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The Medical Surgical Gowns is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the Medical Surgical Gowns met the requirements for Level 3 classification.

The proposed device is a poly-reinforced surgical gown, the critical zone is front chest and sleeves. The critical zone is reinforced with PP/PE composite laminated material and the reinforced layer is attached with the gown by ultrasonic welding. The proposed device is available in five different sizes, include S-160, M-165, L-70, XL-175, XXL-180, and XXXL-185. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the proposed devices can meet the requirements for Level 3 classification. The proposed devices are disposable medical devices and provided in sterile.

This document is a 510(k) Pre-market Notification for a medical device, specifically Medical Surgical Gowns. The information provided does not describe an AI medical device or a study involving human readers.

Therefore, most of the requested points are not applicable. I can only extract information related to the performance of the Medical Surgical Gowns based on the provided text.

Here's a summary of the information that is available:

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

The acceptance criteria are generally based on the ANSI/AAMI PB70:2012 Level 3 classification for liquid barrier performance, along with specific physical and biological properties.

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Surgical gowns are intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gowns met the requirements for Level 3 classification.

The proposed devices are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The proposed devices are single use, disposable medical devices and can be provided in sterile and non-sterile two types. Both the sterile and non-sterile surgical gowns are available in six sizes, including S, M, L, XL, XXL and XXXL. For non-sterile surgical gowns, they shall be sterilized by EO prior to use. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the proposed devices meet the requirements for Level 3 classification.

This document is a 510(k) Summary for a Surgical Gown (Sterile) and Surgical Gown (Non-sterile). It describes the device, its intended use, and a comparison to predicate devices, focusing on non-clinical testing to demonstrate substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

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

The document provides a "Technological Characteristic Comparison Table" (Table 2) that lists various performance criteria and the performance of the Subject Device (K202706). It implies that the acceptance criteria are met if the device's performance is similar to or meets the standards of the predicate devices or specified test methods.

2. Sample size 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 sample sizes used for each non-clinical test or the provenance of the data (e.g., country of origin, retrospective/prospective). It only states that "Non clinical tests were conducted to verify that the proposed device met all design specifications as was similar to the predicate device."

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 section is not applicable. The study involved non-clinical performance testing of a medical device (surgical gown), not studies requiring expert interpretation or ground truth establishment in a medical context.

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

This section is not applicable. Adjudication methods are typically used in clinical studies involving human interpretation or subjective assessment.

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 section is not applicable. No clinical studies, MRMC studies, or AI components are mentioned in this 510(k) summary.

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

This section is not applicable. The device is a surgical gown; it does not involve an algorithm or AI.

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

The "ground truth" for the non-clinical tests were established by the performance specifications outlined in recognized standards such as ANSI/AAMI PB70:2012, 16 CFR Part 1610, AATCC 127:2017, AATCC 42:2017, ISO 9073-10:2003, ASTM D1683/D1683M:2017/(R)2018, ASTM D5587:2019, ASTM D5034:2017, ASTM D737:2018, ASTM F88/F88M:2015, ASTM F1929:2015, ISO 10993-7:2008, ISO 10993-5:2009, and ISO 10993-10:2010.

8. The sample size for the training set

This section is not applicable. There is no mention of a "training set" as this is a non-clinical device performance study, not a machine learning or AI-based study.

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

This section is not applicable. As there is no training set for this type of device submission.

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