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Under the supervision of a healthcare professional, Hylatopic™ Emollient Foam, an aerosolbased emollient foam. is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. Hylatopic™ Emollient Foam also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

Hylatopic TM Emollient Foam is indicated for use in:

• · Atopic Dermatitis
• Allergic Contact Dermatitis
• Radiation Dermatitis .

Hylatopic™ Emollient Foam is a non-steroidal, non-sterile, off-white, low odor, fragrance free, topical aerosol foam. When Hylatopic™ Emollient Foam is dispensed, foam is formed. The propellant in the foam dissipates very quickly and the foam is then rubbed on the affected skin. The Hylatopic™ Emollient Foam when applied to diseased skin forms a protective barrier that helps to maintain a moist wound and skin environment. This device is presented as a prescription product that requires the physician to diagnosis of the disease state and prescribes the product.

This document is a 510(k) Premarket Notification for a medical device called Hylatopic™ Emollient Foam. It focuses on demonstrating substantial equivalence to previously cleared devices rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, the requested information elements cannot be fully extracted as they are typical for a study demonstrating analytical or clinical performance of a diagnostic or therapeutic device through specified metrics.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable. The document does not define specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy, or quantitative measures of clinical effectiveness) and therefore no reported performance against such criteria. The submission is for substantial equivalence to predicates, implying similar intended use and safety profiles.

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

Not applicable. The document does not describe a clinical study with a "test set" in the context of device performance evaluation. The submission is based on comparison to predicate devices and functional/performance testing of the product itself.

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

Not applicable. There is no mention of a "test set" requiring expert-established ground truth for device performance evaluation.

4. Adjudication method for the test set:

Not applicable. No "test set" and corresponding 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 device is a topical Emollient Foam, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study related to AI assistance is irrelevant and not mentioned.

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

Not applicable. This is not an algorithm-based device.

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

Not applicable. There is no mention of a "ground truth" as typically defined for performance studies of diagnostic or AI devices. The basis for the 510(k) is substantial equivalence, functional testing, and intended use as an emollient foam.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning model that requires a training set.

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

Not applicable. As above, this is not an AI/machine learning model.

Summary of what the document does state regarding "Tests and Conclusions":

"Functional and performance testing has been conducted to assess the safety and effectiveness of Hylatopic™ Emollient Foam and all results are satisfactory."

This statement indicates that internal testing was performed to ensure the device met its functional specifications and was safe for its intended use. However, it does not provide details on:

• Specific acceptance criteria for this testing (e.g., pH limits, viscosity, stability, microbiological purity, etc.).
• The actual results of these tests.
• Whether these tests involved human subjects or were solely bench/lab tests.

The 510(k) process for this type of device (a topical emollient foam) primarily relies on demonstrating substantial equivalence to already legally marketed predicate devices with the same intended use and similar technological characteristics, rather than extensive clinical efficacy trials against strict performance metrics. The stated "Tests and Conclusions" are sufficient for a 510(k) submission where substantial equivalence is the primary pathway to market.

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