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The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare provider 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 bodily fluids. This is a single use, disposable device provided non-sterile.

The KDI Med Supply surgical face mask is with blue outer color layer and white inner and middle layer. Subject device is a flat pleated type mask, utilizing ear loop way for wearing, and it has a nose piece designed for fitting the face mask around the nose. The mask materials consist of an outer layer (polypropylene spunbond), inner layer (polypropylene spunbond), filter (polypropylene melt-blown) and ear-loops. The masks contains a malleable nose piece to provide a firm fit over the nose and to secure the mask over the users mouth and face. The mask has level II fluid resistance under ASTM F2100. The mask is a single use, provided nonsterile. This product contains no components made with natural rubber latex.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text, specifically for the "3 Ply Medical Grade Single Use Procedural Disposable Face Mask (K220637)".

The device is a medical face mask, and its acceptance criteria are based on established standards for such devices. The studies conducted are benchtop performance tests comparing the subject device to a predicate device and evaluating its performance against specific ASTM and ISO standards.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document indicates that performance data was provided from "3 nonconsecutive lots" to demonstrate that the subject device meets the criteria. The specifics of the number of masks tested per lot for each particular test are not explicitly detailed in this document.

The data provenance is non-clinical benchtop testing, performed for regulatory submission in the USA (FDA). It is retrospective in the sense that the tests were conducted on manufactured samples to demonstrate compliance.

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

This type of study (benchtop performance testing for medical masks) does not typically involve human experts to establish ground truth in the way medical imaging or diagnostic studies do. The "ground truth" is established by the specifications of the ASTM and ISO standards themselves, which are scientifically validated and widely accepted test methodologies implemented by trained laboratory technicians.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "ground truth" is determined by the physical and chemical properties of the device as measured by standardized tests, not by expert consensus or adjudication. The tests have predefined pass/fail criteria.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human interpretation is involved. For a surgical face mask, the assessment relies on objective benchtop performance metrics.

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

This question is not applicable to a physical medical device like a face mask. "Standalone" performance typically refers to the performance of an AI algorithm without human input or review. The evaluation of this face mask is entirely based on its physical and material properties as measured by laboratory tests.

7. The Type of Ground Truth Used

The ground truth used for this device's evaluation is standardized test results against established medical device performance standards (ASTM and ISO). These standards define the acceptable physical and material properties for surgical masks, such as filtration efficiency, fluid resistance, flammability, and biocompatibility.

8. The Sample Size for the Training Set

Not Applicable. This is a physical medical device (face mask), not a software or AI-driven device. Therefore, there is no "training set" in the context of machine learning or algorithm development. The "training" for such a device would refer to its manufacturing process and quality control to ensure consistency.

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

Not Applicable. As there is no training set in the context of an algorithm, the concept of establishing ground truth for a training set does not apply.

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