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510(k) Data Aggregation
(149 days)
Cardinal Health Secure-Gard® surgical and procedure masks are intended to be worn by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and airborne particulates. The Cardinal Health Secure-Gard® surgical and procedure masks are single use, disposable devices provided non-sterile.
The Cardinal Health Secure-Gard® surgical and procedure masks are all the same four-layer masks constructed of 1 layer of nonwoven cellulose (inner facing), 1 layer of nonwoven polvolefin melt blown (media). 1 laver of nonwoven polyester/polvethylene blends (media), and 1 layer polyolefin spunbond material (outer facing). The four layers of the mask body are collated and sonically welded around the edges to enclose the filter media. The mask is provided with nonwoven polyolefin ties or polyester-spandex earloops (both attached by ultrasonic welding). A malleable nosepiece is placed within the binding for comfort and individualized fit around the wearer's nose. The surgical masks will be provided with or without an eye shield. Cardinal Health surgical and procedure masks are a single use, disposable device provided non-sterile.
Here's an analysis of the acceptance criteria and study detailed in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria per ASTM F2100-11 Level 3 (AQL = 4.0%) | Reported Device Performance (Current device test results) | Average Performance |
|---|---|---|---|
| ASTM F1862 Synthetic Blood (Resistance to Penetration) | 160 mmHg | 32/32 Pass | Not Applicable |
| ASTM F2101 BFE (Bacterial Filtration Efficiency) | ≥ 98% | 32/32 Pass | 99.4 - 99.7% |
| ASTM F2299 PFE at 0.1 micron (Particle Filtration Efficiency) | ≥ 98% | 32/32 Pass | 98.6 - 99.1% |
| Mil-M-36954C Delta P (Differential Pressure / Breathability) | < 5.0 mmH₂O/cm² | 32/32 Pass | 3.1- 3.5 mmH₂O/cm² |
| CPSC 1610 Flammability | Class 1 | 32/32 Pass (Class 1) | Not Applicable |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 32 samples were tested for each performance criterion.
- Data Provenance: The data is prospective, generated from testing the "current device" (Cardinal Health Secure-Gard® surgical and procedure masks) according to the specified ASTM standards. The country of origin for the testing facilities is not explicitly stated in the provided text.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This type of information is generally not applicable to the performance testing of medical face masks. The "ground truth" for mask performance is established by standardized, objective laboratory tests (e.g., bacterial filtration, particle filtration, fluid resistance) defined by consensus standards like ASTM F2100-11. These tests produce quantitative results, not subjective expert opinions. Therefore, no "experts" in the traditional sense (like radiologists or pathologists) were used to establish ground truth for this device's performance claims.
4. Adjudication Method for the Test Set
Not applicable. As described above, the evaluation relies on objective, quantitative measurements from standardized laboratory tests. There is no subjective interpretation or "adjudication" by experts required for determining pass/fail criteria for these specific performance metrics. The text states an AQL (Acceptance Quality Limit) of 4.0%, indicating that for 32 samples tested, acceptance on 3 failures and rejection on 4 failures was the statistical method used for determining lot acceptance, not expert adjudication.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No. An MRMC study is not relevant for evaluating the performance of medical face masks. These studies are typically used to assess diagnostic accuracy or the impact of AI assistance on human readers in interpreting medical images or data. The performance of a surgical mask is evaluated through objective physical and material tests, not through human interpretation or a diagnostic task.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. The device (surgical mask) is a physical product, not an algorithm or AI system. Its performance is inherent in its physical properties and design, tested directly in a standalone manner (the mask itself is tested without human interaction beyond handling for the test).
7. Type of Ground Truth Used
The ground truth used for performance evaluation is based on objective, quantitative results from standardized laboratory tests as defined by ASTM F2100-11, such as direct measurements of bacterial filtration efficiency, particle filtration efficiency, fluid resistance, differential pressure, and flammability.
8. Sample Size for the Training Set
Not applicable. This device is a physical product (surgical mask), not an AI or machine learning model. Therefore, there is no "training set" in the context of AI development. The masks are manufactured according to specifications and then tested for performance.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this physical device.
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