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510(k) Data Aggregation
(120 days)
The DISPOSABLE 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 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, provided non-sterile.
The DISPOSABLE FACE MASK is flat pleated style mask, utilizing ear loops way for wearing, and they all has nose clip design for fitting the face mask around the nose. The proposed device(s) are manufactured with three layers, the inner and outer facing layers are made of spunbonded non-woven, and the middle layer is made of melt-blown non-woven 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 not made with natural rubber latex. The nose clip contained in the proposed device(s) is in the layers of face mask to allow the user to fit the mask around their nose, which is made of PE coated Tin-plate wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The provided document describes the safety and effectiveness of a DISPOSABLE FACE MASK (Models: TX-005, TX-006) by Jiujiang Taixin Technology Co., Ltd. It is a 510(k) premarket notification, indicating a comparison to a legally marketed predicate device (K202424) rather than a de novo approval requiring extensive clinical trials. Therefore, the "study" referred to is a series of non-clinical performance and biocompatibility tests conducted according to established international standards.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test Item | Acceptance Criteria (Predicate Device Levels) | Reported Device Performance (Model: TX-005) | Reported Device Performance (Model: TX-006) |
|---|---|---|---|
| Bacterial Filtration Efficiency (BFE) | Level 2: ≥98% Level 3: ≥98% | 99.84% / Pass | 99.83% / Pass |
| Differential Pressure (Delta-P) | Level 2: <6.0 mm H2O/cm² Level 3: <6.0 mm H2O/cm² | 4.9 mm H2O/cm² / Pass | 5.0 mm H2O/cm² / Pass |
| Particulate Filtration Efficiency (PFE) | Level 2: ≥ 98% (at 0.1 µm) Level 3: ≥ 98% (at 0.1 µm) | 98.60% / Pass | 98.57% / Pass |
| Fluid Resistance | Level 2: Fluid resistant at 120 mm Hg Level 3: Fluid resistant at 160 mm Hg | Fluid Resistant claimed at 120 mm Hg / Pass | Fluid Resistant claimed at 160 mm Hg / Pass |
| Flammability | Class 1 | Class 1 / Pass | Class 1 / Pass |
| Cytotoxicity | Non-cytotoxic (Comply with ISO 10993-5) | Non-cytotoxic / PASS | Non-cytotoxic / PASS |
| Irritation | Non-irritating (Comply with ISO 10993-10) | Non-irritating / PASS | Non-irritating / PASS |
| Sensitization | Non-sensitizing (Comply with ISO 10993-10) | Non-sensitizing / PASS | Non-sensitizing / PASS |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes used for each performance test. The tests were performed according to specified ASTM and ISO standards, which would dictate the appropriate sample sizes for each test in a prospective manner. The provenance of the data is from Jiujiang Taixin Technology Co., Ltd. in China. The tests are non-clinical, meaning they are laboratory tests, not human subject studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is a non-clinical device (face mask). "Ground truth" in the context of expert review for medical imaging or clinical diagnosis is not applicable here. The performance criteria are objective measurements defined by international standards (ASTM, EN, ISO). The "ground truth" is the specified performance criteria for each test.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 are used for human expert review, typically in clinical studies or for establishing ground truth in image analysis. This is a non-clinical device, so such adjudication is not applicable. The device performance is determined by objective laboratory testing.
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
No MRMC comparative effectiveness study was done. This is a basic medical device (face mask) and does not involve AI or human reader interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not incorporate an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance tests are the established international standards (ASTM F2101, EN 14683, ASTM F2299, ASTM F1862, 16 CFR Part 1610, ISO 10993). These standards define the acceptable range or threshold for each performance characteristic (e.g., BFE ≥ 98%, Flammability Class 1, non-cytotoxic).
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as this device does not use an AI/ML algorithm or a training set.
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