(98 days)
The Disposable Procedural Ear-loop Face Mask is 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 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 has 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 spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. 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 nylon and Dacron. 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 iron. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The provided text is a 510(k) summary for a medical device (Disposable Procedural Ear-loop Face Mask) and focuses on demonstrating substantial equivalence to a predicate device. It contains information about non-clinical testing to support this claim, but it does not describe an AI/ML powered device or the types of studies typically conducted for such devices (e.g., studies involving human readers, ground truth establishment by experts, analysis of AI performance metrics like sensitivity/specificity).
Therefore, I will extract information related to the performance of the device as tested in the provided document, but many of the requested points regarding AI/ML powered device studies cannot be answered from this text.
Here's an analysis based on the provided document:
1. Table of acceptance criteria and the reported device performance
| Item | Acceptance Criteria (Level 3) | Reported Device Performance (K211042) | Result |
|---|---|---|---|
| Fluid Resistance Performance ASTM F1862 | 29 out of 32 pass at 160 mmHg | 32 out of 32 per lot pass at 160 mmHg, 3 non-consecutive lots tested | PASS |
| Particulate Filtration Efficiency ASTM F2299 | ≥ 98% | Lot1: 98.92%, Lot2: 98.70%, Lot3: 98.71% (3 non-consecutive lots tested, using a sample size of 32/lot) | PASS |
| Bacterial Filtration Efficiency ASTM F2101 | ≥ 98% | Lot1: 98.89%, Lot2: 98.79%, Lot3: 98.77% (3 non-consecutive lots tested, using a sample size of 32/lot) | PASS |
| Differential Pressure (Delta P) EN 14683 Annex C |
§ 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.