(119 days)
The Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These 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, provided non-sterile.
The proposed devices are single use, three-layer, flat masks with straps and nose piece. The Surgical Masks are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The proposed device is held in place over the user's mouth and nose by two elastic ear loops or four ties welded to the face mask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Malleable aluminum wire. The proposed devices are sold non-sterile and are intended to be single use, disposable devices.
The document provided is a 510(k) summary for a Disposable Surgical Mask, outlining its substantial equivalence to a legally marketed predicate device. As such, the information contained focuses on the device's physical properties, material composition, and performance against established safety and efficacy standards for surgical masks.
This type of submission and the associated testing do not involve AI/ML components, human reader studies, or complex ground truth establishment methods typical for AI/ML-driven medical devices. The tests described are laboratory-based evaluations of the mask's material properties and fluid/particulate blocking capabilities.
Therefore, many of the specific questions posed in your request (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this disposable surgical mask submission.
Here's the relevant information based on the provided text:
Acceptance Criteria and Device Performance
The acceptance criteria are established based on recognized industrial standards for performance of materials used in medical face masks.
Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Fluid Resistance Performance (ASTM F1862) | For evaluating the ability of the mask's material to resist the penetration of blood and body fluids. | Pass at 160 mmHg | Pass at 160 mmHg |
| Particulate Filtration Efficiency (ASTM F2299) | For evaluating a submicron efficiency performance. | > 98% | > 98% |
| Bacterial Filtration Efficiency (ASTM F2101) | For evaluating the ability of the mask's material to prevent the passage of aerosolized bacteria. | > 98% | > 98% |
| Differential Pressure (EN 14683:2019) | For evaluating the breathability and comfort of the surgical mask. |
§ 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.