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The Aplion Topical Care System is an occlusive wound dressing which is intended to provide a moist wound healing environment to facilitate the normal wound healing process. It also permits the introduction of topical wound treatment solutions and suspensions.

An occlusive wound dressing is a nonresorbable, sterile or non-sterile device intended to cover a wound, to provide or support a moist wound environment, and to allow the exchange of gasses such as oxygen and water vapor through the device. It consists of a piece of synthetic polymeric material, such as polyurethane, with or without an adhesive backing (21 CFR 878.4020).

The Aplion Topical Care System ("Aplion System") consists of an occlusive wound dressing, a tubeset connection, and a small fluid-delivery component.

The provided text is related to a 510(k) premarket notification for an occlusive wound dressing, the "Aplion Topical Care System." It describes the device, its indications for use, and a statement about its safety and biocompatibility.

Crucially, the document does not describe a study involving device performance metrics, acceptance criteria, or any AI/algorithm-related elements. This submission is for a Class I, 510(k) exempt device, where the FDA review focused on substantial equivalence to predicate devices rather than clinical performance trials with specific acceptance criteria.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets, data provenance, or expert details for ground truth.
3. Adjudication methods.
4. MRMC comparative effectiveness studies or effect sizes.
5. Standalone algorithm performance.
6. Details about training sets or how their ground truth was established.

The document explicitly states: "As a Class I, 510(k) exempt device, FDA review of the Aplion System is not necessary; nonetheless the materials used in the Aplion System were chosen for their biocompatibility, function, and suitability for the intended use of the device. Biocompatibility testing of the entire system was completed according to ISO 10993-1 and 510(k) Memorandum G95-1."

This indicates that the "study" demonstrating the device meets criteria was focused on biocompatibility testing against established ISO standards, not a comparative performance study with an AI component or clinical endpoints that would typically have the acceptance criteria and detailed study information requested. The acceptance criteria would be compliance with ISO 10993-1 for biocompatibility.

Absence of information for the requested fields:

• 1. A table of acceptance criteria and the reported device performance: Not present. The standard for acceptance was substantial equivalence to predicate devices (K020781 and K060046) and compliance with ISO 10993-1 for biocompatibility. No specific performance metrics (e.g., healing rate, infection reduction) or their acceptance criteria are reported.
• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not present. Biocompatibility testing generally uses laboratory samples or animal models, not a "test set" in the context of clinical performance.
• 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 for this type of submission. Ground truth for biocompatibility is based on standardized assay results.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: 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 device is an occlusive 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 (expert concensus, pathology, outcomes data, etc): For biocompatibility, the "ground truth" would be the results of standardized biological tests as per ISO 10993-1.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

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