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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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Under the supervision of a healthcare professional, for the management and relief of burning, itching and redness associated with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis, and radiation dermatitis (post-radiation treatment).

Eletone® Cream is a semi-viscous emulsion/cream formulation intended for topical application supplied non-sterile in 100g plastic tubes.

The provided text is for a 510(k) premarket notification for Eletone® Cream, a wound dressing. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with specific performance criteria against predefined acceptance criteria for a novel device.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, and training set details is not available in this document.

The conclusion of the 510(k) summary (Section VII) explicitly states: "Functional and performance testing has been conducted to assess the safety and efficacy of Eletone® Cream. Based on the information provided herein, we conclude that the device is substantially equivalent to the above-mentioned predicate devices."

This indicates that the "study" conducted was a comparison to predicate devices to establish substantial equivalence, not a performance trial against specific numerical targets.

However, based on the provided document, here's what can be inferred or stated:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated in terms of numerical performance targets. The acceptance criterion for the 510(k) submission is "substantial equivalence" to the predicate devices. This means that the device must be as safe and effective as the predicate.
• Reported Device Performance: The document states that Eletone® Cream is "identical in composition and function to Locobase® Wound and Skin Emulsion (K060272)" and that its "intended use is identical to other legally marketed wound dressing products." This "identity" and "identical use" constitute the primary "performance" reported to meet the substantial equivalence criteria. Functional and performance testing was conducted but the specific results or metrics are not detailed in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not applicable/Not provided. Clinical trial data with specified sample sizes for a "test set" are not presented in this 510(k) summary. The comparison is primarily based on the composition and intended use relative to predicate devices.

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):

• Not applicable/Not provided. This type of information is relevant for studies involving diagnostic or AI-driven devices requiring expert-adjudicated ground truth, which is not the case for this wound dressing submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable/Not provided.

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:

• Not applicable/Not provided. This is a medical device (topical cream) and not a diagnostic imaging or AI-assisted interpretation device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable/Not provided. This is a topical cream, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not applicable/Not provided in the context of a "test set" for performance evaluation against ground truth. The "truth" for this submission is that the device's composition and intended use are substantially equivalent to already approved devices.

8. The sample size for the training set:

• Not applicable/Not provided. This is relevant for machine learning models, not for a topical cream.

9. How the ground truth for the training set was established:

• Not applicable/Not provided. Relevant for machine learning models, not for a topical cream.

In summary, the provided 510(k) notification for Eletone® Cream demonstrates substantial equivalence to predicate devices based on similarities in composition and intended use. It does not contain information about clinical trials, specific performance metrics, or "acceptance criteria" in the way a novel device or AI-driven system would. The "study" mentioned ("Functional and performance testing has been conducted") is not detailed in this summary, but its outcome was to support the claim of substantial equivalence to the listed predicate devices.

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