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510(k) Data Aggregation
(192 days)
The Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. This is a single use device, provided non-sterile.
The device is a surgical mask which can be described as non-sterile, single-use, 3 layer, flat-pleated style with ear loops and a nose piece. The outer layer of the surgical mask consists of blue nonwoven spunbond polypropylene and the inner layer consists of carded non-woven polyethylene/polyester. The middle layer consists of melt-blown polypropylene filter. The ear loops consists of 140D nylon and spandex elastic string not made with natural rubber latex. The nose piece is made with white galvanized iron with polyethylene coating.
The provided document is a 510(k) premarket notification for a Surgical Mask. It details the device's characteristics and its comparison to a predicate device, focusing on non-clinical performance data to establish substantial equivalence.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Test Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Fluid Resistance Performance | ASTM F1862 | Fluid resistant, pass at 80 mmHg | Lot K-1820-01: Pass, 29 of 32 Passed at 80 mmHg Lot J-0720-02: Pass, 30 of 32 Passed at 80 mmHg Lot J-0920-03: Pass, 29 of 32 Passed at 80 mmHg |
| Particulate Filtration Efficiency | ASTM F2299/F2299M-03 | ≥95% | Lot J-0620-01: Pass, ≥97.6% Lot J-0720-02: Pass, ≥98.8% Lot J-0920-03: Pass, ≥96.8% |
| Bacterial Filtration Efficiency | ASTM F2101-01(2019) | ≥95% | Lot J-0620-01: Pass, ≥99.63% Lot J-0720-02: Pass, ≥99.74% Lot J-0920-03: Pass, ≥99.57% |
| Differential Pressure (Delta-P) | ASTM F2100-19 (EN 14683) | <5.0 mmH2O/cm² | Lot J-0620-01: Pass, Average 3.1 mmH2O/cm² (All < 5.0 mmH2O/cm²) Lot J-0720-02: Pass, Average 3.5 mmH2O/cm² (All < 5.0 mmH2O/cm²) Lot J-0920-03: Pass, Average 4.1 mmH2O/cm² (All < 5.0 mmH2O/cm²) |
| Flammability | 16 CFR Part 1610 | Class 1 | Lot J-0620-01: Pass, 32 samples did not ignite Lot J-0720-02: Pass, 32 samples did not ignite Lot J-0920-03: Pass, 32 samples did not ignite |
| Biocompatibility (ISO 10993) | (Not directly specified in table, but listed) | Non-cytotoxic, Non-sensitizing, Non-irritating | The document states the device is "Non-cytotoxic, Non-sensitizing, Non-irritating," implying it meets these criteria. Specific test results are not detailed in the provided table but are asserted. |
2. Sample Size Used for the Test Set and the Data Provenance
- Fluid Resistance Performance: 32 surgical masks per lot, tested across 3 lots (K-1820-01, J-0720-02, J-0920-03).
- Particulate Filtration Efficiency: 32 surgical masks per lot, tested across 3 lots (J-0620-01, J-0720-02, J-0920-03).
- Bacterial Filtration Efficiency: 32 surgical masks per lot, tested across 3 lots (J-0620-01, J-0720-02, J-0920-03).
- Differential Pressure (Delta-P): 32 surgical masks per lot, tested across 3 lots (J-0620-01, J-0720-02, J-0920-03).
- Flammability: 32 samples per lot, tested across 3 lots (J-0620-01, J-0720-02, J-0920-03).
The data provenance is non-clinical performance data generated from laboratory testing of the device for various physical and biological properties. The document does not specify the country of origin where the testing was conducted, nor does it classify the data as "retrospective" or "prospective" in the context of clinical studies, as these are non-clinical lab tests.
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 to this submission. The "ground truth" for the performance criteria of a surgical mask (e.g., filtration efficiency, fluid resistance) is established by industry standards (like ASTM F2100-19, ASTM F1862, ASTM F2299/F2299M-03, ASTM F2101-01, 16 CFR Part 1610, ISO 10993) and regulatory guidance, not by expert consensus on individual cases. The tests are objective measurements performed in laboratories.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving human interpretation (e.g., radiology reads) to resolve discrepancies among experts. For objective laboratory performance tests of a surgical mask, there is no human interpretation or adjudication process in the same sense. The results are quantitative measurements against predefined pass/fail criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or decision support systems where human readers interpret medical images or data. The submitted device is a surgical mask and does not involve AI or human readers for its intended use.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This concept applies to AI-driven devices. The surgical mask is a physical product, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance criteria of the surgical mask is based on established industry standards and regulatory requirements (e.g., ASTM standards, CFR regulations). These standards define the acceptable performance levels for specific physical and biological properties of surgical masks. The test results are objective measurements compared against these predefined numerical criteria.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical product (surgical mask), not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for a physical device like a surgical mask.
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