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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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The device is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.

The proposed devices, Standard Procedure Mask and Standard Surgical Mask, are a three-layer, singleuse, flat-pleated mask. Both the two masks have the same indications for use. The Standard Procedure Mask is an ear-loop surgical mask, and the Standard Surgical Mask is a tie-on surgical mask. The color of the proposed devices is blue. They are provided in non-sterile.

This document describes the performance testing of a medical device, specifically a Standard Procedure Mask and a Standard Surgical Mask, to demonstrate substantial equivalence to a predicate device (K153496) for FDA 510(k) clearance.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Sample Sizes: The document does not explicitly state the sample sizes used for each of the non-clinical tests (e.g., number of masks tested for BFE, PFE, etc.). It only provides the average results for some tests.
• Data Provenance: The tests were conducted to support a submission from Jiangsu Medplus Non-woven Manufacturer Co., Ltd. located in China. The data is from non-clinical laboratory testing performed on the physical samples of the medical masks. Since these are performance tests of a physical product, they are by definition prospective with respect to the testing itself, i.e., new samples are manufactured and then tested.

3. Number of Experts and Qualifications

• This document describes non-clinical performance testing of a physical device (medical mask). Therefore, it does not involve human expert consensus for establishing ground truth or evaluating diagnostic performance. The "ground truth" here is based on the standardized test methods and their defined outcomes.

4. Adjudication Method

• Not applicable. This is not a study requiring adjudication of expert opinions for ground truth. The tests are objective measurements based on standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC study was done. This document explicitly states: "No clinical study is included in this submission." The testing is purely non-clinical, focusing on the physical and performance characteristics of the mask. An MRMC study would be relevant for diagnostic imaging AI, where human readers interact with AI.

6. Standalone Performance

• The reported performance data (BFE, PFE, Differential Pressure, etc.) represents the standalone performance of the device itself, as measured by standardized laboratory methods. It's important to note that "standalone" in this context refers to the device's inherent physical properties, not an "algorithm only without human-in-the-loop performance" typical of AI devices.

7. Type of Ground Truth Used

• The "ground truth" for this device's performance is established by international and national standard test methodologies (e.g., ASTM F1862/F1862M-17, ASTM F2101-2019, ASTM F2299/F2299M-03, EN 14683:2019, 16 CFR 1610, ISO 10993 series). These standards define the procedures and acceptance criteria for classifying the mask's performance.

8. Sample Size for the Training Set

• Not applicable. This device is a physical medical mask, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The "training" for the manufacturing process would be ensuring the production consistently meets quality standards, which is demonstrated by the non-clinical tests on production samples.

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

• Not applicable. As stated above, this is not an AI/ML device requiring a "training set" with established ground truth labels by experts. The performance is assessed against established engineering and safety standards.

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