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HPRTM Plus Emollient Foam is indicated to manage and relieve the burning, itching and pain associated with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis, and radiation dermatitis. HPRTM Plus Emollient Foam also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

HPR 114 Plus Emollient Foam is a non-sterile, off-white, low odor, fragrance free, topical aerosol foam. When HPRTM 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 HPR " 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 of the disease state and prescribes the product.

This document describes a 510(k) submission for a medical device called HPR™ Plus Emollient Foam. However, the provided text does not contain the kind of detailed information about acceptance criteria and a study design that would apply to an AI/ML-powered diagnostic device, or a device requiring a performance study with specific metrics, sample sizes, and ground truth establishment.

Instead, this submission is for a topical emollient foam. The "study" mentioned is a general statement about "functional and performance testing."

Therefore, I cannot extract the requested information such as:

• A table of acceptance criteria and reported device performance (no specific performance metrics like sensitivity, specificity are mentioned)
• Sample size for the test set and data provenance
• Number of experts and their qualifications
• Adjudication method
• MRMC comparative effectiveness study
• Standalone performance
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

The only relevant information that can be extracted from the provided text regarding "testing and conclusions" is:

1. Acceptance Criteria and Reported Device Performance:

2. Details of the Study:

The provided text only states:
"Functional and performance testing has been conducted to assess the safety and effectiveness of HPR™ Emollient Foam and all results are satisfactory."

This statement is too general to extract any of the other requested specific details. This type of submission for an emollient foam would likely involve chemistry, manufacturing, and controls testing, biocompatibility, and potentially some clinical safety data (e.g., irritation studies), but not the kind of "study" to prove meeting acceptance criteria in the context of an AI/ML or diagnostic device that the request implies.

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