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510(k) Data Aggregation
(259 days)
Grande Medical Masks is intended to be worn to protect both the patient and healthcare personnel from the 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. The Grande Medical Masks are single use, disposable device, provided non-sterile.
Grande Medical Masks are 4-layer surgical masks that covers the user's nose and mouth and provides a physical barrier to fluids and particulate materials. This device is non-sterile and for single use only. The mask is constructed of nonwoven fabric, including the bottom layer, surface layer 1, surface layer 2 and middle layer, and is provided with ear loops and nose clip.
The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the "Grande Medical Masks, Model SF-600".
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (F2100-19 Level 2) | Reported Device Performance | Result |
|---|---|---|---|
| Bacteria Filtration Efficiency (ASTM F2101) | ≥ 98 % | Pass at 99 % | Pass |
| Particle Filtration Efficiency (ASTM F2299) | ≥ 98 % | Pass at 99% | Pass |
| Differential Pressure (EN 14683:2019) | < 6.0 mmH2O/cm² | Less than 4.5 mmH2O/cm² | Pass |
| Resistance to penetration by synthetic blood (ASTM F1862) | 120 mmHg (≥ 29/32 show passing results per lot) | 120 mmHg | Pass |
| Flammability (16 CFR Part 1610) | Class I (Burn time ≥3.5 s, IBE, or DNI) | Class I | Pass |
| In vitro Cytotoxicity (ISO 10993-5) | Non-cytotoxic | Non-cytotoxic | Pass |
| Skin sensitization Test (ISO 10993-10) | Not a sensitizer | Not a sensitizer | Pass |
| Skin Irritation Test (ISO 10993-10) | Not an irritant | Not an irritant | Pass |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes used for each specific non-clinical test. However, it indicates standard test methodologies like ASTM F2101, F2299, F1862, EN 14683:2019, 16 CFR Part 1610, ISO 10993-5, and ISO 10993-10, which inherently involve specific sample sizes as part of their standardized procedures. The data provenance is derived from these non-clinical tests, which are conducted in a controlled environment as per international and national standards. The country of origin of the data is not specified beyond the reference to the manufacturer, Golden Grande Corp. in Taiwan. The data is retrospective in the sense that it's generated from lab tests, not from observations of real-world use over time.
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. For medical masks, ground truth is established by objective pass/fail criteria of standardized performance tests, not by expert consensus on subjective interpretations. The "experts" involved are the certified laboratories and technicians performing the tests according to the specified methodologies.
4. Adjudication method for the test set:
Not applicable. The tests conducted for medical masks (e.g., bacterial filtration, particle filtration, differential pressure) yield objective, quantifiable results that are directly compared against predefined numerical acceptance criteria. There is no subjective interpretation or multi-reader adjudication process involved.
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 device is a medical mask, a physical barrier device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. As stated above, this is a physical medical device, not an algorithm or software. No standalone algorithm-only performance testing was performed because there is no algorithm.
7. The type of ground truth used:
The ground truth used is based on objective, quantifiable results derived from standardized in vitro and in vivo (for biocompatibility) performance tests. These tests have established pass/fail criteria defined by international and national standards (e.g., ASTM F2100-19 Level 2 criteria, ISO 10993 standards). This is not expert consensus, pathology, or outcomes data in the usual sense, but rather a direct measurement of the device's physical and biological properties against established safety and performance benchmarks.
8. The sample size for the training set:
Not applicable. This device is a medical mask, not a machine learning model. Therefore, there is no "training set" in the context of AI or software development.
9. How the ground truth for the training set was established:
Not applicable. As there is no training set for a medical mask, there is no ground truth established for it.
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