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The Unico High Performance Surgical Mask and the Unico High Performance Surgical Mask with Face Shield are 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 potential exposure to blood and body fluids. The face masks are single use, disposable device, provided non-sterile.

The Unico High Performance Surgical Mask and the Unico High Performance Surgical Mask with Face Shield are composed of four layers and are flat-pleated and offers both ear loops and tie strings types. The mask materials consist of outer layer (Polypropylene Spunbond), insertion layer (Polypropylene Spunbond) and inner layer (Polypropylene Spunbond), and middle layer filter (polypropylene melt-blown). Each mask contains ear loops or tie strings to secure the mask over the user's mouth and face with nose piece to firmly fit over the nose. The mask may also contain a face shield made from a polyethylene terephthalate film, with an anti-glare strip. The face shield is adhered to the top edge of the mask to cover the upper part of the face to prevent potential exposure to blood and body fluids. The mask(s) are single use, disposable device(s), provided non-sterile.

The provided text describes a 510(k) premarket notification for a surgical mask, not an AI/ML medical device. Therefore, most of the requested information regarding AI/ML device performance, such as sample sizes for test and training sets, data provenance, expert adjudication, MRMC studies, and standalone performance, is not applicable.

However, I can extract the acceptance criteria and reported performance for the surgical mask based on the provided tables and text.

Acceptance Criteria and Device Performance for Unico High Performance Surgical Mask

Since this is a submission for a surgical mask and not an AI/ML medical device, the following points are not applicable (N/A):

2. Sample size used for the test set and the data provenance: N/A (Not an AI/ML device)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (Not an AI/ML device)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A (Not an AI/ML device)
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: N/A (Not an AI/ML device)
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: N/A (Not an AI/ML device)
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A (Not an AI/ML device)
8. The sample size for the training set: N/A (Not an AI/ML device)
9. How the ground truth for the training set was established: N/A (Not an AI/ML device)

The study proving the device meets the acceptance criteria consists of a series of performance and biocompatibility tests conducted on the Unico High Performance Surgical Mask based on relevant ASTM, ISO, EN, and CFR standards. These tests demonstrate the mask's barrier properties (PFE, BFE, Fluid Resistance), breathability (Differential Pressure), flammability, and biocompatibility (Cytotoxicity, Sensitization, Irritation). The results, as shown in the table above, meet or exceed the specified acceptance criteria for an ASTM Level 3 surgical mask.

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