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Centurion® SorbaView® OTC dressings are intended for medical purposes to cover and protect wounds, hold together the skin edges of a wound, support an injured part of the body, or to secure objects to the skin.

This device is intended for lay or prescription use by pediatric or adult patients.

Sorba View® dressings are highly permeable, self-adhesive, transparent film dressings that are of multi-layer construction. The multi-layer construction consists of:

• Polyurethane film, .
• . Solvent-spun cellulose,
• . Medical grade adhesive,
• ◆ Non-woven fabric, and
• Kraft liner with silicone release coating. .

This is a 510(k) premarket notification for a medical device (dressing), not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and human/AI performance is not applicable.

The provided document describes the Centurion® SorbaView® OTC dressing and its substantial equivalence to predicate devices (Centurion® SiteGuard® Transparent Dressing K945977 and 3M Tegaderm™ + Pad K811291).

Here's a summary of the relevant information provided:

1. Acceptance Criteria and Reported Device Performance: This section is designed for AI/ML performance metrics. For this device, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices through various tests.

   Acceptance Criteria (Implied)	Reported Device Performance
   Biocompatibility: Non-cytotoxic, non-sensitizing, negligible irritant	Results of testing validate SorbaView® is non-cytotoxic, non-sensitizing, and a negligible irritant.
   Barrier effectiveness against viral contaminants	Effective against penetration of viral contaminants (ASTM F 1671-97b).
   Barrier effectiveness against blood contaminants	Effective against penetration of blood contaminants (ASTM F 1671-97b and 107098).

2. Sample Size and Data Provenance: Not applicable for a non-AI/ML device. The testing conducted was for biocompatibility and barrier effectiveness, likely using standardized laboratory samples.

3. Number of Experts and Qualifications: Not applicable. Human experts are not involved in establishing ground truth for biocompatibility or barrier effectiveness tests in the same way they would be for an AI diagnostic.

4. Adjudication Method: Not applicable.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study is for evaluating human performance with and without AI assistance, which is not relevant for a medical dressing.

6. Standalone Performance Study: Not applicable in the context of an "algorithm only" performance. The device itself (the dressing) was tested for its properties (biocompatibility, barrier effectiveness).

7. Type of Ground Truth Used: For biocompatibility, the ground truth is established by standardized biological assays. For barrier effectiveness, the ground truth is established by physical testing against viral and blood contaminants according to ASTM standards.

8. Sample Size for Training Set: Not applicable. There is no training set for a medical dressing.

9. How Ground Truth for Training Set was Established: Not applicable.

In conclusion, the provided document details the safety and effectiveness testing of a transparent film dressing, demonstrating its substantial equivalence to existing products through standardized biological and physical tests, rather than through AI/ML performance evaluation.

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