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THE SURGICAL GOWN/TOGA IS INTENDED TO BE WORN Room BOTH THE SURG PROCEDURES TO PROTE RODM PERSONAL TRANSFER OF MICROORGANIST ARTICULATE MATER MATERIAL

The Microtek gown/toga consists of a non-woven material and woven cuff material manufactured to protect the wearer and patient from contamination during various procedures throughout the clinical setting. This gown/toga is similar to other gowns/togas currently being marketed for the same intended use.

The provided text describes a 510(k) premarket notification for a surgical gown/toga. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive performance studies as might be required for a novel device. Therefore, the information provided does not fully align with all the questions typically asked about acceptance criteria and detailed study designs for AI/ML devices.

However, based on the available text, here's an attempt to answer the questions within the given context:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the exact sample sizes used for the testing of the materials or the final product. It only states that the "materials have been tested alone and together" and the "final finished product conforms" to the standards. The data provenance (country of origin, retrospective/prospective) is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided in the document. The performance evaluation relies on standardized laboratory testing (e.g., ASTM, ISO, ANSI/AAMI) for physical properties and barrier effectiveness, rather than expert judgment on a dataset.

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

This information is not applicable and not provided. The testing involves objective measurements against established standards, not subjective adjudication of cases.

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

No, an MRMC comparative effectiveness study was not done. This device is a surgical gown, not an AI/ML-powered diagnostic tool, so such a study would not be relevant.

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

This question is not applicable. The device is a physical product (surgical gown) and does not involve an algorithm or AI.

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

The "ground truth" for this device's performance is defined by the objective pass/fail criteria of the referenced industry and international standards (e.g., ASTM F1671 for viral penetration, ISO 10993-1 for biocompatibility, ANSI/AAMI PB-70:2003 for general product performance). These standards dictate the methodologies and acceptable limits for various physical and biological properties.

8. The sample size for the training set

This question is not applicable. There is no "training set" for a physical medical device like a surgical gown.

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

This question is not applicable. There is no "training set" for this device.

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