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The Arthrex ProWick™ Postoperative Wound Dressing is indicated for the management of post-surgical wounds and the silver component present in the dressing may act as a barrier to colonization of E coli, S aureus, A. niger, C. albicans, and P. aeruginosa within the dressing.

The ProWick device is a post-surgical antimicrobial wound dressing containing a variety of elements such as elastic straps, waterproof bandages, dressing, foam islands infused with a silver based antimicrobial agent, and a reusable cold pack, sold sterile.

The provided document is a 510(k) summary for the Arthrex ProWick device, which is a post-surgical antimicrobial wound dressing. The submission is a "SPECIAL 510(k)" specifically to obtain clearance for the ProWick device with a two-year shelf-life labeling, a modification to the previously cleared K072378 device.

The document does not contain any information about a study involving acceptance criteria or reported device performance in relation to clinical effectiveness or comparison with human readers for an AI/algorithm-based device. This is because the ProWick is a physical medical device (wound dressing), not an AI or diagnostic software.

Therefore, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable for this type of submission. The "performance" being evaluated is related to shelf-life, not a clinical diagnostic performance.
2. Sample size used for the test set and the data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method 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.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary of Device Acceptance Criteria (based on the provided text):

The acceptance criteria for this specific 510(k) submission revolve around demonstrating substantial equivalence to the predicate device (Arthrex ProWick, K072378) for the purpose of a two-year shelf-life labeling.

The document states:
"The ProWick device is substantially equivalent to the predicate ProWick device in which the basic features and intended uses are the same. Any differences between the ProWick device and the predicate ProWick device is considered minor and do not raise questions concerning safety and effectiveness. Based on the information submitted, Arthrex, Inc. has determined that ProWick with two-year shelf-life labeling is substantially equivalent to the currently marketed predicate device."

This indicates that the primary acceptance criterion for this 510(k) was to provide sufficient data (likely stability testing and packaging integrity data, though not detailed in this summary) to support the safety and effectiveness of the device with a two-year shelf-life, demonstrating that this change does not alter its substantial equivalence to the previously cleared device. The "reported device performance" in this context would likely be the successful completion of such stability testing to justify the extended shelf-life, which the FDA has accepted by granting clearance.

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