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The Stryker T4 Hytrel Zipper Toga is a component of a personal protection system that is intended to provide a barrier between the operating environment and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.

The Stryker Personal Protection Systems include a self-contained ventilation helmet, a hood, a toga, rechargeable battery, and accessories.

The provided text describes a 510(k) summary for a surgical garment, the Stryker T4 Hytrel Zipper Toga. This document outlines the device's equivalence to previously cleared devices rather than presenting a study proving performance against specific acceptance criteria in the manner typically seen for AI/ML or diagnostic devices.

Therefore, many of the requested categories related to AI/ML or diagnostic device studies (like sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of submission.

However, the submission does refer to performance tests demonstrating equivalence, which can be interpreted as meeting acceptance criteria by showing it is "equivalent to or better than" a predicate device.

Here's the information extracted and adapted to the context of this device:

1. Table of Acceptance Criteria and Reported Device Performance

*The acceptance criteria are inferred from the claim of equivalence to the predicate device and the battery of tests performed.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the summary. The document states that the material was "shown to be equivalent to or better than" the predicate device's material, but it does not detail the specific sample sizes used for the penetration, resistance, or flammability tests. Given the nature of material testing, the "test set" would refer to samples of the material itself, not patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This is not applicable. The "ground truth" for material performance is established through standardized laboratory testing methods, not expert consensus in the human health sense.

4. Adjudication Method for the Test Set

This is not applicable. Material performance tests follow established protocols and produce objective measurements, rather than requiring expert adjudication.

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

This is not applicable. This device is a surgical garment and does not involve AI or human readers for diagnostic interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable. This device is a surgical garment and does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through standardized laboratory material testing (e.g., viral penetration, synthetic blood penetration, water resistance, flammability, tear resistance) against the performance characteristics of an already legally marketed and accepted predicate device.

8. The Sample Size for the Training Set

This is not applicable. This device is a surgical garment and does not involve AI/ML requiring a training set.

9. How the Ground Truth for the Training Set was Established

This is not applicable. This device is a surgical garment and does not involve AI/ML.

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