(159 days)
Meets the CDC guidelines for TB exposure control Has a filter efficiency level of 95% or greater against particulate aerosols free of oil (Type N95 respirator) Minimizes wearer exposure to certain airborne particles in a size range of 0.1 to 10.0 microns, such as those generated by electrocautery, laser, and other powered medical instruments Designed to be fluid resistant to splash and spatter of blood and body fluids and other potentially hazardous biomaterials Provides greater than 99% Bacterial Filtration Efficiency* to exhaled wearer generated microorganisms (*as determined by the modified Greene and Vesley test method)
The 3M 1860 is a molded, cup-shaped respirator, consisting of a semi-rigid innershell, filter media, and a coverweb. It covers the nose and mouth of the wearer, and is held snugly in place with two synthetic elastic headbands, conforming to the curvature of the wearer's nose with a malleable aluminum noseclip.
This document is a 510(k) summary for a 3M™ Model 1860 Health Care N95 Particulate Respirator and Surgical Mask. While it describes performance data, it does not describe an AI/ML powered device or a study testing such a device. Therefore, it is impossible to provide the requested information regarding AI/ML-specific acceptance criteria, training/test sets, expert ground truth, or MRMC studies.
However, I can extract the acceptance criteria and reported device performance for this physical medical device based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Filtration Efficiency | Not less than 95% against particulate aerosols free of oil (Type N95 respirator) for particles with C.M.D. of 0.055 to 0.095 microns and aerodynamic diameter of 0.3 microns. | Met the NIOSH required sodium chloride test; filtration efficiency did not drop below 95%. |
| Fluid Resistance | No fluid penetration when challenged with 100 ml ±1 ml for up to 24 hours. | No fluid penetration observed. |
| Multiple Sized Particles Penetration | Filter efficiency level greater than 95% for particles with an aerodynamic diameter range of 0.1 µm to 10.1 µm. | Filter efficiency level was greater than 99%. |
| Bacterial Filtration Efficiency (BFE) | Greater than 99% to exhaled wearer-generated microorganisms. | Tested using the modified Greene and Vesley procedure; filtration efficiency was greater than 99%. |
| Face Fit | Face seal leakage less than 10% (as determined by a qualitative fit test). | Met the requirements of a qualitative fit test; face seal leakage was less than 10%. |
| Ease of Breathing | Initial airflow resistance (inhalation) less than 35 mmH2O. | Met the requirements of the NIOSH airflow resistance test; initial resistance (inhalation) was less than 35mmH2O. |
The document explicitly states: "CONCLUSION: the results of these nonclinical tests, when compared with data available and/or claims made on the predicate devices, demonstrate that the subject device is as safe and effective as the predicate devices. and performs as well as the predicate devices." This confirms that the device meets its acceptance criteria based on these nonclinical tests.
The remaining questions (2-9) are not applicable as the provided text describes a physical respirator/surgical mask, not an AI/ML-powered device. There is no mention of an algorithm, test sets, training sets, data provenance, expert ground truth, adjudication methods, or MRMC studies in the context of AI/ML.
§ 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.