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510(k) Data Aggregation
(86 days)
Medical Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It is 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 as sterile.
The Medical Surgical Mask is single use, three-layer, flat-pleated style with ear loops and nose piece. The Medical Surgical Mask is manufactured with three layers, the inner and outer layers are made of 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 piece in the lavers of facemask is to allow the user to fit the facemask around their nose. which is made of Galvanized iron wire. The Medical Surgical Mask will be provided in blue. The Medical Surgical Mask is sold as sterile and are intended to be single use, disposable devices.
Here's a breakdown of the acceptance criteria and study information for the "Medical Surgical Mask" based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Purpose | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| Fluid Resistance Performance ASTM F1862 | Evaluate the Fluid Resistance | 29 Out of 32 pass at 120 mmHg (21.3 kPa) | Pass - Lot 1: 31 Out of 32 pass at 160mmHg (21.3 kPa) - Lot 2: 31 Out of 32 pass at 160mmHg (21.3 kPa) - Lot 3: 32 Out of 32 pass at 160mmHg (21.3 kPa) |
| Particulate Filtration Efficiency ASTM F2299 | Evaluate the Particulate Filtration Efficiency | ≥ 98% | Pass - Lot 1: 99.02%-99.58% - Lot 2: 99.05%-99.59% - Lot 3: 99.10%-99.68% |
| Bacterial Filtration Efficiency ASTM F2101 | Evaluate the Bacterial Filtration Efficiency | ≥ 98% | Pass - Lot 1: 98.8%-99.7% - Lot 2: 98.7%-99.5% - Lot 3: 98.9%-99.5% |
| Differential Pressure (Delta P) MIL-M-36954C | Evaluate the Differential Pressure (Delta P) | < 6.0 mmH2O/cm² | Pass - Lot 1: 1.66-4.44 mmH2O/cm² - Lot 2: 1.63-4.24 mmH2O/cm² - Lot 3: 1.60-4.43 mmH2O/cm² |
| Flammability 16 CFR 1610 | Evaluate the Flammability | Class 1 | Pass, Class 1 - Lot 1: Class I - Lot 2: Class I - Lot 3: Class I |
| Biocompatibility: Cytotoxicity | Evaluate the Cytotoxicity endpoint | Not explicitly stated as a numerical criterion, but implied as "non-cytotoxic" | Pass (Under the conditions of the study, the subject device was non-cytotoxic) |
| Biocompatibility: Irritation | Evaluate the Irritation endpoint | Not explicitly stated as a numerical criterion, but implied as "non-irritating" | Pass (Under the conditions of the study, the subject device was non-irritating) |
| Biocompatibility: Sensitization | Evaluate the Sensitization endpoint | Not explicitly stated as a numerical criterion, but implied as "non-sensitizing" | Pass (Under the conditions of the study, the subject device was non-sensitizing) |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the total sample size for the entire test set in a singular number. However, it indicates the sample size for specific tests per lot:
- Fluid Resistance: 32 samples per lot (tested against 3 lots).
- Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability: The results are presented for 3 distinct 'Lots' (Lot 1, Lot 2, Lot 3). While the exact number of samples per lot for these tests isn't always explicitly stated (except for fluid resistance), the presentation implies multiple measurements per lot.
- Biocompatibility: The sample size for biocompatibility tests (cytotoxicity, irritation, sensitization) is not specified.
Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given that HUNAN ZHENHEYIKANG MEDICAL INSTRUMENT CO., LTD is located in China, it's highly probable the testing was conducted there.
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 and not provided in the document. The tests performed are objective, quantitative laboratory measurements (e.g., filtration efficiency, fluid resistance) based on established ASTM and military standards, not subjective assessments requiring expert consensus on a "ground truth" (like image interpretation).
4. Adjudication Method for the Test Set
This information is not applicable and not provided. As explained above, the tests are objective laboratory measurements, not subjective assessments requiring an adjudication method among experts.
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
There was no MRMC comparative effectiveness study and no AI component mentioned. This document describes the performance testing of a physical medical device (a surgical mask), not an AI-powered diagnostic tool. Therefore, effects on human reader performance with or without AI assistance are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
There was no standalone (algorithm only) performance study done, as this product is a physical medical device and does not involve an algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests directly stems from standardized laboratory test results against predefined acceptance criteria. For example:
- For filtration efficiency, the ground truth is the measured percentage of particles/bacteria filtered.
- For fluid resistance, the ground truth is whether the sample passed or failed at a specific pressure.
- For biocompatibility, the ground truth is the biological response observed in the in vitro or in vivo tests.
This is based on objective measurements and established scientific methods, not expert consensus, pathology, or outcomes data in the traditional sense of clinical studies.
8. The Sample Size for the Training Set
This information is not applicable and not provided. There is no "training set" in the context of testing a physical medical device like a surgical mask, as there is no algorithm or model being trained.
9. How the Ground Truth for the Training Set was Established
This information is not applicable and not provided, as there is no training set for this type of device submission.
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