(261 days)
PR™ cream is indicated to manage various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and irritant contact dermatitis. PR™ cream helps to relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
PR™ cream is a non-sterile cream formulation intended for topical use only. It is presented for Prescription (requiring a physician diagnosis disease state) use. PRTM cream is or topical dermatologic use only. PR™ cream is applied in a thin layer to affected areas 2-3 times per day or as directed by a physician. PRTM cream is a nonsteroidal cream comprised of aluminum magnesium hydroxide stearate, cetyl dimethicone copolyol, cyclomethicone, hexyl laurate, polyglyceryl-4-isostearate, prified water, and sodium chloride. Contains phenoxyethanol and propylparaben as preservatives.
The provided text is a 510(k) summary for PR™ Cream, a topical dermatological cream. It is a marketing authorization document focusing on substantial equivalence to a predicate device, rather than detailed clinical study results demonstrating performance against specific acceptance criteria.
Therefore, the document does not contain the information requested to comprehensively describe acceptance criteria and the study proving the device meets them. Specifically, the following information is missing or not applicable:
- A table of acceptance criteria and the reported device performance: The document states that "Functional and performance testing has been conducted to assess the safety and efficacy of PR Cream™ Cream and results are satisfactory," but it does not provide specific acceptance criteria or quantitative performance measures.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: This device is a topical cream, not an AI-assisted diagnostic tool, so an MRMC study is not relevant.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not relevant as it is not an algorithm-based device.
- The type of ground truth used: Not mentioned.
- The sample size for the training set: Not relevant for a drug/cream.
- How the ground truth for the training set was established: Not relevant for a drug/cream.
Summary of what is present:
The document describes PR™ Cream as a non-sterile cream formulation for topical use, intended for prescription use, and indicated to manage various types of dermatoses (atopic dermatitis, allergic contact dermatitis, and irritant contact dermatitis). It aims to relieve dry, waxy skin by maintaining a moist wound and skin environment beneficial to healing. The submission asserts substantial equivalence to Tetrix® Cream (cleared under K07143). The conclusion states that "Functional and performance testing has been conducted to assess the safety and efficacy of PR Cream™ Cream and results are satisfactory." However, no specific details about this testing (methodology, results, or acceptance criteria) are provided in this summary.
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