FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

3M™ Tegaderm™ Silver Nonwoven Dressing is a nonwoven dressing that contains (8 mg/gm of dressing) of silver sulfate. Silver ions released from the silver sulfate create an effective barrier. The soft, absorbent dressing is supplied sterile and may be custom cut to fit the wound. The porous, non-occlusive dressing conforms to the wound base and wicks drainage into the dressing where in vitro studies show that the silver ions may reduce the number of microorganisms, including bacteria and yeast.

AI/ML Overview

The provided text describes a medical device called "3M™ Tegaderm™ Silver Nonwoven Dressing" and its clearance through a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical trials to prove effectiveness. Therefore, the information requested in the prompt, which pertains to clinical studies, acceptance criteria, expert ground truth, and AI performance, is largely not applicable to this document.

Here's a breakdown of why and what can be inferred from the provided text:

1. A table of acceptance criteria and the reported device performance

Not Applicable. This document does not establish specific acceptance criteria for a new device's performance in a clinical setting in the way an AI/ML device would. Instead, it demonstrates substantial equivalence to existing predicate devices.
What's reported:
- Safety: Biocompatibility studies (Cytotoxicity, Intracutaneous Irritation, Skin Sensitization) were conducted and showed "No deleterious effects" and "results were comparable to or better than those reported for Acticoat™ Silver Coated Dressing."
- Effectiveness: "in vitro reduction studies against a known number of microorganisms, such as gram-negative and gram-positive bacteria and yeast (Candida albicans)" were performed. The results "demonstrated that 3M™ Tegaderm™ Silver Nonwoven Dressing was substantially equivalent to Acticoat™ Silver Coated Dressing effectiveness."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not Applicable directly for clinical efficacy. The "studies" mentioned are laboratory-based (biocompatibility and in vitro antimicrobial reduction), not human clinical trials.
For biocompatibility: Standard battery of tests in rabbits (for Intracutaneous Irritation) and guinea pigs (for Skin Sensitization). The specific number of animals is not detailed.
For in vitro effectiveness: Microorganisms (gram-negative, gram-positive bacteria, and Candida albicans) were used, but specific sample sizes (e.g., number of replicates or strains) are not provided.
Data Provenance: Not specified, but generally, regulatory studies follow international standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not Applicable. No human experts were used to establish "ground truth" for clinical performance in this context. The evaluation was based on laboratory testing.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable. Adjudication methods are relevant for human expert review in clinical studies, which were not conducted for this 510(k) cleared device.

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. MRMC studies are specific to evaluating AI performance in diagnostic imaging or similar fields where human readers interpret cases. This device is a wound dressing.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a physical wound dressing, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For safety studies: Biocompatibility was assessed against established toxicological endpoints (e.g., irritation, sensitization) in animal models. The "ground truth" is the absence of adverse biological reactions.
For effectiveness studies: The "ground truth" was the quantitative reduction of microorganisms in an in vitro setting, measured against controls and the predicate device.

8. The sample size for the training set

Not Applicable. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established

Not Applicable. As above, no training set.

Summary of Device Acceptance (from the document):

The device was "accepted" or cleared by the FDA because it demonstrated Substantial Equivalence to legally marketed predicate devices (3M™ Tegaderm™ Silver Nonwoven Dressing (K040890) and Acticoat™ Silver Coated Dressing).

The study that proves the device meets the acceptance criteria (i.e., Substantial Equivalence):

The submission relies on:

Biocompatibility Studies: "A standard battery of biocompatibility studies was conducted: Cytotoxicity, Intracutaneous Irritation in rabbits, and Skin Sensitization in guinea pigs. No deleterious effects were observed with 3M™ Tegaderm™ Silver Nonwoven Dressing : results were comparable to or better than those reported for Acticoat™ Silver Coated Dressing." These results were also presented for the previously cleared 3M™ Tegaderm™ Silver Nonwoven Dressing (K040890).
In Vitro Effectiveness Studies: "3M™ Tegaderm™ Silver Nonwoven Dressing was compared with Acticoat™ Silver Coated Dressing in in vitro reduction studies against a known number of microorganisms, such as gram-negative and gram-positive bacteria and yeast (Candida albicans). The results of this study demonstrated that 3M™ Tegaderm™ Silver Nonwoven Dressing was substantially equivalent to Acticoat™ Silver Coated Dressing effectiveness." These results were also presented for the previously cleared 3M™ Tegaderm™ Silver Nonwoven Dressing (K040890).

The FDA's letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This confirms that the presented studies and comparisons adequately met the FDA's criteria for substantial equivalence.

Summary

Regulation Number and Section

N/A