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The various models of Inovel 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.

Device Description

The Inovel 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 filter media is lavered between the inner and outer cover. The head strap is made of a non-latex rubber stapled to the mask. The inside nosepiece is a closed cell foam.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Inovel Health Care N95 Particulate Respirators and Surgical Masks based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Test Method	Acceptance Criteria	Reported Device Performance (New Models)	Predicate Device Performance
Fluid Resistance Performance	ASTM 1862 - 00a	32 of 32 pass	32 of 32 pass	32 of 32 pass
Flammability Class	16 CFR 1610	Flame spread must be within upper and lower limits / No flame spread on 10 of 10 samples, meets Class I	No flame spread on 10 of 10 samples, meets Class I	No flame spread on 10 of 10 samples, meets Class I
Filter Efficiency (%)	NIOSH, 42 CFR Part 84	> 95% Efficient	Average 99.33% efficient of 20 samples	Average 99.11% efficient of 20 samples
Breathing Resistance (mm H2O)	NIOSH, 42 CFR Part 84	≤ 35.0 mm H2O @ 85 lpm	Average 8.1 mm H2O @ 85 lpm of 3 samples	Average 11.3 mm H2O @ 85 lpm of 3 samples
Biocompatibility (Cytotoxicity)	ISO 10993 -- 1	Score of 2 or less	Same as predicate device (Score of 0)	Score of 0
Biocompatibility (Sensitization)	ISO 10993 -- 1	Grade 1 (no different than control)	Same as predicate device (Grade 1)	Grade 1
Biocompatibility (Primary Skin Irritation)	ISO 10993 -- 1	Negligible	Same as predicate device (Negligible)	Negligible
Bacterial Filtration Efficiency	Modified Greene and Vesley Method. J Bacteriol 83:663-667	Greater than 99.9%	Greater than 99.9%	Greater than 99.9%

2. Sample Sizes Used for the Test Set and Data Provenance

Fluid Resistance: 32 samples. Data provenance not explicitly stated (location of testing shown as "Inovel LLC" per the performance tests table, which is the manufacturer).
Flammability Class: 10 samples. Data provenance not explicitly stated (location of testing shown as "Nelson Laboratories").
Filter Efficiency: 20 samples. Data provenance not explicitly stated (location of testing shown as "NIOSH").
Breathing Resistance: 3 samples. Data provenance not explicitly stated (location of testing shown as "NIOSH").
Biocompatibility (Cytotoxicity, Sensitization, Primary Skin Irritation): Sample size for these tests is not explicitly stated, but the results are reported as "Same as predicate device" which had "Score of 0" for cytotoxicity, "Grade 1" for sensitization, and "Negligible" for primary skin irritation. These tests were conducted on predicate devices made from the same materials. Locations of testing shown as "Nelson Laboratories" and "Northview Pacific Laboratories, Inc."
Bacterial Filtration Efficiency: Sample size not explicitly stated, but results indicate "Test results show a bacterial filtration efficiency greater than 99.9%". Location of testing shown as "Nelson Laboratories".

The text doesn't specify if the data is retrospective or prospective, nor does it provide a country of origin beyond identifying the laboratories and the manufacturer's location (Culver City, California).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document describes performance testing based on established standards (ASTM, NIOSH, ISO, CFR) conducted by recognized laboratories. It does not mention "experts" establishing a "ground truth" in the way one might for diagnostic accuracy studies with human-interpreted data. The ground truth for these physical and biological performance characteristics is inherently defined by the test methods and regulatory standards themselves (e.g., a filter either achieves >95% efficiency or it doesn't, as measured by the specified NIOSH method).

4. Adjudication Method for the Test Set

Not applicable. The tests described are objective, standardized laboratory tests. There is no mention of subjective interpretation of results that would require an adjudication method among multiple human readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a physical medical device (N95 respirator and surgical mask), not an AI-powered diagnostic tool, so such a study design is not relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a physical product, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for these performance tests is defined by the objective measurement criteria and standards outlined in the specified test methods (e.g., ASTM F 1862 for fluid resistance, 42 CFR Part 84 for filter efficiency and breathing resistance, 16 CFR 1610 for flammability, ISO 10993 for biocompatibility, and Modified Greene and Vesley Method for bacterial filtration efficiency). These are verifiable, quantitative measurements against regulatory and industry standards.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI model, and therefore does not have a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a physical device.

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