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510(k) Data Aggregation
(162 days)
The Banyan USA Surgical Mask Level 3 is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganism, body fluids, and particulate materials. This face mask are intended for use in infection control practices to reduce potential exposure to blood and body fluids. the face mask is single use, disposable device, provided non-sterile.
The Banyan USA Surgical Mask is composed of three-layers which are flat-pleated and ultrasonically welded together at the edges of the mask at embossment points. The mask materials consist of an outer layer (polypropylene spunbond, white), filter layer (polypropylene melt-blown, white) and inner layer web (polypropylene thermal-bonded, white (22 GSM Thermal Bond White Material)). Each mask has two ear loops ultrasonically welded onto the sides to secure the users' nose and mouth. The construction also includes a polyethylene wire nosepiece to provide a firm fit over the nose. The mask is a single use, disposable device, provided non-sterile.
The provided document is a 510(k) summary for the Banyan USA Surgical Mask Level 3. It details non-clinical laboratory testing performed to demonstrate substantial equivalence to a predicate device, rather than a study with human subjects (clinical study) for an AI/CADe device. Therefore, many of the requested criteria regarding AI device studies are not applicable.
Here's the information that can be extracted and a clear indication of which points are not applicable:
1. A table of acceptance criteria and the reported device performance
| Test | Purpose | Acceptance Criteria (ASTM F2100-11 Level 3) | Reported Device Performance (Banyan USA Surgical Mask Level 3) | Result |
|---|---|---|---|---|
| Fluid Resistance (ASTM F1862) | Determine synthetic blood penetration resistance | 160 mmHg | Pass at 160 mmHg | Pass |
| Particulate Filtration Efficiency (ASTM F2299) | Determine bacterial filtration efficiency | ≥ 98% | 98.69% | Pass |
| Bacterial Filtration Efficiency (ASTM F2101) | Determine submicron particulate filtration efficiency | ≥ 98% | 99.22% | Pass |
| Differential Pressure (Delta P) (EN 14683:2019) | Determine breathing resistance or differential pressure | < 6.0 mmH2O / cm2 | 3.82 mm H2O/cm2 | Pass |
| Flammability (CFR 16 1610) | Determine flammability | Class 1 | Class 1 Pass | Pass |
| Cytotoxicity (ISO 10993-5) | Assess in vitro cytotoxicity | Non-cytotoxic | Non-cytotoxic | Pass |
| Irritation (ISO 10993-10) | Assess irritation | Non-irritating | Non-irritating | Pass |
| Sensitization (ISO 10993-10) | Assess skin sensitization | Non-sensitizing | Non-sensitizing | Pass |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for performance tests (Fluid Resistance, Particulate Filtration, Bacterial Filtration, Differential Pressure, Flammability): 32 samples each from 3 non-consecutive lots (total 96 samples for each test).
- Sample Size for biocompatibility tests (Cytotoxicity, Irritation, Sensitization): Not explicitly stated how many individual mask samples were used for these tests, but the results refer to "the device" as a whole fulfilling the criteria.
- Data Provenance: The document does not specify the country of origin of the data. The tests are laboratory-based, not clinical data.
- Retrospective or Prospective: Not applicable as this is laboratory testing of a physical device, not an AI/CADe study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. The ground truth for this device (a surgical mask) is established by standardized laboratory testing methods (e.g., ASTM, EN, ISO, CFR standards), not by human expert consensus or medical diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Laboratory test results are objective measurements based on the specified standards, not subjective expert reviews requiring adjudication.
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 document is for a physical surgical mask, not an AI or CADe device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI algorithm. The device's performance is standalone in the sense that the mask itself is tested according to specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the surgical mask's performance is defined by the acceptance criteria specified in the relevant international and national standards (e.g., ASTM F2100-11 for performance of materials, ISO 10993 for biocompatibility, EN 14683 for differential pressure, 16 CFR 1610 for flammability). These standards set objective thresholds for physical and biological properties.
8. The sample size for the training set
- Not applicable. This is not an AI/CADe device, and therefore does not involve a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set for an AI/CADe was used or established.
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