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 GDxPRO is a confocal scanning laser ophthalmoscope comprising an optomechanical 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

Here's a breakdown of the acceptance criteria and study information for the GDxPRO™ device based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text for the GDxPRO™ does not explicitly state specific quantitative acceptance criteria or detailed device performance metrics that would typically be seen in a clinical study. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (GDx with ECC Retinal Nerve Fiber Layer Normative Database, K082016).

The key "performance" claimed is that the GDxPRO™ retains the functionality and safety/effectiveness of the predicate device.

Acceptance Criterion (Implicit)	Reported Device Performance (Summary)
Substantial Equivalence to predicate device (GDx with ECC)	Evaluations demonstrate the device is substantially equivalent to the predicate device in terms of safety and effectiveness, and does not raise new questions.
Supports Intended Use	All necessary testing was conducted to ensure the device is safe and effective for its intended use.

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

The provided text does not explicitly mention a separate "test set" sample size or data provenance (e.g., country of origin, retrospective/prospective). Since the submission focuses on substantial equivalence based on modifications to a predicate, it's possible that direct clinical efficacy testing on a dedicated test set, as might be done for a novel device, was not the primary focus here. The "evaluation performed on the GDxPRO" likely involved engineering and performance testing rather than a large-scale clinical study with a distinct patient test set.

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

The provided text does not specify the number of experts or their qualifications for establishing ground truth for a test set. Given the focus on substantial equivalence based on modifications to an existing device, it's unlikely that a new, independent "ground truth" establishment process by external experts for a clinical dataset was undertaken as part of this 510(k) summary.

4. Adjudication Method for the Test Set

The provided text does not mention any adjudication method (e.g., 2+1, 3+1, none) for a test set. This further supports the interpretation that a traditional clinical study with independent review of cases by multiple experts was not the primary basis of this submission.

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

The provided text does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed. Therefore, there is no information on the effect size of how much human readers improve with AI vs. without AI assistance. The GDxPRO™ as described here is an imaging device, not an AI diagnostic assistant, so an MRMC study in that context would not be relevant.

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

The provided text does not describe a standalone (algorithm only) performance study. The GDxPRO™ is a medical imaging device used by clinicians. Its "performance" is tied to its ability to accurately measure RNFL thickness, which then aids in diagnosis and monitoring by a human ophthalmologist.

7. Type of Ground Truth Used

The provided text does not explicitly state the type of ground truth used in the context of clinical validation (e.g., expert consensus, pathology, outcomes data). However, since the device measures Retinal Nerve Fiber Layer (RNFL) thickness for aiding in diagnosis of optic neuropathy, the implicit "ground truth" for the predicate device (and thus the GDxPRO™'s equivalence) would ultimately relate to clinical diagnosis of optic neuropathy by healthcare professionals, potentially based on a combination of clinical findings, imaging, and long-term outcomes for the normative databases.

8. Sample Size for the Training Set

The provided text does not specify a sample size for a "training set." The GDxPRO™ applies a "Normative Database" (GDx Variable Corneal Compensation (VCC) and GDx Enhanced Corneal Compensation (ECC) RNFL Normative Databases). These databases would have been built from a large population of healthy and diseased eyes. While the exact sample size for the original database development is not in this document, it would likely be significant to establish normative ranges.

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

The text mentions "GDx Variable Corneal Compensation (VCC) and GDx Enhanced Corneal Compensation (ECC) RNFL Normative Databases." These databases are fundamental to the device's function, as they provide a reference against which patient RNFL measurements are compared.

The ground truth for these normative databases would have been established by:

Clinical examinations: Identifying healthy individuals to form the "normal" range.
Clinical diagnosis: Identifying individuals with various "diseases and disorders of the eye that may cause changes in the polarimetric retinal nerve fiber layer thickness" (e.g., optic neuropathy, glaucoma) to understand abnormal ranges.
Longitudinal follow-up: In some cases, tracking disease progression or stability to correlate RNFL changes with clinical outcomes.

This process would involve expert ophthalmologists classifying patients and their conditions, likely through a combination of clinical assessment tools, other imaging modalities, and potentially histopathology in cases where it's relevant and obtainable (though less common for RNFL thickness in living patients). The "ground truth" for a normative database essentially means accurate classification of individuals as healthy or having a specific condition based on established clinical criteria at the time the database was built.

Summary

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SECTION 5.

510(K) SUMMARY

510(K) SUMMARY

510 k: K093521 510(k) SUMMARY (per 21 CFR §807.92)

GDxPRO™

GENERAL INFORMATION

Manufacturer:	Carl Zeiss Meditec Inc.5160 Hacienda DriveDublin, California 94568(925) 557-4616 (phone)(925) 557-4259 (fax)Est. Reg. No. 2918630	NOV 2 5 2009
Contact Person:	Judith A. Brimacombe, MADirector, Clinical/Regulatory AffairsCarl Zeiss Meditec Inc.5160 Hacienda DriveDublin, California 94568(925) 557-4616 (phone)(925) 557-4259 (fax)
Date Summary Prepared:	October 23, 2009
Regulation Number:	21 CFR 886.1570
Classification name:	Ophthalmoscope, Laser Scanning
Classification:	Class II
Product Code:	MYC, HLI
Trade/Proprietary name:	GDxPRO™

PREDICATE DEVICE

Company:	Carl Zeiss Meditec, Inc.
Device:	GDx with ECC Retinal Nerve Fiber Layer Normative Database (K082016)

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SECTION 5.

INTENDED 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.

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 laver (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

SUBSTANTIAL EQUIVALENCE

It is the opinion of Carl Zeiss Meditec, Incorporated that the GDxPRO is substantially equivalent to the GDx with ECC Retinal Nerve Fiber Layer Normative Database as it contains modifications to the predicate that do not raise questions of safety or efficacy. The indications for use statement for the GDxPRO is exactly the same as the indications for use statement for the predicate device cited in this application. A technological comparison demonstrates that the GDxPRO is functionally equivalent to the predicate device. Both devices are intended for imaging and three-dimensional analysis of the fundus and retinal nerve fiber layer (RNFL) in vivo.

Evaluation performed on the GDxPRO supports the indications for use statement and demonstrates that the device is substantially equivalent to the predicate device and does not raise new questions regarding safety and effectiveness.

SUMMARY

As described in this 510(k) Summary, all testing deemed necessary was conducted on the GDxPRO 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/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized depiction of an eagle or bird-like figure with flowing lines, suggesting movement or flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the bird symbol.

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

Carl Zeiss Meditec, Inc. c/o Underwriters Laboratories, Inc. Mr. Ned E. Devine Sr. Staff Engineer 333 Pfingten Road Northbrook, IL 60062

NOV 2 5 2009

Re: K093521

Trade/Device Name: GDxPRO Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: II Product Code: MYC Dated: November 11, 2009 Received: November 13, 2009

Dear Mr. Devine:

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.

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

R.C. Anderson for

Malvina B. Eydelman, M 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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SECTION 4.

INDICATIONS FOR USE STATEMENT

4. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): _ |< 0 9 3 S +

GDxPRO™ Device Name:

Indications for Use:

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)

Bob B
(Division Sign Off)

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

510(k) Number k09352/

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.