(128 days)
MEO Med Disposable Medical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It 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.
The MEO Med Disposable Medical Face Mask is single use, three-layer, flat-pleated style with ear straps and nose piece. The mask is manufactured with three layers, the inner and outer layers are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics. The ear straps are held in place over the users' mouth and nose by two elastic ear straps welded to the facemask. The elastic ear straps are not made with natural rubber latex. The nose piece on the layers of facemask is to allow the user to fit the facemask around their nose, which is made of HDPE (high density polyethylene). The MEO Med Disposable Medical Face Mask will be provided in blue. The masks are sold non-sterile and are intended to be single use, disposable devices.
The provided text is a 510(k) summary for a medical device, specifically a disposable medical face mask. It outlines the device's characteristics, intended use, and performance testing results to demonstrate substantial equivalence to a legally marketed predicate device.
It's important to note that the document does not describe a study involving an AI/algorithmic device where the terms like "AI assistance," "human readers," "ground truth," "training set," or "multi-reader multi-case (MRMC) study" would be relevant. The device in question is a physical product (a face mask), and the criteria listed pertain to its physical and functional performance, not the accuracy or effectiveness of an AI algorithm.
Therefore, I cannot provide information on the following points from your request, as they are not applicable to the provided document:
- Sample sized used for the test set and the data provenance (no data set in the AI sense)
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (no ground truth in the AI sense)
- Adjudication method (not applicable)
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance (not applicable to a face mask)
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done (not applicable to a face mask)
- The type of ground truth used (expert consensus, pathology, outcomes data, etc) (not applicable to a face mask)
- The sample size for the training set (not applicable to a face mask)
- How the ground truth for the training set was established (not applicable to a face mask)
However, I can extract and present the acceptance criteria for the physical face mask and its reported performance based on the provided document:
Acceptance Criteria and Reported Device Performance for MEO Med Disposable Medical Face Mask (K210870)
The study conducted for this device is a series of non-clinical performance tests designed to evaluate the physical and functional properties of the face mask, aligning with the standards for a medical face mask (ASTM F2100-19 Level 2). There was no AI component or clinical study involving human readers or large datasets in the context of an algorithm's performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria (ASTM F2100-19 Level 2) | Reported Device Performance (Results) |
|---|---|---|---|
| Bacterial Filtration Efficiency (BFE) (%) | To measure the bacterial filtration efficiency (BFE) of medical face mask materials | ≥98 | Lot 1: 99.1%-99.9% (Passed) |
| Lot 2: 99.0%-99.9% (Passed) | |||
| Lot 3: 99.1%-99.9% (Passed) | |||
| Differential Pressure (mmH2O/cm²) | To determine the breathability of medical face 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.