(71 days)
The Prestige Ameritech N95 Respirator and Surgical Mask RP88020 is a single use non-sterile disposable device intended to be worn in the operating room as well as dental, isolation and other medical procedures to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material.
The Prestige Ameritech N95 Particulate Filter Respirator & Surgical mask is manufactured using ultrasonic bonding, composed of four layers of materials pouched and pleated to form the Mask. The inner layer is composed of nonwoven, the two middle layers is meltblown polypropylene filter material and the outer layer is spunbond polypropylene. Masks are held in place on wearer with latex free elastic headband and contain a malleable aluminum nosepiece strip. All of the materials used in this device are typical materials commonly used in the construction of Respirator and Surgical Masks and are being used in current legally marketed devices.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study used to demonstrate the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Internal Standard) | Reported Device Performance |
|---|---|---|
| Fluid Resistance | Meets ASTM F1862 requirements (implied by "requirements") | Device samples met the ASTM F1862 fluid resistance requirements @160 mmHg. |
| Particulate Filtration Efficiency | Meets ASTM F2299 PFE requirements at 0.1 microns (implied) | Device samples met the ASTM F2299 PFE requirements at 0.1 microns. |
| Bacterial Filtration Efficiency | Meets ASTM F2101 BFE requirements (implied) | Device samples met the ASTM F2101 BFE requirements. |
| Differential Pressure | Meets Mil M36954C Delta P requirements (implied) | Device samples met the Mil M36954C Delta P requirements. |
| Flammability Class | Meets 16CFR 1610 Flammability Class 1 requirements (implied) | Device samples met the 16CFR 1610 Flammability Class 1 requirements. |
| Biocompatibility | Meets ISO-10993-10-2002 requirements (implied) | Device samples met the requirements of ISO-10993-10-2002, "Biological Evaluation of Medical Devices". |
| Sodium Chloride (NaCl) Penetration | NIOSH required sodium chloride test at ≤ 5% Penetration | Device samples met the NIOSH required sodium chloride test at ≤ 5% Penetration. |
| Inhalation Resistance | NIOSH inhalation resistance test which shall not exceed 35 mmH2O | Device samples met the requirements of NIOSH inhalation resistance test which shall not exceed 35 mmH2O. |
| Exhalation Resistance | NIOSH exhalation resistance test which shall not exceed 25 mmH2O | Device samples met the requirements of NIOSH exhalation resistance test which shall not exceed 25 mmH2O. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the numerical sample size used for the test set for each performance metric. It consistently uses the phrase "Subject device samples," which indicates that a representative subset of the manufactured devices was tested for each criterion. The data provenance is not specified (e.g., country of origin). The studies appear to be prospective as they are tests performed on the manufactured device to demonstrate compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable to this type of device and study. The "ground truth" for the performance criteria of a respirator and surgical mask is established by widely accepted international and national standards (e.g., ASTM, NIOSH, ISO, CFR). The tests are objective measurements against these predefined standards, not subjective evaluations by experts to establish a "ground truth."
4. Adjudication Method for the Test Set
This information is not applicable. Since the tests are objective measurements against established standards, there is no need for an adjudication method involving experts. The results are quantitative and either meet the standard or they do not.
5. 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
This information is not applicable. The device is a physical medical product (respirator/surgical mask), not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is a physical product and does not involve any algorithms or AI for standalone performance evaluation.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for each performance criterion is the established test methods and acceptance criteria set forth by recognized standards organizations. For example:
- Fluid Resistance: ASTM F1862
- Particulate Filtration Efficiency: ASTM F2299
- Bacterial Filtration Efficiency: ASTM F2101
- Differential Pressure: Mil M36954C
- Flammability: 16CFR 1610
- Biocompatibility: ISO-10993-10-2002
- Sodium Chloride Penetration, Inhalation Resistance, Exhalation Resistance: NIOSH standards
8. The Sample Size for the Training Set
This information is not applicable. This device is a physical product, not an AI model that requires a training set. The manufacturing process is designed to consistently produce devices that meet the specifications.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8.
§ 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.