(72 days)
ConvaTec Non-Adhesive Dressing is indicated for use on moderately to heavily exuding chronic wounds such as pressure ulcers, leg ulcers and diabetic ulcers, and on moderately to heavily exuding acute wounds such as abrasions, lacerations, biopsies, and open and closed surgical wounds. The dressing may be used alone or in combination with other primary dressings to manage wound exudate.
ConvaTec Non-Adhesive Dressing is a sterile, absorbent wound dressing comprised of an absorbent pad containing acrylic polymer affixed to a hydrocolloid layer.
The provided 510(k) summary for the ConvaTec Non-Adhesive Dressing (K972062) primarily focuses on demonstrating substantial equivalence to a predicate device through comparison of design, intended use, composition, and dressing characteristics, along with biocompatibility testing. It does not include a study that establishes performance against specific acceptance criteria for diagnostic accuracy or device effectiveness in a clinical setting in the way an AI/ML device submission would.
Therefore, many of the requested elements for an AI/ML study (like sample size for test sets, ground truth methodology, expert qualifications, adjudication, MRMC studies, or standalone performance) are not applicable or extractable from this document.
Here's an attempt to answer the questions based on the available information, noting the limitations:
1. A table of acceptance criteria and the reported device performance
Based on the document, the "acceptance criteria" are implied by the requirements for substantial equivalence to the predicate device and satisfactory biocompatibility. The reported "performance" relates to meeting these equivalence and safety standards.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to ConvaTec's CombiDERM™ ACD™ in: | ConvaTec Non-Adhesive Dressing is substantially equivalent to ConvaTec's CombiDERM™ ACD™ in design, intended use, composition, and dressing characteristics. |
| - Design | Equivalent |
| - Intended Use | Equivalent |
| - Composition | Equivalent |
| - Dressing Characteristics | Equivalent |
| Biocompatibility: | ConvaTec Non-Adhesive Dressing demonstrated: |
| - Non-irritating | Non-irritating |
| - Non-cytotoxic | Non-cytotoxic |
| - Non-hemolytic | Non-hemolytic |
| - Weak allergenic potential | Weak allergenic potential |
2. Sample size used for the test set and the data provenance
Not applicable. This device is a wound dressing, not an AI/ML diagnostic device that uses a test set of data. The "test set" would be the samples used for the biocompatibility studies, but specific numbers and provenance are not detailed beyond "Biocompatibility tests for ConvaTec Non-Adhesive Dressing".
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically defined for AI/ML diagnostic studies is not relevant here. Biocompatibility testing is typically performed by laboratory scientists.
4. Adjudication method for the test set
Not applicable. No diagnostic test set requiring adjudication is described.
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 is a physical wound dressing, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical wound dressing.
7. The type of ground truth used
For the biocompatibility claims, the "ground truth" was established by standard laboratory tests and observations for irritation, cytotoxicity, hemolysis, and allergenicity. For the substantial equivalence claim, the "ground truth" was a comparison to the existing predicate device, CombiDERM™ ACD™.
8. The sample size for the training set
Not applicable. This is a wound dressing, not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a wound dressing.
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.