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This device is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

The IMC Surgical Face Mask devices are surgical apparel intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The surgical masks feature either tie-on or ear loop attachment mechanisms. This device is a flat pleated 3 ply mask. The inner and outer layer of the mask is made of polypropylene, sandwiching a middle layer made of melt-blown polypropylene filter media. The outer layer of the mask is offered in a yellow color.

Here's an analysis of the provided text regarding the IMC Surgical Face Mask, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the performance tests (e.g., how many masks were tested for each characteristic). It also does not specify the country of origin of the data or whether the studies were retrospective or prospective. The tests are described as being conducted "in accordance with" specific ASTM and MIL standards, implying standard laboratory testing rather than clinical studies with human subjects.

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

This information is not applicable to the type of device and testing described. The "ground truth" for the performance characteristics of a surgical mask (e.g., fluid resistance, filtration efficiency) is established by the specified test methods and their defined parameters, not by expert consensus or interpretation of imagery.

4. Adjudication Method for the Test Set

Not applicable. The performance testing of a surgical mask involves objective measurements against established standards, not interpretation by multiple experts requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is relevant for diagnostic devices where human readers interpret medical images or data. This document describes the performance characteristics of a physical product (a surgical mask).

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This device is not an algorithm or AI system. The performance studies are laboratory tests of the physical mask's material properties.

7. Type of Ground Truth Used

The ground truth used for this device's performance evaluation is established by objective test standards and defined acceptance criteria. These are standardized test methods (ASTM F1862, ASTM F2299, ASTM F2101, MIL-M36945C, 16 CFR Part 1610) that measure specific physical properties of the mask. The "ground truth" is that a mask either meets or does not meet the specified quantitative threshold for each characteristic (e.g., ≥98% for particulate filtration efficiency).

8. Sample Size for the Training Set

Not applicable. This device is a physical product and not an AI/ML algorithm that requires a "training set" of data.

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

Not applicable, as there is no training set for this type of device.

Study That Proves the Device Meets the Acceptance Criteria:

The device's compliance with the acceptance criteria is demonstrated through a series of performance characteristic tests conducted according to recognized industry standards. The summary states that for each performance characteristic (Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, and Flammability), the "IMC Surgical Face Mask K100846" was found to "Meets Standard Criteria" or "Class 1" (for Flammability).

The predicate devices (Medline K991559 and Crosstex K012602) are also listed as meeting the "Same" standards, indicating that the new device replicates the performance of already legally marketed devices. The document implies that reports from these tests were submitted to the FDA to demonstrate substantial equivalence to the predicate devices. The listed Test Methods are the studies that prove the device meets the acceptance criteria.

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