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510(k) Data Aggregation
(135 days)
The Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.
The Premier Guard Face Mask is a flat-pleated style mask with elastic ear loops to secure it over the users' mouth and face. The mask consists of three-layers. The inner facing layer is white and is manufactured from spunbond polypropylene (three layers of nonwoven polypropylene). The inner filter material is made of meltblown fiber. The outer facing layer is blue and is manufactured from spunbond polypropylene (three layers of nonwoven polypropylene). The mask is a single use, disposable device, provided non-sterile. The proposed device is not made from natural rubber latex.
The provided text presents a 510(k) summary for a surgical face mask, focusing on non-clinical performance and biocompatibility testing. It does not describe a study involving an AI/software device or human readers. Therefore, I cannot extract the information required for questions pertaining to AI performance, human reader improvement with AI assistance, MRMC studies, or multi-expert ground truth establishment.
However, I can provide information based on the presented non-clinical performance testing of the Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask.
Here's the information that can be extracted from the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | 29 out of 32 pass at 160 mmHg | Pass at 160 mmHg | Pass |
| Particulate Filtration Efficiency (ASTM F2299) | ≥98% | ≥98% | Pass |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥98% | ≥98% | Pass |
| Differential Pressure (Delta P) (EN 14683) | <6 mmH2O/cm² | <6 mmH2O/cm² | Pass |
| Flammability (16 CFR 1610) | Class 1 | Class 1 | Pass |
| Biocompatibility Testing: | |||
| Cytotoxicity (ISO 10993-5) | Not explicitly stated as pass/fail, but implied by result. | Grade 0 | Pass |
| Sensitization (ISO 10993-10) | No sensitization reactions (implied) | No sensitization reactions were observed in test animals | Pass |
| Irritation (ISO 10993-10) | Primary Irritation score=0 (Negligible) (implied) | Primary Irritation score=0 (Negligible) | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size for each non-clinical test (e.g., how many masks were tested for particulate filtration). However, for Fluid Resistance, the acceptance criteria explicitly states "29 out of 32 pass at 160 mmHg," indicating a sample size of 32 units for that particular test.
Data Provenance: This is a medical device (surgical face mask), not an AI/software product. The tests were performed according to specified ASTM and EN standards, which are laboratory-based. The data provenance is these standardized tests, likely conducted in a controlled laboratory environment, not from patient populations or clinical sites. The document does not specify country of origin for the testing itself. The filing company is Premier Guard USA LLC, based in the US.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This is for a physical medical device (surgical face mask), not an AI/software device requiring human expert ground truth for interpretation. The "ground truth" for the performance tests comes from the established protocols of the ASTM, EN, and CFR standards.
4. Adjudication Method for the Test Set
Not applicable. This is for a physical medical device; adjudication by multiple readers or experts is not relevant to the described non-clinical performance and biocompatibility testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This is not an AI/software product.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests consists of:
- Established ASTM, EN, and CFR standards and their specified methodologies.
- Laboratory measurements and observations according to these standards (e.g., particle count, pressure differential, visual assessment of fluid penetration, biological responses in test animals).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for this type of device.
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