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The HALYARD* FLUIDSHIELD* N95 Particulate Filter Respirator and Surgical Mask family is intended for use by operating room personnel and other health care workers to protect both the patients and the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials.

Respirator consisting of nonwoven inner facing, filter media(s), a fluid barrier film, and an outer facing. It covers the nose and mouth of the wearer and is held in place with two synthetic elastic headbands, conforming to the curvature of the wearer's nose with a malleable nosepiece

The provided text is a 510(k) Summary for a medical device (HALYARD* FLUIDSHIELD* N95 Particulate Filter Respirator and Surgical Mask family). It describes the device, its intended use, and its performance against pre-defined acceptance criteria through non-clinical testing. It does not involve any clinical studies, expert-based ground truth, or MRMC comparative effectiveness studies as it's a device clearance for a respirator mask, not an AI/software-based medical device.

Therefore, many of the requested elements are "Not Applicable" (NA) for this type of submission.

Here's the information extracted from the text:

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 specify the exact sample sizes used for each non-clinical test (e.g., number of masks tested for filtration efficiency or breathability). The testing is non-clinical bench testing, not involving human subjects or clinical data in the traditional sense. Data provenance is not specified but is typically internal lab testing by the manufacturer or contracted labs.

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):
Not applicable. This is for a physical medical device (respirator mask) and involves non-clinical bench testing, not expert-based ground truth from medical professionals.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is for a physical medical device (respirator mask) and involves non-clinical bench testing, not expert 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:
Not applicable. This is for a physical medical device (respirator mask), not an AI/software-based device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is for a physical medical device (respirator mask), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" here refers to established technical standards and test methods (e.g., NIOSH certification requirements for filtration, ASTM F1862 for fluid resistance, ISO 10993 standards for biocompatibility). The device's performance is compared against these objective criteria rather than expert consensus or pathology.

8. The sample size for the training set:
Not applicable. This is for a physical medical device (respirator mask). The concept of a "training set" is not relevant here as there is no algorithm being trained.

9. How the ground truth for the training set was established:
Not applicable. There is no training set for a physical respirator mask.

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