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510(k) Data Aggregation
(100 days)
The Disposable Medical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
The Disposable Medical Masks are single use, three-layer, flat –folded masks with ear strings or ties and nose clip. The two models are exact same except the loop versus tie on design. The Disposable Medical Masks are manufactured with three layers, the inner and outer layers are made of non-woven Spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The three layers fabric are held together by ultrasonic welding. The earloops/tie-on ties are held in place over the users' mouth and nose by two strings welded to the facemask. The earloops are made of 19cm spandex and the tie-on ties are made of 90cm spandex. The nose clip in the layers of facemask is to allow the user to fit the facemask around their nose, which is not touch with the users' skin directly. The Disposable Medical Masks will be provided in blue. The Disposable Medical Masks are sold non-sterile and are intended to be single use, disposable devices.
The provided document is a 510(k) premarket notification for a Disposable Medical Mask (Models: JBHY01, JBHY02). It details non-clinical performance testing to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against ASTM F2100-19 Level 3 acceptance criteria for medical face masks.
| Item | Acceptance Criteria (Level 3) | Reported Device Performance (Model JBHY01) | Reported Device Performance (Model JBHY02) |
|---|---|---|---|
| Synthetic Blood Performance (ASTM F1862) | 29 out of 32 pass at 160 mmHg | All 3 lots (Lot20200701, Lot20200706, Lot202007014) showed 32 out of 32 pass at 160 mmHg. | All 3 lots (Lot20200701, Lot20200706, Lot202007014) showed 32 out of 32 pass at 160 mmHg. |
| Particulate Filtration Efficiency (ASTM F2299) | $\geq$ 98% | Lot20200701: Max: 99.48%, Min: 99.93% (Note: Apparent typo, min should be <= max?)Lot20200706: Max: 99.85%, Min: 99.68%Lot202007014: Max: 99.93%, Min: 99.73% | Lot20200701: Max: 99.98%, Min: 99.79%Lot20200706: Max: 99.89%, Min: 99.79%Lot202007014: Max: 99.89%, Min: 99.78% |
| Bacterial Filtration Efficiency (ASTM F2101-19 and EN 14683:2019 Annex B) | $\geq$ 98% | Lot20200701: Max: 99.85%, Min: 99.63%Lot20200706: Max: >99.88%, Min: 99.77%Lot202007014: Max: 99.85%, Min: 99.66% | Lot20200701: Max: 99.83%, Min: 99.59%Lot20200706: Max: 99.83%, Min: 99.59%Lot202007014: Max: 99.83%, Min: 99.50% |
| Differential Pressure (Delta P) (ASTM F2100-19 and EN 14683:2019 Annex C) | < 6.0 mmH2O/cm² | All 3 lots showed Max: 3.7 mmH20/cm²Min: 3.1 mmH20/cm². | All 3 lots showed Max: 3.7 or 3.8 H₂O/cm²Min: 3.2 H₂O/cm². |
| Flammability (16 CFR 1610) | Class 1 (Burn time $\geq$ 3.5 seconds) | All 3 lots for both models achieved Class I. | All 3 lots for both models achieved Class I. |
| Biocompatibility - Cytotoxicity (ISO10993-5:2009) | Non-Cytotoxic | No cytotoxic potential (Meet the Criteria). | Not explicitly listed, but the section "Table3 Biocompatibility Testing" states for "Proposed device" "No cytotoxic potential" which includes both models. |
| Biocompatibility - Irritation (ISO10993-10:2010) | Non-Irritating | No Irritation (Meet the Criteria). | Not explicitly listed, but the section "Table3 Biocompatibility Testing" states for "Proposed device" "No Irritation" which includes both models. |
| Biocompatibility - Sensitization (ISO10993-10:2010) | Non-Sensitizing | Not considered a sensitizer (Meet the Criteria). | Not explicitly listed, but the section "Table3 Biocompatibility Testing" states for "Proposed device" "Not considered a sensitizer" which includes both models. |
2. Sample Size Used for the Test Set and Data Provenance
- Synthetic Blood Performance: 32 masks were tested for each lot (3 lots per model). The document states "Sampling: AQL 4% for BFE, PFE, Delta P; 32 masks for Synthetic Blood (Pass=≥29 passing, Fail=≤2passing". This implies that for the Synthetic Blood test, 32 masks were the sample size per lot per model.
- Flammability: 32 masks were tested for each lot (3 lots per model).
- BFE, PFE, Delta P: The sampling detail "AQL 4% for BFE, PFE, Delta P" is mentioned. However, the exact sample size for these tests per lot is not explicitly stated as a number like for Synthetic Blood and Flammability, but rather the results show max/min values from a batch.
- Data Provenance: The testing was conducted by Anhui JBH Medical Apparatus Co., Ltd., based in Mingguang City, Chuzhou, Anhui, China. The data would therefore be from China, and the studies are non-clinical, likely prospective for the purpose of this submission. The report states "Non-clinical tests were conducted to verify that the proposed device met all design specifications".
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a non-clinical device performance study (e.g., material testing, filtration efficiency, flammability) typically conducted in a laboratory setting, not involving human experts for ground truth establishment in the traditional sense of medical image analysis or clinical diagnosis. The "ground truth" is defined by the objective measurement standards of the ASTM and EN tests.
4. Adjudication Method for the Test Set
Not applicable. As described above, these are objective laboratory tests. There is no adjudication by experts.
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 document describes a medical device (face mask), not an AI-enabled diagnostic or analytical tool involving human readers or comparative effectiveness studies of human performance with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. Refer to point 5.
7. The Type of Ground Truth Used
The ground truth is established by objective, standardized laboratory test methods and performance specifications outlined in:
- ASTM F2100-19 (Standard Specification for Performance of Materials Used in Medical Face Masks)
- ASTM F1862 (Resistance of Medical Face Masks to Penetration by Synthetic Blood)
- EN 14683 (Medical Face Masks-Requirements and Test Methods)
- ASTM F2101 (Bacterial Filtration Efficiency (BFE))
- ASTM F2299 (Particulate Filtration Efficiency (PFE))
- 16 CFR 1610 (Flammability of clothing textiles)
- ISO 10993-5 (Biological Evaluation - Cytotoxicity)
- ISO 10993-10 (Biological Evaluation - Irritation and Sensitization)
These standards define the methodologies and the "ground truth" performance metrics such as filtration percentages, pressure differentials, and flammability classifications.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/algorithm-based device and therefore does not involve a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. Refer to point 8.
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