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Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. This surgical gown meets the requrements of AAMI Level 3 barrier protection for a surgical gown per ANSI/A AMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Surgical Gowns are single use, disposable medical devices, provided sterile.

The proposed device Surgical Gown is model 40083, its body, sleeve and belt are made of SSMMS non-woven material, and cuff is made of cotton. The proposed device is available in XS, S, M, L, XL, 2XL, 3XL sizes. This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012. The proposed devices are disposable medical devices and provided in sterile and blue color.

This document is a 510(k) Premarket Notification from the FDA regarding a Surgical Gown. It evaluates the device's substantial equivalence to a legally marketed predicate device. The information provided is primarily focused on the physical and barrier performance characteristics of the surgical gown, not an AI/Software as a Medical Device (SaMD) product.

Therefore, most of the requested information regarding AI/SaMD performance criteria, such as "number of experts used to establish ground truth," "adjudication method," "MRMC study," "standalone algorithm performance," and "training set details," is not applicable to this submission.

However, I can extract the relevant information regarding the surgical gown's acceptance criteria and the studies proving it meets those criteria:

Device: Surgical Gown (Model 40083)
Intended Use: To be worn by operating room personnel during surgical procedures to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. It meets AAMI Level 3 barrier protection.

Acceptance Criteria and Reported Device Performance:

Details Regarding the Study:

1. Sample sizes used for the test set and the data provenance:

   • Seam Strength, Breaking Strength, Tear Strength: "Average result from 30 samples" for each test.
   • Lint and other generation: "Average result from 6 samples."
   • Water Penetration Resistance, Static Hydrostatic Resistance, EO/ECH Residual, Cytotoxicity, Irritation, Sensitization, Flammability: The specific number of samples for these tests is not explicitly stated as "X samples" in the provided text, but the results are reported as "PASS," indicating that the required sample sizes for the respective standards were met.
   • Data Provenance: The document does not specify the country of origin for the testing data (e.g., in-house testing by the manufacturer's lab in China, or third-party labs). The submission is from Ammex-Weida (Hubei) Health and Safety Products Co., Ltd in China. All studies described are non-clinical, laboratory-based tests. They are not categorized as retrospective or prospective clinical studies.

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

   • Not applicable. This is not an AI/SaMD product requiring expert-derived ground truth for diagnostic accuracy. The "ground truth" here is defined by the objective physical and chemical standards and their corresponding test methods (e.g., AATCC, ASTM, ISO).

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

   • Not applicable. This is not an AI/SaMD product. The results are from standardized laboratory tests.

4. 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 not an AI/SaMD product.

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

   • Not applicable. This is not an AI/SaMD product.

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

   • The "ground truth" for this device's performance is established by internationally recognized industry standards and test methods (e.g., ANSI/AAMI PB70:2012 for barrier performance, ASTM for material strength, ISO for biocompatibility, etc.). These standards define the quantitative and qualitative acceptance criteria for the device's physical safety and performance.

7. The sample size for the training set:

   • Not applicable, as this is not an AI/SaMD product that requires a training set.

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

   • Not applicable, as this is not an AI/SaMD product that requires a training set.

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