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510(k) Data Aggregation
(34 days)
The various models of Moldex Type N95 Healthcare Particulate Respirators and Surgical Masks meet CDC Guidelines for TB Exposure Control within healthcare facilities. These devices are also intended to be worn by healthcare personnel during surgical procedures to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material.
The Moldex type N95 Healthcare Particulate Respirators and Surgical Masks are constructed from an extruded plastic mesh used in the outer cover and a nonwoven spunbond used in the inner and outer cover. The polypropylene melt blown fitter media is layered between the inner and outer cover. The head straps are made of a non-latex rubber stapled to the mask, The inside nosepiece is a closed cell foam.
Here's a breakdown of the acceptance criteria and study information for the Moldex Health Care N95 Particulate Respirators and Surgical Masks, based on the provided text:
Acceptance Criteria and Device Performance
| Performance Characteristics | Test Method | Acceptance Criteria | Reported Device Performance (Moldex Health Care N95 Particulate Respirators and Surgical Masks) |
|---|---|---|---|
| Fluid Resistance Performance | ASTM 1862-00a | 32 of 32 pass | 32 of 32 pass |
| Flammability Class | 16 CFR 1610 | Flame spread must be within upper and lower limits / Meets Class 1 | No flame spread on 10 of 10 samples, meets Class I |
| Filter Efficiency (%) | NIOSH, 42 CFR Part 84 | > 95% Efficient | Average 96.81% efficient of 20 samples |
| Breathing Resistance (mm H₂O) | NIOSH, 42 CFR Part 84 | < 35.0 mm H₂O @ 85 lpm | Average 10.2 mm H₂O @ 85 lpm of 3 samples |
| Biocompatibility (Cytotoxicity) | ISO 10993-5 (tested on predicate devices) | Score of 2 or less | Same as predicate device (Predicate device score of 0, so Moldex also meets this) |
| Biocompatibility (Sensitization) | ISO 10993-10 (tested on predicate devices) | Grade 1 (no different than control) | Same as predicate device (Predicate device Grade 1, so Moldex also meets this) |
| Biocompatibility (Primary Skin Irritation) | ISO 10993-10 (tested on predicate devices) | Negligible | Same as predicate device (Predicate device Irritation Negligible, so Moldex also meets this) |
| Bacterial Filtration Efficiency | Modified Greene and Vesley Method. J Bacteriol 83:663-667. | Greater than 99.9% | Test results show a bacterial filtration efficiency greater than 99.9% |
Study Details
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Sample sizes used for the test set and data provenance:
- Fluid Resistance Performance: 32 samples (number of individual masks tested). Data provenance is not specified, but typically these are laboratory tests performed on samples from production batches.
- Flammability Class: 10 samples. Data provenance is not specified.
- Filter Efficiency (%): 20 samples. Data provenance is not specified.
- Breathing Resistance (mm H₂O): 3 samples. Data provenance is not specified.
- Biocompatibility (Cytotoxicity, Sensitization, Primary Skin Irritation): Tested on unspecified number of predicate devices. Data provenance is not specified.
- Bacterial Filtration Efficiency: Not explicitly stated, but the test results show "a bacterial filtration efficiency greater than 99.9%". This would involve testing multiple samples. Data provenance is not specified.
All tests are laboratory-based performance evaluations, not clinical studies involving human subjects in particular countries. They are inherently prospective tests performed on samples of the device to demonstrate compliance with standards.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This report describes the results of physical and performance testing of a medical device (respirators/surgical masks) against established industry standards and regulatory requirements. It does not involve "experts" establishing a "ground truth" in the way one might for diagnostic imaging interpretation. The "ground truth" is defined by the objective measurement criteria of the specified test methods (e.g., ASTM F1862 for fluid resistance, NIOSH 42 CFR Part 84 for filter efficiency). The laboratories performing these tests are accredited for these specific testing methodologies, and their expertise lies in conducting these technical measurements accurately according to protocol. -
Adjudication method for the test set:
Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human interpretation or subjective assessment is a component of ground truth determination (e.g., grading medical images). This document describes objective performance testing. -
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 a study involving human readers or AI assistance; it's a device performance and safety evaluation. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This document pertains to physical device performance, not algorithm performance. -
The type of ground truth used:
The "ground truth" is defined by the objective, quantitative measurements and pass/fail criteria established by standardized test methods (e.g., ASTM, NIOSH, ISO). For instance, for filter efficiency, the ground truth is simply whether the filter achieved >95% efficiency when tested according to NIOSH 42 CFR Part 84. -
The sample size for the training set:
Not applicable. This document describes the testing of finished products, not the development or training of an algorithm. -
How the ground truth for the training set was established:
Not applicable. There is no algorithm training set discussed in this document.
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