(110 days)
The Disposable Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. They are in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
The proposed device(s) are blue color, and flat pleated type mask, utilizing ear loops way for wearing, and they all have nose clips design for fitting the face mask around the nose.
The proposed device(s) are manufactured with three layers, the inner and outer layers are made of Polypropylene non-woven fabric, and the middle layer is made of polypropylene melt-blown cloth. The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Elastic materials consisting of Nylon low elastic yarn and Spandex. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Polypropylene and galvanized iron wire plastic materials. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The document describes the non-clinical performance testing of a disposable surgical mask to demonstrate its substantial equivalence to a predicate device, rather than a study involving an AI-powered device or human readers. Therefore, much of the requested information regarding AI assistance, human readers, effect size, and ground truth establishment for AI models is not applicable to this document.
However, I can provide information based on the performance testing of the surgical mask.
1. A table of acceptance criteria and the reported device performance
| Item | Reported Device Performance | Acceptance Criteria (Level 2) | Result |
|---|---|---|---|
| Fluid Resistance Performance ASTM F1862 | 31 out of 32 Pass at 120 mmHg | 29 out of 32 Pass at 120mmHg | PASS |
| Particulate Filtration Efficiency ASTM F2299 | 99.4% | ≥ 98% | PASS |
| Bacterial Filtration Efficiency ASTM F2101 | 99.36% | ≥ 98% | PASS |
| Differential Pressure (Delta P) EN 14683 Annex C | 4.43mmH2O/cm² |
§ 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.