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510(k) Data Aggregation
(89 days)
When properly worn, the surgical face masks are intended to patient and healthcare workers from transfer of microorganisms, body fluids and airborne particles. This device is non-sterile and for single use only.
The surgical face mask is a non-sterile, single use, three-layer, flat, pleated style with ear loops and a nose piece. The outer and inner layers are spunbond polypropylene, and the middle layer consists of melt-blown polypropylene filter. Each mask is secured to the face with ear loops with a nosepiece to conform the mask to the shape of the nose.
This document describes the validation of a surgical face mask. As such, the concept of "AI assistance for human readers" or "ground truth established by experts with many years of experience" is not applicable in the context of device performance testing for such simple medical devices. The evaluations are based on standardized physical and biological tests against established criteria.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Fluid Resistance (ASTM F1862) | 29 out of 32 pass at 120 mm Hg | 31 out of 32 pass at 80 mm Hg30 out of 32 pass at 120 mm Hg |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | 98.8% |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | > 99.9% |
| Differential Pressure (MIL- M-36954C) | < 5.0 mm H20/cm² | 4.4 mmH20/cm² |
| Flammability (16 CFR 1610) | Class 1 | Class 1 |
| Biocompatibility | Non-Cytotoxic, Non-Sensitizing, Non-Irritating | Non-Cytotoxic, Non-Sensitizing, Non-Irritating |
2. Sample Size Used for the Test Set and Data Provenance
- Fluid Resistance (ASTM F1862): 32 samples were tested for fluid resistance.
- Other Tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability, Biocompatibility): The document does not explicitly state the sample size for these specific tests, but performance data is provided.
- Data Provenance: The tests were conducted on the "proposed device," which implies new testing of the specific product being submitted for clearance. The document does not specify the country of origin for the testing itself, but the manufacturer is Ningbo Green Textile Co., Ltd, which is likely in China. The data would be considered prospective for the purposes of this submission as it was generated specifically for the device's clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for this type of device and testing. The "ground truth" is established by adherence to standardized testing protocols (e.g., ASTM, MIL, ISO, CFR standards) with measurable outcomes, not by expert consensus or interpretation of medical images.
4. Adjudication Method for the Test Set
Not applicable. Testing is against objective, measurable criteria defined by international and national standards.
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 device is a surgical face mask, not an AI-powered diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a surgical face mask, not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth is based on standardized physical and biological testing methods and their predefined acceptance criteria. These standards include:
- ASTM F2100: Standard Specification for Performance of Materials Used in Medical Face Masks
- ASTM F1862/F1862M-17: Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood
- ASTM F2299/F2299M-03: Determining the Initial Efficiency of Materials Used in Medical Face Masks to the Penetration of Particulates Using Latex Spheres
- ASTM F2101: Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials
- MIL - M-36954C: Medical face masks - Requirements and test methods, Annex C
- 16 CFR 1610: Flammability Test Method
- ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests for In Vitro Cytotoxicity
- ISO 10993-10: Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device (surgical face mask), not a machine learning model; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set is involved.
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