7% [24/33] in Group B; 57.8% [26/45] in Group C; 72.4% [21/29] in Group D; 68.3% [28/41] in Group E).

27.4% (48/175) of the safety population were Caucasian (44.4% [12/27] in Group A; 15.2% [5/33] in Group B; 26.7% [12/45] in Group C; 31.0% [9/29] in Group D; 24.4% [10/41] in Group E). 49.1% (86/175) were Black/African American (18.5% [5/27] Group A; 81.8% [27/33] Group B; 46.7% [21/45] Group C; 27.6% [8/29] Group D; 61.0% [25/41] Group E). 10.9% (19/175) were Asian (18.5% [5/27] Group A; 6.1% [2/33] Group B; 2.2% [1/45] Group C; 31.0% [9/29] Group D; 4.9% [2/41] Group E). 9.1% (16/175) were Native American/Alaskan Native (14.8% [4/27] Group A; 20.0% [9/45] Group C; 6.9% [2/29] Group D; 2.4% [1/41] Group E). 24.6% (43/175) were Hispanic/Latino (40.7% [11/27] Group A; 9.1% [3/33] Group

Heidelberg Engineering GmbH Proprietary Information

Traditional 510(k): ANTERION Page 9 of 13

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B; 33.3% [15/45] Group C; 24.1% [7/29] Group D; 17.1% [7/41] Group E). 95.1% (39/41) of Group E participants were pseudophakic and two Group E participants (4.9%) were aphakic. 67% (30/45) of Group B participants had nuclear sclerosis of grade 1.5+ or higher and 29% (13/45) had cortical cataracts. 69% (31/45) of Group C participants had keratoconus. 72% of Group D participants had prior laser-assisted in situ keratomileusis (LASIK) and the remainder had prior photorefractive keratectomy (PRK), radial keratotomy (RK), small-incision lenticular extraction, or corneal inlay implantation. Demographics are similar for the Precision Analysis Population and the Agreement Analysis Population. There were no adverse events related to this study. Manual segmentation correction/extension was performed in 2.9% (7/243), 10.1% (30/297), 11.6% (44/378), and 2.3% (6/261) of Metrics App scans for Groups A, B, C, and D, respectively. Manual segmentation correction was performed in 0.4% (1/243), 3.7% (11/297), 17.1% (64/375), 3.8% (10/261), and 3.5% (12/345) of Cataract App scans for Groups A, B, C, D, and E, respectively.

The following quantitative parameters were evaluated:

- Anterior Corneal Topography (3 mm ring and 6 mm zone) ●
- Posterior Corneal Topography (3 mm ring and 6 mm zone)
- . Central Corneal Thickness (CCT) [um]
- . Thinnest Point Thickness [um]
- Lens Thickness [mm]
- Anterior Chamber Depth [mm] (ANTERION Aqueous Depth plus CCT) ●
- . Pupil Diameter [mm]
- . White-to-White Distance [mm]
- Axial Length [mm]
- Anterior Chamber Volume [mm3] ●

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Image /page/14/Picture/0 description: The image shows the logo for Heidelberg Engineering. The logo consists of two lines of text in a bold, sans-serif font. The top line reads "HEIDELBERG" and the bottom line reads "ENGINEERING". There is a red square to the left of the top line and to the right of the bottom line.

## ANTERION precision results are presented in the tables below:

TABLE 3 B-2018-5 REPEATABILITY AND REPRODUCIBILITY OF ANTERION BIOMETRY MEASUREMENTS PRECISION ANALYSIS POPULATION OF NORMAL EYES

| | # of | # of | | Repeatability | | | Reproducibility | | |
|--------------------------------|----------|-------|-----------|---------------|-------|-------|-----------------|--------|-------|
| Parameter | Subjects | Scans | Intercept | SD | Limit | CV% | SD | Limit | CV% |
| Cataract App: Biometry | | | | | | | | | |
| Central corneal thickness [µm] | 27 | 243 | 545.621 | 0.775 | 2.170 | 0.142 | 4.088 | 11.446 | 0.749 |
| Thinnest point thickness [µm] | 27 | 243 | 542.226 | 0.703 | 1.968 | 0.130 | 3.728 | 10.439 | 0.688 |
| Anterior chamber depth [mm] | 27 | 243 | 3.635 | 0.009 | 0.026 | 0.255 | 0.014 | 0.040 | 0.389 |
| Axial length [mm] | 27 | 243 | 24.513 | 0.004 | 0.012 | 0.018 | 0.006 | 0.018 | 0.027 |
| Lens thickness [mm] | 27 | 243 | 3.982 | 0.011 | 0.030 | 0.270 | 0.015 | 0.042 | 0.377 |
| Metrics App: Biometry | | | | | | | | | |
| Central corneal thickness [µm] | 27 | 243 | 546.679 | 1.106 | 3.096 | 0.202 | 4.181 | 11.706 | 0.765 |
| Anterior chamber depth [mm] | 27 | 243 | 3.636 | 0.009 | 0.024 | 0.239 | 0.013 | 0.037 | 0.362 |
| Anterior chamber volume [mm³] | 27 | 243 | 185.507 | 1.377 | 3.856 | 0.742 | 3.670 | 10.275 | 1.978 |
| Lens thickness [mm] | 27 | 243 | 3.988 | 0.010 | 0.027 | 0.239 | 0.015 | 0.041 | 0.371 |

All statistics are estimated (REML) from two-way random-effect ANOVA model with random effects operator/device, eye and interaction between operator/device and eye.

Reproducibility SD = Square root of the operator/device variance, the interaction variance and the residual variance Repeatability limit = 2.8 x Repeatability CV% = (Repeatability CV% = (Repeatability SD)/Intercept x 100%.

Reproducibility limit = 2.8 × Reproducibility SD. Reproducibility CV% = (Reproducibility SD)/Intercept × 100%.

TABLE 4 B-2018-5 REPEATABILITY AND REPRODUCIBILITY OF ANTERION BIOMETRY MEASUREMENTS PRECISION ANALYSIS POPULATION OF CATARACT EYES

| Parameter | # of<br>Subjects | # of<br>Scans | Intercept | Repeatability | | | Reproducibility | | |
|---------------------------------------|------------------|---------------|-----------|---------------|-------|-------|-----------------|--------|-------|
| | | | | SD | Limit | CV% | SD | Limit | CV% |
| Cataract App: Biometry | | | | | | | | | |
| Central corneal thickness [ $\mu m$ ] | 33 | 297 | 527.694 | 2.351 | 6.584 | 0.446 | 4.321 | 12.100 | 0.819 |
| Thinnest point thickness [ $\mu m$ ] | 33 | 297 | 522.104 | 0.672 | 1.881 | 0.129 | 3.412 | 9.554 | 0.654 |
| Anterior chamber depth [mm] | 33 | 297 | 3.128 | 0.011 | 0.030 | 0.337 | 0.016 | 0.045 | 0.512 |
| Axial length [mm] | 33 | 297 | 23.852 | 0.019 | 0.054 | 0.081 | 0.019 | 0.054 | 0.081 |
| Lens thickness [mm] | 33 | 295 | 4.661 | 0.012 | 0.034 | 0.262 | 0.015 | 0.042 | 0.325 |
| Metrics App: Biometry | | | | | | | | | |
| Central corneal thickness [ $\mu m$ ] | 33 | 297 | 529.101 | 1.277 | 3.574 | 0.241 | 3.972 | 11.122 | 0.751 |
| Anterior chamber depth [mm] | 33 | 297 | 3.130 | 0.006 | 0.016 | 0.186 | 0.010 | 0.028 | 0.320 |
| Anterior chamber volume [ $mm^3$ ] | 33 | 295 | 132.199 | 0.821 | 2.298 | 0.621 | 1.548 | 4.335 | 1.171 |
| Lens thickness [mm] | 33 | 297 | 4.670 | 0.007 | 0.019 | 0.142 | 0.010 | 0.027 | 0.208 |

All statistics are estimated (REML) from two-way random-effect ANOVA model with random effects operator/device, eye and interaction between operator/device and eye.

Reproducibility SD = Square root of the operator/device variance, the interaction variance and the residual variance Repeatability limit = 2.8 × Repeatability CV% = (Repeatability CV% = (Repeatability SD)/Intercept × 100%.

Reproducibility limit = 2.8 x Reproducibility SD. Reproducibility CV% = (Reproducibility SD)/Intercept × 100%.

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Image /page/15/Picture/0 description: The image shows the logo for Heidelberg Engineering. The logo consists of two lines of text in a bold, futuristic font. The first line reads "HEIDELBERG" and the second line reads "ENGINEERING". There is a red square to the left of the word "HEIDELBERG" and to the right of the word "ENGINEERING".

TABLE 5 B-2018-5 REPEATABILITY AND REPRODUCIBILITY OF ANTERION BIOMETRY MEASUREMENTS PRECISION ANALYSIS POPULATION OF EYES WITH CORNEAL ABNORMALITIES

| Parameter | # of<br>Subjects | # of<br>Scans | Intercept | Repeatability | | | Reproducibility | | |
|--------------------------------|------------------|---------------|-----------|---------------|--------|-------|-----------------|--------|-------|
| | | | | SD | Limit | CV% | SD | Limit | CV% |
| Cataract App: Biometry | | | | | | | | | |
| Central corneal thickness [μm] | 43 | 363 | 495.294 | 1.872 | 5.243 | 0.378 | 4.367 | 12.227 | 0.882 |
| Thinnest point thickness [μm] | 43 | 363 | 470.957 | 4.023 | 11.263 | 0.854 | 5.116 | 14.325 | 1.086 |
| Anterior chamber depth [mm] | 43 | 363 | 3.746 | 0.014 | 0.039 | 0.370 | 0.019 | 0.052 | 0.498 |
| Axial length [mm] | 43 | 366 | 24.548 | 0.012 | 0.034 | 0.049 | 0.017 | 0.046 | 0.067 |
| Lens thickness [mm] | 40 | 337 | 4.001 | 0.016 | 0.045 | 0.399 | 0.018 | 0.051 | 0.457 |
| Metrics App: Biometry | | | | | | | | | |
| Central corneal thickness [μm] | 38 | 331 | 513.923 | 1.117 | 3.129 | 0.217 | 7.479 | 20.942 | 1.455 |
| Anterior chamber depth [mm] | 38 | 331 | 3.668 | 0.011 | 0.031 | 0.306 | 0.016 | 0.045 | 0.438 |
| Anterior chamber volume [mm³] | 39 | 339 | 187.635 | 1.124 | 3.148 | 0.599 | 2.669 | 7.472 | 1.422 |
| Lens thickness [mm] | 36 | 313 | 4.039 | 0.012 | 0.035 | 0.308 | 0.018 | 0.049 | 0.434 |

All statistics are estimated (REML) from two-way random-effect ANOVA model with random effects operator/device, eye and interaction between operator/device and eye.

Reproducibility SD = Square root of the operator/device variance, the interaction variance and the residual variance Repeatability limit = 2.8 × Repeatability CV% = (Repeatability CV% = (Repeatability SD)/Intercept × 100%.

Reproducibility limit = 2.8 x Reproducibility SD. Reproducibility CV% = (Reproducibility SD)/Intercept × 100%.

TABLE 6 B-2018-5 REPEATABILITY AND REPRODUCIBILITY OF ANTERION BIOMETRY MEASUREMENTS PRECISION ANALYSIS POPULATION OF POST-KERATOREFRACTIVE SURGERY EYES

| | # of | # of | | Repeatability | | | Reproducibility | | |
|---------------------------------------|----------|-------|-----------|---------------|-------|-------|-----------------|--------|-------|
| Parameter | Subjects | Scans | Intercept | SD | Limit | CV% | SD | Limit | CV% |
| Cataract App: Biometry | | | | | | | | | |
| Central corneal thickness [ $\mu m$ ] | 29 | 261 | 479.893 | 1.076 | 3.012 | 0.224 | 4.637 | 12.984 | 0.966 |
| Thinnest point thickness [ $\mu m$ ] | 29 | 261 | 473.157 | 1.224 | 3.427 | 0.259 | 4.394 | 12.304 | 0.929 |
| Anterior chamber depth [mm] | 29 | 261 | 3.568 | 0.008 | 0.024 | 0.236 | 0.012 | 0.033 | 0.328 |
| Axial length [mm] | 29 | 261 | 25.264 | 0.004 | 0.012 | 0.018 | 0.007 | 0.020 | 0.028 |
| Lens thickness [mm] | 29 | 260 | 4.110 | 0.009 | 0.024 | 0.209 | 0.013 | 0.037 | 0.322 |
| Metrics App: Biometry | | | | | | | | | |
| Central corneal thickness [ $\mu m$ ] | 28 | 251 | 489.173 | 1.062 | 2.975 | 0.217 | 4.485 | 12.558 | 0.917 |
| Anterior chamber depth [mm] | 28 | 251 | 3.555 | 0.007 | 0.020 | 0.196 | 0.010 | 0.027 | 0.275 |
| Anterior chamber volume [mm $^3$ ] | 28 | 251 | 177.715 | 1.203 | 3.368 | 0.677 | 2.477 | 6.935 | 1.394 |
| Lens thickness [mm] | 28 | 250 | 4.124 | 0.007 | 0.021 | 0.182 | 0.012 | 0.035 | 0.300 |

All statistics are estimated (REML) from two-way random-effect ANOVA model with random effects operator/device, eye and interaction between operator/device and eye.

Reproducibility SD = Square root of the operator/device variance, the interaction variance and the residual variance Repeatability limit = 2.8 × Repeatability CV% = (Repeatability SD)/Intercept × 100%.

Reproducibility limit = 2.8 × Reproducibility CV% = (Reproducibility SD)/Intercept × 100%.

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Image /page/16/Picture/0 description: The image contains the words "HEIDELBERG" on the top line and "ENGINEERING" on the bottom line. There is a red square on the left side of the word "HEIDELBERG" and on the right side of the word "ENGINEERING". The words are in a sans-serif font.

TABLE 7 B-2018-5 REPEATABILITY AND REPRODUCIBILITY OF ANTERION BIOMETRY MEASUREMENTS PRECISION ANALYSIS POPULATION OF EYES WITHOUT A CRYSTALLINE LENS

| | # of | # of | | Repeatability | | | Reproducibility | | |
|--------------------------------|----------|-------|-----------|---------------|-------|-------|-----------------|-------|-------|
| Parameter | Subjects | Scans | Intercept | SD | Limit | CV% | SD | Limit | CV% |
| Cataract App: Biometry | | | | | | | | | |
| Central corneal thickness [um] | 39 | 345 | 539.041 | 0.800 | 2.241 | 0.148 | 3.420 | 9.576 | 0.634 |
| Thinnest point thickness [um] | 39 | 345 | 533.188 | 0.753 | 2.110 | 0.141 | 3.015 | 8.443 | 0.566 |
| Lens thickness [mm] | 39 | 345 | 24.175 | 0.007 | 0.018 | 0.027 | 0.027 | 0.075 | 0.111 |
| Metrics App: Biometry | | | | | | | | | |
| Central corneal thickness [um] | 40 | 358 | 540.115 | 1.202 | 3.365 | 0.223 | 3.413 | 9.555 | 0.632 |

All statistics are estimated (REML) from two-way random-effect ANOVA model with random effects operator/device, eye and interaction between operator/device and eye.

Reproducibility SD = Square root of the operator/device variance, the interaction variance and the residual variance Repeatability limit = 2.8 × Repeatability CV% = (Repeatability SD)/Intercept x 100%.

Reproducibility limit = 2.8 × Reproducibility SD. Reproducibility CV% = (Reproducibility SD)/Intercept × 100%.

## CONCLUSION

ANTERION (with software version 1.2.4) has the same intended use as the legally marketed predicate device identified in this 510(k) notification. The Indications for Use (IFU) statement differs from those of the predicate device, but these differences do not change the intended use of the device. The technological characteristics of the ANTERION V1.2.4 differ from those of the predicate device, however, the differences do not raise new or different questions of safety or effectiveness. Results of the non-clinical performance testing demonstrate that the ANTERION V1.2.4 functions as intended. Results of the clinical performance testing demonstrate a favorable clinical performance profile that supports a determination of substantial equivalence. The non-clinical and clinical performance testing demonstrate that the device is as safe, as effective, and performs as well or better than the legally marketed predicate.