(123 days)
Hexagen Derm is a topical emulsion to be used to treat dry skin conditions and to manage and relieve the burning and itching associated with various types of dermatoses, including atopic dermatitis, and radiation dermatiis. Hexagen Derm helps to relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
Hexagen Derm is an amorphous, odorless, petrolatum-based emollient consisting of petrolatum (95%), water, and the antimicrobial preservatives Polyhexamethylene Biguanide (PHMB) and Benzalkonium Chloride (BZK). Hexagen Derm's petrolatum base locks in moisture at the skin surface to keep wounded skin moist. Hexagen Derm is non-sterile, RX only, and available in 30 and 90 gram low density polyethylene tubes.
The provided text is a 510(k) summary for a medical device called Hexagen Derm. However, it does not contain specific acceptance criteria, detailed study results, or information about the performance of a device against numerical acceptance criteria.
The "Performance Testing" section is very brief and states: "The product is non-cytotoxic, non-sensitizing, and non-irritating per ISO 10993 biocompatibility trials. USP 51 trials confirm that the preservatives are effective." This indicates that some testing was performed, but it doesn't provide the level of detail requested in your prompt (e.g., acceptance criteria for non-cytotoxicity, sensitivity, irritation, or specific results).
Furthermore, the document describes Hexagen Derm as a "topical emulsion" and lists its ingredients. It's a "Wound Dressing, Drug Product" and its indications for use involve treating dry skin conditions and managing burning and itching associated with various dermatoses. This type of device is typically evaluated based on its biocompatibility, stability, and effectiveness of its components, rather than performance metrics like sensitivity, specificity, or reader improvement, which are common for AI/ML or diagnostic devices.
Therefore, I cannot populate the table or provide answers to most of your questions as the document does not contain the required information for a study proving device performance against detailed acceptance criteria for an AI/ML or diagnostic device.
Here's a breakdown of why I can't fulfill your request based on the provided input:
- Acceptance Criteria & Reported Performance: The document only vaguely mentions "non-cytotoxic, non-sensitizing, and non-irritating per ISO 10993 biocompatibility trials" and "USP 51 trials confirm that the preservatives are effective." It doesn't provide numerical acceptance criteria or specific numerical results.
- Sample Size (Test Set), Data Provenance, Number of Experts, Adjudication Method, MRMC Study, Standalone Study, Type of Ground Truth, Training Set Size, Training Set Ground Truth: All these questions are geared towards the evaluation of AI/ML or diagnostic devices with specific performance metrics (e.g., accuracy, sensitivity, specificity, reader studies). The Hexagen Derm is a topical emulsion, and its evaluation for a 510(k) primarily focuses on safety (biocompatibility) and equivalence to predicates, not on the type of performance study you're asking about.
In summary, the provided content describes the regulatory submission for a topical dermatological product, not a device that would typically undergo the kind of performance studies you're inquiring about for AI/ML or diagnostic tools.
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