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

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.

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.

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.

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Corneal Topographer: Indicated for use for measuring the shape and curvature of the anterior surface of the eye and for displaying the topographical maps of the surface of the cornea. This information can be used to analyze, monitor and evaluate the shape and symmetry of the comea following refractive surgery, to assist in the diagnosis of keratoconus, to assist in the fitting of contact lenses, to assist in the understanding of various corneal irregularities such as those induced by post operative sutures and wounds, and to assist in the understanding of various refractive conditions of the cornea, such as myopia, hyperopia, and astigmatism.

Not Found

The provided document is an FDA 510(k) clearance letter for the Euclid Systems Corneal Topographer Model ET800. It does not contain information about acceptance criteria, device performance, study details (sample size, provenance, ground truth, experts, adjudication, MRMC, standalone performance), or training set information.

Therefore, I cannot provide the requested information based solely on this document. The letter signifies that the device has been found substantially equivalent to a legally marketed predicate device, but it does not include the detailed technical study results that would typically contain the requested criteria and performance data.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device