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510(k) Data Aggregation
(82 days)
Aurelia Surgical Masks ASTM Level-3 (2130) is intended for use to minimize contamination caused by inhaled and exhaled microorganisms and reduce the potential exposure of the wearer to blood and body fluids. This is a single use, disposable device and provided non-sterile
The Aurelia Surgical Masks ASTM Level 3 are constructed with three layers of nonwoven polypropylene. The direct body contact materials include polypropylene, polyurethane, and nylon. The indirect body contacting materials include polypropylene and aluminum wire coated with melt-blown polypropylene embedded within the three layers.
The provided text is a 510(k) summary for the Aurelia Surgical Mask ASTM Level-3 (2130). It details the non-clinical performance testing conducted to demonstrate substantial equivalence to a predicate device, rather than a study proving a device meets AI/ML acceptance criteria.
Therefore, many of the requested data points (like sample size for test/training sets in an AI/ML context, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for training) are not applicable to this document. This document describes the testing of a physical medical device (a surgical mask) against established performance standards for such devices.
Here's a breakdown based on the provided text, focusing on the relevant information:
Acceptance Criteria and Device Performance for Aurelia Surgical Mask ASTM Level-3 (2130)
This section describes the performance testing of a physical product (surgical mask) against established standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM F2101-19 | Bacterial Filtration Efficiency | ≥ 98% | 99% (Pass) |
| ASTM F2299/F2299M-03(2017) | Sub-micron Particulate Filtration Efficiency | ≥ 98% | 99% (Pass) |
| EN 14683:2019, Annex C | Differential Pressure (Breathability) | <6 H2O/cm² | 5.5 H2O/cm² (Pass) |
| ASTM F1862/F1862M-17 | Resistance to penetration by synthetic blood | 160 mmHg | 160 mmHg (Pass) |
| 16 CFR Part 1610 | Flame Spread | Class 1 | Class 1 (Pass) |
| ISO 10993-5 | Cytotoxicity | Non-toxic | Non-cytotoxic (Pass) |
| ISO 10993-10 | Irritation | Non-irritating | Not an irritant (Pass) |
| ISO 10993-10 | Sensitization | Non-sensitizing | Not a sensitizer (Pass) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of masks) used for each individual test. It refers to "non-clinical tests" conducted to verify design specifications. The data provenance is implied to be from laboratory testing related to the device manufacturer (Supermax Healthcare Canada), rather than patient data. The tests are "non-clinical" and therefore do not involve retrospective or prospective human subject data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This is not an AI/ML diagnostic device requiring expert consensus for ground truth on medical images or conditions. The "ground truth" here refers to the physical properties and performance metrics of the surgical mask, established through standardized laboratory testing methods (e.g., measuring filtration efficiency, pressure differential).
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human readers or interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI/ML medical device.
6. Standalone (Algorithm Only) Performance
Not applicable. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
The ground truth is based on established objective performance standards and test methods (e.g., ASTM F2101-19 for Bacterial Filtration Efficiency, ISO 10993 for biocompatibility). These standards define what constitutes a "pass" or "fail" for the specified performance characteristics of a medical face mask.
8. Sample Size for the Training Set
Not applicable. This is a physical device, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set is involved for this type of device.
In summary, this document is a regulatory submission for a physical medical device (surgical mask), providing evidence of its performance against established industry standards. It does not pertain to the development or validation of an AI/ML diagnostic or therapeutic device.
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