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The Pleats Plus™ 1050 and 1050S N95 Respirators and Surgical Masks are intended for single use by operating room personnel and other health care workers to protect both the patients and the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials. This includes use as a procedure mask, isolation mask or dental face mask. This device also meets CDC Guidelines for TB Exposure Control.

These masks are pleated, 3-ply masks, with a center layer of polypropylene meltblown material sandwiched by inner and outer layers of nonwoven material. The mask has 2 braided synthetic elastic headbands and a flexible wire tie nosepiece that allows the respirator to form to the bridge of the wearers nose. No fiberglass media is used in this product.

Here's a breakdown of the acceptance criteria and study information for the Aearo Company Pleats Plus™ Surgical N95 Respirators, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details:

1. Sample sizes used for the test set and the data provenance:

   • Fluid resistance: 32 masks were tested. (Provenance not specified, but implied to be from Aearo Company products).
   • Flammability class: 10 samples were tested. (Provenance not specified).
   • Filter efficiency: 20 samples were tested. (Provenance not specified).
   • Breathing resistance: 3 samples were tested. (Provenance not specified).
   • Bacterial Filtration Efficiency (BFE): "All samples tested" showed >95.5% BFE. The number of samples for BFE is not explicitly stated, but it was conducted by Nelson Laboratories.
   • Cytotoxicity: Samples of Pleats Plus were tested by Nelson Laboratories.
   • Primary skin irritation: 3 rabbits were used, tested by NAMSA.
   • Delayed Hypersensitivity (Sensitization): Albino guinea pigs were used, tested by Northview Pacific Laboratories.

   All tests appear to be prospective to demonstrate the device's performance against specific standards. The country of origin for the data is implied to be the United States, given the testing organizations (Nelson Laboratories, NAMSA, Northview Pacific Laboratories) and the submission to the FDA.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   The document describes performance testing against established standards (e.g., ASTM, NIOSH, CFR, ISO). The "ground truth" for these tests is implicitly defined by the accepted methodologies and criteria of these standards. There is no mention of human experts establishing a subjective ground truth for the performance test set. The results are objective measurements against defined thresholds.

3. Adjudication method for the test set:
   Not applicable. The tests are objective measurements against published standards and acceptance criteria. There is no mention of physician or expert adjudication as would be seen in diagnostic imaging studies.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
   No, an MRMC comparative effectiveness study was not done. This document focuses on the physical barrier and material properties of a surgical N95 respirator, not on the performance of an AI-assisted diagnostic tool or human decision-making.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Yes, in a sense, the entire performance testing is "standalone" in that it assesses the device's physical performance independent of human interaction for diagnostic purposes. The device itself, a respirator, is the "algorithm" here, and its performance is measured directly against physical and biological challenges. There's no AI algorithm involved.

6. The type of ground truth used:
   The ground truth is based on established engineering and biological standards and their defined acceptance criteria. For example, fluid resistance is measured against a specific pressure (120 mmHg) using ASTM, filter efficiency against NIOSH standards, and biocompatibility against ISO-10993. The "ground truth" is a pass/fail against these objective criteria.

7. The sample size for the training set:
   Not applicable. This notice describes the testing of a physical medical device (respirator), not a machine learning model. Therefore, there is no "training set" in the context of an AI algorithm.

8. How the ground truth for the training set was established:
   Not applicable. As there is no AI algorithm and no training set, the establishment of ground truth for such a set is irrelevant to this submission.

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