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For the local management of pressure ulcers, stasis ulcers, 1st and 2nd degree burns, and full and partial thickness wounds.

The Dermaplex Hydrogel Wound Dressing is a solid hydrogel dressing covered with a polyester liner which is removed prior to application. The product is available in three sizes (3" × 3", 5" , and 6" × 10") and is supplied sterile in sealed aluminum/plastic laminate pouches.

The provided text is a 510(k) summary for the Dermaplex Hydrogel Wound Dressing. It describes the device, its intended use, and comparison to a predicate device.

However, this document does not contain the information required to answer your request about acceptance criteria and a study proving the device meets those criteria.

Specifically, the text does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for testing or data provenance. The only tests mentioned are "primary dermal irritation test in rabbits," "sensitization test in guinea pigs," and "USP Cytotoxicity Test (Agarose Diffusion)," but no sample sizes or detailed results are provided.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Information about a standalone performance study. The phrase "standalone" usually refers to algorithm-only performance in AI device studies, which is not applicable here as this is a physical wound dressing.
7. Type of ground truth used.
8. Sample size for the training set.
9. How the ground truth for the training set was established.

The document primarily focuses on administrative details, a brief device description, and a statement of substantial equivalence to a predicate device based on composition, function, and intended use, rather than a detailed performance study with acceptance criteria.

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For the local management of pressure ulcers, stasis ulcers, 1st and 2nd degree burns, and full and partial thickness wounds.

The Dermaplex Hydrogel Wound Dressing consists of a 12-ply cotton gauze pad dressing impregnated with a clear, viscous hydrogel. The product is available in four sizes (2" x 2", 4" x 4", 4" x 8" and 6" x 10") and is supplied sterile in sealed aluminum/plastic laminate pouches.

This 510(k) summary (K962439) for the Dermaplex Hydrogel Wound Dressing does not contain any information about acceptance criteria, device performance metrics, or a study proving the device meets specific criteria related to clinical effectiveness or diagnostic accuracy.

The summary focuses on:

• Administrative details: Submitter, contact, date, device name.
• Device description: Composition, sizes, sterility, and biocompatibility testing (which is a safety assessment, not a performance study in the context of clinical outcomes).
• Intended use: The types of wounds the dressing is meant to treat.
• Comparison to predicate device: Stating similarity in composition, function, and intended use to a previously cleared device (MPM GelPad). This is the basis for claiming substantial equivalence, implying it is "as safe and effective" as the predicate.

Therefore, I cannot provide the requested information, particularly items 1 through 9, because the provided text does not include any clinical study data or performance metrics for the Dermaplex Hydrogel Wound Dressing itself, beyond biocompatibility tests. The device's claim of safety and effectiveness is based on its similarity to a predicate device, not on a new study demonstrating specific performance criteria.

To answer your questions, such information would need to be present, detailing a study that measured outcomes for the Dermaplex Hydrogel Wound Dressing against defined acceptance criteria.

Ask a specific question about this device