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510(k) Data Aggregation
(316 days)
The PRECISION ECO™ Compostable / Plant Based Procedural Mask with Earloops is intended to be worn to protect both the patient and healthcare professional from transfer of microorganisms, body fluids, and particulate material. The PRECISION ECO™ Compostable / Plant Based Procedural Mask with Earloops is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, non-sterile, disposable device.
The PRECISION ECO™ Compostable / Plant Based Procedural Masks with Earloops are single use, ASTM Level 3 disposable devices, provided non-sterile. The mask has a four-layer, flat, pleated body with two earloops and a malleable nose piece. All components of the mask design are bonded together via ultrasonic welding, and it does not include any drugs, biologics, or nanoparticles. The mask comes in one configuration with two (2) different color schemes: black (100195), and white (100196).
The provided text is a 510(k) summary for the PRECISION ECO™ Compostable / Plant Based Procedural Mask with Earloops. It details the device's characteristics, intended use, and a comparison to a predicate device, focusing on laboratory performance testing rather than studies involving AI or human readers for diagnostic purposes.
Therefore, the requested information regarding acceptance criteria and study proving device meets acceptance criteria, in the context of an AI/human reader diagnostic device, cannot be extracted from this document. The document describes acceptance criteria and testing for a medical face mask, not a diagnostic AI device.
However, I can provide the acceptance criteria and the (laboratory) study results for the medical face mask as presented in the document:
1. A table of acceptance criteria and the reported device performance
Based on the "TABLE V: STANDARDS AND ACCEPTANCE CRITERIA" and the statement "The device met the acceptance criteria for both production lots and artificially aged samples" in the document, we can infer that the reported performance met these criteria. The document does not provide specific numerical results for each test, only that the acceptance criteria were met.
| Characteristic | Test Method | Acceptance Criteria | Reported Device Performance (Implied) |
|---|---|---|---|
| Bacterial filtration Efficiency (BFE) | ASTM F2101-19: Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus | ≥ 98% | Met Criteria (≥ 98%) |
| Sub-micron particulate efficiency at 0.1 µm (PFE) | ASTM F2299: Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres | ≥ 98% | Met Criteria (≥ 98%) |
| Blood Penetration | ASTM F1862: Standard Test Method for Resistance of Medical Face Masks to penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) | @160 mm Hg | Met Criteria (@160 mm Hg) |
| Differential Pressure | EN 14683:2019 Annex C: Medical face masks - Requirements and test methods | < 6.0 mm H2O/cm² | Met Criteria (< 6.0 mm H2O/cm²) |
| Flammability | 16 CFR Part 1610: Standard for the Flammability of Clothing Textiles | Class 1 (≥3.5 s flame spread) | Met Criteria (Class 1, ≥3.5 s flame spread) |
| Cytotoxicity | ISO10993-5: Biological evaluation of medical devices -Part 5: Tests for invitro cytotoxicity. | ≤ Grade 2 | Met Criteria (≤ Grade 2) |
| Irritation | ISO10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity. | Non-irritant | Met Criteria (Non-irritant) |
| Sensitization | ISO10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity. | Non-sensitizer | Met Criteria (Non-sensitizer) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "The performance testing was conducted on production lots and on artificially aged samples." It does not specify the exact sample size (the number of masks tested for each characteristic) or the country of origin of the data. It is implicitly prospective testing as new masks were produced and tested, along with artificially aged samples.
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)
This information is not applicable. The device is a medical face mask, not a diagnostic device requiring expert interpretation for ground truth establishment. The "ground truth" for this device is based on standardized laboratory test methods for material properties and filtration efficiency.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is laboratory testing of a physical product, not diagnostic image interpretation.
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 is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI-driven device. The testing described is performance testing of the physical mask itself in a laboratory setting.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the performance claims of the medical face mask is based on the results obtained from standardized laboratory test methods, as listed in Table V (e.g., ASTM F2101-19 for BFE, ASTM F2299 for PFE, ASTM F1862 for blood penetration). These are objective, quantitative measurements derived from specific protocols.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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