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510(k) Data Aggregation
(216 days)
The disposable medical face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are 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 face mask is pleated three-layer mask with ear loops and nose piece. The inner and outer layers are made of spun-bond non-woven fabric.The middle layer is made of melt blown polypropylene filter.only the outer layers' color is blue (colorant: Pigment Blue 15:3/Model:147-14-8), which is held to cover the users' mouth and nose by two spandex elastic bands ultrasonic welded to the disposable medical face mask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the disposable medical face mask is in the middle layer of disposable medical face mask to allow the user to fit the disposable medical face mask around their noses, which is made of malleable aluminum wire. The dimensions of each disposable medical face mask are length 175±10 mm and width 95±10 mm, The dimensions of nose piece is length 120±10 mm, and the ear loop is length 180±10 mm.
The mask model TP-001 meets both level 2 & level 3 performance requirements in ASTM F2100.The disposable medical face mask are sold non-sterile and are intended to be single use,disposable devices.
This document is a 510(k) Premarket Notification for a Disposable Medical Face Mask, seeking to demonstrate substantial equivalence to a predicate device. It addresses the physical and filtration performance of the mask, rather than the performance of an AI/ML-driven medical device. Therefore, many of the requested criteria relating to AI/ML device performance, such as sample size for test/training sets, expert ground truth establishment, MRMC studies, and human-in-the-loop performance, are not applicable to this document.
However, I can extract and present the information available regarding the acceptance criteria and the study that proves the device meets those criteria for this medical face mask.
Device: Disposable Medical Face Mask (Model TP-001)
Product Code: FXX
Regulation Number: 21 CFR 878.4040
Regulatory Class: Class II
1. Table of Acceptance Criteria and Reported Device Performance
The device model TP-001 is stated to meet both Level 2 and Level 3 performance requirements in ASTM F2100. The table below combines the acceptance criteria and the observed performance for both levels as presented in the document.
| Test Item (Performance Level 2/Level 3) | Acceptance Criteria (Level 2) | Acceptance Criteria (Level 3) | Reported Device Performance (Model TP-001 - across 3 lots) | Verdict |
|---|---|---|---|---|
| Bacterial Filtration Efficiency (BFE) (ASTM F2101-19) | BFE ≥ 98% | BFE ≥ 98% | Lot A: 99.9%, Lot B: 99.9%, Lot C: 99.9% | Pass |
| Differential Pressure (Delta-P) (EN 14683:2019, Annex C) | Delta-P < 6.0 mmH2O/cm² | Delta-P < 6.0 mmH2O/cm² | Lot A: 2.24 mmH2O/cm², Lot B: 2.17 mmH2O/cm², Lot C: 2.07 mmH2O/cm² | Pass |
| Sub-micron Particulate Filtration Efficiency (PFE) at 0.1 micron (ASTM F2299) | PFE ≥ 98% | PFE ≥ 98% | Lot A: 99.9%, Lot B: 99.9%, Lot C: 99.9% | Pass |
| Resistance to Penetration by Synthetic Blood (ASTM F1862) | Fluid resistant claimed at 120 mmHg | Fluid resistant claimed at 160 mmHg | 32 out of 32 per lot pass at 120 mmHg; 32 out of 32 per lot pass at 160 mmHg | Pass |
| Flame Spread (16 CFR Part 1610) | Class 1 | Class 1 | Class 1 | Pass |
Additionally, for biocompatibility:
| Biocompatibility Test | Acceptance Criteria | Reported Device Performance (Model TP-001) | Result |
|---|---|---|---|
| Cytotoxicity (ISO 10993-5:2009) | Noncytotoxic | Device is noncytotoxic | Pass |
| Irritation (ISO 10993-10:2010) | Nonirritating | Device is nonirritating | Pass |
| Sensitization (ISO 10993-10:2010) | Nonsensitizing | Device is nonsensitizing | Pass |
2. Sample size used for the test set and the data provenance
- Sample Size for Performance Tests: For performance tests, the document states "3 non-consecutive lots tested, using a sample size of 32/lot" for some tests like fluid resistance. For other tests (BFE, PFE, Differential Pressure), results are provided for 3 lots (Lot A, B, C), implying samples were taken from each of these lots. The exact number of samples tested per lot for each specific test (other than fluid resistance) is not explicitly stated, but it's understood to be sufficient to demonstrate compliance with the standards.
- Data Provenance: The device manufacturer, Zhejiang The Purples Protective Products Co.,Ltd, is located in China. The testing was conducted as part of a premarket notification for submission to the U.S. FDA. The document does not specify if the tests were performed in China or other regions, nor does it explicitly state if the data is retrospective or prospective, but as it pertains to a new device submission, it would implicitly be prospective testing of newly manufactured lots.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. This is a physical device performance study (e.g., filtration, fluid resistance), not an AI/ML-based diagnostic or imaging device. The "ground truth" is established by adherence to standardized test methods (e.g., ASTM, EN, ISO) and laboratory measurements of physical properties, not by expert human interpretation of clinical data or images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not Applicable. As this is not an AI/ML device where human interpretation or consensus is required for ground truth, adjudication methods are irrelevant. The test results are based on objective, standardized physical measurements.
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 is a physical device (face mask). There is no "human reader" involved in its direct performance assessment in the context of an MRMC study or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a physical device (face mask). There is no algorithm or AI component to assess for standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established by standardized laboratory testing and measurements according to recognized international and US standards. These standards define the test methodologies and the criteria for acceptable performance. Examples include:
- ASTM F2101 (Bacterial Filtration Efficiency)
- EN 14683 (Differential Pressure)
- ASTM F2299 (Particulate Filtration Efficiency)
- ASTM F1862 (Synthetic Blood Penetration)
- 16 CFR Part 1610 (Flammability)
- ISO 10993 (Biocompatibility - Cytotoxicity, Irritation, Sensitization)
8. The sample size for the training set
Not Applicable. This is a physical device, not an AI/ML model. Therefore, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not Applicable. As there is no AI/ML model or training set, this question is not relevant. The "ground truth" for device acceptance is defined by adherence to established material and performance standards, as measured through laboratory testing.
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