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510(k) Data Aggregation
(162 days)
The 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 of the wearer to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
The Medical Masks are single use, three-layer, flat –folded masks with ear loops and nose clamp. The Medical Masks 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 ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose clamp in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. The Medical Masks will be provided in blue. The medical masks are sold non-sterile and are intended to be single use, disposable devices.
The provided text describes the acceptance criteria and the study conducted for the Medical Mask (Model L1171801) by Zhende Medical Co., Ltd. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Item | Acceptance Criteria (Level 1) | Reported Device Performance | Result |
|---|---|---|---|
| Fluid Resistance Performance (ASTM F1862) | 29 out of 32 pass at 80 mmHg | 32 out of 32 per lot pass at 80 mmHg, 3 non-consecutive lots tested | PASS |
| Particulate Filtration Efficiency (ASTM F2299) | $\ge$ 95% | $\ge$ 95% | PASS |
| Bacterial Filtration Efficiency (ASTM F2101) | $\ge$ 95% | $\ge$ 95% | PASS |
| Differential Pressure (Delta P) (EN 14683 Annex C) | < 5.0 mmH2O/cm² | < 5.0 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 the data provenance:
- Fluid Resistance Performance (ASTM F1862): 3 non-consecutive lots were tested. For each lot, 32 samples were tested. Thus, the total sample size for fluid resistance testing was $3 \times 32 = 96$ masks.
- Other performance tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability) and Biocompatibility tests (Cytotoxicity, Irritation, Sensitization): The specific sample sizes for these tests are not explicitly stated in the provided text, beyond the acceptance criteria for fluid resistance.
- Data Provenance: Not explicitly stated whether the data is from the country of origin (China) or elsewhere. The study appears to be a manufacturer-conducted non-clinical study to demonstrate compliance with international standards. The study is retrospective in the sense that it's a pre-market submission, testing the final manufactured device according to established protocols.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the study is a non-clinical performance evaluation of a physical medical device (Medical Mask) rather than an AI/software device requiring expert interpretation of results. The "ground truth" for the test set is defined by the objective measurement standards outlined in the industrial specifications (e.g., ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, ISO 10993).
4. Adjudication method for the test set:
This is not applicable since the study involves objective physical and biological performance tests, not human interpretation or adjudication of complex data. The acceptance criteria define the pass/fail for each test.
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:
This is not applicable as the device is a Medical Mask, not an AI/software device that would involve human readers or AI assistance for medical image interpretation or diagnosis.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable as the device is a Medical Mask.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance evaluation is based on objective, standardized test methods and their defined limits (e.g., minimum filtration efficiency, maximum pressure differential, pass/fail for cytotoxicity). These standards are well-established in the medical device industry for surgical masks.
8. The sample size for the training set:
This is not applicable as the Medical Mask is a physical device, not an AI/machine learning model that requires a training set. The manufacturing process is designed and validated, not "trained" in the AI sense.
9. How the ground truth for the training set was established:
This is not applicable for the reasons stated above.
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