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Silon Scar Strips are indicated for the management of hypertrophic scars and keloids. Consistent use of Silon Scar Strips can reduce hypertrophic scaring and keloid formation resulting from surgical or traumatic injury of the skin.

Silon Scar Strips may be useful as a prophylaxis after surgical or traumatic dermal injury to aid in the prevention of hypertrophic scars and keloids.

The Applicant presently markets Silon-SES® Silicone Elastomer Sheeting for the management of hypertrophic scars and keloids. The new product does not introduce any new concepts in silicone scar management products. Silon-SES is presently labeled for sale by or on the order of a physician. The Applicant hereby intends to remove this restriction and offer the product directly to consumers "over-the-counter."

This 510(k) summary (K982036) describes the Silon Scar Strips, which are intended for the management of hypertrophic scars and keloids. The key aspect of this submission is the intention to remove the "by or on the order of a physician" restriction, allowing the product to be sold directly to consumers "over-the-counter."

The document focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices, rather than presenting a novel clinical study with explicit acceptance criteria and corresponding device performance data for a new efficacy claim. Therefore, many of the requested categories for a new device's performance study will not be applicable or will have limited information.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for substantial equivalence based on a change in market availability (OTC vs. prescription) for an already marketed material, there are no specific performance acceptance criteria for clinical efficacy studies provided in the document for the new "Silon Scar Strips" product. The acceptance criteria are related to the material's biocompatibility, and the device's substantial equivalence to predicate devices.

2. Sample Size Used for the Test Set and the Data Provenance

• Biocompatibility Tests: The document does not specify the sample size for the in vitro or in vivo biocompatibility tests described. It only states that "All tests were performed by an FDA registered independent testing company." The data provenance is implied to be from a certified testing laboratory, but no country of origin is specified. These tests are usually conducted on material samples, not human subjects, and are retrospective in the sense that the material for testing is prepared and then analyzed.
• Substantial Equivalence: For substantial equivalence, the "test set" is essentially the comparison of the new device's characteristics and indications against the predicate devices. There isn't a "sample size" in the traditional sense for a clinical trial here. The data provenance for this comparison comes from the characteristics of the new Silon Scar Strips and the known characteristics of the predicate devices.

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

Not applicable. This submission relies on biocompatibility testing results and a comparison to predicate devices, not expert review of a test set for clinical performance.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is not a study requiring adjudication of clinical observations. The "adjudication" for substantial equivalence is carried out by the FDA during its review process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission is not for a diagnostic device or an AI-assisted device, and it doesn't involve human readers interpreting cases.

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

Not applicable. "Silon Scar Strips" is a medical device (silicone sheeting), not an algorithm or software. Therefore, no standalone algorithm performance study was conducted.

7. The Type of Ground Truth Used

• Biocompatibility: The "ground truth" for the biocompatibility tests is established by standardized laboratory testing protocols (e.g., Kligman Maximization, Primary Dermal Irritation, etc.) as outlined in the Tripartite Biocompatibility Guidance for Medical Devices. The results (e.g., "non-sensitizing," "non-irritant," "no cytopathic effects") serve as the ground truth for compliance with these standards.
• Substantial Equivalence: For substantial equivalence, the "ground truth" is primarily based on the established safety and effectiveness profiles, and indicated uses of the predicate devices (Silon-SES and Rejuveness). The new device is considered substantially equivalent if it shares the same technological characteristics or has different characteristics that do not raise new questions of safety and effectiveness, and is as safe and effective as a legally marketed device.

8. The Sample Size for the Training Set

Not applicable. There is no training set mentioned or implied, as this is not a machine learning or AI-based device.

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

Not applicable. There is no training set for this device.

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