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510(k) Data Aggregation
(67 days)
The Disposable Medical Face Mask is intended to be worn to protect 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.
Disposable Medical Face Mask is a blue flat-pleated mask, which is worn in the way of earrings and has a nose clip design to fit the mask around the nose. This product is composed of a mask body (three-layer structure: two layers of polypropylene adhesive nonwoven fabric with a layer of polypropylene melt-blown nonwoven fabric in the middle), a nose clip (made of polyethylene) and ear loops (made of polyester + spandex). The nose clip is located in the middle layer of the mask. Ear loops, string-like material, are attached to the mask and placed behind the ears. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The provided text describes the acceptance criteria and the results of a study for a Disposable Medical Face Mask (K223055) to demonstrate its substantial equivalence to a predicate device.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Item | Acceptance Criteria | Proposed Device Performance (Reported Result) | Result |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | 29 out of 32 pass at 160 mmHg for Level 3 | 32 out of 32 pass at 160 mmHg (across 3 non-consecutive lots) | PASS |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | Lot1: 99.39%, Lot2: 99.54%, Lot3: 99.37% (across 3 non-consecutive lots) | PASS |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | Lot1: 99.01%, Lot2: 98.94%, Lot3: 99.06% (across 3 non-consecutive lots) | PASS |
| Differential Pressure (EN 14683 Annex C) | < 6.0 mmH2O/cm² | Lot1: 2.91 mmH2O/cm², Lot2: 2.67 mmH2O/cm², Lot3: 2.73 mmH2O/cm² (across 3 lots) | PASS |
| Flammability (16 CFR 1610) | Class I | Class I (across 3 non-consecutive lots) | PASS |
| Cytotoxicity (ISO 10993-5) | Non-Cytotoxic | Non-cytotoxic | PASS |
| Irritation (ISO 10993-10) | Non-Irritating | Non-irritating | PASS |
| Sensitization (ISO 10993-10) | Non-Sensitizing | Non-sensitizing | PASS |
2. Sample size used for the test set and the data provenance:
- Sample Size for performance tests (Fluid Resistance, Particulate Filtration, Bacterial Filtration, Differential Pressure, Flammability): 3 non-consecutive lots were tested. For each lot, a sample size of 32 was used.
- Data Provenance: The document does not explicitly state the country of origin of the data for these tests. However, the applicant is Xiantao Zhuobo Industrial Co., LTD, located in Hubei Province, China. The tests are non-clinical (laboratory tests) rather than retrospective or prospective clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This device is a Disposable Medical Face Mask, and the evaluation is based on non-clinical performance testing against established industry standards (ASTM, EN, ISO, CFR). Therefore, the concept of "experts used to establish ground truth" as it would apply to a diagnostic imaging device, for example, is not applicable here. The "ground truth" is defined by the objective pass/fail criteria of the scientific/engineering standards themselves.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. The tests are objective measurements against predefined thresholds, not subjective assessments requiring adjudication by multiple readers.
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 medical device (face mask) and not an AI/software as a medical device (SaMD) that would involve human readers or AI assistance. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for this device's performance is based on established quantitative and qualitative criteria defined by international and national standards (e.g., ASTM F2100, ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, 16 CFR 1610, ISO 10993). For biocompatibility, the ground truth is the classification as "non-cytotoxic," "non-irritating," and "non-sensitizing" as per ISO 10993 standards.
8. The sample size for the training set:
- Not applicable. There is no concept of a "training set" for physical medical devices being evaluated through non-clinical performance and biocompatibility testing. This is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device and study.
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