Pentacam AXL

K152311 · Oculus Optikgerate GmbH · MXK · Jan 20, 2016 · Ophthalmic

Device Facts

• Record ID: K152311
• Device Name: Pentacam AXL
• Applicant: Oculus Optikgerate GmbH
• Product Code: MXK · Ophthalmic
• Decision Date: Jan 20, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1850
• Device Class: Class 2

Intended Use

The Pentacam® is designed to take photos of the anterior segment of the cornea, pupil, anterior chamber and lens of the eye. To evaluate: - · corneal shape, - · analyze condition of the lens (opaque crystalline lens), - · analyze the anterior chamber angle, - · analyze anterior chamber depth, - · analyze the volume of the anterior chamber, - · analyze anterior or posterior cortical opacity. - · analyze the location of cataracts (nuclear, sub capsular and or cortical), using cross slit imaging with densitometry, - · corneal thickness, - · axial length, - · white-to-white distance. The Pentacam® AXL also performs calculations to assist physicians in determining the power of the intractular lens for implantation.

Device Story

Pentacam AXL captures Scheimpflug images of anterior eye segment via rotating camera; measures axial length via interferometry. Device generates 3D mathematical model of anterior segment, corrected for eye movement. Used in clinical settings by physicians/technicians to evaluate corneal shape, lens opacity, anterior chamber metrics, and white-to-white distance. Output includes diagnostic images, densitometry data, and IOL power calculations. Assists physicians in surgical planning for cataract procedures; provides objective measurements to guide IOL selection.

Clinical Evidence

Clinical agreement studies compared Pentacam AXL against IOL Master 500 (N=80) and Pentacam (N=138). Parameters included axial length, corneal curvature, anterior chamber depth, and white-to-white distance. Results showed high agreement across four populations: normal eyes, cataracts, abnormal corneal shape, and pseudophakic eyes. Precision testing (N=40) demonstrated high repeatability and reproducibility with CVs <1% for most parameters (axial length, CCT, ACD, radii) and <10% for corneal cylinder/axis.

Technological Characteristics

Rotating Scheimpflug camera system; interferometry for axial length measurement. Connectivity to external PC for image processing and analysis. 3D mathematical modeling of anterior segment. No specific material standards cited. Software-based analysis of Scheimpflug images for densitometry and geometric measurements.

Indications for Use

Indicated for patients requiring anterior segment evaluation, including corneal shape, lens condition (cataracts), anterior chamber parameters, corneal thickness, axial length, and white-to-white distance, to assist in intraocular lens power calculation for cataract surgery.

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

• Carl Zeiss Meditec AG, IOLMASTER 500 (K122418)
• OCULUS Optikgeräte GmbH, Pentacam Scheimpflug Camera (K030719)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a central emblem. The emblem consists of a stylized representation of three human profiles facing to the right, stacked one behind the other, with flowing lines beneath them.

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

January 20, 2016

Oculus Optikgerate Gmbh % Mr. Randy Prebula Partner Hogan Lovells US LLP 555 Thirteenth Street NW Washington, DC 20016

Re: K152311

Trade/Device Name: Pentacam AXL Regulation Number: 21 CFR 886.1850 Regulation Name: AC-Powered Slitlamp Biomicroscope Regulatory Class: Class II Product Code: MXK, HJO Dated: December 21, 2015 Received: December 21, 2015

Dear Mr. Prebula:

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.

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

{1}------------------------------------------------

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" (21 CFR 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 -A

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

Enclosure

{2}------------------------------------------------

#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page

510(k) Number (if known)

Device Name

Pentacam® AXL Indications for Use (Describe)

The Pentacam® is designed to take photos of the anterior segment of the cornea, pupil, anterior chamber and lens of the eye. To evaluate:

- · corneal shape,
- · analyze condition of the lens (opaque crystalline lens),
- · analyze the anterior chamber angle,
- · analyze anterior chamber depth,
- · analyze the volume of the anterior chamber,
- · analyze anterior or posterior cortical opacity.
- · analyze the location of cataracts (nuclear, sub capsular and or cortical), using cross slit imaging with densitometry,
- · corneal thickness,
- · axial length,
- · white-to-white distance.

The Pentacam® AXL also performs calculations to assist physicians in determining the power of the intractular lens for implantation.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/2 description: The image is the logo for Oculus. The logo is a stylized eye inside of a star. The word "OCULUS" is written in block letters below the star.

# 510(k) SUMMARY

# OCULUS Pentacam® AXL

# General Information

# Applicant:

OCULUS Optikgeräte GmbH Müncholzhäuserstr. 29 35582 Wetzlar Germany Phone: [phone] Fax [phone]

# Contact Person:

Mr. Eckhard Loh Head of Quality and Regulatory Affairs OCULUS Optikgeräte GmbH Müncholzhäuserstr. 29 35582 Wetzlar Germany Phone: [phone] Fax [phone] Summary Prepared: December 18, 2015

# Device Information

Classification Name:

Trade/Propriety Name: Regulation Number: Device class: Product Code:

Device, analysis, anterior segment (AC-powered slitlamp biomicroscope) Pentacam® AXL 886.1850 ll MXK. HJO

# Predicate Devices

Carl Zeiss Meditec AG, IOLMASTER 500 (K122418) OCULUS Optikgeräte GmbH, Pentacam Scheimpflug Camera (K030719)

{4}------------------------------------------------

Image /page/4/Picture/23 description: The image is a logo for Oculus. The logo is a stylized eye inside of a star shape. The word "OCULUS" is written below the eye. The logo is blue and white.

# Intended Use / Indications for Use

The intended use of the Pentacam® AXL is defined as:

The Pentacam® is designed to take photos of the anterior segment of the eye which includes the cornea, pupil, anterior chamber and lens of the eye. To evaluate:

- · corneal shape,
- · analyze condition of the lens (opaque crystalline lens),
- · analyze the anterior chamber angle,
- · analyze anterior chamber depth,
- · analyze the volume of the anterior chamber,
- · analyze anterior or posterior cortical opacity,
- · analyze the location of cataracts (nuclear, sub capsular and or cortical), using cross slit imaging with densitometry,
- · corneal thickness,
- · axial length,
- · white-to-white distance.

The Pentacam® AXL also performs calculations to assist physicians in determining the power of the intraocular lens for implantation.

# Product Description/Technological Characteristics

The Pentacam AXL is designed to take photos of the anterior segment of the eye to measures eye components such as Axial length, Corneal thickness, Anterior chamber depth, Corneal curvature, Corneal cylinder, Corneal cylinder axis and White-to-white-distance. The measured parameters can be used by physicians to calculate the power of the intraocular lens (IOL) implanted during a cataract surgery.

While rotating around the eye. the Pentacam® AXL captures Scheimpflug images of the anterior eye segment through varying axes. The Scheimpflug images created during an examination are transmitted to the connected PC. The axial length of the eye is measured by interferometry.

Scheimpflug images can be captured within maximum two seconds. Up to 138,000 genuine height values are measured and analyzed from the Scheimpflug images.

The Scheimpflug images are the basis for the height data which are used to calculate a mathematical 3D model of the anterior eye segment.

The mathematical 3D model, corrected for eye movements, provides the basis for all subsequent analysis.

{5}------------------------------------------------

Image /page/5/Picture/2 description: The image is a logo for Oculus. The logo is a stylized eye inside of a star shape. The word "OCULUS" is written below the star.

# Summary of clinical results

# Comparison Pentacam AXL with IOL Master

A clinical study was performed to compare the parameters axial length (AL), corneal curvature flat meridian (Rf), corneal curvature steep meridian (Rs), corneal cylinder (Astig), corneal cylinder axis (Axis flat), anterior chamber depth (ACD), White-to-White-distance (WTW) measured by the Pentacam AXL with those obtained by the IOL Master 500 (K122418; Carl Zeiss Meditec AG, Jena, Germany) as predicate device

Eighty (80) subject eyes were assessed in the first Agreement study, 20 eyes in each of the four eye populations.

The four eye populations consisted of:

- 1. Normal eyes (phakic eyes without cataracts or corneal disease);
- 2. Eyes with cataracts; 3. Eyes with abnormal corneal shape (including eyes postkeratorefractive surgery), and
- 4. Eyes without a natural lens (including aphakic and pseudophakic eyes);

{6}------------------------------------------------

# 510(k) Summary

Pentacam® AXL

| | ปี – ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑ ๑<br>oculus |
|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | |

# Eye Population total

Eighty eyes were assessed in the agreement portion of the study with IOL Master 500 as predicated device. Mean age was 49.2 ± 16.6 years (minimum age was 17, maximum 79 years).

Table 1 shows the descriptive statistics for all parameters, the mean differences ± SD, the confidence intervals for the mean differences and the Limit of Agreement for the differences.

| Measure | Pentacam<br>AXL (Mean ± SD) | IOL Master<br>(Mean ± SD) | Difference<br>(Mean ± SD) | 95% CI for<br>Mean<br>Difference | 95% LoA for<br>Difference |
|---------------------------------------|-----------------------------|---------------------------|---------------------------|----------------------------------|---------------------------|
| Axial Length<br>[mm] | N=80<br>24.23 ± 1.73 | N=80<br>24.23 ± 1.71 | -0.003 ± 0.058 | [-0.016; 0.010] | (-0.116; 0.110) |
| Radius Flat<br>Meridian<br>[mm] | N=76<br>7.86 ± 0.35 | N=79<br>7.82 ± 0.38 | 0.024 ± 0.044 | [0.014; 0.034] | (-0.063; 0.111) |
| Radius Steep<br>Meridian<br>[mm] | N=76<br>7.58 ± 0.37 | N=79<br>7.51 ± 0.44 | 0.037 ± 0.058 | [0.024; 0.051] | (-0.077; 0.152) |
| Mean Radius<br>(Rm)<br>[mm] | N=76<br>7.72 ± 0.34 | N=79<br>7.67 ± 0.39 | 0.030 ± 0.038 | [0.022; 0.040] | (-0.045; 0.106) |
| Corneal<br>Cylinder [D] | N=76<br>1.6 ± 1.4 | N=79<br>1.8 ± 1.7 | -0.10 ± 0.45 | [-0.20; 0.01] | (-0.99; 0.79) |
| Corneal<br>Cylinder Axis<br>[°] | N=76<br>102.0 ± 71.8 | N=79<br>97.6 ± 69.6 | 3,6 ± 13.6 | [0.4; 6.7] | (-23.0; 30.2) |
| Anterior<br>Chamber<br>Depth [mm] | N=60<br>3.53 ± 0.36 | N=60<br>3.48 ± 0.36 | 0.05 ± 0.10 | [-0.03; 0.08] | (-0.14; 0.24) |
| White-to<br>White<br>Distance<br>[mm] | N=68<br>11.69 ± 0.38 | N=73<br>11.95 ± 0.43 | -0.26 ± 0.16 | [-0.30; -0.22] | (-0.57; 0.04) |

{7}------------------------------------------------

Image /page/7/Picture/2 description: The image is a logo for Oculus. The logo features a stylized eye inside of a star shape. The word "OCULUS" is written in a sans-serif font below the eye.

# Eye Population Normal

Among the 80 eyes were 20 eyes of healthy patients without any known corneal pathology and without cataract. Mean age was 42.6 ± 14 years.

Table 2 shows the descriptive statistics for all parameters, the mean differences ± SD, the confidence interval for the mean differences and the Limit of Agreement for all parameters of the 20 normal eyes.

| Measure | Pentacam<br>AXL (Mean ± SD) | IOL Master<br>(Mean ± SD) | Difference<br>(Mean ± SD) | 95% CI for<br>Mean<br>Difference | 95% LoA for<br>Difference |
|---------------------------------------|-----------------------------|---------------------------|---------------------------|----------------------------------|---------------------------|
| Axial Lenght<br>[mm] | N=20<br>24.22 ± 1.06 | N=20<br>24.24 ± 1.06 | -0.014 ± 0.057 | [-0.041; 0.012] | -0.126; 0.098 |
| Radius Flat<br>Meridian<br>[mm] | N=19<br>7.85 ± 0.24 | N=20<br>7.86 ± 0.29 | 0.03 ± 0.03 | [0.02; 0.05] | -0.03; 0.09 |
| Radius Steep<br>Meridian<br>[mm] | N=19<br>7.66 ± 0.18 | N=20<br>7.67 ± 0.26 | 0.04 ± 0.04 | [0.02; 0.05] | -0.03; 0.11 |
| Mean Radius<br>[mm] | N=19<br>7.75 ± 0.20 | N=20<br>7.76 ± 0.27 | 0.03 ± 0.02 | [0.02; 0.04] | -0.01; 0.08 |
| Corneal<br>Cylinder [D] | N=19<br>1.03 ± 0.55 | N=20<br>1.05 ± 0.54 | -0.04 ± 0.28 | [-0.18; 0.09] | -0.60; 0.51 |
| Corneal<br>Cylinder Axis<br>[°] | N=19<br>81.7 ± 80.7 | N=20<br>81.7 ± 79.9 | 5.0 ± 21.0 | [-5.1; 15.2] | -36.2; 46.2 |
| Anterior<br>Chamber<br>Depth [mm] | N=20<br>3.57 ± 0.28 | N=20<br>3.51 ± 0.26 | 0.06 ± 0.09 | [0.02; 0.10] | -0.12; 0.24 |
| White-to<br>White<br>Distance<br>[mm] | N=20<br>11.7 ± 0.3 | N=14<br>12.0 ± 0.3 | -0.24 ± 0.23 | [-0.38; -0.11] | -0.70; 0.21 |

{8}------------------------------------------------

Image /page/8/Picture/2 description: The image is divided into three rectangular sections. The first two sections are blank. The third section contains the Oculus logo, which features a stylized star shape with a blue accent and the word "OCULUS" written below it.

# Eye Population Cataract

In this group patients were included with cataract but without any other known ocular pathology. Mean age of the 20 eyes was 57 ± 14 years.

Table 3 shows the descriptive statistics for all parameters, the mean difference ± SD, the confidence interval for the mean differences and the limits of agreement (LoA) for the differences of the 20 eyes with cataract.

| Measure | Pentacam AXL<br>(Mean ± SD) | IOL Master<br>(Mean ± SD) | Difference<br>(Mean ± SD) | 95% CI for<br>Mean Difference | 95% LoA for<br>Difference |
|------------------------------|-----------------------------|---------------------------|---------------------------|-------------------------------|---------------------------|
| Axial Lenght [mm] | N=20<br>24.28 ± 1.24 | N=20<br>24.27 ± 1.25 | 0.014 ± 0.039 | [-0.004; 0.032] | -0.062; 0.091 |
| Radius Flat Meridian [mm] | N=20<br>7.83 ± 0.29 | N=20<br>7.81 ± 0.31 | 0.018 ± 0.048 | [-0.005; 0.040] | -0.076; 0.112 |
| Radius Steep Meridian [mm] | N=20<br>7.68 ± 0.28 | N=20<br>7.65 ± 0.28 | 0.031 ± 0.037 | [0.013; 0.048] | -0.043; 0.104 |
| Mean Radius (Rm) [mm] | N=20<br>7.76 ± 0.28 | N=20<br>7.73 ± 0.29 | 0.024 ± 0.033 | [0.009; 0.040] | -0.041; 0.090 |
| Corneal Cylinder [D] | N=20<br>0.83 ± 0.42 | N=20<br>0.90 ± 0.60 | -0.07 ± 0.28 | [-0.20; 0.06] | -0.62; 0.48 |
| Corneal Cylinder Axis [°] | N=20<br>102.9 ± 68.6 | N=20<br>100.4 ± 67.3 | 2.6 ± 11.0 | [-2.6; 7.8] | -19.1; 24.2 |
| Anterior Chamber Depth [mm] | N=20<br>3.37 ± 0.39 | N=20<br>3.29 ± 0.37 | 0.08 ± 0.13 | [0.02; 0.14] | -0.02; 0.33 |
| White-to White Distance [mm] | N=15<br>11.6 ± 0.4 | N=19<br>11.9 ± 0.5 | -0.26 ± 0.08 | [-0.30; -0.21] | -0.41; -0.11 |

{9}------------------------------------------------

Image /page/9/Picture/2 description: The image is a rectangular box divided into three equal sections. The first two sections are blank. The third section contains the Oculus logo, which is a stylized eye inside of a star shape, with the word "OCULUS" written below it.

# Eye Population abnormal corneal shape

In this group patients were included that had either a corneal pathology or previous refractive surgery (LASIK or PRK). Mean patient age in this subgroup was 39 ± 11 years.

Table 4 shows the descriptive statistics for all parameters, the mean differences ± SD. the confidence interval for the mean differences and the Limit of Agreement (LoA) for the differences of the 20 eyes with cataract.

| Measure | Pentacam AXL (Mean ± SD) | IOL Master (Mean ± SD) | Difference (Mean ± SD) | 95% CI for Mean Difference | 95% LoA for Difference |
|------------------------------|--------------------------|------------------------|------------------------|----------------------------|------------------------|
| Axial Lenght [mm] | N=20<br>24.00 ± 1.15 | N=20<br>23.99 ± 1.13 | 0.016 ± 0.030 | [0.003; 0.030] | -0.042; 0.075 |
| Radius Flat Merdian [mm] | N=17<br>8.02 ± 0.42 | N=20<br>7.89 ± 0.47 | 0.020 ± 0.044 | [-0.002; 0.042] | -0.007; 0.106 |
| Radius Steep Meridian [mm] | N=17<br>7.56 ± 0.52 | N=20<br>7.37 ± 0.64 | 0.051 ± 0.086 | [0.006; 0.095] | -0.118; 0.219 |
| Mean Radius [mm] | N=17<br>7.79 ± 0.44 | N=20<br>7.63 ± 0.53 | 0.035 ± 0.047 | [0.011; 0.060] | -0.129; 0.059 |
| Corneal Cylinder [D] | N=17<br>2.6 ± 1.9 | N=20<br>3.2 ± 2.3 | -0.26 ± 0.69 | [-0.62; 0.10] | -1.62; 1.10 |
| Corneal Cylinder Axis [°] | N=18<br>107.7 ± 71.2 | N=18<br>98.7 ± 67.7 | 5.0 ± 12.4 | [-1.4; 11.3] | -19.4; 29.3 |
| Anterior Chamber Depth [mm] | N=18<br>3.64 ± 0.37 | N=18<br>3.63 ± 0.38 | 0.01 ± 0.05 | [-0.01; 0.04] | -0.09; 0.12 |
| White-to White Distance [mm] | N=18<br>11.9 ± 0.3 | N =20<br>12.1 ± 0.3 | -0.26 ± 0.18 | [-0.35; -0.17] | -0.62; 0.10 |

{10}------------------------------------------------

Image /page/10/Picture/2 description: The image is divided into three sections. The first two sections are blank. The third section contains the Oculus logo, which is a stylized eye inside of a star shape. The word "OCULUS" is written below the logo.

# Eyes without natural lens

In this group eyes without a natural crystalline lens were analyzed. All 20 eyes had cataract surgery before and the crystalline lens was replaced by an intraocular lens (IOL). Mean patient age was 60 ± 15 years.

Table 5 shows the descriptive statistics for all parameters. the mean difference ± SD. the confidence interval for the mean differences and the Limit of Agreement (LoA) for the differences of the 20 eyes with cataract.

| Measure | Pentacam<br>AXL<br>(Mean ± SD) | IOL Master<br>(Mean ± SD) | Difference<br>(Mean ± SD) | 95% CI for<br>Mean<br>Difference | 95% LoA for<br>Difference |
|---------------------------------------|--------------------------------|---------------------------|---------------------------|----------------------------------|---------------------------|
| Axial Length<br>[mm] | N=20<br>24.40 ± 2.88 | N=20<br>24.43 ± 2.84 | -0.027 ± 0.081 | [-0.066; 0.011] | -0.187; 0.132 |
| Radius Flat<br>Meridian<br>[mm] | N=20<br>7.76 ± 0.42 | N=19<br>7.72 ± 0.44 | 0.027 ± 0.054 | [0.001; 0.053] | -0.079; 0.133 |
| Radius Steep<br>Meridian<br>[mm] | N=20<br>7.40 ± 0.38 | N=19<br>7.35 ± 0.37 | 0.033 ± 0.067 | [0.005; 0.065] | -0.098; 0.163 |
| Mean Radius<br>[mm] | N=20<br>7.58 ± 0.37 | N=19<br>7.54 ± 0.39 | 0.030 ± 0.049 | [0.006; 0.054] | -0.066; 0.126 |
| Corneal<br>Cylinder [D] | N=20<br>2.1 ± 1.6 | N=19<br>2.2 ± 1.5 | -0.04 ± 0.47 | [-0.26; 0.19] | -0.95; 0.88 |
| Corneal<br>Cylinder Axis<br>[°] | N=14<br>115.5 ± 67.8 | N=14<br>110.4 ± 64.6 | 1.9 ± 6.6 | [-1.3; 5.1] | -11.1; 14.9 |
| Anterior<br>Chamber<br>Depth [mm] | - | N=19<br>4.3 ± 0.61 | - | - | - |
| White-to<br>White<br>Distance<br>[mm] | N=15<br>11.5 ± 0.5 | N=20<br>11.8 ± 0.5 | -0.29 ± 0.08 | [-0.33; -0.24] | -0.45; -0.12 |

The Pentacam® AXL demonstrated agreement to the IOL Master 500 (K122418; Carl Zeiss Meditec AG, Jena, Germany) for the assessment of axial length (AL), corneal curvature flat meridian (Rf), corneal curvature steep meridian (Rs), corneal cylinder (Astig), corneal cylinder axis (Axis flat), anterior chamber depth (ACD) and White-to-White-distance (WTW) parameters in normal eyes, eyes with cataracts, eyes with Abnormal corneal shape and eyes without natural lens.

{11}------------------------------------------------

Image /page/11/Picture/2 description: The image contains a logo for Oculus. The logo is a stylized eye inside of a geometric shape that resembles a star. The word "OCULUS" is written below the shape.

# Agreement between Pentacam AXL and Pentacam

In a second agreement study between the Pentacam® AXL and Pentacam® (K030719, OCULUS Optikgeräte GmbH, Wetzlar, Germany) as predicated device was tested. Both devices are using an automatic rotating Scheimpflug camera in order to derive a three dimensional model of the anterior segment. Based on this model all parameters that describe corneal shape such as mean radius of curvature or corneal thickness are calculated. The anterior chamber depth is also calculated based on the rotating Scheimpfluq camera. As both devices are using the same measuring technique a high agreement between the two devices can be expected.

For this study 138 eyes of 138 patients were measured with both devices. Mean age was 69 ±11 years (youngest 26 years. oldest 90 years), 78 males (57%) and 60 (43 %) females were measured.

Table 6 shows the agreement results for the analyzed parameters Central Corneal Thickness (CCT). Radius Flat Meridian (Rf), Radius Steep Meridian (Rs), mean Radius of Curvature (Rm), Corneal Cylinder (Astigmatism) and Anterior Chamber Depth (ACD).

| Measure | Pentacam<br>AXL (Mean ±<br>SD) | Pentacam<br>(Mean ± SD) | Difference<br>(Mean ± SD) | 95% CI for<br>Mean<br>Difference | 95% LoA for<br>Difference |
|-----------------------------------|--------------------------------|-------------------------|---------------------------|----------------------------------|---------------------------|
| CCT[µm] | N=113<br>559 ± 34 | N=120<br>555 ± 35 | 2 ± 9 | [0; 4] | -15; 19 |
| Radius Flat<br>Meridian [mm] | N=113<br>7.91 ± 0.31 | N=120<br>7.89 ± 0.31 | 0.011 ± 0.032 | [0.005; 0.017] | -0.051; 0.074 |
| Radius Steep<br>Meridian [mm] | N=113<br>7.76 ± 0.30 | N=120<br>7.74 ± 0.30 | 0.009 ± 0.040 | [0.001; 0.016] | -0.071; 0.088 |
| Mean Radius<br>[mm] | N=113<br>7.83 ± 0.30 | N=120<br>7.82 ± 0.30 | 0.009 ± 0.031 | [0.004; 0.015] | -0.051; 0.069 |
| Corneal<br>Cylinder [D] | N=113<br>0.8 ± 0.6 | N=120<br>0.8 ± 0.6 | 0.0008± 0.23 | [-0.04; 0.04] | -0.46; 0.46 |
| Anterior<br>Chamber<br>Depth [mm] | N=113<br>3.26 ± 0.41 | N=120<br>3.20 ± 0.40 | 0.05 ± 0.06 | [0.03; 0.06] | -0.07; 0.16 |

The Pentacam® AXL demonstrated agreement to the Pentacam® (K030719, OCULUS Optikgeräte GmbH, Wetzlar, Germany) for the assessment of Central Corneal Thickness (CCT), Radius Flat Meridian (Rf), Radius Steep Meridian (Rs), mean Radius of Curvature (Rm), Corneal Cylinder (Astigmatism) and Anterior Chamber Depth (ACD).

{12}------------------------------------------------

| | | Image: Oculus logo<br>OCULUS |
|--|--|------------------------------|
|--|--|------------------------------|

# In-house Precision Testing: Results

40 eyes of 40 subjects were assessed in the Precision part of the study. To obtain repeatability values three measurements were performed on the same eye and on the same instrument under the same conditions. Mean age of the subjects involved in this study was 35 ± 9 years. 20 right and 20 left eyes were analyzed. 12 females and 28 males were involved in the study.

Table 7 shows the results of the Precision study for the analyzed parameters axial length (AL), mean radius of curvature, corneal cylinder (astigmatism), cylinder axis (axis flat meridian), central corneal thickness (CCT) and anterior chamber depth (ACD).

| Measure | Number of<br>subjects | mean | Repeatability | | Reproducibility | |
|--------------------------|-----------------------|--------|---------------|--------|-----------------|--------|
| | | | SD | CV [%] | SD | CV [%] |
| Axial length [mm] | 40 | 23.779 | 0.025 | 0.10 | 0.030 | 0.13 |
| CCT[um] | 40 | 550 | 4 | 0.67 | 5 | 0.90 |
| Radius flat (Rf) [mm] | 40 | 7.85 | 0.012 | 0.15 | 0.017 | 0.21 |
| Radius steep (Rs) [mm] | 40 | 7.69 | 0.012 | 0.15 | 0.018 | 0.23 |
| Mean Radius (Rm)<br>[mm] | 40 | 7.77 | 0.010 | 0.13 | 0.015 | 0.19 |
| Corneal Cylinder [D] | 40 | 0.92 | 0.07 | 7.68 | 0.10 | 10.84 |
| Axis flat Meridian [°] | 40 | 102.0 | 4.9 | 4.76 | 6.35 | 6.22 |
| ACD [mm] | 40 | 3.53 | 0.022 | 0.61 | 0.026 | 0.75 |
| WTW [mm] | 40 | 11.8 | 0.04 | 0.37 | 0.08 | 0.70 |

All parameters showed reproducibility and repeatability with coefficients of variation in most cases of less than one percent. Axial length measurement showed repeatability and reproducibility with a coefficient of variation of close to zero percent and intraclass correlation coefficients close to 1. Two parameters that had CV values above 1 percent were corneal cylinder measurements and the determination of axis of flat meridian. In both cases the coefficient of variation was still below 10 percent which is still reflecting repeatability.

{13}------------------------------------------------

| | OCULUS |
|--|--------|
|--|--------|

# Substantial Equivalence

The Pentacam® AXL is as safe and effective as the IOLMASTER 500 and the Pentacam®. The Pentacam® AXL has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the Pentacam® AXL and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrates that the Pentacam® AXL is as safe and effective as IOLMASTER 500 and Pentacam®. Thus, the Pentacam® AXL is substantially equivalent.