The Silon Topomat device provides a convenient method of imaging the surface of the cornea with existing corneal topography apparatuses while avoiding the use of dves and wetting agents. The Silon Topomat device consists of a hydrophobic silicone-based membrane. It can accurately contour to irregular surfaces, closely following even minute topographical features. The membrane is fixed within two couplings as to provide a rigid ring structure in the form of a "drum-head" of approximately 13 millimeters in diameter. The ring has a gripping tab on one edge to facilitate handling and serve as an orientation reference. The membrane is applied against the surface of the cornea, and an accurate topographic image is obtained directly from the distal surface of the membrane using videokeratographic or rasterstereographic imaging techniques.

AI/ML Overview

The provided document is a 510(k) Premarket Notification summary for the Silon® Topomat™ Corneal Topography Image Enhancement Device. The document focuses on establishing substantial equivalence to existing predicate devices and providing biocompatibility testing results. It does not describe a study with acceptance criteria and device performance in the way typically associated with validating an AI/ML diagnostic device's accuracy or effectiveness.

Therefore, many of the requested elements are not present in this type of submission. I can, however, extract the relevant information and indicate where data is not available from the provided text.

Here's an analysis based on the provided document:

Acceptance Criteria and Study for Silon® Topomat™ Corneal Topography Image Enhancement Device

The provided document describes a 510(k) Premarket Notification, which primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than a detailed study with specific acceptance criteria for performance metrics (like sensitivity, specificity, etc.) for image enhancement. The "study" presented is a biocompatibility summary to ensure the device is safe for its intended use.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly related to the safety and biocompatibility of the device, rather than diagnostic performance metrics. The reported "performance" refers to the results of these biocompatibility tests.

Test	Acceptance Criteria (Implicit)	Reported Device Performance
Kligman Maximization	Non-sensitizing (e.g., 0% sensitization)	Non-sensitizing (0% sensitization)
Primary Dermal Irritation	Non-irritant (e.g., PDII = 0)	Non-irritant (PDII = 0)
Hemolysis	Non-hemolytic (e.g., low percentage)	Non-hemolytic (2.0 %)
Agarose Overlay Cytotoxicity	No cytopathic effects (e.g., grade 0)	No cytopathic effects (grade 0)
MEM Cytotoxicity	Non-cytotoxic (e.g., grade 0)	Non-cytotoxic (grade 0)

Note: The acceptance criteria in the above table are inferred from the "Results" described in the biocompatibility summary, as explicit numerical acceptance thresholds are not stated. The goal is to show the device material does not cause adverse biological reactions.

2. Sample Size for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable in the context of the biocompatibility tests. The tests refer to the biological samples/materials used for the specific in vitro and in vivo (animal) tests (e.g., guinea pigs for Kligman Maximization, human red blood cells for Hemolysis, cell cultures for cytotoxicity). The document does not specify the number of biological samples used for each test.
Data Provenance: The tests were performed by "Toxicon Corporation of Woburn, MA," an FDA registered independent testing company. This indicates the data is from the USA and is laboratory-based. The tests are prospective in nature, designed specifically to evaluate the device material.

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

This information is not applicable to the biocompatibility study described. The ground truth for biocompatibility tests is established through standardized laboratory protocols and measurements, not expert human interpretation.

4. Adjudication Method for the Test Set

This information is not applicable to the biocompatibility study described. Biocompatibility tests follow established laboratory procedures, and their results are typically quantitative or categorically defined by the test protocol, not through adjudication by multiple experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC comparative effectiveness study was not done. The submission focuses on device safety (biocompatibility) and functional equivalence (ability to image the cornea without dyes/wetting agents), not on improving human reader performance with AI assistance.

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

No. The Silon Topomat is a physical device (a membrane) designed to be used with existing corneal topography apparatuses. It is not an algorithm, and therefore, a standalone algorithm performance study is not relevant or described. The device's "performance" is its ability to facilitate imaging and its biocompatibility.

7. The Type of Ground Truth Used

For the biocompatibility assessment, the ground truth is based on standardized laboratory test results and established biological safety parameters (e.g., non-sensitization, non-irritation, non-cytotoxicity). This type of ground truth is derived from laboratory measurements and observations under controlled conditions, not expert consensus, pathology, or outcomes data in the diagnostic sense.

8. The Sample Size for the Training Set

Not applicable. The Silon Topomat is a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. As indicated above, this is not an AI/ML algorithm, and therefore, there is no training set or ground truth in that context.

Summary

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Image /page/0/Picture/0 description: The image shows a logo for Bio Med Sciences, Inc. with the letters "BMS" in a stylized font. The text "Bio Med Sciences, Inc." is printed below the logo. The image also includes the date "DEC 7 1998" and the text "FDA/CDRH/ODE/DMC".

K98 No 65

101 Technology Drive . Bethlehem, PA 18015 Phone: (610) 974-8801 FAX: (610) 974-8831 Toll Free: 1-800-25-SILON (257-4566) http://www.silon.com

Summary 510 (k) Premarket Notification

CONTACT PERSON

Mark E. Dillon, President, Bio Med Sciences, Inc.

PRODUCT NAME

Silon® Topomat™ Corneal Topography Image Enhancement Device

PRODUCT DESCRIPTION

The Silon Topomat device provides a convenient method of imaging the surface of the cornea with existing corneal topography apparatuses while avoiding the use of dves and wetting agents.

The Silon Topomat device consists of a hydrophobic silicone-based membrane. It can accurately contour to irregular surfaces, closely following even minute topographical features. The membrane is fixed within two couplings as to provide a rigid ring structure in the form of a "drum-head" of approximately 13 millimeters in diameter. The ring has a gripping tab on one edge to facilitate handling and serve as an orientation reference. The membrane is applied against the surface of the cornea, and an accurate topographic image is obtained directly from the distal surface of the membrane using videokeratographic or rasterstereographic imaging techniques.

PRODUCT EQUIV ALENCY

Bio Med Sciences claims substantial equivalency for Silon Topomat to the following devices:

1. Silon® Transparent Wound Dressings (K912032 & K923150)

Bio Med Sciences, Inc. 101 Technology Drive Bethlehem, PA 18015 USA

Silon interpenetrating polymer network of polydimethylsiloxane and polytetrafluoroethylene in membrane form used on de-epithelialized dermal tissue.

2. SilSoft® Aphakic Extended-Wear Contact Lens

Bausch & Lomb One Bausch & Lomb Place P.O. Box 450 Rochester, NY 14692

60 Registered Trademark, Bio Med Sciences, Inc.

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510(k) Premarket Notification Summary Silon® Topomat™ Corneal Topography Image Enhancement Device Bio Med Sciences, Inc., Bethlehem, PA Page 2 of 2

Soft contact lens made from Elastofilcon A™ polydimethylsiloxane from Dow Corning corporation. Used in direct contact with the human eye.

3. Fluorescein Dye

Akorn. Inc. 100 Akorn Drive Abita Springs, LA 70420

Used as an image enhancement dye for corneal topographic mapping.

BIOCOMPATIBILITY SUMMARY

The Silon membrane passes the Tripartite Biocompatibility Guidance for Medical Devices as prepared by the Toxicology Sub-group of the Tripartite Sub-Committee on Medical Devices (September 1986) as related to external devices contacting breached surfaces for short durations. The tests were performed by an FDA registered independent testing company (Toxicon Corporation of Woburn, MA). The data can be summarized as follows:

Test	Results	Toxicon Reference
Kligman Maximization	Non-sensitizing (0% sensitization)	91G-0388
Primary Dermal Irritation	Non-irritant (PDII = 0)	91G-0387
Hemolysis	Non-hemolytic (2.0 %)	90G-0670
Agarose Overlay Cytotoxicity	No cytopathic effects (grade 0)	90G-0669
MEM Cytotoxicity	Non-cytotoxic (grade 0)	90G-0668

Bio Med Sciences has taken the following position relative to the use of the proposed materials:

1. The Silon membrane material is the corneal contacting surface of the device, and therefore is the material of interest with respect to biocompatibility.
1. In all biocompatibility tests conducted to date, the Silon membrane has never induced a negative biological response.
1. The Silon membrane is presently used for woundcare applications wherein it is in direct contact with de-epithelialized tissue for up to 10 days.
1. The device is only used intermittently for short periods, and therefore is not subject to more rigorous biocompatibility requirements.
1. Although not in direct contact with the patient, the polyethylene ring and the opacifying agent are known to be generally regarded as safe and are both sterilizable by the EtO method.

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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 in flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

7 1998 DEC

Mr. Mark E. Dillon President Bio Med Science, Inc. 101 Technology Drive Bethlehem, PA 18015

Re: K981665

Trade Name: Silcon® Topomat ™ Corneal Topography Image Enhancement Device Regulatory Class: I Product Code: 86 MMQ Dated: November 13, 1998 Received: November 18, 1998

Dear Mr. Dillon:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .

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Page 2 - Mr. Mark E. Dillon, President

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on.the.promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A Roerl Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number: K981665

Device Name:

Silon® Topomat™ Corneal Topography Image Enhancement Device

Indications For Use:

For the measurement of the topographical surface of the cornea using rasterstereographic imaging techniques.

Evelyn Horton Boone

510(k) Number

Prescription Use
(Per 21 CFR 801.109)

® Registered Trademark, Bio Med Sciences, Inc.

Regulation Number and Section

§ 886.1350 Keratoscope.

(a)
Identification. A keratoscope is an AC-powered or battery-powered device intended to measure and evaluate the corneal curvature of the eye. Lines and circles within the keratoscope are used to observe the corneal reflex. This generic type of device includes the photokeratoscope which records corneal curvature by taking photographs of the cornea.(b) The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9. The battery-powered device is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180 of this chapter, with respect to general requirements concerning records, and § 820.198 of this chapter, with respect to complaint files