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The Fluidshield* 2 Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. The Fluidshield* 2 Surgical Mask is a single use, disposable device, provided non-sterile.

The Fluidshield* 2 Procedure Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. The Fluidshield* 2 Procedure Mask is a single use, disposable device, provided non-sterile.

The subject device(s) are ASTM Level 2 Surgical and Procedure Mask(s). Fluidshield* 2 Surgical Mask(s), Fluidshield* 2 Procedure Mask(s) family of products are a four-layer mask, constructed of well-known non-woven materials used in facial protection. The Surgical Masks are provided with ties while the Procedure Masks are provided with earloops and a malleable nosepiece.

The Fluidshield* 2 Surgical Mask(s), Fluidshield* 2 Procedure Mask(s) family will be provided in designs with and without a protective visor. The Fluidshield* 2 Surgical Mask(s), Fluidshield* 2 Procedure Mask(s) family are single use, disposable devices, provided non-sterile.

The provided document is a 510(k) Premarket Notification for medical devices, specifically surgical and procedure masks. It describes non-clinical performance testing to demonstrate substantial equivalence to a predicate device, rather than a study proving the device meets acceptance criteria derived from clinical performance. Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set sample size, ground truth for training set) are not applicable or cannot be extracted from this document as it pertains to a different type of evaluation.

However, I can extract information related to the acceptance criteria and reported device performance from the non-clinical testing section.

1. Table of acceptance criteria and the reported device performance:

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

• Sample size used for the test set: Not specified in the provided document. The document refers to "testing" the proposed device(s) but does not detail the number of units or samples tested for each criteria.
• Data provenance: Not explicitly stated, but these are non-clinical (laboratory) tests performed on the device by the manufacturer as part of the 510(k) submission process. It's retrospective in the sense that the testing was completed before the submission.

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

• Not applicable. This document describes non-clinical performance testing against established standards, not a study involving expert-established ground truth for a diagnostic device.

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

• Not applicable. This pertains to expert review for diagnostic studies, not laboratory performance testing of physical characteristics.

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 510(k) submission for surgical and procedure masks, not an AI-assisted diagnostic device.

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

• Not applicable. This is a 510(k) submission for surgical and procedure masks, not an algorithm.

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

• For the non-clinical tests, the "ground truth" is defined by the established international and national standards (e.g., ASTM F2100, ASTM F2101, EN 14683, ISO 10993 series). The device's performance is measured against the quantitative or qualitative criteria set forth in these standards.

8. The sample size for the training set:

• Not applicable. This document describes material and physical performance testing of a physical device, not a machine learning algorithm that requires a training set.

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

• Not applicable for the same reason as above.

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