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KeraStat® Cream is intended to maintain a moist wound environment. KeraStat® Cream is indicated for the management of a number of partial thickness skin wounds such as: partial thickness (first and second degree) burns, superficial injuries, cuts, and incisions/surgical wounds. Under the direction of a healthcare professional, KeraStat® Cream also may be used in the management of dry, light, and moderately exuding partial thickness wounds including: pressure (stage I-II) ulcers, venous stasis ulcers caused by mixed vascular etiologies, diabetic ulcers, radiation dermatitis, donor sites, and grafts.

KeraStat® Cream is not indicated for full thickness or third degree will be available by prescription.

KeraStat® Cream is a non-sterile, non-implantable wound dressing intended to provide a moist environment in the management of a variety of partial thickness dermal wounds. KeraStat® Cream is provided in a screw top tube for multiple uses. Each tube contains 1 oz (29.6 mL) of KeraStat® Cream, which contains 5% keratin protein incorporated into a cream base.

The provided document is a 510(k) summary for KeraStat® Cream. It focuses on demonstrating substantial equivalence to a predicate device (KeraStat® Gel) and a reference device (Biafine®), rather than presenting a study with specific acceptance criteria and performance data for the KeraStat® Cream's effectiveness in wound management.

Therefore, the document does not contain the acceptance criteria or a study that proves the device meets specific performance criteria related to its clinical efficacy in terms of wound healing endpoints.

Here's a breakdown of the requested information based on the provided text, indicating what is not available:

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

• Not Available: The document does not provide a table with specific acceptance criteria for clinical efficacy (e.g., wound size reduction, healing time, infection rates) or reported device performance against such criteria. The "Performance Data Summary of Non-Clinical Tests" lists types of tests (e.g., protein content, viscosity, pH, microbial contamination, stability) performed to ensure product quality and safety, but these are not clinical acceptance criteria for wound healing efficacy.

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

• Not Available for clinical efficacy: The document mentions "Radiation Dermatitis Clinical Study", "Repeat Insult Patch Test", and "Skin Prick Test" as "human clinical testing". However, it does not provide details on the sample size for these tests, their design (retrospective or prospective), or data provenance. These clinical tests appear to be primarily for safety (e.g., sensitization, irritation) or to support specific indications like radiation dermatitis, not necessarily general wound healing efficacy benchmarks.

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 Available: This question typically applies to studies involving interpretation of medical images or diagnostic classification, where expert consensus establishes ground truth. Since this document is for a wound dressing and does not describe such a study for clinical efficacy, this information is not relevant or provided.

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

• Not Applicable/Not Available: Similar to point 3, this is relevant for studies involving subjective assessments or classifications by multiple readers, which is not described here for the clinical efficacy of the wound dressing.

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 Available: This device (KeraStat® Cream) is a medical device (wound dressing), not an Artificial Intelligence (AI) device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

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

• Not Applicable/Not Available: This device is a wound dressing, not an algorithm, so this question is not relevant.

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

• Not Available for clinical efficacy: For the mentioned clinical tests (e.g., Radiation Dermatitis Clinical Study), the document does not specify how "ground truth" (e.g., actual wound status, healing progress) was established or measured. For biocompatibility and performance tests, the "ground truth" is typically defined by standardized ISO or USP methods.

8. The sample size for the training set

• Not Applicable/Not Available: This device is a wound dressing, not a machine learning model, so there is no training set in this context.

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

• Not Applicable/Not Available: As identified in point 8, there is no training set for this device.

In summary: The provided 510(k) summary primarily focuses on demonstrating that KeraStat® Cream is substantially equivalent to existing predicate and reference devices based on intended use, principles of operation, and technological characteristics (including biocompatibility and physical performance tests). It does not present a detailed clinical study with specific acceptance criteria and efficacy performance data in the way an AI or diagnostic device submission might. The "clinical tests" mentioned appear to be more geared towards safety and specific indications (like radiation dermatitis) rather than comprehensive efficacy endpoints for all listed indications.

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