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Silgel is intended for use in the management of hypertrophic and keloid scars, prophylactic management of healed incisions and as a splint lining insert to relieve friction on newly healed scars.

Silgel, Topical Gel Sheet, consists of durable medical grade silicone reinforced with polyester mesh. Sheets are protected on one side by a film which is removed before use and on the other by a paper backing. Sheets are individually packaged in grip seal bags. A sheet can be trimmed to the desire shape prior to placement on the scar. It is secured by wrapping with either gauze and hypoallergenic adhesive tape, light conforming crepe or tubular bandages, or compression garments. Firm pressure in not required for a therapeutic effect.

This document describes a 510(k) submission for the "Silgel Topical Gel Sheet," a medical device intended for scar management. As such, the information provided focuses on demonstrating substantial equivalence to predicate devices rather than reporting on a standalone study with acceptance criteria in the typical sense for a diagnostic or AI-driven device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set information) are not applicable to this type of submission. The "acceptance criteria" here are defined by the product's bio-compatibility and safety tests, and its technological characteristics matching predicate devices.

Here's the breakdown based on the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not Applicable. This submission relies on biocompatibility and safety testing of the device materials and final product configuration, as well as comparison to existing clinical knowledge regarding the effectiveness of silicone gel sheeting. It does not present a clinical study with a "test set" of patients in the typical sense. The "data provenance" for the effectiveness claim is based on "numerous clinical studies" demonstrating the effectiveness of silicone gel sheet products in general, not a specific Silgel study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not Applicable. No ground truth established by experts for a test set was mentioned in this submission. The effectiveness is referenced from pre-existing knowledge about the class of devices.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not Applicable. No clinical test set and subsequent adjudication method are described.

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

• Not Applicable. This is not an AI-driven device or study.

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

• Not Applicable. This is not an algorithm or AI device.

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

• The "effectiveness" for the class of silicone gel sheeting devices is based on clinical findings and outcomes from numerous clinical studies (not specific to Silgel). For the Silgel device itself, the "ground truth" for its safety is derived from standardized biocompatibility and safety tests (Hemolysis, Cytotoxicity, Pyrogenicity) which yielded "acceptable" results.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device.

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

• Not Applicable. This is not an AI/machine learning device.

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