The GDx is a confocal polarimetric scanning laser ophthalmoscope that is intended for imaging and three-dimensional analysis of the fundus and retinal nerve fiber layer (RNFL) in vivo. The GDx and its GDx Variable Corneal Compensation (VCC) and GDx Enhanced Corneal Compensation (ECC) RNFL Normative Databases aid in the diagnosis and monitoring of diseases and disorders of the eye that may cause changes in the polarimetric retinal nerve fiber layer thickness. The GDx is to be used in patients who may have an optic neuropathy.

Device Description

The GDx with ECC Retinal Nerve Fiber Layer Normative Database is a confocal scanning laser ophthalmoscope comprising an opto-mechanical scanning laser head unit and a computer. The device employs Scanning Laser Polarimetry (SLP) to measure the Retinal Nerve Fiber Layer (RNFL) thickness using polarized light.

AI/ML Overview

The provided text does not explicitly state acceptance criteria in a quantitative format (e.g., target accuracy, sensitivity, or specificity). However, it describes the clinical evaluation conducted to demonstrate the device's substantial equivalence and improved performance compared to a previous algorithm.

Here's a breakdown of the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to predicate devices for intended use.	The GDx with ECC Retinal Nerve Fiber Layer Normative Database is substantially equivalent to the predicate devices regarding intended use, operating principle, function, and materials. Clinical evaluation supports expanded indications for use and demonstrates substantial equivalence.
Ability to measure RNFL thickness.	The ECC and VCC algorithms correlated well, and their ability to measure RNFL thickness was similar.
Improved atypical scan rate compared to VCC algorithm.	The ECC algorithm generated a lower atypical scan rate than the VCC algorithm.
Improved compensation for anterior segment birefringence.	The ECC algorithm compensated for anterior segment birefringence better than the VCC algorithm.
Safety and effectiveness for intended use.	"All testing deemed necessary was conducted... to ensure that the device is safe and effective for its intended use..." (General statement)

2. Sample Size Used for the Test Set and Data Provenance

The text doesn't explicitly define a "test set" in the context of typical AI model evaluation (i.e., a separate, unseen dataset for final performance evaluation). However, it mentions a model validation subset:

Sample Size for Model Validation: One-third of the normal and glaucoma study eyes.
- Since 251 normal subjects and 215 glaucoma subjects were collected, the total number of subjects is 466.
- Therefore, the model validation subset would be approximately 466 / 3 ≈ 155 subjects.
Data Provenance: The study was conducted at ten sites. The text does not specify the country of origin but implies a multi-center study likely within the US, given the FDA submission. The study collected data on prospective subjects for the normative database and glaucoma cohorts.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The text does not specify the number of experts used to establish ground truth for the model validation subset.

For the normative database, subjects were "deemed representative of the normal population." This implies clinical assessment but no specific number of experts or their qualifications are provided.
For the glaucoma subjects, they were identified as having "early, moderate and late stage glaucoma." This also implies clinical diagnosis, but the number and qualifications of experts are not stated.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method (e.g., 2+1, 3+1) for establishing the ground truth or validating the model's performance. The selection of data for model building and validation was done "randomly... by statistical programs."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No explicit MRMC comparative effectiveness study involving human readers with and without AI assistance is described. The study primarily compares two algorithms (VCC and ECC) against each other for measuring RNFL thickness. It does not evaluate the effect of AI assistance on human reader performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone study was performed. The clinical evaluation focuses on the performance of the ECC algorithm itself, particularly its ability to measure RNFL thickness, its atypical scan rate, and its compensation for anterior segment birefringence, in comparison to the VCC algorithm. The "nerve fiber indicator (NFI)" was trained and validated, which represents the algorithm's output.

7. Type of Ground Truth Used

Clinical Diagnosis/Assessment:
- For the normative database, subjects were "deemed representative of the normal population."
- For the glaucoma subjects, they were identified as having "early, moderate and late stage glaucoma." This indicates a clinical diagnosis based on the standard of care at the ten study sites. The specific criteria for diagnosis (e.g., visual field defects, optic disc appearance) are not detailed.

8. Sample Size for the Training Set

The "model building subset" was used for training:

Two-thirds of the normal and glaucoma study eyes were randomly selected as the model building subset.
- Normal subjects: 251 * (2/3) ≈ 167 subjects
- Glaucoma subjects: 215 * (2/3) ≈ 143 subjects
- Total training set size: Approximately 167 + 143 = 310 subjects.

9. How the Ground Truth for the Training Set Was Established

The ground truth for the training set (model building subset) was established in the same manner as described for the overall study:
- Subjects were identified as "normal" (deemed representative of the normal population) or as having various stages of "glaucoma" (early, moderate, and late stage). This implies clinical diagnosis based on established medical criteria at the ten study sites, but specific details on diagnostic methods and expert qualifications are not provided.

Summary

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SECTION 5.

510(K) SUMMARY

K082016

AUG 1 0 2009

510(k) SUMMARY (per 21 CFR §807.92)

GDx with ECC Retinal Nerve Fiber Layer Normative Database

GENERAL INFORMATION

Manufacturer:

Carl Zeiss Meditec Inc. 5160 Hacienda Drive Dublin, California 94568 (925) 557-4616 (phone) (925) 557-4481 (fax) Est. Reg. No. 2918630

Contact Person:

Judith A. Brimacombe, MA Director, Regulatory/Clinical Affairs Carl Zeiss Meditec Inc. 5160 Hacienda Drive Dublin, California 94568 (925) 557-4616 (phone) (925) 557-4481 (fax)

Class II (acc. 21 CFR 886.1570)

Classification name:

↑

Ophthalmoscope

Classification:

MYC, HLI Product Code:

Trade/Proprietary name:

GDx with ECC Retinal Nerve Fiber Layer Normative Database

PREDICATE DEVICE

Company:	Carl Zeiss Meditec, Inc.
Device:	Nerve Fiber Analyzer (K941705)
Company:	Carl Zeiss Meditec, Inc.
Device:	Stratus OCT (K030433)

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SECTION 5.

INTENDED USE

DEVICE DESCRIPTION

SUBSTANTIAL EQUIVALENCE

The GDx with ECC Retinal Nerve Fiber Layer Normative Database is substantially equivalent to the predicate devices identified previously. The GDx with ECC Retinal Nerve Fiber Layer Normative Database is substantially equivalent to the predicate devices with regards to intended use, operating principle, function, and materials.

Clinical evaluation performed on the GDx supports the expanded indications for use statement and demonstrates the device is substantially equivalent to the predicate devices and does not raise new questions regarding safety and effectiveness with respect to ophthalmoscopes.

CLINICAL EVALUATION

A clinical study was conducted at ten sites to gather data for the ECC normative database, to train the nerve fiber indicator (NFI), and to compare two GDx algorithms, variable corneal compensation (VCC) and enhanced corneal compensation (ECC).

The GDx ECC RNFL thickness normative database was created using GDx ECC scan data from 251 subjects. 18 to 82 years of age, who were deemed representative of the normal population. The normative database has an even distribution of right and left eves, as well as gender, and has a wide representation of the general population with regard to refractive error, intraocular pressure, axial length, corneal curvature and thickness measurement spectrum.

Data from 215 subjects with early, moderate and late stage glaucoma were also collected for the purpose of training the ECC NFI. Two-thirds of the normal and

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SECTION 5.

glaucoma study eyes were randomly selected by statistical programs as the model building subset for the development of the ECC NFI. The other one-third of the study eyes was used for model validation.

Results revealed that the ECC and VCC algorithms correlated well, and their ability to measure the RNFL thickness was similar. The ECC algorithm generated a lower atypical scan rate than the VCC algorithm and the ECC algorithm compensated for the anterior segment birefringence better than the VCC algorithm.

SUMMARY

As described in this 510(k) Summary, all testing deemed necessary was conducted on the GDx with ECC Retinal Nerve Fiber Layer Database to ensure that the device is safe and effective for its intended use when used in accordance with its Instructions for Use.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the caduceus in a circular fashion. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002

Carl Zeiss Meditec Incorporated c/o Judith A. Brimacombe, M.A. Director, Clinical/Regulatory Affaires 5160 Hacienda Drive Dublin, CA 94568

AUG 1 0 2009

Re: K082016

Trade Name: GDx VCC with ECC Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: MYC, HLI Dated: June 4, 2009 Received: June 9, 2008

Dear Ms. Brimacombe:

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, Or to 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 1011, 1 general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbanding and adulteration.

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-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,

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Page 2 - Judith A. Brimacombe, M.A.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Kesia Alexander for
Kesia R. Felder, MD

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

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K082016

Device Name:

GDx with ECC Retinal Nerve Fiber Layer Normative Database

Indications for Use:

The GDx is a confocal polarimetric scanning laser ophthalmoscope that is intended for imaging and three-dimensional analysis of the fundus and retinal nerve fiber layer (RNFL) in vivo. The GDx and its GDx Variable Corneal Compensation (VCC) and (DDx Enhanced Corneal Compensation (ECC) RNFL Normative Databases aid in the diagnosis and monitoring of diseases and disorders of the eye that may cause changes in the polarimetric retinal nerve fiber layer thickness. The GDx is to be used in patients who may have an optic neuropathy.

Prescription Use x (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sexyhe 8/7/2009

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number.

Regulation Number and Section

§ 886.1570 Ophthalmoscope.

(a)
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.(b)
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.