Search Results

The Disposable Medical Surgical Mask is intended to be worn to protect and healthcare personnel from transfer of microorganisms, blood, body fluids and particulate material. This surgical mask is intended for use in infection control practices to reduce potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.

The Disposable Medical Surgical Mask (rectangular) is single use, three-layer, flat-folded masks with ear loops and nose piece. The Surgical Mask is manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. The mask is held in place by the elastic ear loops. 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 document is a 510(k) Premarket Notification for a Disposable Medical Surgical Mask, which is a Class II medical device. The document details the device's characteristics, intended use, and comparative analysis against a predicate device, focusing on non-clinical performance and biocompatibility testing. It is important to note that this document does not describe an AI/ML-driven medical device, and therefore, many of the requested criteria regarding AI model evaluation (e.g., training set, ground truth experts, MRMC studies) are not applicable.

However, I can extract the relevant information regarding the acceptance criteria and the study that proves the device meets those criteria, as detailed in the non-clinical performance testing section.

Here's the breakdown based on the provided text:

Device Type: Disposable Medical Surgical Mask (Not an AI/ML device)

1. A table of acceptance criteria and the reported device performance:

The device performance is evaluated against the ASTM F2100-19 standard for medical face masks, along with other relevant standards for specific tests.

Biocompatibility Testing:

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

• Sample Size:
  • For Fluid Resistance (ASTM F1862): 32 samples were tested, with 29 passing the 160 mmHg threshold.
  • For other performance tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability): The specific sample size per test is not explicitly stated but is implied to be sufficient to meet the standards (e.g., "Pass" results).
  • For Biocompatibility testing: The sample size for each test (Cytotoxicity, Irritation, Sensitization) is not explicitly stated.
• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective, beyond stating that non-clinical tests were conducted. Given the nature of performance and biocompatibility testing for a physical medical product, these are almost certainly prospective laboratory tests following standardized protocols.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. This is a physical medical device. "Ground truth" in the context of AI/ML evaluation (e.g., expert consensus on medical images) does not apply here. The "ground truth" for this device is established by the results of standardized laboratory tests conducted according to established protocols (e.g., ASTM, ISO standards).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable. As this is a performance evaluation of a physical device against predefined quantitative standards, an adjudication method for human interpretation is not relevant. The results are objective measurements from laboratory equipment.

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 device is a surgical mask, not an AI-driven diagnostic or assistive tool. Therefore, MRMC studies are not relevant.

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

• Not Applicable. This is a physical device, not a software algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

• Standardized Test Results / Quantitative Measurements: The "ground truth" is based on the objective outcomes of laboratory tests performed according to recognized industry standards (e.g., ASTM F2101 for Bacterial Filtration Efficiency, ASTM F1862 for Fluid Resistance). These standards define the methodology and the acceptable performance thresholds.

8. The sample size for the training set:

• Not Applicable. This is a physical medical device, not an AI/ML model that requires a training set.

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

• Not Applicable. As there is no AI/ML model or training set, the concept of establishing ground truth for a training set does not apply.

Ask a specific question about this device