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Under the supervision of a health care professional, Epicyn HydroGel is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including radiation dermatitis and atopic dermatitis. Epicyn HydroGel may be also used to relieve the pain of first and second degree burns. Epicyn HydroGel helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

Epicyn™ HydroGel is an emollient containing, non oily pH neutral hydrogel. The product is preserved with a unique mixture of hypochlorous acid and sodium hypochlorite generated through a proprietary process. The gel forms a protective barrier which retains moisture and provides relief of the burning and itching associated with various types of dermatoses including atopic dermatitis. The gel will be supplied in polyethylene terephthalate (PET) tube-bottles with polypropylene (PP) tamper resistant snap-top closure as described in Section 11.3.

The provided text is a 510(k) Premarket Notification for Epicyn™ HydroGel, a wound and burn hydrogel dressing. It focuses on demonstrating substantial equivalence to a predicate device and outlines safety testing. It does not present acceptance criteria for device performance, nor does it describe a study proving the device meets performance-based acceptance criteria.

Therefore, I cannot provide the requested information in the format specified because the document does not contain details about:

• Acceptance criteria for device performance: The document discusses "safety and effectiveness" and "functions as intended" but does not quantify performance metrics or acceptance thresholds.
• A study proving device meets acceptance criteria: The document refers to "in-vitro and in-vivo biocompatibility testing," "bench testing including bioburden, biocompatibility and animal testing," and "USP Antimicrobial Effectiveness Testing and Microbial Enumeration testing characterization studies." These are safety and characterization tests, not performance studies against specific acceptance criteria for the intended use (managing burning, itching, pain, and maintaining a moist wound environment).
• Sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone study, type of ground truth, training set size, or ground truth for training set.

The document's primary argument for substantial equivalence is based on:

1. Same intended use as the predicate device (Sinclair Wound and Skin Emulsion, Atopiclair®).
2. Similar basic function and technological characteristics (clear, aqueous, emollient-containing, non-oily, pH neutral hydrogel for moisture control, wound exudate management, and barrier protection).
3. Safety established through biocompatibility, in-vitro cytotoxicity, and sensitization testing in animal species (ISO 10993-1 compliance).

The document states: "Performance Testing: Epicyn™ HydroGel has been subjected to in-vitro and in-vivo biocompatibility studies to demonstrate that the device is safe for the indications for use. Extensive bench testing including bioburden, biocompatibility and animal testing have been performed to support the safety and efficacy of the Epicyn™ HydroGel. Test results demonstrate that the gel functions as intended and without adverse effects." However, it does not elaborate on what "functions as intended" means in terms of specific performance metrics or how it was quantitatively measured.

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