The STRATUSOCT™ is a high resolution tomographic device for the viewing and axial cross sectional imaging of posterior ocular structures. It is used for in vivo imaging and measurement of the retinal nerve fiber layer, macula, and optic disk. The STRATUSOCT™ with Retinal Nerve Fiber Layer ("RNFL") & Macula Normative Database is a quantitative tool for the comparison of retinal nerve fiber layer and the macula in the human retina to a database of known normal subjects. 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 edema, central serous retinopathy, and glaucoma.

Device Description

The STRATUSOCT™ with RNFL & Macula Normative Database is a microprocessor-based low-coherence digital instrument employing low coherence interferometry to generate inages of internal ocular tissue microstructures. The device measures optical reflections or backscatter from tissue using a scanning optical beam. Results obtained for the Retinal Nerve Fiber Layer and the Macula can be compared to a database of known normal human patients.

AI/ML Overview

The provided text focuses on the 510(k) summary for the STRATUSOCT™ with RNFL & Macula Normative Database, primarily discussing its intended use, device description, and substantial equivalence to a predicate device.

Unfortunately, the document does not explicitly state specific acceptance criteria (numerical thresholds for performance metrics) or provide a detailed study that proves the device meets such criteria.

Instead, the submission emphasizes that:

Clinical evaluation was performed to support expanded indications for use. "Clinical evaluation performed on the STRATUS with RNFL & Macula Normative Database supports the expanded indications for use statement and demonstrates the device is substantially equivalent to the predicate device and does not raise new questions regarding safety and effectiveness with respect to ophthalmoscopes and ultrasonic pulsed echo imaging systems."
Clinical data was collected on a statistically significant number of normal human patients. "Clinical data was collected on a statistically significant number of normal human patients and analyzed to support the inclusion of the Macula Normative Database in the STRATUSOCT™."
Testing was deemed necessary to ensure safety and effectiveness. "As described in this 510(k) Summary, all testing deemed necessary was conducted on the STRATUSOCT™ with RNFL & Macula Normative Database to ensure that the device is safe and effective for its intended use when used in accordance with its Instructions for Use."

Given this, I cannot construct the table of acceptance criteria and reported device performance as requested, nor can I provide detailed answers to many of the bullet points, as the specific information is not present in the provided text.

However, I can extract what is implied and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the document. The submission focuses on substantial equivalence to a predicate device and demonstrating safety and effectiveness for expanded indications, rather than meeting specific performance thresholds.	The clinical evaluation was sufficient to demonstrate substantial equivalence and support expanded indications, indicating that the device performs comparably to the predicate and is safe/effective for its intended uses. No specific metrics (e.g., sensitivity, specificity, accuracy) are reported.

2. Sample size used for the test set and the data provenance

Sample size for test set: The document states "statistically significant number of normal human patients" for the clinical data collected to support the Macula Normative Database. However, an exact numerical sample size is not provided.
Data provenance: Not explicitly stated (e.g., country of origin). The data supported the "inclusion of the Macula Normative Database," implying it was used to establish or validate the normative values.
Retrospective or prospective: Not specified in the provided text.

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. The "normative database" suggests comparison to known normal subjects, but the process of establishing "ground truth" for disease states or for the normative data itself (e.g., by expert consensus or other diagnostics) is not detailed.

4. Adjudication method 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

An MRMC study is not explicitly mentioned. The device is described as a "quantitative tool for the comparison... to a database of known normal subjects," which is a diagnostic aid. The document does not describe studies on human reader performance improvement with this specific device.

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

The device is a "diagnostic device to aid in the detection and management of ocular diseases." The "normative database" component is likely a standalone feature comparing patient data to established norms. However, no specific "algorithm-only" performance metrics (e.g., sensitivity, specificity of the device itself in diagnosing disease without human interpretation) are provided. The focus is on the device being a "quantitative tool" for comparison.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the "normative database," the ground truth is implicitly defined by "known normal subjects." For aiding in the detection and management of diseases, the "ground truth" for the clinical evaluation is not specified but would likely involve established diagnostic criteria for those ocular diseases. The document does not detail how these "known normal subjects" or disease diagnoses were confirmed (e.g., by expert consensus, other gold standard tests, pathology).

8. The sample size for the training set

The document refers to a "database of known normal subjects" and clinical data collected on a "statistically significant number of normal human patients" to support the inclusion of the Macula Normative Database. This implies that these "normal human patients" form the basis of the normative database, which acts as a reference or "training" set for comparison. However, a specific numerical sample size for this database is not provided. The submission mainly discusses the clinical evaluation to support the expanded indications based on this database.

9. How the ground truth for the training set was established

The ground truth for the "normative database" is established by using "known normal subjects." The criteria or methods used to definitively classify these subjects as "normal" are not detailed in the provided text.

Summary

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APR 2 0 2004

510(k) Summary Carl Zeiss Meditec Incorporated STRATUSOCT™ with RNFL & Macula Normative Database

This 510(k) summary for the STRATUSocr™ with RNFL & Macula Normative Database is submitted in accordance with the requirements of SMDA 1990 and 21 C.F.R § 807.92.

GENERAL INFORMATION

Manufacturer:	Carl Zeiss Meditec Inc.5160 Hacienda DriveDublin, California 94568(925) 557-4353 (phone)(925) 557-4481 (fax)Est. Reg. No. 2918630
Contact Person:	R. Michael CromptonVice President, Regulatory / Clinical Affairsand Quality Assurance
DEVICE DESCRIPTION
Classification:	Class II
Trade Name:	STRATUSOCTTM with Retinal Nerve Fiber Layer and MaculaNormative Database
Generic/Common Name:	Ophthalmoscope (21 CFR § 886.1570)Ultrasonic pulsed echo imaging system (21 CFR § 892.1560)

PREDICATE DEVICE

STRATUSOCT™ with Retinal Nerve Fiber Layer Normative Database (1)

INTENDED USE

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DEVICE DESCRIPTION

SUBSTANTIAL EQUIVALENCE

The STRATUSOCT™ with RNFL & Macula Normative Database is substantially equivalent to the predicate device identified previously. The STRATUSOCT™ with RNFL & Macula Normative Database is substantially equivalent to the predicate device with regard to intended use, operating principle, function, and materials.

Clinical evaluation performed on the STRATUS with RNFL & Macula Normative Database supports the expanded indications for use statement and demonstrates the device is substantially equivalent to the predicate device and does not raise new questions regarding safety and effectiveness with respect to ophthalmoscopes and ultrasonic pulsed echo imaging systems.

CLINICAL EVALUATION

Clinical data was collected on a statistically significant number of normal human patients and analyzed to support the inclusion of the Macula Normative Database in the STRATUSOCT™.

CONCLUSION

As described in this 510(k) Summary, all testing deemed necessary was conducted on the STRATUSOCT™ with RNFL & Macula Normative 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/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing line that forms the shape of a bird. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the image.

MAY 2 9 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Carl Zeiss Meditec, Inc. c/o Ms. Judith A. Brimacombe 5160 Hacienda Drive Dublin, CA 94568

Re:

K030433 and K033123 Trade/Device Name: STRATUSOCT™ with Retinal Nerve Fiber Layer (RNFL) & Macula Normative Database Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: II Product Code: OBO Dated: February 7, 2003 and September 26, 2003 Received: February 10, 2003 and September 30, 2003

Dear Ms. Brimacombe:

This letter updates our substantially equivalent letters of May 1, 2003 and April 20, 2004, respectively.

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 (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

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Page 2 - Ms. Judith A. Brimacombe

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); 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.

This letter will allow you to continue 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/dsma/dsmamain.html

Sincerely vours.

Evenette W. Beers PhD

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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Statement of Indications for Use

510(k) Number (if known): K033123_____________________________________________________________________________________________________________________________________________

Device Name: STRATUSOCT™ with RNFL & Macula Normative Database

Indications for Use: TThe STRATUSocT™ is a high resolution tomographic device for the viewing and axial cross sectional imaging of posterior ocular structures. It is used for in vivo imaging and measurement of the retina, retinal nerve fiber layer, macula, and optic disk. The STRATUSOCT™ with Retinal Nerve Fiber Layer ("RNFL") & Macula Normative Database is a quantitative tool for the comparison of retinal nerve fiber layer and the macula in the human retina to a database of known normal subjects. 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 edema, central serous retinopathy, and glaucoma.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Ophthalmic Ear, Nose and Throat Devises
510(k) Number	K033123
Prescription Use	✓ OR Over-the-Counter Use ______
(Per 21 C.F.R. § 801.109)

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.