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PHMB Foam Wound Dressings are indicated for use in the management of post-surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, 1st and 2nd degree burns, dermatologic disorders, other wounds inflicted by trauma and, as a secondary dressing for packed wounds.

The subject device, PHMB Foam Wound Dressing, is a polyurethane foam impregnated with Polyhexamethylene Biguanide (PHMB), an agent that protects the dressing from bacterial penetration and colonization. The foam in the dressings has a microporous hydrophilic foam structure that absorbs wound exudate and maintains a moist wound healing environment. Based on in vitro performance data, the PHMB Foam Wound Dressing provides a barrier to bacterial penetration through the dressing and the PHMB prevents colonization and proliferation of bacteria within the dressing for up to 7 days. PHMB Foam dressing, when tested in-vitro has demonstrated to be effective against the following three gram positive bacteria (MRSA, MRSE, VRE), three gram negative bacteria (Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa) and two yeast (Candida albicans, Rhodotorula mucilaginosa) challenge organisms within the dressing. The device is available in Non-border (non-adhesive) and Border (adhesive) versions. The dressing is supplied sterile in a range of sizes between 4 in squared to 64 in squared.

This is a 510(k) premarket notification for a medical device, specifically a PHMB Foam Wound Dressing. The document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed clinical study with acceptance criteria for an AI/algorithm-based diagnostic device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth for an AI device is not applicable to this document.

The document describes the device's in vitro performance against various bacteria and yeast, and biological evaluation, but these are not the type of studies relevant to the detailed AI/algorithm questions.

Here's why each specific point you asked for is not available in the provided text:

1. A table of acceptance criteria and the reported device performance: This document describes the performance of the wound dressing in terms of its ability to absorb exudate, maintain a moist environment, and prevent bacterial colonization in vitro. It does not present acceptance criteria for an AI's diagnostic performance (e.g., sensitivity, specificity, AUC).
2. Sample sized used for the test set and the data provenance: The document mentions in vitro performance data and animal testing, but not clinical test sets or data provenance in the context of an AI device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is irrelevant for a wound dressing's in vitro or animal testing.
4. Adjudication method for the test set: Not applicable for this type of device submission.
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: This relates to AI-assisted human reading, which is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI algorithm.
7. The type of ground truth used: For this device, the "ground truth" would be established through laboratory testing (e.g., bacterial inhibition, fluid absorption measurements) and biological evaluation for safety, not expert consensus or pathology on images.
8. The sample size for the training set: Not applicable as there is no AI training.
9. How the ground truth for the training set was established: Not applicable as there is no AI training.

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