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The Medical Face Masks are intended to be worn to protect both the patient and healthcare persomel 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. Face Masks are single use, disposable device, provided non-sterile.

Device Description

The Medical Face Mask is composed of three layers and is flat-pleated. The mask materials consist of an outer layer (spun-bond polypropylene), a middle layer, between the outer layer and inner layers (PTFE membrane filter) and an inner layer (spun-bond polypropylene). Each mask contains tie strings (spun-bond polypropylene) or ear loops (Spandex elastic cord) to secure the mask over the users' mouth and face and includes a malleable nosepiece (iron wire with white plastic covering) to provide a firm fit over the nose.

AI/ML Overview

The provided text is a 510(k) summary for a Medical Face Mask (K202493). This document details the device's characteristics, its comparison to a predicate device, and the results of non-clinical performance tests.

Here's an analysis of the acceptance criteria and study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The relevant information is presented under "Table 1 Summary of Performance Test" in the document.

Performance Characteristics	Acceptance Criteria	Test Result
Bacterial Filtration Efficiency Performance (%)	≥98%	99.9%
Differential Pressure (Delta-P) (mm H2O/cm²)	<6.0	4.01
Particulate Filtration Efficiency at 0.1micron Performance (%)	≥98%	99.1%
Resistance to penetration by synthetic blood, Minimum pressure in mmHg for pass results	160	160
Flammability Class	Class 1	Class 1
Cytotoxicity	If viability is reduced to <70% of the blank, it has a cytotoxic potential.	Non-cytotoxic
Irritation	Primary irritation index: (0-0.4) negligible; (0.5-1.9) slight; (2-4.9) moderate; (5-8) severe	Non-sensitizing
Sensitization	Magnusson and Kingman grades of 1 or greater in the test group generally indicate (sensitization)	Non-irritating

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

The document does not explicitly state the sample size for each specific test or the data provenance (e.g., country of origin, retrospective/prospective). However, for the Fluid Resistance test, it mentions "32/32 passed at 160 mmHg", which implies a sample size of 32 for that specific test. The document focuses on demonstrating substantial equivalence through non-clinical testing against established standards, rather than new clinical trials with patient data.

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

This information is not provided in the document. The tests performed are laboratory-based and follow established international standards (ASTM, MIL-M, ISO, 16 CFR). These standards define the methodology and acceptance criteria, and their execution would typically be undertaken by trained laboratory technicians or scientists, rather than by medical experts establishing "ground truth" in the clinical sense.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. "Adjudication method" usually refers to a process of resolving disagreements among experts when establishing ground truth for a test set, typically in a clinical or image-interpretation context. The tests described are objective, standardized laboratory tests with clear pass/fail criteria.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI systems on human performance in diagnostic tasks, which is not the purpose of this submission (which concerns a medical face mask).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No, a standalone (algorithm only) performance study was not done. This type of study is specifically for AI/software devices. The device in question is a physical medical face mask, and its performance is evaluated through physical and material tests, not algorithm performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the tests performed on the Medical Face Mask is based on objective, quantitative measurements in accordance with established international testing standards. For example:

Bacterial Filtration Efficiency (BFE): Measured objectively as a percentage according to ASTM F2101.
Differential Pressure: Measured objectively in mmH2O/cm² according to MIL-M-36954C.
Particulate Filtration Efficiency (PFE): Measured objectively as a percentage according to ASTM F2299.
Fluid Resistance: Measured objectively by resistance to synthetic blood penetration at a specific pressure (160 mmHg) according to ASTM F1862.
Flammability: Objectively classified according to 16 CFR Part 1610.
Biocompatibility (Cytotoxicity, Irritation, Sensitization): Evaluated through standardized biological assays with defined endpoints (e.g., cell viability for cytotoxicity, irritation index for irritation), as per ISO 10993 series.

There is no "expert consensus," "pathology," or "outcomes data" ground truth in the traditional sense for these types of physical product performance tests.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. "Training set" refers to data used to train AI algorithms. The Medical Face Mask is a physical medical device, not an AI or software device, so there is no training set in this context.

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

This information is not applicable and therefore not provided, for the reasons mentioned in point 8.

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