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The device is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

Barrier® N95 Particulate Respirators. Models #4273 are NIOSH certified (TC-84A-4350), trapezoid shaped respirators. Barrier® N95 Particulate Respirators, Models #4273 consists of a flat folded disposable face mask that is a piece of three layered non-woven fabric folded in two. An aluminum filament is enclosed in a binding tape welding the top edge, which forms a conformable nose clamp for the purpose of shaping the mask to the contours of the face. It features elastic head bands, ultrasonically welded, to secure the masks in place for the wearer.

Here's a breakdown of the acceptance criteria and the study information for the Barrier® N95 Particulate Respirators, Models #4272 and #4273, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are established by various standards and NIOSH certifications. The document states that the device "meets the requirements" of these standards and certifications.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set for each characteristic. It refers to meeting the requirements of established standards and NIOSH certifications. For example, for Fluid Resistance, it states it meets ASTM F1862, which would have its own defined sample sizes for testing. The data provenance is not explicitly mentioned as a specific "country of origin" for testing, but given the applicant is a US LLC and the submission is to the FDA, it is likely that testing adhered to US regulations or internationally recognized standards. The study appears to be retrospective in the sense that it relies on existing standardized tests and certifications rather than a new prospective clinical trial.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. The "ground truth" for the performance characteristics is established by the methods, parameters, and pass/fail criteria defined within the referenced standards (e.g., ASTM F1862, NIOSH TC 84A-4350, 16 CFR 1610). These standards are developed by expert committees, but the specific number and qualifications of individuals involved in the testing that led to these results are not detailed here.

4. Adjudication Method for the Test Set

This information is not applicable in the context of this submission. The "adjudication method" usually refers to how discrepancies are resolved when multiple human readers interpret data, often in medical imaging studies. Here, the performance is measured against objective technical standards which typically have clear pass/fail criteria, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical data was required." The clearance is based on substantial equivalence to a predicate device, supported by technical performance testing.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This is not applicable as the device is a physical N95 respirator, not an algorithm or AI system. The performance evaluated is that of the physical product itself.

7. The Type of Ground Truth Used

The ground truth used is primarily objective technical standards and certifications. These include:

• ASTM F1862 (for Fluid Resistance)
• NIOSH Certification Number (TC 84A-4350 for filtration efficiency and differential pressure)
• 16 CFR 1610 Standard for Flammability of Clothing Textiles
• Implied biological reactivity testing standards (for cytotoxicity, irritation, sensitization).

8. The Sample Size for the Training Set

This is not applicable. The device is a physical product, not an AI or machine learning model 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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