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The Convertors®SMS Polyolefin Gowns are devices intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material.

The standard, fabric- and poly-reinforced gowns are comprised of a single layer of SMS Polyolefin fabric. The fabric-reinforced gowns have an additional layer of SMS Polyolefin fabric in the sleeve and body areas; the poly-reinforced gowns have an additional layer of polyolefin film in the sleeve and body areas.

The provided text describes the 510(k) summary for the Convertors®SMS Polyolefin Gowns, detailing its intended use, substantial equivalence, and summary of testing. However, it does not include detailed acceptance criteria or the specific study results proving the device meets those criteria in the format requested (e.g., specific performance metrics, sample sizes for test/training sets, expert qualifications, or adjudication methods).

The information provided focuses on the regulatory submission and biocompatibility testing, not a performance study in the context of AI/medical imaging device evaluation.

Therefore, I cannot populate the table or answer most of the questions as the necessary information is not present in the provided text.

Based on the provided text, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document states that "All materials used... were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 'Biological Evaluation of Medical Devices'." It concludes that these materials "have met the requirements of the guidance and were found to be acceptable for the intended use." Specific quantitative acceptance criteria or detailed results for these tests (e.g., specific scores or thresholds) are not provided in this summary. The comparison to the predicate device mentions "the performance attributes are the same," but these attributes are not elaborated upon.

Missing Information/Not Applicable Based on Provided Text:

• 2. Sample sized used for the test set and the data provenance: Not applicable. This refers to biocompatibility testing, not a dataset for an algorithm. The sample size for material testing is not specified.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Biological testing relies on laboratory standards, not expert radiologists/medical practitioners for ground truth.
• 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 a surgical gown, not an AI 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 (expert consensus, pathology, outcomes data, etc): For biocompatibility, the ground truth would be established by the adherence to ISO 10993-1 standards and the results of laboratory tests.
• 8. The sample size for the training set: Not applicable. The device is a physical product, not an AI model.
• 9. How the ground truth for the training set was established: Not applicable.

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