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510(k) Data Aggregation
(177 days)
The Single Use Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a single use device provided non-sterile.
The Single-Use Surgical Mask is a 3-ply, disposable surgical face mask. The outer and inner layers of the mask are made of spunbond polypropylene, while the middle layer consists of a meltblown polypropylene filter fabric. The device is secured on the user's face via elastic earloops and are labeled non-sterile, single-use, and disposable. This device is a surface device intended to come in contact with intact skin for a duration of less than 24 hours.
The provided document describes the acceptance criteria and the study that proves the performance of a Single-Use Surgical Mask (K211773). This is a non-clinical study, as stated in section 8. Clinical Testing.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Item/Test Method | Purpose | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| Fluid Resistance (ASTM 1862) | Demonstrate resistance to fluid spray | Pass at 80 mmHg (level 1 fluid resistance) | Pass |
| Bacterial Filtration Eff. (ASTM F2101-19) | Demonstrate resistance to bacterial penetration | Pass at ≥ 99% | Pass |
| Particulate Filtration Eff. (ASTM F2299) | Demonstrate resistance to penetration of particulate matter | Pass at ≥ 95% | Pass |
| Differential Pressure (EN 14683) | Demonstrate breathability | Pass at < 5.0 mm H2O/cm² | Pass |
| Flammability (16 CFR 1610) | Demonstrate low flammability Class 1 | (Implicitly Class 1, based on predicate) | Pass |
| Biocompatibility: Cytotoxicity (ISO 10993-5) | Demonstrate low cytotoxic potential | Under the conditions of the study, non-cytotoxic | Pass |
| Biocompatibility: Skin Sensitization (ISO 10993-10) | Demonstrate low skin sensitization potential | Under the conditions of the study, not a sensitizer | Pass |
| Biocompatibility: Skin Irritation (ISO 10993-10) | Demonstrate low skin irritation potential | Under the conditions of the study, not an irritant | Pass |
| ASTM F2100 Level (ASTM F2100) | Demonstrates face mask performance | Meet Level 1 requirements | 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 individual test. It mentions "non-clinical testing" and the results are presented as "Pass" for each criterion. The data provenance is also not specified in terms of country of origin or whether it's retrospective or prospective, beyond being non-clinical (laboratory-based) 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. The device is a surgical mask, and its performance criteria are objectively measured via standardized laboratory tests (e.g., ASTM, ISO, EN standards) rather than requiring expert interpretation for ground truth.
4. Adjudication method for the test set
This information is not applicable. The tests are laboratory-based and produce quantitative results compared against predefined thresholds, not subjective assessments requiring adjudication.
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. This document describes the performance of a physical device (surgical mask) through non-clinical testing, not an AI or diagnostic imaging device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The subject is a physical surgical mask, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance of the surgical mask is established by the specified industry and regulatory standards and test methods (e.g., ASTM F1862 for fluid resistance, ASTM F2101-19 for Bacterial Filtration Efficiency, ISO 10993 for biocompatibility). These standards define objective criteria and measurement procedures.
8. The sample size for the training set
This information is not applicable. This is not a study involving a training set for an algorithm or a similar machine learning context. The tests are for a physical product.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated in point 8.
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