(190 days)
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
| Acceptance Criteria (Test) | Standard / Requirement | Reported Device Performance (Master-Frank N95 Particulate Respirator Model MF-01) | Satisfies Criteria |
|---|---|---|---|
| Biocompatibility | |||
| In Vitro Cytotoxicity | ISO 10993-5 (Non-cytotoxic) | Non-cytotoxic | Yes |
| Skin Irritation | ISO 10993-10 (Non-irritating) | Non-irritating | Yes |
| Skin Sensitization | ISO 10993-10 (Non-sensitizing) | Non-sensitizing | Yes |
| Physical Performance | |||
| Fluid Resistance | ASTM F1862 (Pass at 160 mmHg) | Pass at 160 mmHg | Yes |
| Flammability | 16 CFR 1610 (Class 1) | Class 1 | Yes |
| Particulate Filtration Efficiency (PFE) | NIOSH Certification (TC-84A-7697, N95 standard) | NIOSH Certified (TC-84A-7697) | Yes |
| Bacterial Filtration Efficiency (BFE) | NIOSH Certification (TC-84A-7697, N95 standard) | NIOSH Certified (TC-84A-7697) | Yes |
| Differential Pressure (ΔP) | NIOSH Certification (TC-84A-7697, N95 standard) | NIOSH Certified (TC-84A-7697) | Yes |
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.
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are 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. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.