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DuoDERM CGF Control Gel Formula Dressing is indicated for use on chronic wounds such as pressure ulcers, leg ulcers, diabetic ulcers and on acute wounds such as surgical wounds (post-operative wounds, donor sites), traumatic wounds (minor abrasions, lacerations), burns (first and second degree), dermatological excisions. DuoDERM CGF Control Gel Formula Dressing provides a moist wound environment that is supportive of the healing process by aiding autolytic debridement and allowing nontraumatic removal of the dressing without damaging newly formed tissue.

The concept of DuoDERM CGF Control Gel Formula Dressing is not significantly different from other commercially available absorbent dressings intended to manage exudating wounds.

The provided 510(k) Premarket Notification for DuoDERM® CGF® Control Gel Formula Dressing does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically expected for a medical AI device.

This document describes a traditional medical device (a wound dressing) and its substantial equivalence to a predicate device. The review process for such devices, especially back in 1997, largely focused on demonstrating similarity to an already legally marketed product in terms of intended use, materials, and basic characteristics, rather than rigorous performance metric testing against acceptance criteria in a study format detailed for AI.

Therefore, many of the requested categories for AI device studies cannot be filled from the given text.

Here's a breakdown based on the information available in the document, and where information is missing:

The core of this submission is about substantial equivalence, meaning the device is similar enough to an existing (predicate) device that it does not raise new questions of safety or effectiveness.

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

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

• Not Applicable/Not Provided. The document references "Data/information supporting the safety of DuoDERM CGF Control Gel Formula Dressing was presented in Premarket Notification K881050" but does not detail specific sample sizes or study designs in this K973632 submission. This is not an AI device, so a "test set" in the AI sense is not relevant here.

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/Not Provided. Ground truth establishment by experts for performance metrics is not part of this type of submission for a physical wound dressing demonstrating substantial equivalence. The FDA reviewers are the "experts" evaluating the submission.

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

• Not Applicable/Not Provided. No such adjudication method is described or required for this type of device submission.

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 not an AI device.

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

• Not Applicable. This is not an AI device.

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

• Not Applicable in the AI sense. For this wound dressing, the "ground truth" for its equivalence and safety/effectiveness claims would be derived from:
  • Previous clinical data and performance of the predicate device (SignaDRESS Hydrocolloid Dressing).
  • Basic material testing, biocompatibility studies, and other standard non-clinical tests (implied by "All testing was performed in accordance with Good Laboratory Practices Regulations" and reference to K881050 for safety data).
  • Clinical experience and medical understanding of moist wound healing.

8. The sample size for the training set

• Not Applicable/Not Provided. This is not an AI device, so there is no training set in that context.

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

• Not Applicable/Not Provided. This is not an AI device.

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