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OTC: For minor wounds, ulcerations and burns, abraded skin, and irritated areas.

Professional: Intended in the management of:

• diabetic foot ulcers;
• leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology);
• pressure ulcers/sores (partial and full thickness);
• 1st and 2nd degree partial thickness burns;
• grafted and donor sites and traumatic and surgical wounds.

Activon Tulle is a sterile wound care dressing for use in moist wound management. Activon Tulle is offered as 2x2 inch and 4x4 inch non-adherent knitted viscose primary dressing impregnated with 100% Manuka honey for effective wound treatment.

The provided text does not contain information about acceptance criteria or a study proving that the device (Activon Tulle) meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity.

Instead, the document is a 510(k) summary for a medical device (Activon Tulle) and its FDA clearance letter. It focuses on demonstrating substantial equivalence to an existing predicate device (Medihoney Dressings With Active Manuka Honey) for its intended use, rather than presenting a performance study against predefined acceptance criteria for the device's efficacy.

Here's a breakdown of what the document does include, and why it doesn't fit the requested format:

• Device Description and Intended Use: Clearly defines what Activon Tulle is and what types of wounds it is intended to manage.
• Technological Characteristics and Substantial Equivalence: Compares Activon Tulle's characteristics to its predicate device, highlighting similarities and minor differences (e.g., 100% Manuka honey in Activon Tulle vs. Manuka honey with calcium alginate in the predicate). This is the core of a 510(k) submission.
• Assessment of Performance Data and Safety: Mentions "Biocompatibility testing (cytotoxicity, sensitization and irritation) performed with Activon Tulle demonstrates that the dressing is safe for its intended use." This is about safety, not performance against clinical efficacy metrics.
• FDA Clearance Letter: Confirms that the FDA has reviewed the 510(k) submission and determined the device to be substantially equivalent to previously cleared devices.

Therefore, I cannot provide the requested table and study information because it is not present in the provided text. The document describes a regulatory submission pathway (510(k)) that focuses on substantial equivalence for market clearance, which typically does not require extensive clinical efficacy studies with predefined acceptance criteria as would be expected for novel or high-risk devices.

To summarize, for each of your requested points:

1. A table of acceptance criteria and the reported device performance: Not provided. The document focuses on substantial equivalence rather than performance metrics.
2. Sample sized used for the test set and the data provenance: Not provided. No clinical performance study data is included. Biocompatibility testing is mentioned, but no details on sample size or data provenance are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. No clinical performance study requiring expert ground truth is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/Not provided.
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/Not provided. This device is a 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/Not provided.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable/Not provided.
8. The sample size for the training set: Not applicable/Not provided.
9. How the ground truth for the training set was established: Not applicable/Not provided.

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