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The Surgical 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 is a single use, disposable device, provided non-sterile.

The Surgical Masks are single use, three-layer, flat-pleated masks with ear loops and nose clip. The inner and outer layers of the mask are made of spunbond polypropylene, and the middle layer is made of meltblown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the mask by ultrasound. The ear loops are made of polyester and spandex. The nose clip is made of polyethylene and galvanized iron wire. Users can adjust the nose clip according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The size of the proposed device is 17.5cm×9.5cm. The proposed device is a Level 2 mask based on ASTM F2100-2019. The Surgical Masks are blue and provided non-sterile.

This document describes the performance testing for the Bain Medical Equipment (Guangzhou) Co., Ltd. Surgical Masks (K203524).

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 size used for each test. However, it indicates that the tests were performed in accordance with recognized international standards (ASTM, EN, CFR), which typically specify sample sizes for such evaluations. The data provenance is from non-clinical testing conducted by Bain Medical Equipment (Guangzhou) Co., Ltd., as part of their 510(k) submission to the FDA. The country of origin for the data is implicitly China, where Bain Medical Equipment (Guangzhou) Co., Ltd. is located. It is retrospective in the sense that the testing was performed and the results are being reported for regulatory submission.

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

Not applicable. This report details non-clinical laboratory performance testing of a medical device (surgical masks), not a diagnostic or AI-based device requiring human expert consensus for ground truth. The "ground truth" for these tests is established by the specified methodology and measurement against the defined acceptance criteria in the respective standards.

4. Adjudication Method for the Test Set

Not applicable, as this is laboratory performance testing against established standards, not a clinical study involving human assessment or adjudication of outcomes.

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 submission is for a medical device (surgical masks) which is evaluated through non-clinical performance testing against established standards, not through clinical comparative effectiveness studies with human readers or AI assistance.

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

Not applicable. This is not an AI/algorithm-based device.

7. The Type of Ground Truth Used

The ground truth for this device's performance is based on objective measurements and defined acceptance criteria outlined in specific industry standards and regulations (e.g., ASTM F1862, ASTM F2101, ASTM F2299, EN 14683, 16 CFR 1610). These standards dictate the methodology and expected outcomes for each performance characteristic of a surgical mask.

8. The Sample Size for the Training Set

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

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

Not applicable. This is not an AI/machine learning device.

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