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Surgical gown 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 Level 2 standard surgical gowns met the requirements for Level 2 classification, the Level 3 standard surgical gowns and Level 3 reinforced surgical gowns met the requirements for Level 3 classification.

The proposed devices 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. The proposed devices are single use, disposable medical devices and are provided in sterile.

There are three types of surgical gown: Level 2 standard surgical gown, Level 3 standard surgical gown and Level 3 reinforced surgical gown. And each type of surgical gown is available in seven product sizes, including XS, S, M, L, XL, XXL and XXXL. The barrier protection level for Level 2 standard surgical gown meets AAMI Level 2, while the barrier protection level for Level 3 standard surgical gown and Level 3 reinforced surgical gown meet AAMI Level 3.

Acceptance Criteria and Device Performance Study for Surgical Gowns (K211422)

This document describes the acceptance criteria and the studies performed to demonstrate that the Jiangsu Medplus Non-woven Manufacturer Co., Ltd. Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, and Level 3 Reinforced Surgical Gown meet these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes for each non-clinical test. However, it indicates "the test sample" for each test, implying that a representative sample for each product type (Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown) was used for testing.

The data provenance is for the proposed device (K211422). Based on the manufacturer and correspondent information (Jiangsu Medplus Non-woven Manufacturer Co., Ltd. located in China, and Mid-Link Consulting Co., Ltd. in China), the data is most likely generated in China. The studies are retrospective in the sense that they were conducted on already manufactured devices to demonstrate compliance with standards.

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

This information is not applicable as the studies conducted are non-clinical performance and biocompatibility tests for medical devices (surgical gowns). These tests rely on standardized methodologies (e.g., AATCC, ASTM, ISO, CFR) and objective measurements rather than expert human interpretation for establishing ground truth. The "ground truth" is defined by the parameters and thresholds set by recognized international and national standards for medical device performance.

4. Adjudication Method for the Test Set

This information is not applicable as the studies are non-clinical laboratory tests with objective, measurable outcomes. There is no human adjudication process involved in comparing different interpretations of results. The results are compared directly against predefined numerical or qualitative acceptance criteria from the specified standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-assisted interpretation devices to assess human reader performance with and without AI. The devices in question are surgical gowns, and their effectiveness is evaluated through physical and material property tests rather than clinical diagnostic interpretation.

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

This information is not applicable. The device is a surgical gown, not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm without human involvement does not apply.

7. The Type of Ground Truth Used

The "ground truth" for the test results is established by the specified, internationally recognized performance standards (e.g., 16 CFR Part 1610, AATCC 127: 2017, AATCC 42: 2017, ASTM D5034: 2009(2017), ASTM D5587: 2015(2019), ISO 9073-10: 2003, ASTM D737: 2018, ISO 11135:2014 Annex B, ISO 10993-5: 2009, ISO 10993-10: 2010). These standards define the quantitative and qualitative requirements for surgical gown performance and biocompatibility.

8. The Sample Size for the Training Set

This information is not applicable. Surgical gowns are physical medical devices, not AI or machine learning models that require a "training set."

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

This information is not applicable as there is no training set for this device.

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