Search Results

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

Additionally, bioreactivity tests were conducted:

• Cytotoxicity: Under the conditions of the study, the device is noncytotoxic. (Passed)
• Irritation: Under the conditions of the study, the device is nonirritating. (Passed)
• Sensitization: Under the conditions of the study, the device is nonsensitizing. (Passed)

2. Sample Size Used for the Test Set and Data Provenance
The sample sizes are indicated as the number of items tested for each specific criterion (e.g., "315/315 passed" for flame spread, or "309/315 passed" for synthetic blood penetration across three lots). The data provenance is implied to be from laboratory testing conducted on manufactured lots of the product. The manufacturer is Fujian MEO Medical Technology Limited, located in China. The study is a pre-market notification (510(k)) submission, meaning it is a prospective evaluation (tests are conducted specifically for the submission).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The "ground truth" for a face mask's performance is established by standardized, objective laboratory testing methodologies (e.g., ASTM F2100-19) that measure physical properties, not by human expert interpretation of data.

4. Adjudication Method for the Test Set
Not applicable. Performance is measured objectively according to specified test standards.

5. 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. This is a physical device, not an AI algorithm.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, not an AI algorithm.

7. The Type of Ground Truth Used
The ground truth used for this device is based on standardized laboratory testing protocols (e.g., those outlined in ASTM F2100-19) for measuring specific physical and performance characteristics of medical face masks (e.g., filtration efficiency, breathability, fluid resistance, flammability, and biocompatibility).

8. The Sample Size for the Training Set
Not applicable. This is a physical device, not an AI algorithm that requires a training set. The "training" for such a product would typically refer to the manufacturing process and quality control, not data training.

9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, this is a physical device.

Ask a specific question about this device