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Exudating wounds, infected or non-infected including pressure ulcers, diabetic ulcers, venous stasis ulcers, arterial ulcers, 1st and 2nd degree burns, donor sites, postoperative incisions, other bleeding surface wounds, dermal lesions, trauma injuries or incisions, cuts, abrasions and general first aid.

OsmoCyte® RA Wound Dressing utilizes a powdered polymer absorbent pad contained in a non-woven mesh pillow attached to a sheet of foam polyurethane and coated with a medical grade acrylic emulsion adhesive.

The provided text describes a 510(k) submission for the OsmoCyte® RA Wound Dressing, claiming substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through quantitative metrics.

The "Assessment of Performance Data" section only states: "Biocompatibility testing has been performed as recommended in the 'International Standard for the Biological Evaluation of Medical Devices, ISO 10993-1.' These tests support the safe use of OsmoCyte® RA Wound Dressing as a wound dressing temporary in contact with breached or compromised skin." This indicates general safety testing, not performance against specific acceptance criteria.

Therefore, the requested information cannot be extracted from the given text.

Here's a breakdown of why each specific point cannot be answered:

1. A table of acceptance criteria and the reported device performance: Not provided. The document focuses on substantial equivalence to predicate devices, not on meeting predefined performance metrics.
2. Sample sized used for the test set and the data provenance: Not provided. No test set for performance is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no specific performance test set or ground truth establishment is described.
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 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.
7. The type of ground truth used: Not applicable as no specific performance evaluation with ground truth is mentioned.
8. The sample size for the training set: Not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

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