(164 days)
The N95 Particulate Respirator and Surgical Mask, Models TN01-12 are single-use, disposable devices, provided non-sterile, and are intended to be worn by operating room personnel or other healthcare workers to protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
The N95 Particulate Respirator and Surgical Mask, Models #TN01-11 and #TN01-12 are NIOSH certified (TC 84A-3348), pouchedshaped respirators when worn. The flat-folded masks are composed of four layers of materials consisting of polypropylene and polyethylene (inner layer), polypropylene meltblown (two filter layers), and polypropylene spunbond (outer layer). The masks contain a conformable nose clamp enclosed in a binding tape welding the top edge to conform to the contours of the face. In addition, the masks contain an ultrasonically welded, polyurethane elastic headband not made with natural rubber latex, to secure the masks in place on the wearer. The masks are offered in orange or white.
The provided document describes the acceptance criteria and performance of the N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12, in comparison to a predicate device.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Criteria | Acceptance Criteria (Implied by Predicate & Standards) | Reported Device Performance (Models TN01-11 and TN01-12) |
|---|---|---|
| Fluid Resistance | Pass at 160 mmHg (ASTM F1862) | Pass at 160 mmHg (ASTM F1862). Models TN01-11 and TN01-12 meet the requirements of ASTM F1862. |
| Particulate Filtration Efficiency (PFE) | NIOSH Certification (e.g., 84A-5216) | NIOSH Certification Number: TC 84A-3348 (includes TN01-11 & TN01-12) |
| Bacterial Filtration Efficiency (BFE) | NIOSH Certification (e.g., 84A-5216) | NIOSH Certification Number: TC 84A-3348 (includes TN01-11 & TN01-12) |
| Differential Pressure (△ P) | NIOSH Certification (e.g., 84A-5216) | NIOSH Certification Number: TC 84A-3348 (includes TN01-11 & TN01-12) |
| Flammability | Class 1 (16 CFR 1610) | Class 1 (16 CFR 1610). Meets 16 CFR 1610 Standard for class 1 flammability. |
| Biocompatibility | Non-cytotoxic, non-sensitizing, non-irritating (ISO 10993) | Under the conditions of the study, the device was non-cytotoxic, non-sensitizing, and non-irritating (ISO 10993). |
| - Cytotoxicity | (ISO 10993-5) | Under the conditions of the study, the subject device was non-cytotoxic (ISO 10993-5). |
| - Irritation | (ISO 10993-10) | Under the conditions of the study, the subject device was non-irritating (ISO 10993-10). |
| - Sensitization | (ISO 10993-10) | Under the conditions of the study, the subject device was non-sensitizing (ISO 10993-10). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes used for each performance test (e.g., number of masks tested for fluid resistance or flammability). It simply states that the models meet the requirements of the standards. The provenance of the data is not specified beyond indicating it was a submission to the FDA. The tests are described as performance testing and non-clinical tests, which are typically prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable to the type of device and testing described. The "ground truth" for N95 masks is established through standardized laboratory performance tests according to recognized standards (e.g., ASTM, NIOSH, ISO) and not through expert consensus or interpretation of medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods like 2+1 are typically used in studies where human readers interpret medical data (e.g., radiology studies) and their findings need to be reconciled. For performance testing of a physical device like an N95 mask, objective laboratory measurements are taken against predefined criteria.
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
This information is not applicable. The device is a physical N95 mask, not an AI-powered diagnostic tool. Therefore, MRMC studies and "human readers improving with AI" are irrelevant to this document.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a physical N95 mask; there is no algorithm or AI component involved. The testing described is for the physical performance of the mask.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance of the N95 mask is based on objective measurements against established performance standards set by regulatory bodies and testing organizations. These include:
- ASTM F1862 for Fluid Resistance
- NIOSH Certification (TC 84A-3348) for Particulate Filtration Efficiency, Bacterial Filtration Efficiency, and Differential Pressure
- 16 CFR 1610 for Flammability
- ISO 10993 series for Biocompatibility (cytotoxicity, irritation, sensitization)
8. The sample size for the training set
This information is not applicable. There is no "training set" in the context of performance testing for a physical medical device like an N95 mask. Training sets are relevant for machine learning or AI models.
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for this type of device and study.
§ 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.