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KeraStat® Gel is intended to provide a moist environment and absorb excess wound exudate. KeraStat® Gel is indicated for management of a number of partial thickness skin wounds such as: partial thickness (first and second degree) burns, severe sunburns, superficial injuries, cuts, and incisions/surgical wounds. Under the direction of a healthcare practitioner. KeraStat® Gel 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, donor sites, and grafts.

KeraStat® Gel is not indicated for full thickness (third degree) burns. This device will be available by prescription.

KeraStat® Gel is a sterile, non-implantable, water-based gelatinous (hydrogel) wound dressing intended to act as a protective covering in the management of a variety of partial thickness dermal wounds. KeraStat Gel is provided in a sterile, screw top tube for one-time use. Each tube contains 5 mL of KeraStat Gel, which contains 5% keratin protein rehydrated and polymerized in a water base, and is available by prescription from a healthcare professional.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the KeraStat® Gel device:

This document is a 510(k) summary, which focuses on demonstrating "substantial equivalence" to a predicate device, rather than proving the device meets specific performance acceptance criteria in the same way a PMA (Premarket Approval) would. Therefore, the information provided is geared towards showing similarity to an already approved device rather than standalone performance against pre-defined metrics.

1. Table of Acceptance Criteria and Reported Device Performance

Because this is a 510(k) submission based on substantial equivalence, explicit "acceptance criteria" for clinical performance metrics (like sensitivity, specificity, or improvement rates) are not typically defined or reported for the new device in the same way they would be for a novel device. Instead, the "acceptance criteria" are effectively that the new device (KeraStat® Gel) is demonstrated to be as safe and effective and performs as well as the legally marketed predicate device (Keratec Wound Dressings) through various non-clinical and clinical tests.

The document states:

• "Biocompatibility and device performance study results support the safety and effectiveness of KeraStat Gel. Biocompatibility, non-clinical, and clinical testing have confirmed that KeraStat Gel functions as intended without adverse effects."
• "KeraStat Gel is as safe and effective and performs as well as the legally marketed predicate device based on an evaluation of biocompatibility, bench, nonclinical, and clinical performance; any differences in technological characteristics outlined in Table 1 do not raise new questions about the safety and effectiveness of KeraStat Gel."

So, the "reported device performance" is essentially that it meets the safety and effectiveness profile of the predicate device, although no specific quantitative metrics are provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance

The document lists "Clinical testing: ● Repeat Insult Patch Test O - Skin Prick Test O" and "nonclinical, and clinical testing" under Performance Testing. However, it does not specify the sample size used for these clinical tests. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for any clinical or non-clinical studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable or not provided in this 510(k) summary. The clinical tests mentioned (Repeat Insult Patch Test, Skin Prick Test) are designed to assess direct physiological responses (e.g., allergic reactions) rather than requiring expert interpretation of diagnostic images or outcomes for establishing a "ground truth" in the way it might be needed for an AI/CAD decision support system. These tests are typically evaluated by qualified medical professionals (e.g., dermatologists or allergists), but the specific number and qualifications are not detailed here.

4. Adjudication Method for the Test Set

This information is not applicable or not provided. Since the primary clinical tests mentioned are patch and prick tests for biocompatibility (allergies/irritation), they don't typically involve adjudication methods like those used for expert consensus on image interpretation. The outcome of such tests is usually a direct observation of a physical reaction.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable. The KeraStat® Gel device is a wound dressing, not an AI or CAD (Computer-Aided Detection) system that assists human readers in interpreting data. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. As stated above, KeraStat® Gel is a wound dressing, not an algorithm or AI device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the biocompatibility aspects, the "ground truth" would be established by the direct physiological response observed during the Repeat Insult Patch Test and Skin Prick Test (e.g., presence or absence of a reaction) and possibly standard toxicological endpoints in animal studies. For device performance in wound healing, while not explicitly detailed how results are measured in this summary, the "ground truth" would typically relate to clinical assessment of wound healing, reduction in exudate, and absence of adverse events, observed during clinical use or in animal models (like the "Porcine thermal burn" mentioned). However, the specific methodology for establishing this in the context of clinical observations is not described.

8. The Sample Size for the Training Set

This information is not applicable or not provided. This is not an AI/ML device that requires a training set. If there were multiple studies performed, the sample sizes for participant enrollment in those studies are not detailed.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. Since this is not an AI/ML device, there is no "training set" in that context.

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