(123 days)
The Surgical Face Masks are 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 the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided sterile.
The Surgical Face Masks are Flat Pleated type mask, utilizing Ear straps way for wearing, and they all have Nose clip design for fitting the face mask around the nose. The Surgical Face Masks are manufactured with three layers. The outer layer is made of polypropylene spun-bond non-woven fabric. The middle layer with filtration function is made of polypropylene melt-blown non-woven fabric. The inner layer contact with face is made of polypropylene spun-bond non-woven fabric. The nose clip is made of polyethylene strip with iron wire inside. The ear straps are made of spandex polyester fiber. The Surgical Masks are single use, disposable device, provided sterile.
The provided text is a 510(k) Premarket Notification for a Surgical Face Mask. It details the device's characteristics, comparison to a predicate device, and non-clinical testing results. However, it does not contain information about an AI/ML-based device or a comparative effectiveness study involving human readers.
Therefore, I cannot fulfill your request for information regarding:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Sample size used for the test set and data provenance for an AI/ML device.
- Number of experts and qualifications to establish ground truth for an AI/ML device.
- Adjudication method for an AI/ML device.
- Multi-reader multi-case (MRMC) comparative effectiveness study or effect size for an AI/ML device.
- Standalone performance for an AI/ML algorithm.
- Type of ground truth used for an AI/ML algorithm.
- Sample size for the training set for an AI/ML algorithm.
- How ground truth for the training set was established for an AI/ML algorithm.
The document focuses on the physical and performance characteristics of a surgical face mask, such as fluid resistance, particulate filtration, bacterial filtration, differential pressure, flammability, and biocompatibility.
Here's the information that is available in the document regarding the physical device (surgical face mask):
1. Table of Acceptance Criteria and Reported Device Performance (for a Surgical Face Mask):
| Test Purpose | ISO/ASTM Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Fluid Resistance | ASTM F2100-19 | 29 out of 32 pass at 160mmHg | Meet the requirement |
| Particulate Filtration Efficiency (PFE) | ASTM F2100-19 & ASTM F2299-03 | ≥98% | Meet the requirement |
| Bacterial Filtration Efficiency (BFE) | ASTM F2101-19 | ≥98% | Meet the requirement |
| Differential Pressure | EN 14683:2019 |
§ 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.