The Cirrus™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device. It is indicated for in vivo viewing, axial cross-sectional, and threedimensional imaging and measurement of posterior ocular structures, including retina, retinal nerve fiber layer, macula, and optic disc. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age- related macular degeneration and glaucoma.

Device Description

The Cirrus™ HD-OCT is a computerized instrument that acquires and analyzes crosssectional tomograms of posterior ocular structures (including retina, retinal nerve fiber layer, macula, and optic disc.). It employs non-invasive, non-contact, low-coherence interferometry to obtain these high-resolution images. Using this non-invasive optical technique, Cirrus HD-OCT produces high-resolution cross-sectional tomograms of the eye without contacting the eye.

AI/ML Overview

The document provided is a 510(k) Summary for the Carl Zeiss Meditec Inc. Cirrus™ HD-OCT device, submitted to the FDA. It focuses on demonstrating substantial equivalence to predicate devices rather than providing specific acceptance criteria and detailed study results for device performance.

Therefore, the requested information elements related to specific acceptance criteria, detailed device performance metrics, sample sizes for test/training sets, ground truth establishment methods, expert qualifications, and comparative effectiveness studies cannot be fully extracted from the provided text.

Here's a breakdown of what can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the document. The 510(k) summary asserts that "all testing deemed necessary was conducted" and that the device "demonstrates the device is substantially equivalent to the predicate devices and does not raise new questions regarding safety and effectiveness with respect to ophthalmoscopes." However, no specific performance metrics or acceptance criteria (e.g., accuracy, sensitivity, specificity, measurement tolerances) are detailed.

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

Sample Size for Test Set: Not explicitly stated. The document mentions "Clinical data was collected and evaluated."
Data Provenance (e.g., country of origin, retrospective/prospective): Not explicitly stated. It only mentions "Clinical data was collected."

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

This information is not provided in the document.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:

This information is not provided in the document.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not provided and is unlikely to be relevant. The Cirrus™ HD-OCT is described as an imaging device for "in vivo viewing, axial cross-sectional, and three-dimensional imaging and measurement of posterior ocular structures." It's a diagnostic device to aid in detection and management of diseases. The description does not suggest an AI-driven interpretation or assistive role for human readers in the way an MRMC study typically assesses. The primary goal of the 510(k) is to demonstrate substantial equivalence of the device itself as an ophthalmoscope, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not provided. As noted above, the device's function is imaging and measurement, not solely algorithmic diagnosis.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

This information is not provided. The document only states "Clinical data was collected and evaluated."

8. The Sample Size for the Training Set:

This information is not provided. The Cirrus™ HD-OCT is an imaging device, and the summary focuses on its hardware and measurement capabilities rather than an AI model that would require a distinct training set. If there are normative databases, their sample sizes are not mentioned.

9. How the Ground Truth for the Training Set was Established:

This information is not provided.

Summary of available information regarding the clinical evaluation (as described in the 510(k) summary):

The document states:

Study Purpose: "Clinical data was collected and evaluated to support the indications for use statement for the Cirrus™ HD-OCT and to demonstrate substantial equivalence to the Stratus OCT."
Conclusion: "As described in this 510(k) Summary, all testing deemed necessary was conducted on the Cirrus™ HD-OCT to ensure that the device is safe and effective for its intended use when used in accordance with its Instructions for Use."

Crucially, this 510(k) summary is for an ophthalmoscope, an imaging device. The focus is on its ability to produce images and measurements comparable to existing predicate devices, rather than a novel AI diagnostic algorithm with specific performance criteria against a detailed ground truth. The document does not provide the kind of detailed clinical study results (e.g., sensitivity, specificity, AUC, reader performance) that would typically be found for an AI-powered diagnostic aid. The substantial equivalence argument often relies on demonstrating that the new device operates similarly and yields comparable output to predicate devices, without needing to re-prove the clinical utility of the imaging modality itself.

Summary

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510(K) SUMMARY

5. 510 (K) SUMMARY

	510(k) SUMMARY
	(per 21 CFR §807.92)	JAN 26 2007
	CIRRUS™ HD-OCT
GENERAL INFORMATION
Manufacturer:	Carl Zeiss Meditec Inc.5160 Hacienda DriveDublin, California 94568(925) 557-4616 (phone)(925) 557-4481 (fax)Est. Reg. No. 2918630
Contact Person:	Judith A. Brimacombe, MADirector, Regulatory/Clinical AffairsCarl Zeiss Meditec, Inc.5160 Hacienda DriveDublin, California 94568(925) 557-4616 (phone)(925) 557-4481 (fax)
Classification Name:	Ophthalmoscope
Classification:	Class II (acc. 21 CFR 886.1570)
Product Code:	86 HLI
Trade/Proprietary Name:	Cirrus™ HD-OCT
PREDICATE DEVICE
Company:Device:	Carl Zeiss Meditec, Inc.Stratus OCT™ with Retinal Nerve Fiber Layer Normativeand Macula Database
Company:Device:	Carl Zeiss Meditec, Inc.Visante™ OCT
INTENDED USE

The Cirrus™ HD-OCT is intended for use in the viewing and axial cross sectional imaging of posterior ocular structures.

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INDICATIONS FOR USE

DEVICE DESCRIPTION

SUBSTANTIAL EQUIVALENCE

The Cirrus™ HD-OCT is substantially equivalent to the predicate devices identified previously. The Cirrus™ HD-OCT is substantially equivalent to the predicate devices with regard to intended use, operating principle, function, and materials.

Evaluation performed on the Cirrus™ HD-OCT supports the 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

Clinical data was collected and evaluated to support the indications for use statement for the Cirrus™ HD-OCT and to demonstrate substantial equivalence to the Stratus OCT.

CONCLUSION

As described in this 510(k) Summary, all testing deemed necessary was conducted on the Cirrus™ HD-OCT 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 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 in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Carl Zeiss Meditec, Inc. c/o Judy Brimacombe Director, Regulatory/Clinical Affairs 5160 Hacienda Drive Dublin, CA 94568

JAN 26 2007

Re: K063378

Trade/Device Name: Cirrus HD-OCT Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope, AC-Powered Regulatory Class: Class II Product Code: HLI Dated: November 6, 2006 Received: November 8, 2006

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, 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 such 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, RDA 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); 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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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

M.B. Eichelman Simd

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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4. INDICATIONS FOR USE STATEMENT

Device Name: Cirrus™ HD-OCT

Indications for Use:

Prescription Use (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Clay R. Buttereau

510(k) Number K063378

000012

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.