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The following Liberty Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. These are single use, disposable device(s) provided non-sterile.

The LM Surgical Masks are white, single use, three-layer, pleated masks that come in 2 models: LM Surgical Mask Level 3 & LM Surgical Mask Level 2. The inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene. The masks are held in place over the users' mouth and nose by either two elastic ear loops, welded to the facemask. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose. The nose piece is made of polypropylene coated steel wire. The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.

Here's a breakdown of the acceptance criteria and study information for the "LM Surgical Mask Level 2" and "LM Surgical Mask Level 3," based on the provided FDA 510(k) summary:

This document describes a medical device clearance for surgical masks. These devices are typically evaluated through bench testing (non-clinical) to meet specific performance standards, rather than full clinical trials with patient outcomes. Therefore, most of the questions relating to clinical study design (experts, adjudication, MRMC, human-in-the-loop, training set details) are not applicable in this context.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Flammability: For each model (LM Surgical Mask Level 3 and LM Surgical Mask Level 2), 96 samples were tested, drawn from 3 nonconsecutive lots.
• Differential Pressure: Not explicitly stated how many samples per model, but the results are reported as single values (4.80 mmH2O/cm² and 5.20 mmH2O/cm²), which typically represent an average of multiple samples.
• Biocompatibility: The specific sample sizes for cytotoxicity, irritation, and sensitization tests are not detailed, but these tests are generally conducted on extracts from the device material.
• Data Provenance: The tests are non-clinical (bench testing) and were performed by the manufacturer or a contracted lab. The document does not specify the country of origin of the data beyond the manufacturer's address in Plano, Texas. These are prospective tests conducted specifically for this submission.

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

Not applicable. For surgical mask performance evaluations, ground truth is established by standardized laboratory test methods (e.g., ASTM, MIL-M) that provide objective, measurable outcomes, not by expert interpretation of images or observations.

4. Adjudication Method for the Test Set:

Not applicable. The tests are objective laboratory measurements, not subjective evaluations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a medical device clearance for physical surgical masks, not an AI-powered diagnostic or assistive technology.

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

Not applicable. This is a physical medical device.

7. The Type of Ground Truth Used:

The ground truth is based on objective measurements from standardized laboratory tests (e.g., fluid penetration, particle count, bacterial colony count, pressure differential, burn time, cellular response for biocompatibility). These standards (ASTM F1862, ASTM F2299, ASTM F2101, MIL-M-36954C, 16 CFR 1610, and ISO 10993 for biocompatibility) define the methodology and expected results.

8. The Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI-based device that requires a training set.

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

Not applicable. (See #8)

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