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Under the supervision of a health care professional, Vashe® Skin and Wound Hydrogel is indicated for the management and relief of pain, burning and itching experienced with various dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis, as well as for the relief of pain from first and second degree burns, and aids to relieve dry waxy skin by maintaining a moist wound and skin environment. A moist wound and skin environment is beneficial to the healing process.

Vashe® Skin and Wound Hydrogel is an emollient containing, non oily hydrogel. The gel forms a protective barrier which retains moisture and provides relief of the burning and itching experienced with various dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. The Hydrogel when applied to diseased skin forms a protective barrier that helps to maintain a moist wound and skin environment. The product contains hypochlorous acid as a preservative. The Hydrogel will be supplied in plastic tottles as described in Section 3.2. The device is presented as a prescription product that requires the physician to diagnose the disease state and prescribe the product.

The document provided refers to a 510(k) premarket notification for a medical device called "Vashe® Skin & Wound Hydrogel". This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for demonstrating performance against specific numerical acceptance criteria through a clinical study.

Therefore, the information you've requested regarding acceptance criteria, reported device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully extracted from the provided text because the 510(k) summary focuses on biocompatibility and preservative activity, not a clinical efficacy study with numerical performance metrics against specific conditions.

However, I can extract what is mentioned about the studies conducted:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated in terms of numerical performance for efficacy. The implied acceptance criteria for the Vashe® Skin & Wound Hydrogel is that it is safe for use and has effective preservative activity, similar to its predicate device.
• Reported Device Performance:
  • "Vashe® Skin and Wound Hydrogel is safe for use when in contact with abraded, breached or compromised skin."
  • "Vashe® Skin & Wound Hydrogel at its minimum recommended concentration demonstrates effective preservative activity and supports a preservative claim."

2. Sample size used for the test set and the data provenance: Not applicable. The studies mentioned are "in-vivo and in-vitro biocompatibility testing" and "preservative activity" testing, which are not typically presented with test set sample sizes or data provenance in the context of comparative clinical efficacy as one would expect for an AI/diagnostic device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The studies mentioned (biocompatibility and preservative activity) do not involve expert-established ground truth for interpreting clinical outcomes.

4. Adjudication method for the test set: Not applicable based on the nature of the described studies.

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: No, an MRMC comparative effectiveness study was not done. This device is a hydrogel, not an AI or diagnostic device that would involve human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a hydrogel, not an algorithm.

7. The type of ground truth used:
* For biocompatibility: Adherence to ISO-10993 standards (likely comparing against established biological response limits).
* For preservative activity: Demonstrated effective preservative activity (likely against specific microbial challenges, though not detailed).

8. The sample size for the training set: Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The document indicates that the Vashe® Skin & Wound Hydrogel underwent the following testing:

• Study Type: In-vivo and in-vitro biocompatibility testing.
• Standards: ISO-10993 standards.
• Purpose: To demonstrate the device's safety when in contact with abraded, breached, or compromised skin.
• Conclusion: The results demonstrated that Vashe® Skin & Wound Hydrogel is safe for such use.
• Additional Study: Testing for preservative activity.
• Purpose: To ascertain if the hydrogel, at its minimum recommended concentration, could effectively act as a preservative.
• Conclusion: The device demonstrated effective preservative activity, supporting a preservative claim.

These studies were conducted to support the device's safety and preservative function, which are critical aspects of its substantial equivalence to the predicate device, Epicyn™ HydroGel (K102945). The 510(k) process primarily relies on demonstrating substantial equivalence in terms of intended use, technological characteristics, and safety and effectiveness, often through non-clinical testing and comparison to an existing predicate.

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