(87 days)
This device is a disposable filtering facepiece respirators intended for use by the general public in public health medical emergencies - Pasture™ A520G Respirator and Pasture™ F550G Respirator
Pasture F550G respirator is a duck bill mask as described in NIOSH N95 standard It 1s in 5 layers and composed of spunbond, meltblown and polyester, also with nose cushion, elastic loops and/or strip and nosepiece which is the combination of zinc wires and embedded polyester inside of layers
Pasture A520G respirator is a cone shaped mask as described in NIOSH N95 standard It is in 4 layers and composed of spunbond, meltblown and polyester, also with synthetic rubber band which is coated with polyester and free of latex
The provided text describes a 510(k) summary for Filtering Facepiece Respirators (Pasture™ F550G & A520G). This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria, sample sizes, and expert evaluations as would be expected for a diagnostic or AI-driven device.
Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth type for test/training sets, training set size) are not applicable or not available in this type of submission. This 510(k) is for a physical device (respirator), and the "performance" discussed is related to its physical properties and NIOSH certification, not an AI algorithm.
Here's the information that can be extracted or derived from the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" here are typically the requirements for NIOSH certification and meeting the performance of the predicate device. The document primarily relies on comparative testing to the predicate device and NIOSH certification.
| Criterion Type | Acceptance Criterion (Implicit) | Reported Device Performance (Pasture F550G & A520G) |
|---|---|---|
| Intended Use | Same as predicate (for use by general public in public health emergencies) | Same |
| NIOSH Certification | N95 (TC-84A-4516 for predicate) | N95 (TC-84A-4665 for F550G, TC-84A-4664 for A520G) |
| Fluid Resistant | Yes | Yes |
| Fit Assessment Test | Done | Done |
| Biocompatibility | Cytotoxicity, Dermal sensitization, Skin irritation | Cytotoxicity, Dermal sensitization, Skin irritation (all indicated as performed/met) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the 510(k) summary. For physical products like respirators, testing typically involves a sufficient number of units to demonstrate consistent performance against standards (e.g., NIOSH testing protocols would define sample sizes for particle filtration, breathability, fit, etc.). However, these specific numbers are not provided here.
- Data Provenance: Not explicitly stated regarding country of origin or retrospective/prospective. The testing would have been conducted to support the NIOSH certification and biocompatibility claims. This is prospective testing specifically for the device submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This is a physical device (respirator), not an AI diagnostic. "Ground truth" in the context of diagnostic performance by experts is not relevant here. Performance is assessed against physical and biochemical standards.
4. Adjudication Method for the Test Set
- Not Applicable. As above, no expert adjudication is involved for physical performance testing of a respirator.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This is not an AI diagnostic device, so an MRMC study comparing human readers with and without AI assistance is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. There is no algorithm. The device itself is the "standalone" product.
7. The Type of Ground Truth Used
- Physical/Chemical Standards: The "ground truth" for a respirator's performance is established by standardized testing methods defined by bodies like NIOSH (e.g., particle filtration efficiency, breathing resistance, fit testing protocols) and biocompatibility standards (e.g., ISO 10993 for cytotoxicity, sensitization, irritation). The predicate device's performance also acts as a reference for substantial equivalence.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. No training set is involved.
§ 880.6260 Filtering facepiece respirator for use by the general public in public health medical emergencies.
(a)
Identification. A filtering facepiece respirator for use by the general public in public health medical emergencies is a device that is a disposable half-facepiece non-powered air-purifying particulate respirator intended for use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during a public health medical emergency. The device is made of polymeric materials and is intended to fit closely to the face and to function by filtering particulate material.(b)
Classification. Class II (special controls). The special controls are:(1) Certification by the National Institute for Occupational Safety and Health (NIOSH) as a non-powered air-purifying particulate respirator with a minimum filtration efficiency classification of N95, in accordance with 42 CFR part 84.
(2) The FDA guidance document entitled: “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Filtering Facepiece Respirator for use by the General Public in Public Health Medical Emergencies.” See § 880.1(e) for information on obtaining a copy of this guidance document.