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Wound contact layer dressings are indicated to provide covering for the wound bed.

For OTC applications, CicaNet* Wound Contact Layer Dressing may be used for the management of minor wounds including

• Abrasions
• Skin tears
• Minor burns and scalds

Under the care of a healthcare professional, CicaNet* Wound Contact Layer Dressing may be used in the management of partial and full thickness wounds including:

• Leg ulcers
• Pressure ulcers
• Second degree burns
• Surgical wounds
• Diabetic foot ulcers

CieaNet+ Wound Contact Layer Dressing is an air permeable, transparent, bi-axially stretched net constructed of high density polyethylene. This product is used in moist wound management of partial and full thickness wounds.

The provided text describes a 510(k) submission for the CicaNet* Wound Contact Layer Dressing and does not include information about a study based on acceptance criteria or device performance in the context of AI/machine learning. The submission focuses on demonstrating substantial equivalence to predicate devices through technological characteristics and biocompatibility testing. Therefore, I cannot provide the requested information.

Here's why each point cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not establish specific quantitative acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy) that would be relevant to an AI/ML device, nor does it report such performance metrics. The "performance" described relates to biocompatibility.

2. Sample size used for the test set and the data provenance: No test set in the context of an AI/ML model is mentioned. The biocompatibility tests used animal and cell models.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there is no AI/ML test set or ground truth establishment mentioned.

4. Adjudication method: Not applicable.

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 document is for a wound dressing, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used: For the biocompatibility studies, the "ground truth" was the observed biological response to the material (e.g., cell viability, skin irritation, hemolytic index, systemic toxicity, mortality). This is not equivalent to ground truth in the context of AI/ML performance evaluation.

8. The sample size for the training set: Not applicable. There is no AI/ML model or training set mentioned.

9. How the ground truth for the training set was established: Not applicable.

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