ARGOS

K150754 · Santec Corporation · MXK · Oct 2, 2015 · Ophthalmic

Device Facts

• Record ID: K150754
• Device Name: ARGOS
• Applicant: Santec Corporation
• Product Code: MXK · Ophthalmic
• Decision Date: Oct 2, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1850
• Device Class: Class 2

Intended Use

ARGOS is a non-invasive, non-contact biometer based on swept-source optical coherence tomography (SS-OCT). The device is intended to acquire ocular measurements as well as perform calculations to determine the appropriate intraocular lens (IOL) power and type for implantation during intraccular lens placement. ARGOS measures the following 9 parameters: Axial Length, Corneal Thickness, Anterior Chamber Depth, Lens Thickness, K-values (Radii of flattest and steepest meridians), Astigmatism, White (corneal diameter) and Pupil Size. It is intended for use by ophthalmologists, physicians, and other eye-care professionals and may only be used under the supervision of a physician.

Device Story

ARGOS is a non-invasive, non-contact swept-source optical coherence tomography (SS-OCT) biometer used by eye-care professionals in clinical settings. It captures 3 OCT B-scans and 3 CMOS camera images of the eye in seconds. The device segments the cornea, iris, lens, and retina from OCT images and uses infrared LED ring reflections for keratometry. It calculates 9 ocular parameters: axial length, corneal thickness, anterior chamber depth, lens thickness, K-values, astigmatism, white-to-white diameter, and pupil size. These measurements are used with standard IOL formulas (Hoffer Q, Haigis, Holladay1, SRK/T) to assist physicians in selecting the appropriate IOL power and type for cataract surgery. The system includes an Enhanced Retinal Visualization (ERV) mode for improved imaging of cataractous eyes. Output is displayed on a PC-connected monitor, allowing manual adjustment of parameters by the operator. The device benefits patients by reducing procedure time and discomfort while providing accurate biometric data for surgical planning.

Clinical Evidence

Clinical evidence includes a prospective agreement study (N=115 eyes) comparing ARGOS to the Lenstar LS900, and a precision study (N=43 healthy eyes). Agreement study results showed high correlation (Spearman r=0.48-1.00) and statistically insignificant differences across parameters. Repeatability and reproducibility were assessed via nested ANOVA; AL repeatability SD was 0.01mm. ERV mode validation in 45 cataractous eyes showed mean difference of 0.03 ± 0.04 mm vs. Lenstar, with Spearman correlation of 1.00.

Technological Characteristics

SS-OCT biometer; 1060nm swept laser source (3kHz rate); 850nm IR-LED for keratometry. Six sub-assemblies: Interferometer/Camera, Illumination, Light source, Electronics, Chinrest, Joystick. Complies with IEC 60601-1 (Class 1 Type B), IEC 60825-1 (Laser Class 1), ISO 15004-2 (Group 2), and ISO 10343. Connectivity via PC-based Windows control program.

Indications for Use

Indicated for patients undergoing cataract surgery requiring ocular biometry and keratometry measurements to determine appropriate intraocular lens (IOL) power and type for implantation.

Regulatory Classification

Identification

An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.

Special Controls

*Classification.* Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, 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

• Lenstar, LS900 (K082891)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 2, 2015

Santec Corporation c/o Changho Chong, Ph.D. Sr. Vice President 5150 El Camino Real, D23 Los Altos, CA 94022

Re: K150754 Trade/Device Name: ARGOS Regulation Number: 21 CFR 886.1850 Regulation Name: AC-Powered Slitlamp Bio-Microscope Regulatory Class: Class II Product Code: MXK Dated: September 2, 2015 Received: September 3, 2015

Dear Dr. Chong:

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 (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. 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.

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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Kesia Y. Alexander -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K150754

Device Name ARGOS

#### Indications for Use (Describe)

ARGOS is a non-invasive, non-contact biometer based on swept-source optical coherence tomography (SS-OCT). The device is intended to acquire ocular measurements as well as perform calculations to determine the appropriate intraocular lens (IOL) power and type for implantation during intraccular lens placement. ARGOS measures the following 9 parameters: Axial Length, Corneal Thickness, Anterior Chamber Depth, Lens Thickness, K-values (Radii of flattest and steepest meridians), Astigmatism, White (corneal diameter) and Pupil Size. It is intended for use by ophthalmologists, physicians, and other eye-care professionals and may only be used under the supervision of a physician."

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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| SANTEC CORPORATION |
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| Title: 510(k) Summary |
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Title: 510(k) Summary

## SUMMARY OF 510(K) SAFETY AND EFFECTIVENESS INFORMATION

The information contained in this premarket notification 510(k) summary is submitted as required by 21 CFR 807.92:

### 1. Type of Submission

510k Traditional submission for New Devices

### 2. Applicant Company:

SANTEC CORPORATION, 5823 Ohkusa-Nenjyozaka, Komaki, Aichi 485-0802, JAPAN Phone: [phone] www.santec.com

# 3. Applicant (Contact Person) Name:

Changho Chong

- 4. Date Summary Prepared: Mar. 5, 2015
#### 5. Device Trade / Proprietary Name:

#### ARGOS

- 6. Common Name: Optical Biometer
- 7. Classification Name: Device, Analysis, Anterior Segment

#### 8. Class:

II

- 9. Classification Panel: Ophthalmic Device Panel
- 10. Product Code: MXK - Device, Analysis, Anterior Segment
- 11. Regulation Number: 21CFR 886.1850

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### 12. Device Description:

Argos is a swept-source based biometer that provides the biometry and keratometry of the eye prior to cataract surgery and aids in the selection of the appropriate IOL.

Argos processes 3 OCT images (B-scans) and 3 CMOS camera images per measurement in seconds - reducing procedure time and minimizing patient discomfort. From the OCT images the biometry parameters are evaluated by segmenting the cornea, iris, lens, and retina. The operator can edit the biometry parameters by manual adjustment: Axial length, Corneal thickness, Anterior chamber depth (or aqueous depth), Lens thickness, White-towhite (corneal diameter), Pupil size. The keratometry values: K-values (flattest and steepest meridians), Astigmatism (angle of flattest meridian), are evaluated from the CMOS camera image, in combination with the OCT information.

All distance/thickness parameters (Axial length, Corneal thickness, Anterior chamber depth, Lens thickness, White, Pupil size) are simultaneously measured from 2dimensional OCT images.

All the boundaries of ocular segments are detected and distances and thicknesses are calculated by taking into account the refractive indices of each medium.

Axial length is the distance from the corneal apex to the fovea or, more specifically, to the ILM (Internal Limiting Membrane). The calculation is performed as the sum of the thicknesses (after refraction correction) of the cornea, aqueous humor, lens and vitreous.

Corneal thickness is the distance between the anterior and the posterior apexes of the cornea divided by the cornea refractive index (1.375).

Aqueous depth is evaluated as the distance between the posterior surface of the cornea and the anterior surface of the lens divided by the refractive index (1.336).

Anterior chamber depth is the sum of corneal and aqueous humor distances.

Lens thickness is the distance between the anterior and the posterior surfaces of the lens divided by its refractive index (1.410).

Pupil size is the lateral distance between the two inner boundaries of the iris region.

White-to-white (Corneal diameter) is the lateral distance between the inner boundaries of the cornea-sclera interface.

K-values (Radii of flattest and steepest meridians) and Astigmatism are evaluated by the size and distance of the reflected images of the infrared LED ring projected onto the cornea.

Safety protocol is well integrated into the device in both hardware and software to ensure the safety of both the patient and the operator.

The control program on the computer runs on Windows. The operation panel on the display attached to the PC provides all the functionalities.

IOL calculation uses widely recognized formulas; Hoffer Q, Haigis, Holladay1, SRK/T, etc.

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#### Device Design:

ARGOS construction is divided as six sub-assemblies, which are:

- 1. Interferometer/Camera Assembly
- 2. Illumination Assembly
- 3. Light source(Biometry) Assembly
- 4. Electronics Assembly
- 5. Chinrest Assembly
- 6. Joystick Assembly

### 13. Indication for Use:

ARGOS is a non-invasive, non-contact biometer based on swept-source optical coherence tomography (SS-OCT). The device is intended to acquire ocular measurements as well as perform calculations to determine the appropriate intraocular lens (IOL) power and type for implantation during intraocular lens placement. ARGOS measures the following 9 parameters: Axial Length, Corneal Thickness, Anterior Chamber Depth, Lens Thickness, Kvalues (Radii of flattest and steepest meridians), Astigmatism, White-to-white (corneal diameter) and Pupil Size. It is intended for use by ophthalmologists, physicians, and other eye-care professionals and may only be used under the supervision of a physician.

### 14. Identification of a Legally Marketed Predicate Device:

The following shows the substantially equivalent predicate devices to our submitted new devices

- I. Company: Haag-Streit AG Model: Lenstar, LS900 510(K) No.: K082891 Classification: MXK - Device, Analysis, Anterior Segment Establish Registration number: 1000176188
#### 15. Guidance on the Recognition and Use of Consensus Standards:

ARGOS complies with the requirements of listed FDA Recognized Consensus Standards.

| Compliant standard | Description | Classification |
|--------------------|----------------------------------------------------|---------------------|
| IEC 60601-1 | Electrical safety | Class 1 Type B |
| IEC 60601-1-2 | Electrical safety | Refer to Appendix 5 |
| IEC 60529 | Housing protection | IP20 |
| ISO 15004-2 | Light hazard protection for ophthalmic instruments | Group 2 |
| IEC 62471 | LED light hazard | Exempt group |
| IEC 60825-1 | Laser product safety | Laser Class 1 |
| ISO 10343 | Ophthalmometer | |
| FDA | | Class 2 |

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| Title: 510(k) Summary | | | | | |

### 16. Substantial equivalence to the predicate device

Comparisons of technological characteristics of the ARGOS with Predicate Devices were performed and found to be substantially equivalent.

# Table of comparison between the ARGOS and the predicate device

| | New Device | Predicate Device |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | santec corporation | Haag-Streit |
| Model | ARGOS | Lenstar LS900 |
| 510(k) number | ARGOS | K082891 |
| Class | II | II |
| Classification panel | Ophthalmic device panel | Ophthalmic device panel |
| Product code | MXK | MXK |
| Classification<br>number | Device, Analysis, Anterior Segment | Device, Analysis, Anterior Segment |
| Type | Optical biometer | Optical biometer |
| Intended Use | ARGOS is a non-invasive, non-contact<br>biometer based on swept-source optical<br>coherence tomography (SS-OCT). The<br>intended use is to measure the biometry<br>and keratometry of the eye to calculate<br>intra-ocular lens (IOL) power using well-<br>established formulas and to determine<br>the appropriate type of IOL prior to<br>cataract surgery (i.e. implantation of IOL<br>after removal of crystalline lens with<br>cataract). | The LENSTAR LS900 is a non-<br>invasive, non-contact OLCR (Optical<br>Low-Coherence Reflectometry)<br>Biometer used for obtaining ocular<br>measurements and performing<br>calculations to assist in the<br>determination of the appropriate<br>power and type of IOL (intraocular<br>lens) for implantation after removal<br>of the natural crystalline lens<br>following cataract removal. |
| Measured<br>parameters | Axial Length, Corneal Thickness,<br>Anterior Chamber Depth, Lens<br>Thickness, K-values (Radii of flattest and<br>steepest meridians), Astigmatism ,<br>White-to-white (corneal diameter), and<br>Pupil Size. | Axial Length, Corneal Thickness,<br>Anterior Chamber Depth, Lens<br>Thickness, K-values (Radii of flattest<br>and steepest meridians),<br>Astigmatism, White-to-white<br>(corneal diameter), and Pupil Size. |
| In-vivo repeatability | Axial length: range 15-30mm, SD<br>0.01mm | Axial length: range 14-32mm, SD<br>0.035mm |
| | Corneal thickness: range 300-800um, SD<br>10 μm | Corneal thickness: range 300-<br>800um, SD 2.3um |
| | Anterior Chamber Depth: range 1.5-<br>5.5mm SD 0.01mm | Anterior Chamber Depth: range 1.5-<br>5.5mm SD 0.04mm |
| | Lens Thickness: range 0.5-6.5mm SD<br>0.02mm | Lens Thickness: range 0.5-6.5mm<br>SD 0.08mm |
| | Keratometry: range 5-10.5mm SD<br>0.02mm | Keratometry: range 5-10.5mm SD<br>0.03mm |
| | Astigmatism: range 0-180deg, SD 4deg<br>(Cylinder<1D) | Astigmatism: range 0-180deg, SD<br>11deg |
| | Pupil size: range 2-13mm SD 0.09mm | Pupil size: range 2-13mm SD not<br>specified |
| | White-to-White: range 7-15mm SD<br>0.06mm | White-to-White: range 7-16mm SD<br>0.04mm |

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Title: 510(k) Summary

| Method for biometry | Interferometry (SS-OCT) | Interferometery (OLCR) |
|---------------------------|----------------------------------------------------------------------|-------------------------------------------------------------------|
| Method for<br>keratometry | Video keratometry (16 LED) | Video keratometry (32 LED) |
| Optical radiation | | |
| Type of light source | Wavelength swept laser (3kHz swept<br>rate) | Light source: Superluminescent<br>Diode (CW) |
| | Wavelength 1060nm | Wavelength 820nm |
| | Power <0.72mW (<0.1mW average at<br>1mm aperture during B-scan) | Power <0.6mW |
| | | |
| Laser class | Class 1 (IEC 60825)<br>ISO15004-2 Group2 | Class 1 (IEC 60825)<br>ISO15004-2 Group2 |
| Keratometry | Light source: IR-LED<br>Wavelength: 850nm delivered power<br><0.02mW | Light source: IR-LED<br>Wavelength: 950nm |
| Illumination | The above (IR-LED) | Green LED |
| Fixation light | Green LED (530nm) delivered power<br><10nW | The same as for A-scan |
| | | |
| Compliant standards | ISO60601-1, ISO15004-2, ISO62471,<br>ISO60825, ISO 10343, IP20 | ISO60601-1, ISO15004-2,<br>ISO62471, ISO60825, ISO 10343,<br>IP20 |
| Power supply | Input: 100-240V, 50/60Hz IEC60601<br>compliant Secondary side: 24V | Input: 100-240V, 50/60Hz EN60601<br>compliant Secondary side: 12V |

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#### 17. Performance Testing

#### 17.1 Bench Test

Performance of the ARGOS was evaluated by bench tests based on the relevant standards (ISO15004-1, 2, IEC 60825, ISO 10343) as well as side-by-side comparison tests at the clinic with the predicated device.

Both ISO 15004-1 and ISO 15004-2, and IEC60825 tests prove the fundamental requirements for ophthalmic instruments and optical radiation safety of ARGOS are equivalent to predicate device. ISO 10343 tests results provided the required accuracy performance for ophthalmometer which measures corneal radii of curvature and angle of meridian with a certain cylinder (toroidal surface).

Hardware specifications were validated for axial/lateral distance measurement accuracy and range, signal-to-noise ratio, and depth attenuation, to prove that ARGOS meets the hardware performance requirements.

#### 17.2 Clinical Tests

A prospective clinical study was conducted at a single U.S, clinical site for assessing the agreement of Argos to predicate device Lenstar LS900. A precision study on healthy eyes was also conducted to calculate the repeatability and reproducibility of Argos. Finally, a validation study was conducted to evaluate the agreement for the Enhanced Retinal Visualization of Argos with respect to the Lenstar LS900.

#### 17.2.1 Agreement Study

Table 17.2.1 shows the Mean, Standard Deviation (SD) every biometric and keratometric parameter for all eyes that could be measured by the instruments. The biometric parameters are: Axial Length (AL), Corneal Thickness (CCT), Aqueous Depth (AD), Anterior Chamber Depth (ACD), Lens Thickness (LT), Pupil Size* (PS), Corneal Diameter** (CD) (Argos uses the definition proposed by Pavlin et al 1992).The keratometry parameters are: Flattest radius of curvature (R1), Steepest radius of curvature (R2), Average Radius of curvature (Rav) and Astigmatism angle (AST) distinguishing between cylinders below and over 1 Diopter (D). The average differences in measurement between the biometers, the SD, the Spearman rank correlation coefficient t. the Bland-Altman means, SDs. and LoA, the Deming regression analysis intercepts, slopes, and 95% CI.

*The differences in the PS measurement between the Argos and Lenstar are attributed to a lack of annient light control during the agreement study.

^** Accuracy of this finction has not been well confirmed due to the different measurement principle. Argos uses the definition proposed by Pavin CJ, Harasiewicz K, Foster FS. Utrasound biomicroscopy of anterior sin normal and glaucomatous eyes. Am J Ophthaimol.1992; 113:381–389.

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Table 17.2.1: Summary of the comparison performed for the 2 systems: Lenstar and Argos with and without the exclusion of outliers. AV the average of the results, SD the standard deviation, the Spearman correlation coefficient, the average of the differences, the standard deviation of the difference, limits of agreement, and the Deming regression analysis intercepts, slopes, and 95% confidence interval.

| | All Data | | | | | | | |
|---------|---------------------------------------------------------------------------------------------------------------------------------------------------|------|----------|--------------------|----------------------------|--------------|-------------------|---------------------|
| | | | | | | Bland-Altman | Deming | |
| | | | | | | Spear | Mean (SD) | Intercept [95% Ci] |
| | Parameter Units | | Biometer | N | Mean (SD) | man | [LoA] | Slope [95% CI] |
| | AL | | Lenstar | | 23.43 (1.01) (1.00) | 1.00 | 0.00(0.05) | -0.68 [-0.93,-0.43] |
| | | [mm] | Argos | 100 | 23.44 (0.98) (0.00) | | [-0.10,0.09] | 1.03 [1.02,1.04] |
| | ССТ | | Lenstar | | 0.53 (0.04) (0.98) | 0.97 | 0.00(0.01) | -0.02 [-0.05,0.01] |
| | | [mm] | Argos | 115 | 0.53 (0.03) (0.00) | | [-0.02,0.02] | 1.04 [0.99,1.10] |
| | | | Lenstar | | 2.66 (0.41) (0.95) | | 0.05(0.16) | -0.10 [-0.29,0.09] |
| | AD | [mm] | Argos | 115 | 2.63 (0.39) (0.00) | 0.89 | [-0.27,0.37] | 1.06 [0.98,1.13] |
| ometr | | | Lenstar | | 3.19 (0.42) (0.95) | | 0.05(0.17) | -0.17 [-0.39,0.06] |
| | ACD | [mm] | Argos | 115 | 3.16 (0.39) (0.00) | 0.89 | [-0.28,0.37] | 1.07 [1.00,1.14] |
| | LT | | Lenstar | 111 | 4.46 (0.45) (0.89) | 0.87 | -0.18(0.22) | -0.58 [-1.10,-0.05] |
| | | [mm] | Argos | | 4.62 (0.41) (0.00) | | [-0.61,0.24] | 1.09 [0.97,1.20] |
| | ારડ<br>[mm] | | Lenstar | 4.10 (0.77) (0.89) | 0.88 | -0.26(0.46) | 0.55 [-0.02,1.11] | |
| | | | Argos | 108 | 4.38 (0.91) (0.00) | | [-1.16,0.64] | 0.81 [0.68,0.95] |
| | CD<br>[mm] | | Lenstar | | 11.86 (0.49) (0.50) | 0.48 | -0.28(0.69) | 4.91 [1.79,8.04] |
| | | | Argos | 115 | 12.11 (0.68) (0.00) | | [-1.62,1.06] | 0.57 [0.31,0.83] |
| | R1 | [mm] | Lenstar | 115 | 7.79 (0.30) (0.98) | 0.97 | -0.01(0.07) | -0.09 [-0.45,0.26] |
| | | | Argos | | 7.80 (0.29) (0.00) | | [-0.15,0.13] | 1.01 [0.96,1.06] |
| | R2<br>[mm] | | Lenstar | | 7.61 (0.27) (0.98) | | 0.00(0.07) | 0.22 [-0.05,0.48] |
| | | | Argos | 115 | 0.96<br>7.61 (0.28) (0.00) | [-0.14,0.14] | 0.97 [0.94,1.01] | |
| | Rav<br>[mm] | | Lenstar | 115 | 7.70 (0.28) (0.99) | 0.97 | -0.01(0.06) | 0.06 [-0.17,0.30] |
| ratomet | | | Argos | | 7.70 (0.28) (0.00) | | [-0.12,0.11] | 0.99 [0.96,1.02] |
| | AST | | Lenstar | 77 | 94.07 (45.94) (0.91) | 0.56 | 8.29(48.04) | -1.27 [-24.26,21.71 |
| | (Cyl. <id)< td=""><td>[°]</td><td>Argos</td><td></td><td>87.89 (46.85) (0.00)</td><td></td><td>-85.87,102.45</td><td>1.11 [0.90,1.33]</td></id)<> | [°] | Argos | | 87.89 (46.85) (0.00) | | -85.87,102.45 | 1.11 [0.90,1.33] |
| | AST | | Lenstar | 36 | 81.44 (46.96) (0.97) | | 4.36(9.71) | 0.07 [-6.02,6.15] |
| | (Cyl.>1D) | [0] | Argos | | 78.40 (46.34) (0.00) | 0.97 | [-14.67,23.39] | 1.05 [0.96,1.15] |

#### 17.2.2 Precision Study

Repeatability study was performed for every healthy eye (43) analyzed for same machine, same operator and 3 acquisitions after realignment. The measurements were analyzed in terms of precision in a fully nested variance analysis as per ISO 5725. The overall mean, repeatability are presented in Table 17.2.2, together with the CV. The Reproducibility study was performed in a fully-nested (5725 ISO standard) variance analysis using 3 measurements for every operator and machine. A total number of 43 eyes were analyzed. The overall mean, reproducibility is presented in Table 17.2.2 with the CV.

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| | | Repeatability | | Reproducibility | |
|------|-------------------------|---------------|-------|-----------------|-------|
| | Overall<br>mean<br>(mm) | SD(mm) | CV(%) | SD(mm) | CV(%) |
| AL | 25.20 | 0.01 | 0.02 | 0.02 | 0.09 |
| CCT | 0.53 | 0.00 | 0.89 | 0.01 | 1.19 |
| AD | 2.93 | 0.01 | 0.37 | 0.03 | 0.90 |
| ACD | 3.46 | 0.01 | 0.27 | 0.03 | 0.77 |
| LT | 4.16 | 0.02 | 0.38 | 0.06 | 1.45 |
| PS | 4.95 | 0.09 | 1.83 | 1.01 | 20.31 |
| CD | 13.07 | 0.06 | 0.46 | 0.10 | 0.77 |
| R1 | 8.00 | 0.01 | 0.14 | 0.03 | 0.34 |
| R2 | 7.77 | 0.02 | 0.21 | 0.04 | 0.48 |
| Rav | 7.88 | 0.01 | 0.13 | 0.03 | 0.35 |
| AST* | 78.54 | 4.39 | 5.59 | 11.13 | 14.17 |

Table 17.2.2: Summary of the repeatability value for 3 measurements performed by the same machine and operator. Summary of the reproducibility value for 3 measurements per 3 machines and 3 operators. *AST - All the reproducibility parameters are in mm, except the Astigmatism that it is in degrees.

#### 17.2.3 Enhanced Retinal Visualization (ERV) mode Validation Study

A comparison was performed with ERV and Lenstar for cataractous 45 eyes (23 right eyes). Table 17,2,3 summarizes the comparison made between both biometers, Argos ERV mode, and Lenstar. For the comparison between Lenstar-Argos there was a difference of 0.03 ± 0.04 mm and the LoA were from -0.06 mm to 0.12 mm. The Spearman rank correlation coefficient was 1.00 for all 3 comparisons. Statistically insignificant differences were found when performing a pairwise t-test with a confidence interval of 95%. The p-values for the comparison Lenstar-ERV was below 0.05. In terms of a Bland-Altman plot, the mean difference (MD) is -0.01, while the limits of agreement (LoA) are placed at -0.07 mm and 0.05 mm. The Deming regression analysis shows an intercept of -0.70 with 95% CI of [-0.93. -0.46] and a slope of 1.03 with 95% CI of [1.02, 1.04].

Table 17.2.3: Summary of the comparison performed for the systems: Lenstar, and ERV. AV the average of the results, SD the standard deviation, the Spearman correlation coefficient, the average of the differences, the standard deviation of the difference and the Limits of agreement.

| Devices | AV<br>[mm] | SD [mm] | Spearman<br>Rank<br>Correlation<br>Coefficient<br>(rs) | AV Difference<br>[mm] | SD of AV<br>Difference [mm] | Limits of<br>Agreement [mm] |
|---------|------------|---------|--------------------------------------------------------|-----------------------|-----------------------------|-----------------------------|
| Lenstar | 23.46 | 1.08 | 1.00 | 0.03 | 0.04 | -0.06 , 0.12 |

To characterize the ERV technique in Axial Length (AL), a repeatability study was performed by means of 3 repeated acquisitions in 43 consecutive healthy eyes. The Repeatability and Coefficient of Variation were calculated from 3 consecutives measurements with realignment by one operator and one machine and analyzed as a fully-

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| Section : 13 | Rev. 5 | | Oct.2, 2015 | | Page 9/9 |
| Title: 510(k) Summary | | | | | |

nested ANOVA study as described in ISO 5725. The overall mean was 25.20mm with a Repeatability was 0.01 mm and a coefficient of variation (CV) was 0.06 % for ERV (Table 17.2.4).

Table 17.2.4: Summary of the performed repeatability for ERV mode of ARGOS. It presents the Standard Deviation and Coefficient of Variation.

| Repeatability | | | |
|---------------|----------------------|---------|-------|
| | Overall mean<br>(mm) | SD (mm) | CV(%) |
| AL | 25.20 | 0.01 | 0.06 |

17.3 Conclusion drawn from Performance Testing

The summary of bench tests and side-by-side performance comparison with predicate devices showed that the ARGOS is substantially equivalent to the predicate devices for measuring 9 biometry and keratometry parameters as well as IOL power calculation formulas. Optical power of the light beam entering into patient's eye is the same or even lower than level of predicate devices. The detail hazard analysis was certified by a recognized expert in the field of optical radiation hazards and safety analysis of medical instruments, Dr. David Sliney (Reference: 042) Appendix 8 ISO 15004-2 Test Report, 043 Appendix 9 Optical Radiation Safety Evaluation letter). Information was submitted to demonstrate that there are no significant differences in technological characteristics between the ARGOS and the predicate devices.

#### 18. Conclusion:

In accordance with the Federal Food. Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this Premarket Notification, santec corporation concludes that the ARGOS is safe and effective, and substantially equivalent to predicate devices as described herein.

END OF SUMMARY