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510(k) Data Aggregation
(90 days)
The Surgical Face Mask (non-sterile) is 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 a single use, disposable device(s), provided non-sterile.
The proposed device(s) are blue color, and flat pleated type mask, utilizing ear loops way for wearing, and they all has Nose clips design for fitting the face mask around the nose.
The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of nylon and spandex. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
Here's a breakdown of the acceptance criteria and study information for the "Surgical Face Mask (non-sterile)" as presented in the FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
| Item | Acceptance Criteria (Level 2) | Reported Device Performance (Proposed Device) | Result |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | 29 out of 32 pass at 120 mmHg | 32 out of 32 pass at 120 mmHg | PASS |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | 99.16% | PASS |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | 99.74% | PASS |
| Differential Pressure (Delta P) (EN 14683 Annex C) | < 6.0 mmH₂O/cm² | 3.7 mmH₂O/cm² | PASS |
| Flammability (16 CFR 1610) | Class 1 | Class 1 | PASS |
| Cytotoxicity (ISO 10993-5) | Non-Cytotoxic | Under the conditions of the study, the device is non-cytotoxic. | PASS |
| Irritation (ISO 10993-10) | Non-Irritating | Under the conditions of the study, the device is non-irritating. | PASS |
| Sensitization (ISO 10993-10) | Non-Sensitizing | Under the conditions of the study, the device is non-sensitizing. | PASS |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes for each specific test (e.g., number of masks tested for BFE). However, for Fluid Resistance (ASTM F1862), the criteria and result are given as "32 out of 32 passes," suggesting a sample size of 32 tests for this particular performance characteristic.
- Data Provenance: The tests appear to be conducted by or on behalf of Nantong Taiweishi Medical Technology Co., Ltd. in China, as indicated by the company's address on the document. The document presents these tests as non-clinical laboratory evaluations. There is no information provided about whether these studies were retrospective or prospective, but given they are laboratory performance tests for device clearance, they would typically be considered prospective studies on manufactured samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This type of information is generally not applicable to the performance testing of a physical product like a surgical face mask. The "ground truth" here is established by the standardized test methods themselves (e.g., ASTM F2100, F1862, F2299, F2101, EN 14683, ISO 10993, 16 CFR 1610). The results are quantitative measurements against predefined criteria, not subjective expert interpretations. Therefore, no experts were used to establish ground truth in the traditional sense of clinical or image-based studies.
4. Adjudication Method for the Test Set:
Not applicable. As noted above, these are objective physical and biological performance tests against established standards, not studies requiring expert adjudication of subjective findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human reader performance (with or without AI assistance) is being evaluated against some ground truth. This document pertains to the performance characteristics of a physical medical device (surgical face mask).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No, this question is not applicable. This device is a physical product, not an algorithm or AI system.
7. The Type of Ground Truth Used:
The ground truth is established by standardized test methods and predefined acceptance criteria from recognized international and national standards such as ASTM, ISO, EN, and CFR. These standards define the methodology for measuring specific performance characteristics and the thresholds for acceptable performance (e.g., ≥ 98% BFE, Class 1 Flammability).
8. The Sample Size for the Training Set:
Not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As above, this information is not relevant for a physical medical device.
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