(316 days)
PriMatrix Ag Antimicrobial is intended for the management of wounds that include:
- Partial and full thickness wounds
- Pressure, diabetic, and venous ulcers
- Second-degree burns
- Surgical wounds-donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence
- Trauma wounds-abrasions, lacerations, and skin tears
- Tunneled/undermined wounds
- Draining wounds
PriMatrix Ag Antimicrobial is an acellular dermal tissue matrix derived from fetal bovine dermis. PriMatrix Ag Antimicrobial is supplied sterile in a variety of sizes that can be trimmed by the surgeon to meet the individual patient's needs. The Ionic Silver content is intended to prevent microbial colonization of the device.
The provided text describes a 510(k) premarket notification for a medical device called PriMatrix Ag Antimicrobial Dermal Repair Scaffold. The submission focuses on establishing substantial equivalence to legally marketed predicate devices and demonstrates biocompatibility and antimicrobial effectiveness.
However, the document does not contain information related to a study that establishes acceptance criteria for its performance in the context of diagnostic accuracy, such as sensitivity, specificity, or AUC, as would be common for AI/ML-driven diagnostic devices. The device described is a dermal repair scaffold with antimicrobial properties, not an AI/ML diagnostic tool. Therefore, many of the requested categories (e.g., test set sample size, ground truth establishment, MRMC studies, standalone performance) are not applicable to the type of device being described.
Based on the provided information, I can extract the following:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a dermal repair scaffold and not a diagnostic device, the "acceptance criteria" discussed are largely related to biocompatibility and antimicrobial effectiveness, rather than diagnostic performance metrics like sensitivity or specificity.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Demonstrated biocompatibility through independent certified laboratory testing. Tests included: cytotoxicity, hemolysis, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, implantation, and pyrogenicity. |
| Viral Inactivation | Manufacturing methods tested by an independent laboratory to assure safe levels of viral inactivation. |
| Antimicrobial Effectiveness (In Vitro) | Effective against a range of bacteria in CLSI Disc Susceptibility testing, including: Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli, Methicillin Resistant Staphylococcus aureus (MRSA), Enterococcus faecium, Klebsiella pneumonia, Serratia marcescens, Listeria monocytogenes, Vancomycin Resistant Enterococcus faecalis (VRE), Acinetobacter baumanni, and Streptococcis pyrogenes (Group A). |
| Antimicrobial Effectiveness (In Vivo) | In a rodent model, reduced levels of Staphylococcus aureus recovered from a contaminated wound site from ten million to no viable bacteria recovered on PriMatrix AG Antimicrobial or at the wound site within three days. |
Regarding the other requested information:
- 2. Sample size used for the test set and the data provenance: Not applicable. The studies described are laboratory and animal model tests, not human diagnostic test sets.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic accuracy is not relevant here. Ground truth for antimicrobial effectiveness was established through standard microbiological and animal model assays.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 device is not an AI/ML-assisted diagnostic tool.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For biocompatibility, the ground truth was established by standard toxicology and biological safety testing methods. For antimicrobial effectiveness, the ground truth was established by microbiological culture (CLSI Disc Susceptibility testing) and bacterial enumeration in an animal model.
- 8. The sample size for the training set: Not applicable. This is not an AI/ML device.
- 9. How the ground truth for the training set was established: Not applicable.
In summary, the K100261 submission for PriMatrix Ag Antimicrobial is for a biological wound care product with antimicrobial properties, not an AI/ML-driven diagnostic medical device. Therefore, the typical "acceptance criteria" and "study" details requested for AI/ML devices (like sensitivity, specificity, test/training sets, expert adjudication, MRMC studies) are not present in this document. The provided text details the device's biocompatibility and antimicrobial efficacy through laboratory and animal model testing to demonstrate its safety and function.
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