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510(k) Data Aggregation
(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.
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