(93 days)
The Disposable Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Disposable Surgical Mask is 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 non-sterile.
Disposable Surgical Mask, Ear Loop Type, Size M and S is a single use, three-layer, flat-pleated mask with ear loops and a nose piece. The Disposable Surgical Mask is manufactured with three layers, of which the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The latex free elastic ear loops are made of polyamide fibers and spandex. The nose piece in the layers of face mask allows the user to fit the face mask around their nose, which is made of core iron wire with halogen-free polyethylene covering. The Disposable Surgical Mask will be provided in blue of outside and white of inside. The Disposable Surgical Mask is provided non-sterile and for single use.
The provided document is a 510(k) Premarket Notification for a Disposable Surgical Mask (K212944). It describes the device, its intended use, and a comparison with a predicate device, along with non-clinical test results.
However, the questions you've asked are typically relevant to the validation of Artificial Intelligence (AI)/Machine Learning (ML) medical devices, particularly those that involve image analysis, diagnosis, or risk prediction. This document is for a physical medical device (surgical mask) and the submitted information pertains to its physical performance characteristics, not its performance in an AI/ML context.
Therefore, many of your specific questions, such as those related to:
- Ground truth establishment by experts
- Adjudication methods
- Multi-reader multi-case (MRMC) studies
- Standalone algorithm performance
- Training set size and ground truth establishment
are not applicable to the context of this 510(k) submission for a surgical mask. The document does not involve AI/ML.
I can, however, extract the relevant information regarding the acceptance criteria and the study that proves the device meets those criteria for the surgical mask, based on the provided text.
Acceptance Criteria and Device Performance for Disposable Surgical Mask (K212944)
The device in question is a Disposable Surgical Mask, and its performance is evaluated against established physical and biological standards for medical masks.
Here's a summary tailored to the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Test Method | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|---|
| Fluid Resistance Performance | ASTM F1862 | 29 out of 32 pass at 120 mmHg | 31 out of 32 pass at 120 mmHg | Pass |
| Particulate Filtration Efficiency | ASTM F2299 | ≥ 98% | 99.7% | Pass |
| Bacterial Filtration Efficiency | ASTM F2101 | ≥ 98% | 99.5% | Pass |
| Differential Pressure (Delta-P) | MIL-M-36954C |
§ 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.