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510(k) Data Aggregation
(60 days)
The 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. The MEDICAL SURGICAL MASK 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, provided non-sterile.
The subject device is a non-sterile, single-use, and flat pleated mask with ear loops and a Nose piece. The product is manufactured with three layers, the inner and outer layer is made of polypropylene spunbond, the middle layer is made of melt blown polypropylene. The elastic ear loops are not made with natural rubber latex. The Nose piece in the facemask is to allow the user to fit the facemask around their nose, which is made of polyethylene coated iron wire. The mask will be provided in black and blue color, the colorant for the model JM92B is Carbon black (CAS No.1333-86-4), and for the model JM92 is Pigment Blue 15 (CAS No.147-14-8). The model JM92 will be provided in blue and labeled in Level 3, the model JM92B will be provided in black and labeled in Level 1.
The provided text describes the acceptance criteria and performance of a Medical Surgical Mask (Model: JM92, JM92B) based on non-clinical testing for FDA 510(k) clearance, not a study involving human readers or AI. Therefore, I cannot provide information on points 2, 3, 4, 5, 8, and 9 as they are not applicable to this type of device submission.
Here is the information from the document related to acceptance criteria and device performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Test Method | Acceptance Criteria for Level 1 | Acceptance Criteria for Level 3 | Reported Device Performance (Verdict) |
|---|---|---|---|---|
| Bacterial filtration efficiency | ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus according to ASTM F2100: 2019 | ≥ 95% | ≥ 98% | Pass |
| Differential pressure (Delta-P) | EN 14683: 2019, Annex C Medical face masks - Requirements and test methods according to ASTM F2100: 2019 | < 5.0 mm H2O/cm² | < 6.0 mm H2O/cm² | Pass |
| Sub-micron particulate filtration efficiency | ASTM F2299 Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres according to ASTM F2100: 2019 | ≥ 95% | ≥ 98% | Pass |
| Resistance to penetration by synthetic blood | ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) according to ASTM F2100: 2019 | Pass at 80 mmHg | Pass at 160 mmHg | Pass |
| Flame spread | 16 CFR Part 1610 Standard for the Flammability of Clothing according to ASTM F2100: 2019 | Class 1 | Class 1 | Pass |
| Biocompatibility (Cytotoxicity) | ISO 10993-5: 2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Non-cytotoxic | Non-cytotoxic | Conform to ISO 10993-5:2009 SE |
| Biocompatibility (Irritation) | ISO 10993-10: 2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Non-irritating | Non-irritating | Conform to ISO 10993-10:2010 SE |
| Biocompatibility (Sensitization) | ISO 10993-10: 2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (Note: The provided text only partially lists the standard for sensitization, but implies compliance.) | Non-sensitizing | Non-sensitizing | Conform to ISO 10993- SE |
2. Sample size used for the test set and the data provenance: Not applicable. This document pertains to non-clinical performance testing of a physical device (surgical mask), not a test set of data for an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for non-clinical performance testing is established by standardized test methods and laboratory results, not expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is not a study requiring adjudication of expert opinions.
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 for a surgical mask, not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for a surgical mask, not an algorithm.
7. The type of ground truth used:
For the performance tests (bacterial filtration efficiency, differential pressure, particulate filtration efficiency, resistance to synthetic blood, flame spread), the "ground truth" is defined by the requirements of the specific ASTM and EN standards used for testing (e.g., ASTM F2100, ASTM F2101, ASTM F2299, ASTM F1862, 16 CFR Part 1610). For biocompatibility, the "ground truth" is defined by the ISO 10993 series of standards (ISO 10993-5 and ISO 10993-10). The device is deemed to meet the acceptance criteria if its measured performance falls within the specified limits of these standards.
8. The sample size for the training set: Not applicable. This is for a physical device, not a machine learning model.
9. How the ground truth for the training set was established: Not applicable.
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