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Paneffort 3-ply Surgical and Procedural Masks are intended to be worn to protect both the patient and healthcare personnel 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. This is a single use, disposable device, provided non-sterile.

The Paneffort 3-Ply Surgical and Procedural masks are flat pleated 3-ply device, which consist of three layers, i.e., Outer layer is made of Spunbond Polypropylene, Middle/Filter layer is made of Melt-blown Polypropylene and Inner layer is made of Spunbond Polypropylene. There are two options for the mask to be secured on the user, viz. earloops or tie-on. Earloops are made of spandex and polyamide and the tie-on model are made of spunbond polypropylene. The nosepiece is made up of Iron wire, polypropylene and Zinc, and is encased between Outer and Middle later. Paneffort 3-ply Surgical and Procedural masks are available in blue colour.

The provided text is a 510(k) Premarket Notification for Paneffort 3-Ply Surgical and Procedural Masks. It details the device's technical specifications, intended use, and comparative testing against predicate devices to demonstrate substantial equivalence.

Based on the provided information, here's a description of the acceptance criteria and the study that proves the device meets them:

Device: Paneffort 3-Ply Surgical and Procedural Masks
Regulatory Class: Class II
Product Code: FXX
Regulation Name: Surgical Apparel (21 CFR 878.4040)

The study focuses on non-clinical performance and biocompatibility testing, primarily against ASTM F2100 standards for surgical masks. It does not describe a study involving human readers or AI-assisted performance analysis, as the device is a physical medical mask, not a diagnostic AI system or image analysis tool. Therefore, questions 2, 3, 4, 5, 8, and 9 are largely not applicable as they pertain to clinical studies, AI performance evaluation, and ground truth establishment for such studies, which are not relevant to this type of device submission.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from ASTM F2100-19e1, an FDA-recognized consensus standard for medical face mask materials. The performance results show that the Paneffort masks meet or exceed these criteria for both Level 2 and Level 3 masks.

2. Sample Size and Data Provenance

• Sample Size: The document does not specify the exact sample size for each performance test (e.g., how many masks were tested for BFE, PFE, etc.). It only provides the acceptance criteria and whether the tested product met them.
• Data Provenance: The data is gathered from non-clinical laboratory testing of the subject device (Paneffort 3-Ply Surgical and Procedural Masks). The manufacturer is Paneffort (Cambodia) Garment Co. Ltd. (Cambodia), and the legal manufacturer is PANEFFORT, LLC (USA). The testing was conducted in accordance with FDA-recognized consensus standards (ASTM and ISO). The document does not specify if the tests were performed retrospectively or prospectively, but typically, these are prospective tests conducted on representative samples of the manufactured product.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable. This is a non-clinical performance and biocompatibility study of a physical device (surgical mask), not an AI or image analysis system requiring expert review for ground truth establishment. The "ground truth" is the objective measurement defined by the standards (e.g., a BFE of >98%).

4. Adjudication Method for Test Set

• Not applicable. This is a non-clinical performance and biocompatibility study. Adjudication methods are relevant for clinical studies, especially those involving subjective assessments or disagreements among human readers.

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

• Not applicable. This study does not involve human readers or AI assistance. It is a technical performance assessment of a surgical mask.

6. Standalone (Algorithm Only) Performance

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

7. Type of Ground Truth Used

• The "ground truth" for this device and study type is established by objective, standardized test methods and criteria defined by international consensus standards (ASTM F2100-19e1, ASTM F2101, EN 14683, ASTM F2299, ASTM F1862, 16 CFR Part 1610, ISO 10993-5, ISO 10993-10). The performance of the mask is measured directly against these established physical and biological benchmarks.

8. Sample Size for Training Set

• Not applicable. This is a physical medical device, not an AI model, so there is no "training set."

9. How Ground Truth for Training Set was Established

• Not applicable. As there is no training set for an AI model, this question is not relevant.

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