The Visante™ OCT is a non-contact, high resolution tomographic and biomicroscopic device indicated for the in vivo imaging and measurement of ocular structures in the anterior segment, such as corneal and LASIK flap thickness.

Device Description

The Visante OCT is computerized instrument that acquires and analyzes cross-sectional tomograms of the anterior eye segment (cornea, anterior chamber, iris and the central portion of the lens). It employs non-invasive, non-contact, low-coherence interferometry to obtain these high-resolution images. Using this non-invasive optical technique, Visante OCT produces high-resolution cross-sectional tomograms of the eye without contacting the eye.

AI/ML Overview

The provided text is a 510(k) summary for the Visante OCT, a device intended for imaging and measuring anterior segment ocular structures. However, it does not contain the specific information required to complete the detailed table and answer the questions about acceptance criteria and a study proving the device meets those criteria.

The document states:

"Clinical evaluation performed on the Visante 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 anterior segment analysis devices and ophthalmoscopes."
"Clinical data was collected on a statistically significant number of normal human patients and analyzed to support the indications for use statement for the Visante OCT."
"As described in this 510(k) Summary, all testing deemed necessary was conducted on the Visante OCT to ensure that the device is safe and effective for its intended use when used in accordance with its Instructions for Use."

This indicates that clinical data was used to establish substantial equivalence, but it does not provide details on:

Specific acceptance criteria (numerical thresholds for performance metrics).
Reported device performance against those criteria.
The sample size of the test set, its provenance, or how ground truth was established for it.
Any information regarding training sets, expert involvement, or adjudication methods.
Whether MRMC or standalone performance studies were conducted.

Therefore, the requested tables and answers cannot be fully generated from the provided text.

Unable to fill the table and answer the questions with the provided information.

The document discusses a clinical evaluation that supported the device's indications for use and demonstrated substantial equivalence to predicate devices. However, it does not specify any quantifiable "acceptance criteria" or present "reported device performance" against such criteria. It also lacks details on the methodology of the clinical evaluation beyond stating that data was collected on a "statistically significant number of normal human patients."

Detailed Information Missing from the provided text:

Table of acceptance criteria and the reported device performance: This information is not present in the document.
Sample sized used for the test set and the data provenance: The document states "Clinical data was collected on a statistically significant number of normal human patients" but does not specify the exact sample size, country of origin, nor if it was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not provided.
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: Not explicitly stated, and this device (Visante OCT) is an imaging device, not an AI interpretation tool intended to assist human readers in the way an MRMC study typically assesses. The primary goal stated is imaging and measurement.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes the device as a "computerized instrument that acquires and analyzes cross-sectional tomograms," implying standalone functionality for image acquisition and initial analysis, but no specific "standalone performance study" details are given regarding algorithm accuracy for specific measurements or diagnostic tasks without human oversight.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): This information is not provided.
The sample size for the training set: This information is not provided. The term "training set" is not mentioned, as the focus is on clinical evaluation for substantial equivalence, not algorithm development and validation in the AI sense.
How the ground truth for the training set was established: This information is not provided.

Summary

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SEP 3 0 2005

510(k) Summary KOS/789 Carl Zeiss Meditec Incorporated

This 510(k) summary for the Visante OCT 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) 557-4616 (phone)(925) 557-4481 (fax)Est. Reg. No. 2918630
Contact Person:	Judith A. Brimacombe, MADirector, Regulatory / Clinical Affairs

DEVICE DESCRIPTION

Classification:	Class II
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Visante™ OCT Trade Name:

Device, Analysis, Anterior Segment; Ophthalmoscope Generic/Common Name:

PREDICATE DEVICES

(1) STRATUSOCT™ with Retinal Nerve Fiber Layer Normative and Macula Database
(2) Orbscan™ II

INTENDED USE

The Visante OCT is intended for use in the viewing and imaging of anterior segment ocular structures.

INDICATIONS FOR USE

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DEVICE DESCRIPTION

SUBSTANTIAL EQUIVALENCE

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

Clinical evaluation performed on the Visante 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 anterior segment analysis devices and ophthalmoscopes.

CLINICAL EVALUATION

Clinical data was collected on a statistically significant number of normal human patients and analyzed to support the indications for use statement for the Visante OCT.

CONCLUSION

As described in this 510(k) Summary, all testing deemed necessary was conducted on the Visante 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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads in profile, facing to the right. The eagle is enclosed in a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 9 2007

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

Re: K051789

Trade/Device Name: Visante™ OCT Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: II Product Code: OBO Dated: July 1, 2005 Received: July 7, 2005

Dear Ms. Brimacombe:

This letter updates our substantially equivalent letter of September 30, 2005.

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 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.

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Page 2 - Ms. Judith A. Brimacombe

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 yours,

Evenette N. Beers PhD

for

N
L
I

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): K051789

Device Name: Visante™ OCT

Indications for Use: The Visante™ OCT is a non-contact, high resolution Indications for OSCF The Nearly device indicated for the in vivo imaging and tomographic und blomierosoph a in the anterior segment, such as corneal and LASIK flap thickness.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Clay R. Butterman, DOED

Prescription Use
(Per 21 C.F.R. § 801.109)

Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________

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.