(58 days)
Nonwoven Dressing is indicated for use in the management of light to moderately exuding acute wounds such as minor burns, superficial cuts, skin tears, lacerations and abrasions and minor irritations of the skin; and light to moderately exuding chronic wounds such as diabetic ulcers, leg ulcers and pressure ulcers.
Nonwoven Dressing is a sterile wound dressing indicated for use in the management of light to moderately exuding acute wounds such as minor burns, superficial cuts, skin tears, lacerations and abrasions and minor irritations of the skin; and light to moderately exuding chronic wounds such as diabetic ulcers, leg ulcers and pressure ulcers. Nonwoven Dressing absorbs wound exudate. The absorbent material, on hydration, forms a gel which immobilizes absorbed fluid exudate and helps prevent migration. The wound contact layer is designed to facilitate easy removal from both wet and dry wounds.
The provided text describes a 510(k) premarket notification for a "Nonwoven Dressing." This document is a regulatory submission for a medical device and, as such, outlines its intended use and demonstrates its substantial equivalence to a predicate device.
However, the provided text does not contain any information regarding specific acceptance criteria, a study proving the device meets those criteria, or any of the detailed aspects of a study typically associated with AI/ML device evaluations. This is because the device in question (a nonwoven dressing) is a physical medical device, not an AI/ML-based diagnostic or analysis tool. The "studies" mentioned are limited to comparative bench testing and biocompatibility testing against established standards for physical materials.
Therefore, it is not possible to complete the requested table and answer the study-related questions (2-9) in the context of an AI/ML device, as the provided document pertains to a traditional medical dressing.
Here's what can be extracted from the document regarding the device's performance based on the general information provided:
Table of Acceptance Criteria and Reported Device Performance (as far as discernible for a non-AI/ML device)
| Acceptance Criteria Category (Implied by regulatory pathways for traditional medical devices) | Description of Performance (from the document) |
|---|---|
| Intended Use | Nonwoven Dressing is indicated for use in the management of light to moderately exuding acute wounds (minor burns, superficial cuts, skin tears, lacerations, minor irritations) and light to moderately exuding chronic wounds (diabetic ulcers, leg ulcers, pressure ulcers). It absorbs wound exudate and forms a gel to immobilize fluid and prevent migration. The wound contact layer facilitates easy removal. |
| Substantial Equivalence (to Predicate Device) | The Nonwoven Dressing is substantially equivalent to DeRoyal's MULTIPAD™ Non-Adherent Wound Dressing in intended use, design, and function. Comparative bench testing showed the two products to be equivalent. |
| Biocompatibility | Considered to be nonsensitizing, non-cytotoxic, non-hemolytic, and a negligible irritant based on ISO 10993 Part I testing conducted in accordance with Good Laboratory Practices. |
Regarding the specific questions about AI/ML device studies:
- Sample size used for the test set and the data provenance: Not applicable. The document describes bench testing and biocompatibility testing, not a test set of data for an AI/ML model.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth in the context of AI/ML is established.
- Adjudication method for the test set: Not applicable.
- 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 not an AI/ML device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided K974823 document details a traditional wound dressing device. The "acceptance criteria" are based on its intended use, performance in comparative bench testing against a predicate, and biocompatibility, as required for a Class I/unclassified medical device. It does not involve any AI/ML components or associated studies.
§ 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.