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The Welspun Health Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The surgical face masks are intended for use in infection control practices to reduce the potential exposure to blood & body fluid. This device is disposable, non-sterile and for single use only.

Welspun Health Surgical Mask is a surgical face mask identified by Regulation 21 CFR 878.4040 under FDA product code, FXX. This medical device is offered in two colors – medical blue (Model No.: WHSM002ELB) and white (Model No.: WHSM002ELW). The Welspun Health Surqical Mask is three-layer, flat pleated mask. It is made up of three layers of non-woven polypropylene on automatic mask making machine using the ultrasonic sealing technology. The inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The proposed device is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The ear loops are made of round knitted elastic band. The nose strip contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene coated single core aluminium wire. The surgical masks are single-use, disposable devices, provided non-sterile.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Welspun Health Surgical Mask, formatted as requested:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes used for each specific performance test (e.g., number of masks tested for fluid resistance, BFE, PFE). However, for Fluid Resistance, the acceptance criteria are stated as "29 out of 32 Pass at 160 mmHg," which implies a sample size of at least 32 for that particular test.

The data provenance is not explicitly stated as "retrospective" or "prospective." The tests were conducted to demonstrate the effectiveness and safety of the device according to specified standards. Given that this is a 510(k) submission for a new device, these tests would typically be prospective and conducted specifically for this submission. The applicant is Welspun India Limited, based in India, so the testing was likely performed in India or by an accredited lab on behalf of Welspun.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is Not Applicable as the provided document describes performance testing for a surgical mask, not a diagnostic or AI device that relies on expert interpretation for ground truth. The "ground truth" for surgical mask performance is established by standardized, objective laboratory test methods (e.g., measuring filtration efficiency, fluid resistance) against predefined numerical criteria.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is Not Applicable. Adjudication methods like 2+1 or 3+1 consensus are typically used in studies involving subjective human interpretation (e.g., radiology reads) to resolve discrepancies. For the objective laboratory tests conducted on the surgical mask, there is no human interpretation requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is Not Applicable. The device described is a surgical mask, not an AI-assisted diagnostic or imaging system. Therefore, an MRMC study is not relevant.

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

This is Not Applicable. The device is a physical surgical mask, not an algorithm or software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the device's performance is established by the results of standardized laboratory tests as defined by:

• ASTM F2100-19: Standard Specification for Performance of Materials Used in Medical Face Masks
• ASTM F2101-19: Standard Test Method For Evaluating The Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials
• ASTM F2299/F2299M-03(2017): Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates
• EN 14683 (Annex C):2019: Medical Face Masks - Requirements And Test Methods (for Differential Pressure)
• ASTM F1862/F1862M-17: Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood
• 16 CFR 1610: Standard for the Flammability of clothing textiles
• ISO 10993-5:2009: Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
• ISO 10993-10:2010: Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization

These standards define the methodologies and acceptable performance thresholds that constitute the "ground truth" for the device's claims of safety and effectiveness.

8. The sample size for the training set

This is Not Applicable. The document describes a physical medical device (surgical mask) that does not involve a "training set" in the context of machine learning or AI.

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

This is Not Applicable for the same reasons as above.

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