(75 days)
The Honeywell Procedure Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.
The Honeywell Procedure Mask is composed of three layers that are a flat, pleated style mask with earloops to secure it over the users' mouth and face. The inner and outer layers are manufactured from spun-bond polypropylene. The middle layer is made of melt-blown polypropylene. The mask is a single use, disposable device, provided nonsterile and is not made from natural rubber latex.
The provided text is a 510(k) Premarket Notification for a medical device, specifically the "Honeywell Procedure Mask". It describes the device, its intended use, comparison to a predicate device, and the non-clinical testing performed to establish substantial equivalence.
However, it's crucial to understand that this document does not describe a study involving an AI/Machine Learning device or a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to the physical and performance characteristics of a surgical mask, not the performance of an AI algorithm in a diagnostic imaging context.
Therefore, many of the requested points related to AI/MRMC studies, such as the number of experts, adjudication methods, effect size, and ground truth establishment for AI training/test sets, are not applicable to this submission.
I will interpret the request in the context of the provided document, focusing on the acceptance criteria and performance testing for the surgical mask device.
Here's the information extracted from the document:
1. A table of acceptance criteria and the reported device performance:
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| Performance Testing | |||
| ASTM F1862 | Fluid Resistance/Synthetic Blood Penetration | 120 mmHg | 120 mmHg |
| ASTM F2299 | Particulate Filtration Efficiency | ≥98% | ≥99.45% @ 0.1 micron |
| ASTM F2101 | Bacterial Filtration Efficiency | ≥98% | ≥98.2% @ 3.0 micron |
| EN 14683 Annex C | Differential Pressure "Breathability" |
§ 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.