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The 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 matter. This is a single use, disposable device, provided sterile.

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

The proposed device Surgical Gown its body, sleeve and belt are made of SMMS non-woven material, and cuff is made of cotton. The proposed device is available in S(110×130cm), M(120×140cm), L(130×150cm), XL(140×160cm), XXL(150×170cm), XXXL(155×180cm) sizes . This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012.

The proposed device Reinforced Surgical Gown is its body, sleeve and belt are made of SMMS nonwoven material, and cuff is made of cotton. The reinforced and critical zone is front chest and sleeves. This zone is reinforced with PP/PE composite breathable film. The proposed device is available in S(110×130cm), M(120×140cm), L(130×150cm), XL(140×160cm), XXL(150×170cm), XXXL(155×180cm) 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.

The provided FDA 510(k) summary for the Surgical Gown and Reinforced Surgical Gown details the device's technical specifications and non-clinical testing for substantial equivalence to a predicate device, rather than an AI/ML-driven medical device. Therefore, the information requested regarding acceptance criteria, study methodologies, and performance related to AI/ML device evaluation (such as sample sizes for test/training sets, expert consensus, MRMC studies, or ground truth establishment) is not applicable to this document.

The document focuses on the physical and barrier properties of surgical gowns. Here is a summary of the acceptance criteria and performance as presented in the non-clinical testing section:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample sizes for test set and data provenance:

• Seam strength: Reported result is an average from 30 samples.
• Breaking strength: Reported result is an average from 30 samples.
• Tear strength: Reported result is an average from 30 samples.
• Lint and other generation in the dry state: Reported result is an average from 6 samples.
• The document does not specify the country of origin of the data or whether the tests were retrospective or prospective, beyond stating "Non-clinical tests were conducted to verify that the proposed device met all design specifications."

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

• This is not applicable as the device is a physical product (surgical gown) and not an AI/ML-driven device requiring expert interpretation for ground truth. Performance is measured against established physical and chemical standards.

4. Adjudication method for the test set:

• Not applicable for physical product testing. Performance is determined by quantitative measurements against predefined criteria in laboratory settings.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• Not applicable. This type of study is relevant for AI-assisted diagnostic or interpretative devices, not for surgical gowns.

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

• Not applicable as this is not an AI/ML driven device.

7. The type of ground truth used:

• The "ground truth" for this device's performance is established by physical and chemical measurement standards (e.g., ASTM, ISO, AATCC, CPSC standards) and the specified acceptance criteria for each test. For example, a seam strength greater than or equal to 30N is the "ground truth" for acceptable seam strength.

8. The sample size for the training set:

• Not applicable. There is no AI/ML component requiring a training set.

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

• Not applicable. There is no AI/ML component or training set.

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The Disposable Surgical Face Masks are 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 a single use, disposable device(s), provided non-sterile.

The proposed device(s) are White color, and Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all has Nose Piece design for fitting the facemask around the nose. The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the proposed device(s) is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of malleable aluminum wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.

The provided document is a 510(k) premarket notification for a Surgical Face Mask. It details the device's technical characteristics, intended use, and comparison to a predicate device.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The device is evaluated against the standards for a Level 2 surgical face mask, primarily following ASTM F2100-11.

2. Sample Size and Data Provenance for Test Set

• Fluid Resistance (ASTM F1862): 32 samples were tested. The country of origin for the data is not explicitly stated but implied to be from the manufacturer's testing (Xiantao Zhibo Non-woven Products Co., Ltd in China). The data is from non-clinical performance testing.
• For other performance tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability, Biocompatibility), specific sample sizes are not provided in the summary, but the results indicate tests were conducted and met the criteria. The data provenance is non-clinical performance testing, likely conducted by or for the manufacturer.

3. Number of Experts and Qualifications for Ground Truth

This document describes technical performance testing of a physical device (surgical face mask), not an AI/software device that requires expert review for ground truth. Therefore, this section is not applicable. The "ground truth" here is established by standardized laboratory testing methods and measured physical properties.

4. Adjudication Method for Test Set

Not applicable, as this is laboratory testing of a physical product against defined standards, not an expert-driven assessment.

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

Not applicable. This is a premarket notification for a physical medical device (surgical face mask), not an AI/software device that would typically undergo MRMC studies to assess human reader improvement with AI assistance.

6. Standalone (Algorithm Only) Performance Study

Not applicable, as this is a physical medical device.

7. Type of Ground Truth Used

The ground truth is established through standardized laboratory testing protocols and measurements according to recognized consensus standards such as ASTM F2100-11, ASTM F1862, ASTM F2101, MIL-M-36954C, 16 CFR 1610, and ISO 10993 for biocompatibility. These standards define the methods and acceptance criteria for measuring specific physical and biological properties of the face mask.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/machine learning algorithm that requires a training set.

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

Not applicable. This is a physical medical device.

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