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When properly worn, the surgical face masks are intended to patient and healthcare workers from transfer of microorganisms, body fluids and particulate matter. This device is non-sterile and for single use only.

The Nordiwell Medical Face Masks are composed of 3-layers and are flat-pleated. The mask materials consist of an outer layer (polypropylene spunbond, blue), inner layer (polypropylene spunbond white), filter (polypropylene melt-blown, white) and ear-loops. The mask contains a malleable nosepiece to provide a firm fit over the nose and then to secure the mask over the users' mouth and face. The mask is a single use, provided non-sterile. This device is not made from Natural Rubber Latex. Shelf-life of the device is 2 years.

The provided text describes the acceptance criteria and the study conducted for the Nordiwell Medical Face Mask (K202615) to demonstrate substantial equivalence to a predicate device. This is a medical device, specifically a surgical face mask, not an AI/ML powered device. Therefore, many of the requested categories in the prompt, such as those related to AI model performance, expert ground truth, adjudication methods, and training/test sets for AI, are not applicable.

Here's the information that can be extracted from the provided text, focused on the device's physical and performance characteristics:

1. Table of Acceptance Criteria and Reported Device Performance

Device: Nordiwell Medical Face Mask (K202615)

2. Sample size used for the test set and the data provenance

The document indicates that for fluid resistance testing (ASTM F1862-17), a sample size of 32 units was used for testing against the acceptance criteria of "≥29 of 32 pass". For the shelf-life accelerated aging test, 3 non-consecutive lots were used (sample size per lot not specified for each performance test, but it can be inferred that appropriate sample sizes were used for each test on these lots).

Data Provenance: The tests were conducted internally by the manufacturer, Changzhou Combat Protective Equipment Co., Ltd., in China, or by their designated testing facilities. The data is prospective, generated specifically for this 510(k) submission.

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

Not Applicable. This device is a physical medical face mask. Ground truth is established through standardized laboratory bench testing rather than expert interpretation of data.

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

Not Applicable. Adjudication methods are relevant for subjective assessments, typically in clinical or image-based studies. The performance of this device is measured using objective, standardized bench tests.

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

Not Applicable. This is a physical medical device, not an AI-powered diagnostic or assistive tool.

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

Not Applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for this device's performance is derived from objective measurements against established industry standards and regulatory criteria through bench testing (e.g., ASTM and EN standards for filtration, pressure, flammability, and ISO standards for biocompatibility).

8. The sample size for the training set

Not Applicable. This product is a physical medical device, not a machine learning model; therefore, there is no "training set."

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

Not Applicable. As there is no training set, this question is not relevant.

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