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The Sil-K is designed and indicated for treating thick painful, itchy, red and raised hypertrophic or keloid scars.

Sil-K is a thin soft silicone sheet used to treat thick painful, itchy, red and raised hypertrophic or keloid scars. Sil-K is designed to be used only after the skin has completely healed and is non invasive.

This document is a 510(k) summary for Degania Silicone Sil-K, a silicone elastomer sheet used to treat hypertrophic or keloid scars. It primarily focuses on demonstrating substantial equivalence to a previously marketed device rather than presenting a performance study with acceptance criteria.

Therefore, many of the requested elements for a study proving device meets acceptance criteria cannot be extracted because such a study is not detailed in the provided text.

Here's a breakdown of what can be inferred and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in the provided text, as this is a 510(k) for substantial equivalence, not a performance study against specific criteria. The core acceptance criterion for a 510(k) is demonstrating "substantial equivalence" to a predicate device.
• Reported Device Performance: Not detailed in terms of measurable outcomes (e.g., scar height reduction, pain relief) from a clinical study. The document states the device "is a thin soft silicone sheet used to treat thick painful, itchy, red and raised hypertrophic or keloid scars," implying its intended function, but no performance metrics are provided.

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

• Sample Size: Not applicable. No test set or clinical study is described.
• Data Provenance: Not applicable. No study data is presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No test set or ground truth establishment by experts is described.

4. Adjudication method for the test set:

• Not applicable. No test set or adjudication process is 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 device is a silicone sheet, not an AI-powered diagnostic tool. MRMC studies are irrelevant in this context.

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

• Not applicable. This device is a physical product, not an algorithm.

7. The type of ground truth used:

• Not applicable. No ground truth is established as no performance study is detailed.

8. The sample size for the training set:

• Not applicable. This device is a physical product, not a machine learning model, so there is no "training set."

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

• Not applicable. (See #8)

Key Information from the Document Regarding "Acceptance Criteria" for a 510(k):

The primary "acceptance criteria" for a 510(k) submission is to demonstrate Substantial Equivalence (SE) to a legally marketed predicate device.

• Predicate Device: "We are Substantially Equivalent to ourselves." This statement indicates that Degania Silicone is submitting for a new Premarket Notification for a device (Sil-K) that is deemed substantially equivalent to a previous version of their own device that was already cleared (510(k) number K914701).
• Basis for SE: The document states: "The Sil-K is manufactured from the same raw materials, from the same vendors and using the same manufacturing processes as our previous 510(k)." This is the justification for claiming substantial equivalence.

In essence, the "study" proving the device meets 510(k) acceptance criteria (i.e., substantial equivalence) is the comparison of the manufacturing process, raw materials, and intended use of the new Sil-K device to its previously cleared predicate device, and finding them identical or sufficiently similar. There is no performance study against specific clinical outcomes detailed in this document.

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