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This device is intended to be used as protective coverings used to isolate incision sites and protect against contamination during surgical procedures.

International Medsurg Connection Surgical Drape.

This document, K050538, is a 510(k) Premarket Notification for a Surgical Drape. It describes the device's intended use and claims substantial equivalence to a predicate device.

Crucially, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, as it is related to a physical medical device (surgical drape) and not an AI/software-as-a-medical-device (SaMD).

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and the reported device performance: This type of data is not applicable to a surgical drape's 510(k) submission, which focuses on material properties, sterility, and substantial equivalence.
2. Sample size used for the test set and the data provenance, etc.: Not applicable. Performance testing for drapes typically involves laboratory tests for barrier properties, fluid resistance, etc., not a "test set" in the context of AI/SaMD.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method 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.
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 consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

This 510(k) submission confirms that the International Medsurg Connection Surgical Drape (specifically Angiography & Cardiovascular Drapes) is "substantially equivalent" to Surgical Drapes, Reference K030365 owned by DeRoyal Industries. The basis for this equivalence would be similarity in materials, design, intended use, and performance claims regarding barrier properties and safety, typically demonstrated through standardized physical and biological testing, not clinical studies with "ground truth" or "expert consensus" in the way an AI/SaMD would be evaluated.

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