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Earloop Mask and Tie-On Mask is intended for use by healthcare workers to procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and airborne particles. This device is single-use and provided non-sterile.

Earloop Mask and Tie-On Mask is a single use non-sterile three layer mask with outer layer (Layer #1) and inner layer (Layer #3) made of spunbound polypropylene and a middle layer (Layer #2) made with meltblown polypropylene filter. Layer #1 has either no pigment (White) or a pigment (Either Blue or Green). There are 2 options for the mask to be secured on the user, either earloops or 2 sets of ties. Earloops are made of urethane elastic fiber and the ties are made of spunbound polypropylene. The nosepiece is a pliable aluminum strip covered by a polypropylene spunbound material and is encased between Layers # 1 and 2 and is affixed in place by ultrasonic heat seal. The three layers of material are pleated 3 times and Layer #3 is folded over the two other layers in front of the Layer #1. An edge material with 30 gsm spunbound polypropylene material is wrapped around the 3 layers at the 2 lateral edges. All 4 edges are ultrasonically heat sealed and ties or earloops are attached inside the edge material and ultrasonically heat sealed. All of the materials in the Standard Earloop Mask and the Standard Tie-On Mask are latex free. All materials are being used in currently marketed devices.

The provided document is a 510(k) Summary for the Protect U Guard Earloop and Tie-On Mask. It details the device's characteristics and performance to establish substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from recognized standards and outlined in the "Guidance for Industry and FDA Staff Surgical Masks - Premarket Notification [510(k)] Submissions."

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

• Fluid Resistance: 32 samples were tested for fluid resistance ("passed 29 of 32").
• For other tests (BFE, Delta-P, PFE, Flammability, Biocompatibility, Latex), specific sample sizes are not explicitly stated in the provided document. The document usually states "Tested at..." or "result was...", implying that testing was performed, but the number of units/samples involved for each test is generally missing.
• Data Provenance: The document does not explicitly state the country of origin or whether the studies were retrospective or prospective. Given that these are performance tests for a new device submission, it's highly probable they were prospective studies conducted specifically for this submission. The "Nelson Labs report following" for flammability suggests an independent testing laboratory was used, which is common for such evaluations.

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

This is not applicable as the studies described are performance tests against established scientific and engineering standards for medical devices (e.g., ASTM, ISO, CFR, MIL-M). The "ground truth" for these tests isn't established by expert consensus on clinical cases, but rather by the objective measurement against predefined technical specifications and thresholds within these standards.

4. Adjudication Method for the Test Set

This is not applicable for this type of device and performance testing. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies where human readers independently evaluate medical images or clinical data, and a disagreement resolution process is needed. Here, the tests are objective measurements of physical and filtration properties.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study focuses on comparing human reader performance with and without AI assistance, which is irrelevant for a surgical mask.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This is not applicable. The device is a physical surgical mask, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth for these tests is based on objective measurements against established criteria and thresholds defined by recognized industry standards (e.g., ASTM F1862 for fluid resistance, ASTM F2101 for BFE, MIL-M-36954C for Delta-P, ASTM F2299 for PFE, 16 CFR Part 1610 for flammability, ISO 10993 for biocompatibility, ASTM D6499 for latex). These standards themselves provide the "ground truth" for what constitutes acceptable performance for a surgical mask.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical product (surgical mask), not an AI/ML algorithm that requires a training set. The descriptions are for product performance verification.

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

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

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