(134 days)
The Livocare 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 surgical mask is intended for use in infection control practices to reduce potential exposure to blood and body fluids. The surgical mask is a single use, disposable device, provided non-sterile.
The Livocare Surgical Mask is a single use, three-layer, flat-folded mask with ear loops and nose piece. The Surgical Mask is 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 ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the surgical mask. The nose piece in the layers of surgical mask is to allow the user to fit the mask around their nose, which is made of malleable polyethylene wire. The mask is a single use, disposable device, provided non-sterile. This device is not made from Natural Rubber Latex.
The provided text is a 510(k) summary for the Livocare Surgical Mask (K201380). It details the device's technical characteristics, intended use, and comparison to a predicate device (K182515). However, this document does not describe a study involving an AI/Machine Learning device. Instead, it outlines the non-clinical performance testing for a surgical mask, an entirely different type of device.
Therefore, I cannot extract information related to acceptance criteria and studies for an AI/ML device because the provided text is about a physical medical device (a surgical mask).
If you have a document describing an AI/ML device, please provide it, and I will be happy to answer your request.
Based on the provided document for the LIVOCARE SURGICAL MASK:
I will extract the requested information as it pertains to this surgical mask, even though it's not an AI/ML device, to demonstrate the structure of the answer you're looking for, given the limitations of the input.
Acceptance Criteria and Study for Livocare Surgical Mask (K201380)
This document describes the premarket notification for a physical medical device, a surgical mask, not an AI/Machine Learning device. Therefore, the "study" described refers to non-clinical performance testing rather than an AI model's performance. Many of the requested categories are not applicable to the evaluation of a surgical mask (e.g., number of experts for ground truth, adjudication method, MRMC study, training set).
1. Table of acceptance criteria and the reported device performance:
| Performance Test | Acceptance Criteria (Level 2) | Reported Device Performance (Livocare Surgical Mask) | Results |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | 29 out of 32 pass at 120 mmHg | 32 out of 32 passed at 120 mmHg | Pass |
| Particulate Filtration Efficiency (ASTM F2299) | ≥98% | > 98% | Pass |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥98% | > 99% | 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.