(49 days)
HPR™ 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 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 Emollient Foam is a non-sterile, off-white, low odor, fragrance free, topical aerosol foam. When HPR™ 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™ 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.
The provided document is a 510(k) summary for a medical device called "HPR™ Emollient Foam". It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed information necessary to fully answer the request regarding acceptance criteria and a study proving those criteria are met.
Specifically, the document states: "Functional and performance testing has been conducted to assess the safety and effectiveness of HPR™ Emollient Foam and all results are satisfactory." This indicates that testing was performed, but it does not provide any specific acceptance criteria or the results or details of the study itself.
Therefore, I cannot provide most of the requested information.
Here's what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance
- Cannot provide. The document states that testing was conducted and results were satisfactory but does not specify the acceptance criteria or report any performance metrics.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Cannot provide. The document mentions functional and performance testing but provides no details about sample size, study design, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Cannot provide. This information is typically relevant for studies evaluating human interpretation aided by or compared to AI. This device is an emollient foam, not an AI or diagnostic imaging device, so "ground truth" in this context would likely refer to clinical outcomes, not expert interpretation of data. Even so, no details of such a study are provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Cannot provide. As above, this is not relevant or provided for this type of device.
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
- Cannot provide. This type of study is for diagnostic or AI-assisted devices involving human readers. HPR™ Emollient Foam is a topical product, not an AI or diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot provide. This refers to AI algorithm performance. HPR™ Emollient Foam is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot provide. While a clinical trial for an emollient foam would typically use patient-reported outcomes or clinical assessments as "ground truth" (e.g., reduction in itching, pain, skin condition improvement), the document does not mention the specifics of the study, nor how "ground truth" was established.
8. The sample size for the training set
- Cannot provide. This is relevant for AI models, not for a topical emollient foam.
9. How the ground truth for the training set was established
- Cannot provide. This is relevant for AI models, not for a topical emollient foam.
In summary, the provided 510(k) document only states that "Functional and performance testing has been conducted... and all results are satisfactory" for the HPR™ Emollient Foam. It does not offer any specifics on the acceptance criteria, study design, sample sizes, expert involvement, or adjudication methods that would be necessary to answer your detailed questions.
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