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510(k) Data Aggregation
(100 days)
The "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. The "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(s), provided non-sterile.
The "SURGICAL MASK" is single use, blue color, without face shield, Flat Pleated type, utilizing elastic ear loops for wearing, and it has a Nose Piece design for fitting the facemask around the nose. The "SURGICAL MASK" is manufactured with three layers. The inner and outer layers are made of Non-woven fabric (Polypropylene), and the middle filter layer is made of a melt blown fabric (Polypropylene). The subject device is held in place over the user's mouth and nose by two ear loops welded to the facemask. The elastic ear loop is made of Polyester and Spandex. The nose piece contained in masks is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of iron strip and polypropylene. The "SURGICAL MASK" is sold non-sterile and are intended to be single-use, disposable devices. This product contains no components made with natural rubber latex.
The document provided describes the acceptance criteria and performance of a SURGICAL MASK, Model Name: C015. This is a medical device and not an AI/ML powered device, therefore many of the points in your request are not applicable.
Here's the breakdown of the information available:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Test Method | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| Performance: | |||
| Bacterial Filtration Efficiency (BFE) | ASTM F2101-19 | ≥98% | 32 pass / 32 tested, Accepted |
| Particulate Filtration Efficiency (PFE) | ASTM F2299-03 (2017) | ≥98% | 32 pass / 32 tested, Accepted |
| Differential Pressure | EN 14683:2019+AC (2019)(E), Annex C | <6.0 mm H2O/cm² | 32 pass / 32 tested, Accepted |
| Synthetic Blood Penetration Resistance | ASTM F1862M-17 | 160 mmHg | 32 pass / 32 tested, Accepted |
| Flammability | 16 CFR Part 1610 (As Amendment In 2008) | (A) No burn times; or (B) One burn time ≥ 3.5 seconds; or (C) Average burn time of two or more specimens ≥ 3.5 seconds. | Class 1 |
| Biocompatibility: | |||
| In Vitro Cytotoxicity | ISO 10993-5:2009 (via L-929 cell culture and MTT assay) | 50% extract of test article should have at least the same or higher viability than 100% extract. If viability reduced to <70% of blank, it has cytotoxic potential. Viab.% of 100% extract is final result. | Non-cytotoxic |
| Skin Sensitization | ISO 10993-10:2010 (via Guinea Pig Maximization Test) | Magnusson and Kligman grades of 1 or greater in test group generally indicate sensitization (if control < 1). If control ≥ 1, reactions exceeding most severe control reaction are presumed sensitization. | Non-sensitizing |
| Skin Irritation Test | ISO 10993-10:2010 (via New Zealand White Rabbits) | Primary irritation index for test article (calculated from erythema and oedema scores) compared to control. | Non-irritating |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- For performance tests (BFE, PFE, Differential Pressure, Synthetic Blood Penetration Resistance): "32pass/32tested" indicates that 32 samples were likely tested for each of these criteria.
- For Flammability: "Class 1" likely refers to the result of testing a specific number of specimens as per the standard (not explicitly stated, but typically multiple samples).
- For Biocompatibility:
- Cytotoxicity: L-929 cells (implied large number of cells).
- Skin Sensitization: Guinea pigs (implied multiple animals for test and control groups).
- Skin Irritation: New Zealand White Rabbits (implied multiple animals for test and control groups).
- Data Provenance: The document does not specify the country of origin of the data. It does not explicitly state whether the studies were retrospective or prospective, but given they are laboratory tests on a new device, they are inherently prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This section is not applicable as the document describes performance and biocompatibility testing for a medical device (surgical mask), not an AI/ML system that requires expert ground truth for image interpretation or diagnosis. The "ground truth" here is established by standardized test methods and criteria.
4. Adjudication Method for the Test Set
This section is not applicable as the document describes performance and biocompatibility testing for a medical device (surgical mask), not an AI/ML system that requires adjudication for establishing ground truth or resolving discrepancies in interpretations.
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
This section is not applicable. The device is a surgical mask, not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a surgical mask and does not involve any algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" for the surgical mask's performance and safety is established by adherence to well-defined, internationally recognized standards and test methods. For example:
- Performance: ASTM F2100-19, ASTM F2101-19, ASTM F2299-03(2017), EN 14683:2019+AC (2019), ASTM F1862M-17, 16 CFR Part 1610. These standards define the parameters and methodologies for testing physical properties like filtration efficiency, breathability, and fluid resistance.
- Biocompatibility: ISO 10993-5:2009 for cytotoxicity and ISO 10993-10:2010 for irritation and sensitization. These standards define the biological response parameters and test procedures.
8. The Sample Size for the Training Set
This section is not applicable. The device is a physical product (surgical mask), not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This section is not applicable. The device is a physical product (surgical mask) and does not involve a training set or AI.
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