Search Results

The surgical face masks (Ear loops) are 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 is a single-use, disposable device, provided non-sterile.

The Surgical Face Mask are Non-sterile, single use, 3 layers, flat-pleated style with mask belt and nose clip. The outer layer and inner facing layer of face mask consist of spunbond polypropylene, and the middle layer consists of melt blown polypropylene filter. Each mask contains mask belt to secure the mask over the user's face and mouth with nose clip to firmly fit over the nose. This device is not made from any natural rubber latex.

The provided document (K210222) is a 510(k) premarket notification for a Disposable Medical Mask. This type of device is a Class II medical device, and the submission primarily focuses on demonstrating substantial equivalence to a predicate device (K160269) through performance testing against established standards for medical masks, rather than a clinical study involving human subjects or AI algorithm validation data.

Therefore, many of the requested points, such as "Sample sized used for the test set and the data provenance," "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," "training set establishment," etc., are not applicable to this specific submission. The "acceptance criteria" here refer to meeting the performance requirements for physical properties of the mask as per recognized standards (e.g., ASTM F2100-19), not diagnostic accuracy or clinical outcomes assessed by an algorithm.

Here's a breakdown based on the information available in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and performance data are primarily derived from standard test methodologies for medical face masks.

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes (number of masks) used for each individual performance test (e.g., how many masks were tested for BFE). However, these are standard laboratory tests typically performed on a statistically relevant sample size of units from a production batch to ensure consistency. The provenance of the data is from non-clinical laboratory testing, likely conducted in China, as the manufacturer is based in China. The testing is retrospective in the sense that it's performed on manufactured samples for regulatory submission. It is not clinical data.

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 the performance tests of a medical mask (e.g., BFE, PFE, fluid resistance) is established by the standardized test methodologies themselves and the physical measurements obtained. It does not involve expert readers or clinical interpretation like in diagnostic AI.

4. Adjudication method for the test set

Not applicable. There is no human interpretation or adjudication step in these physical performance tests.

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 medical device (mask), not an AI-powered diagnostic tool. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device, which is a physical barrier, is defined by its measured physical performance characteristics as specified by internationally recognized standards (e.g., ASTM F2100-19, EN 14683). This includes:

• Bacterial Filtration Efficiency (BFE)
• Particulate Filtration Efficiency (PFE)
• Fluid Resistance
• Differential Pressure (Breathability)
• Flammability
• Biocompatibility (Cytotoxicity, Irritation, Sensitization)

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for a physical device.

Ask a specific question about this device