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510(k) Data Aggregation
(133 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. This face 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(s), provided non-sterile.
The Surgical Mask is Blue color, and Flat Pleated type mask, utilizing Ear Loops ' way for wearing, and they all have Nose Piece design for fitting the facemask around the nose. The mask is manufactured with three layers, the inner and outer layers are made of PP spun-bond non-woven, and the middle layer is made of Melt-blown non-woven fabric. The Mask is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. Theelastic ear loops are made with Polyester fiber and Polyurethane. The nose piece contained in the proposed device(s) is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of Polyethylene and Metal Wire. The mask is sold non-sterile and are intended to be single-use, dis posable devices and the colorant used for mask is TiO2 + Phthalocyanine Blue BGS + Pigment Violet23.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Surgical Mask (K202640), structured according to your request.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (ASTM F2100 Level 2 Requirements) | Reported Device Performance (Proposed Device K202640) |
|---|---|---|
| Fluid Resistance (ASTM) | 120 mmHg | 120 mmHg |
| Particulate Filtration Efficiency (ASTM) | ≥ 98% | ≥99.73% |
| Bacterial Filtration Efficiency (ASTM) | ≥ 98% | ≥99.07% |
| Differential Pressure (Delta P) | < 6.0 mmH₂O/cm² | ≤4.7 mmH₂O/cm² |
| Flammability (16 CFR 1610) | Class 1 | Class 1 |
| Cytotoxicity (ISO 10993-5) | Non-cytotoxic | Non-cytotoxic (Comply with ISO 10993-5) |
| Irritation (ISO 10993-10) | Non-irritating | Non-irritating (Comply with ISO 10993-10) |
| Sensitization (ISO 10993-10) | Non-sensitizing | Non-sensitizing (Comply with ISO 10993-10) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the test sets used in each non-clinical test (e.g., how many masks were tested for BFE, PFE, etc.). It only mentions that "Non clinical tests were conducted to verify that the proposed device met all design specifications."
The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. It is implied to be prospective testing conducted for the purpose of this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a surgical mask, and its performance is evaluated through standardized laboratory tests (e.g., ASTM, ISO standards) rather than expert review of clinical data. There is no mention of human experts establishing ground truth for these performance metrics.
4. Adjudication Method for the Test Set
Not applicable. Performance is determined by objective laboratory measurements and adherence to specified standard values, not through human adjudication of qualitative assessments.
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 not a diagnostic device involving human readers or AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm or AI-powered device. The device itself (the surgical mask) is the subject of the standalone performance testing against recognized standards.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is established by recognized industry standards and test methods. Specifically:
- ASTM F2100-19: Standard Specification for Performance of Materials Used in Medical Face Masks, which defines performance levels (e.g., Level 2) based on objective measurements.
- ASTM F2101-19: Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials.
- ASTM F2299-03: Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates.
- ASTM F1862-17: Standard Test Method for Resistance of Medical Face Masks to Penetration By Synthetic Blood.
- 16 CFR 1610: Standard for the Flammability of clothing textiles.
- ISO 10993-5: 2009: Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity.
- ISO 10993-10: 2010: Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
The device's performance is measured and compared directly against the quantitative or qualitative requirements specified in these standards.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set. The "training" for this type of device involves adherence to manufacturing processes and material specifications.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, there is no training set in the context of this device.
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