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ProgenaMatrix™ is indicated for dry and exuding partial and full thickness wounds such as: pressure (stage I-IV) and venous stasis ulcers caused by mixed vascular etiologies, diabetic ulcers, donor sites and grafts, first and second degree burns, superficial injuries, cuts, abrasions and surgical wounds.

ProgenaMatrix™ is not intended to be used on third degree burns.

ProgenaMatrix™ is a clear keratin matrix derived from human hair designed to assist wound healing by facilitating a moist wound healing environment. It is packaged in a sterile, moisture-proof, peel-open pouch containing water and propylene glycol.

The provided text is a 510(k) summary for the ProgenaMatrix™ device, a wound dressing. This document confirms the device's substantial equivalence to predicate devices based on non-clinical and biocompatibility testing, rather than a clinical study evaluating its performance in relation to acceptance criteria for diagnostic efficacy. Therefore, it does not contain the information required to populate most of the requested fields.

Here's a breakdown of what can and cannot be extracted:

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

The document does not specify quantitative acceptance criteria or device performance measurements in the context of diagnostic accuracy, as it is not a diagnostic device. It lists mechanical properties, biocompatibility tests, and clinical tests (patch and prick tests) that were conducted to demonstrate substantial equivalence to a predicate device.

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. The document describes non-clinical and biocompatibility testing, not a clinical study with a "test set" in the diagnostic sense.

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. Ground truth establishment by experts is not described for this type of device submission.

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

Not applicable. This is not a study requiring adjudication of diagnostic findings.

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. This is a wound dressing, not an AI-assisted diagnostic device.

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

Not applicable. This is a wound dressing, not an algorithm.

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

Not applicable. The "ground truth" here refers to established scientific methods for evaluating material properties, biocompatibility, and safety, not diagnostic categories.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for this type of device.

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

Not applicable.

Summary of available information (based on the provided text):

The document indicates that the ProgenaMatrix™ device underwent Non-Clinical Testing and Biocompatibility Testing to demonstrate substantial equivalence to its predicate device. This testing focused on material properties and safety.

Non-Clinical Testing evaluated:

• Tensile Strength
• Moisture Vapor Transmission Rate
• Water Transmission Rate
• Degradation Potential
• Manufacturing Residuals
• Viral Inactivation
• Protein Characterization
• Removal of Contaminants

Biocompatibility Testing included:

• Cytotoxicity
• Sensitization
• Irritation
• Acute Toxicity
• Subacute & Subchronic Toxicity (Implantation Endpoint Assessment)
• Endotoxin Testing
• Pyrogenicity
• Toxicological Risk Assessment
• Chronic Toxicity
• Genotoxicity
• Carcinogenicity

Clinical Testing (mentioned in the non-clinical testing section, which is unusual phrasing) involved:

• Repeat Insult Patch Test
• Skin Prick Test

The conclusions state that the device "has the same intended use, principles of operation and substantially equivalent technological characteristics as Keratec Wound Dressing... While ProgenaMatrix™ differs from the predicate device in the source of keratin protein (human vs. sheep), both devices share the same mode of action in that they assist in providing a moist wound healing environment." It concludes the device is "substantially equivalent with respect to safety and effectiveness to the predicate and reference devices and does not raise different questions of safety and effectiveness."

However, specific quantitative acceptance criteria or detailed results for these tests are not provided in the summary. The document focuses on the types of tests performed to establish equivalence for regulatory clearance, not detailed performance metrics against specific acceptance thresholds in the way a diagnostic study would.

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