(68 days)
Under the supervision of a healthcare professional, Hylatopic™ Plus Emollient Foam, an aerosol-based 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™ Plus Emollient Foam also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
Hylatopic™ Plus Emollient Foam is indicated for use in:
- Atopic Dermatitis
- Allergic Contact Dermatitis
- Radiation Dermatitis
Hylatopic™ Plus Emollient Foam is a non-steroidal, non-sterile, off-white, low odor, fragrance free, topical aerosol foam. When Hylatopic™ Plus 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™ Plus 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 the disease state and prescribe the product.
The provided text describes a medical device called Hylatopic™ Plus Emollient Foam and its 510(k) submission for premarket notification. However, the text does not include the specific information requested in the prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.
The document states:
- "Functional and performance testing has been conducted to assess the safety and effectiveness of Hylatopic™ Plus Emollient Foam and all results are satisfactory." (Section 2.9, page 2)
- "To the best of our knowledge there are no performance standards applicable to these devices that have been adopted under section 514 of the Act." (Section 2.10, page 2)
This indicates that internal testing was performed and deemed satisfactory, but the report does not detail the methodology, acceptance criteria, or results of these tests, nor does it refer to a specific clinical study with statistical endpoints. It is a submission for a topical emollient foam, which typically undergoes different kinds of equivalence testing than, for example, an AI-powered diagnostic device.
Therefore, I cannot provide the requested information from the given text. The prompt's questions are tailored for a different type of medical device submission (e.g., an AI/ML device with performance metrics like sensitivity/specificity, reader studies, etc.) than what is presented in this 510(k) summary for a topical emollient foam.
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