(238 days)
Under the management of a healthcare professional, PolyPlex Wound Dressing is intended for the management of first and second degree burns, venous stasis ulcers, diabetic ulcers, partial and full thickness wounds, donor sites, postsurgical incisions, trauma wounds, and abrasions. It can be used during wound dressing changes to soften encrusted wound dressings.
PolyPlex Wound Dressing is an amorphous, odorless, petrolatum-based emulsion intended to maintain a moist environment that is conducive to healing. The product contains the preservatives polyhexamethylene biguanide (PHMB) and benzalkonium chloride (BZK) to prevent microbial colonization within the dressing.
The provided text is related to the FDA 510(k) clearance for the PolyPlex Wound Dressing. This document is a regulatory submission for a medical device and, as such, focuses on demonstrating substantial equivalence to existing predicate devices based on design, materials, and intended use.
The document does not contain information about:
- A table of acceptance criteria and reported device performance in the context of a diagnostic or algorithmic device.
- Sample sizes for test sets, data provenance, or details about training sets.
- The number or qualifications of experts used to establish ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or human-in-the-loop performance.
- Standalone algorithmic performance.
- Specific types of ground truth (e.g., pathology, outcomes data).
Instead, the document focuses on biocompatibility testing to demonstrate safety, which is typical for a wound dressing.
Here's what the document does provide relevant to "acceptance criteria" and "study":
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implicit for safety) | Reported Device Performance |
|---|---|
| Non-cytotoxic | Product is non-cytotoxic |
| Non-sensitizing | Product is non-sensitizing |
| Non-irritating | Product is non-irritating |
2. Sample size used for the test set and the data provenance: Not applicable to the type of testing performed (biocompatibility). The document refers to "biocompatibility trials" per ISO 10993. These trials involve specific protocols for in vitro and in vivo testing on biological systems, not a "test set" of clinical data in the context of an AI/diagnostic device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Biocompatibility testing relies on standardized laboratory procedures and scientific assessment, not expert consensus for ground truth on clinical images/data.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is not a diagnostic device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This is a physical wound dressing, not an algorithm.
7. The type of ground truth used: For biocompatibility, the "ground truth" is defined by the specific biological responses observed in standardized tests, such as cell viability (for cytotoxicity), skin reaction (for sensitization/irritation), as per ISO 10993 standards.
8. The sample size for the training set: Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable.
Study that proves the device meets the acceptance criteria:
The study referenced is "biocompatibility trials" conducted "per ISO 10993." This refers to a series of international standards for the biological evaluation of medical devices. These standards specify how to assess cytotoxicity, sensitization, irritation, and other biological effects to ensure a device is safe for patient contact. The document states that the product passed these tests, meaning it was found to be non-cytotoxic, non-sensitizing, and non-irritating.
In summary, this document is a 510(k) clearance for a physical wound dressing, not an AI or diagnostic device. Therefore, many of the typical questions regarding AI/ML performance studies, expert ground truth, and clinical test sets are not relevant to this submission. The core performance evaluation here is focused on the device's biocompatibility and safety, demonstrated through adherence to ISO 10993 standards.
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