(173 days)
The INTENDED MEDICAL USE is to protect the healthcare personnel and patient from transfer of microorganisms, body fluids and particulate material.
Not Found
This document describes the acceptance criteria and study proving the device meets those criteria for the "TIA Disposables -- 3-Ply Face Mask."
Here's an analysis of the provided text:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
Based on the "Test Results" and "Descriptive Comparison" sections, the acceptance criteria and device performance are as follows. Note that some "acceptance criteria" are implied by the reported predicate device performance or general product characteristics.
| Acceptance Criteria / Performance Metric | Predicate Device (Implied Acceptance) | TIA Disposables -- 3-Ply Face Mask (Reported Performance) |
|---|---|---|
| Protective Properties | ||
| Synthetic Blood Penetration Resistance | Fluid Resistant | Fluid Resistant |
| Bacterial Filtration Efficiency (BFE) | 98.5% | 99.28% |
| Particle Filtration Size (Microns) | 3.2 microns | 3 microns |
| Differential Pressure (Delta P) | Not stated | 2.35 |
| Material Characteristics | ||
| Material Composition | Polypropylene | Polypropylene |
| Weave | Non-woven | Non-woven |
| Resistance to Tears (max. tear resistance) | Not stated | 29.54 lbs |
| Elongation (strain at maximum) | Not stated | 12.82% |
| Breaking Force (max. force) | Not stated | 23.25 lbs |
| Design & Intended Use | ||
| Design | Earloop/Tie-On | Earloop/Tie-On |
| Anatomical Sites Protection | Nostril and mouth | Nostril and mouth |
| Sterility | Nonsterile | Nonsterile |
| Intended Use | Protective | Protective Apparel |
| Target Population | Healthcare professionals | Healthcare professionals |
| Use Life | Disposable | Disposable |
| Where Used | Medical & Dental offices | Medical & Dental offices |
2. Sample Size and Data Provenance
The document provides performance metrics for the device (e.g., 99.28% BFE), but does not specify the sample size used for the tests to derive these metrics. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective. The tests cited (MIL Spec 36954C, NFPA 1999, ASTM D5034-90) are standard industry tests, implying a controlled laboratory setting.
3. Number and Qualifications of Experts for Ground Truth
The provided text does not mention any experts being used to establish ground truth. The nature of the tests (material properties, filtration efficiency) suggests objective laboratory measurements rather than expert human interpretation.
4. Adjudication Method for Test Set
As no expert review or human interpretation of data is mentioned, no adjudication method (e.g., 2+1, 3+1) is relevant or described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done or reported. This device is a face mask, and its performance is evaluated through objective physical and material property tests, not through human reader interpretation of images or other data where AI assistance would be relevant. Therefore, there's no discussion of human readers improving with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
No standalone algorithm performance study was done. The device is a physical product (face mask), not an algorithm or software. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply.
7. Type of Ground Truth Used
The ground truth for the reported performance metrics is based on objective laboratory measurements and standardized test methods (MIL Spec 36954C, NFPA 1999, ASTM D5034-90). For example, BFE is measured by challenging the material with a bacterial aerosol and counting the colony-forming units, not through expert consensus, pathology, or outcomes data in the usual clinical sense.
8. Sample Size for the Training Set
No training set is mentioned or applicable. This is a physical medical device, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical face mask.
§ 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.