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The Medical 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 surgical 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 Medical Surgical Masks are single use, flat-pleated masks that are provided in blue. The Medical Surgical Masks are available in two types, which are Level 3 based on ASTM F2100-19. The outer and inner layers of the mask are made of spunbond polypropylene. The middle filter layer of Level 2 mask is made of one layer of meltblown polypropylene filter, and the middle filter layer of Level 3 mask is made of two layers of meltblown polypropylene filter. The nose clip is made of polyethylene (PE) and iron. 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 Level 2 masks are ear-loop masks. The Level 3 masks are available in two types, ear-loop and Tie-on. The ear loops for Level 2 and Level 3 masks are made of spandex. The ties are made of spunbond polypropylene. The ear loops/ties are held in place over the users' mouth and nose by two ear loops/ties welded to the mask.

The provided document (K210030 510(k) Summary for the Medical Surgical Mask) describes the performance and testing of a medical surgical mask, not an AI/ML powered device. Therefore, many of the questions related to AI/ML specific studies (e.g., sample size for training set, MRMC study, ground truth establishment for training, number of experts for test set ground truth) are not applicable to this submission.

However, I can extract the acceptance criteria and performance data for the medical device described.

Summary of Device Performance and Testing (Medical Surgical Mask)

The submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing against recognized standards. No clinical studies were included.

1. Table of Acceptance Criteria and Reported Device Performance

The device is evaluated against the requirements for ASTM F2100-19, which defines performance levels for medical face masks. The proposed device includes both Level 2 and Level 3 masks.

Note: The document explicitly states: "The test result for the proposed device can meet the requirements of level 2 mask and Level 3 mask." This confirms that the reported performance metrics meet or exceed the established acceptance criteria for their respective levels.

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

• Sample Size: The specific sample sizes for each non-clinical test (e.g., number of masks tested for BFE, PFE, etc.) are not explicitly provided in this 510(k) summary. These details would typically be found in the full test reports, which are part of the detailed submission reviewed by the FDA but not included in this public summary.
• Data Provenance: The tests were non-clinical (laboratory-based) and conducted to verify compliance with standards like ASTM F1862/F1862M-17, ASTM F2299/F2299M-03, ASTM F2101: 2019, ASTM F2100: 2019, and ISO 10993. The manufacturer is Tianjin Aoshang Outdoor Equipment Co., Ltd. in China, so it is highly probable that the testing was conducted in laboratories in China or by accredited labs recognized by the manufacturer. The data would be considered retrospective in the context of the 510(k) submission, meaning the tests were completed prior to the submission.

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

This question is not applicable. The device is a medical surgical mask, and its performance is evaluated through objective, standardized laboratory tests (e.g., BFE, PFE, fluid resistance) rather than through subjective interpretation by human experts establishing "ground truth" for diagnostic or AI tasks. The "ground truth" here is the objective measurement obtained by the specific test methodology.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in subjective assessments. The tests conducted for this device are objective, quantitative laboratory measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This question is not applicable. This submission is for a medical surgical mask, not an AI-powered device. Therefore, no MRMC study or AI-assisted human reader performance evaluation was conducted.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable. The device is a physical medical mask, not an algorithm or software. Its performance is inherent to the product itself, not to a computational model.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is based on objective, quantitative measurements derived from standardized non-clinical laboratory tests (e.g., ASTM F2100, F1862, F2299, F2101, etc., alongside ISO 10993 for biocompatibility). There is no "expert consensus," "pathology," or "outcomes data" in the typical sense of AI/ML or clinical trial ground truth. The "truth" is the measured physical property of the mask.

8. The Sample Size for the Training Set

This question is not applicable. This is a physical medical device, not a machine learning model. There is no "training set."

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

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

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