(124 days)
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
| Performance Characteristics | Test Method | Acceptance Criteria/Results (Pleats Plus 1050 and 1050S) | Predicate Device Results (Gerson Isolair APR, Type N95 Model 2735) |
|---|---|---|---|
| Fluid resistance Performance | ASTM 1862-00a @ 120mmHg | Acceptance Criteria: 29 of 32 show no fluid penetration. | |
| Reported Performance: 31 of 32 pass | 32/32 pass | ||
| Flammability class | 16 CFR 1610 | Acceptance Criteria: Flame spread must be within upper and lower control limits. | |
| Reported Performance: No flame spread on 10 of 10 samples, meets Class I | Meets Class I | ||
| Filter efficiency | NIOSH, 42CFR Part 84 | Acceptance Criteria: ≥95% Efficient | |
| Reported Performance: Average 99.11% efficient of 20 samples | Average 96.86% efficient of 20 samples | ||
| Breathing resistance | NIOSH 42CFR Part 84 | Acceptance Criteria: ≤35.0 mm H20 @ 85 lpm | |
| Reported Performance: Average 3.5 mm H20 @ 85 lpm of 3 samples | Average 15.2 mm H20 of 3 samples | ||
| Biocompatibility: Cytotoxicity | ISO-10993-1 / agar overlay | Acceptance Criteria: Score of 2 or less | |
| Reported Performance: Score of 0 | N/A (Not Applicable as it was not evaluated for the predicate device in this table) | ||
| Biocompatibility: Sensitization | ISO-10993-1 / closed patch | Acceptance Criteria: No visible change | |
| Reported Performance: Score of 0 | N/A | ||
| Biocompatibility: Primary Skin Irritation | ISO-10993-1 / modified 16 CFR 1500 | Acceptance Criteria: Negligible | |
| Reported Performance: Score of 0 | N/A | ||
| Bacterial Filtration Efficiency (BFE) | ASTM F2101-01 (using Staphylococcus aureus) | Acceptance Criteria: Not explicitly stated but the reported performance exceeds the Filter efficiency criteria of ≥95%. | |
| Reported Performance: Greater than 95.5% on all samples tested. | Not explicitly stated in the comparison table. |
Study Details:
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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.
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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. -
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. -
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. -
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. -
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. -
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. -
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.
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are 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. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.