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The N95 Particulate Respirator (MF01) is single-use, disposable device, provided non-sterile, and are intended to be worn by operating room personnel or other healthcare workers to protect and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

The N95 particulate respirator (Model MF-01) is NIOSH certified (TC-84A-7697), pouched-shaped respirators when worn. The flat-folded respirator is composed of four layers-inner layer, filter (2 layers) and outer layer. The four layers are combined via ultrasonically welded. The respirator also contains a nose-piece enclosed in a binding tape welding the top edge to conform to the contours of the face. The respirator contains straps to secure the respirator in place on the wearer. The respirator is offered in white. The respirator is provided non-sterile and for single use only.

This document is a 510(k) Premarket Notification for a Master-Frank N95 Particulate Respirator. It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study of diagnostic AI. Thus, much of the requested information (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth types for AI models) is not applicable or present in this document.

However, I can extract the acceptance criteria and reported device performance from the "Non-Clinical Performance Data" and "Performance testing" sections, which are focused on the physical performance and biocompatibility of the respirator.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for each of the biocompatibility and physical performance tests. It refers to established standards (e.g., ISO 10993, ASTM F1862, 16 CFR 1610, NIOSH certification), which would have their own specified sample sizes. The data provenance is from tests conducted on the Master-Frank N95 Particulate Respirator (Model MF-01) by accredited labs for NIOSH certification and other standards. The document doesn't specify the country of origin of the testing data itself, but the manufacturer is based in China. The data is prospective as it pertains to the device being submitted for clearance.

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

Not applicable in the context of this device clearance. The "ground truth" for these tests is defined by the objective measurement criteria within the specified international standards and NIOSH certification protocols. These tests are conducted by trained technicians in certified laboratories, following stringent procedures rather than subjective expert interpretation.

4. Adjudication method for the test set

Not applicable. The tests performed are objective, quantitative measurements following standardized protocols (e.g., measuring filter efficiency, fluid penetration, flame spread). There is no "adjudication" in the sense of reconciling differing expert opinions. The results are either "pass" or "fail" against defined thresholds.

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 document is for the clearance of an N95 particulate respirator, not an AI-powered diagnostic device. Therefore, no MRMC study involving human readers or AI assistance was performed or reported.

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

Not applicable. This device is a physical respirator, not an algorithm.

7. The type of ground truth used

The "ground truth" for the performance claims of the N95 respirator is based on objective, standardized physical and biocompatibility testing criteria. Examples include:

• Physical Measurements: Filtration efficiency (% of particles filtered), differential pressure (airflow resistance), fluid penetration (absence of synthetic blood penetration at a given pressure), and flame spread time.
• Biocompatibility Assessments: Observational and analytical results from in vitro cytotoxicity assays, irritation tests (e.g., skin irritation), and sensitization tests (e.g., skin sensitization) performed according to ISO 10993 standards.

These are verifiable, objective measures against international standards and regulatory requirements.

8. The sample size for the training set

Not applicable. There is no training set as this is not an AI/machine learning device. The device is a physical product designed and manufactured to meet specific performance standards.

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

Not applicable. As there is no training set for an AI model, the concept of establishing ground truth for a training set does not apply here. The device's performance is established through direct physical and biological testing against predefined standards.

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