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UltraGard™ Blue O. R. Gown with Impervious Reinforced Chest and Sleeves is indicated for use in operating room procedures as a sterile cover garment.

The UltraGard™ Blue O. R. Gown with Impervious Reinforced Chest and Sleeves is composed of a single base layer of SMS non-woven material with reinforced areas of the chest and sleeves. The reinforced area contains an additional layer of polyester laminated to a film.

The provided text describes a 510(k) submission for a surgical gown and therefore does not include information relevant to a medical device that utilizes AI/ML or requires a study with a test set, ground truth establish by experts, or training set as described in the prompt. The "device" in this context is a physical product (a surgical gown), not a software algorithm.

Therefore, most of the requested fields are not applicable.

Here's an analysis of the provided text based on the categories you've requested, highlighting why many are not present:

Acceptance Criteria and Device Performance for UltraGard™ Blue Operating Room Gown

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified for any of the performance tests. The text refers to "the material" being tested.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). This type of information is typically not relevant for material performance testing of a physical product.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. The "ground truth" for a physical product like a surgical gown is established by performance against standardized, objective test methods (e.g., ASTM, ISO) and laboratory measurements, not by expert consensus on clinical images or data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. Adjudication methods are relevant for subjective assessments, particularly in clinical or image-based studies where different expert opinions need to be reconciled to establish a ground truth. Material performance testing relies on objective, quantifiable results from standardized laboratory procedures.

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 is a physical product (surgical gown), not a diagnostic or interpretive AI-driven device. There are no "human readers" interpreting data, nor is there an AI component.

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

• Not applicable. This refers to the performance of a software algorithm without human intervention, which is not relevant for a surgical gown.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Ground Truth Type: Objective, standardized laboratory test results against established performance criteria (e.g., measurement of synthetic blood penetration, viral penetration, flammability, biocompatibility as defined by the respective ASTM, NFPA, and ISO standards).

8. The sample size for the training set:

• Not applicable. This is a physical product, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:

• Not applicable, as there is no training set for a physical product.

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