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The nPro surgical masks are intended for operating room personnel health care workers to protect both patients and healthcare workers from the transfer of microorganisms, blood and particulate materials. nPro Surgical Masks are single use, disposable devices provided non-sterile.

The nPro surgical mask meets ASTM F2100-19 Level 1 performance requirements for bacterial filtration efficiency, differential pressure, sub-micron particulate filtration efficiency, resistance to penetration by synthetic blood and flame spread.

The three-ply pleated mask fabric can be vertically adjusted to cover the user's mouth and nose. The inner and outer layers are constructed of non-woven fabric. The middle layer is constructed of melt-blown negative charge non-woven fabric and includes a flexible nose wire to the user's nose and reduce air gaps. The three layers of the mask body are collated and ultrasonically welded around the edges to enclose the filter media and nose wire. The polyester-spandex ear loops are ultrasonically welded to the mask body. All materials are not made with natural rubber latex. The nPro Surgical Masks are single use, disposable devices that are provided non-sterile in a dispensing carton.

This document is a 510(k) premarket notification for a surgical mask, not an AI-powered medical device. Therefore, the information typically requested regarding AI/ML device performance (like MRMC studies, training set details, or multiple expert ground truth establishment) is not applicable here.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the non-clinical performance testing conducted on the surgical mask to demonstrate its substantial equivalence to a predicate device.

Here's the breakdown of the relevant information provided:

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

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

• Sample Size:
  • Bacterial filtration efficiency, Differential pressure, Sub-Micron particulate filtration efficiency, Resistance to penetration by synthetic blood, Flammability Class: 32 each from 3 lots
  • Structural Integrity Failure: 23 each from 3 lots
• Data Provenance: Not specified in terms of country of origin or retrospective/prospective. The testing appears to be standard laboratory/engineering testing for product performance.

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 is not applicable as this pertains to a surgical mask and its physical performance characteristics, not an AI/ML device requiring expert interpretation of medical images or data. The "ground truth" here is established by the standardized test methods (e.g., ASTM F2101-19, EN 14683:2019, ASTM F2299-03, ASTM F1862-17, 16 CFR Part 1610, NP-TM-2019-0188-1) and their associated measurement protocols.

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

This is not applicable. Adjudication methods are relevant for human interpretation of data, typically in clinical studies or AI ground truth establishment. For physical product testing, results are typically objective measurements against defined acceptance criteria.

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. MRMC studies are for evaluating AI-assisted medical imaging devices impacting human reader performance. This document is about a surgical mask's physical performance.

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

This is not applicable. This refers to AI algorithm performance. The "standalone" performance here is the mask's ability to perform against physical and biological challenges.

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

The "ground truth" for the surgical mask's performance is established by standardized laboratory test methods defined by organizations like ASTM, EN, and CFR. These methods provide quantifiable metrics for properties like filtration efficiency, differential pressure, and resistance to synthetic blood penetration. For example, a 99.1% bacterial filtration efficiency is a direct measurement result from the ASTM F2101-19 test method, serving as its own "ground truth" against the acceptance criterion.

8. The sample size for the training set

This is not applicable. This device is a physical product (surgical mask), not an AI/ML algorithm that requires a training set.

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

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

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