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Protective gown AAMI Level 4 is intended to protect health care personnel and patients from transfer of microorganisms, body fluids and particulate material. The Protective Gowns is a single use, disposable gown provided non-sterile. The back of the gown is open and non-protective. The gown is not intended for use in the operating room.

Protective Gown AAMI Level 4

I am sorry, but the provided text from the FDA 510(k) clearance letter for the "Protective Gown AAMI Level 4" does not contain the information required to answer your request about acceptance criteria and a study proving a device meets these criteria.

The document is a regulatory clearance letter for a medical device (a protective gown), and as such, it focuses on the administrative aspects of regulatory approval, such as:

• Device name and product code
• Regulation number and name
• Regulatory class
• Date of submission and receipt
• Determination of substantial equivalence
• General controls provisions and other applicable regulations (e.g., registration, listing, labeling, GMP)
• Contact information for regulatory questions

It does not include details about:

1. Acceptance criteria table and reported device performance: This type of information would typically be found in test reports, design specifications, or a summary of safety and effectiveness (SSE) document that supports the 510(k) submission, not the clearance letter itself. For a protective gown, acceptance criteria would likely involve fluid barrier properties (e.g., AAMI Level 4 standards for liquid barrier performance), tensile strength, tear resistance, and other material properties.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study information.
6. Standalone (algorithm only) performance information.
7. Type of ground truth used.
8. Sample size for the training set.
9. Method for establishing ground truth for the training set.

These points are highly relevant to studies involving AI/ML medical devices or complex diagnostic/imaging devices, where performance metrics like sensitivity, specificity, AUC, and expert reader studies are crucial. The device in question, a protective gown, is a physical barrier device, and its performance is evaluated through standardized material testing, not typically through human reader studies or AI algorithms.

Therefore, I cannot fulfill your request based on the provided text.

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