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When properly worn, DWFritz ASM2000 surgical face mask is intended to protect both the patient and healthcare worker from transfer of microorganisms, body fluids and particulate matter. The device is non-sterile and for single use only.

DWFritz ASM2000 is a 3-ply, flat-pleated style surgical face mask. The device 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. Each mask contains ear loops made of polyester filament and spandex fiber to secure the mask over the user's face and mouth with galvanized wire nose bridge to fit firmly over the nose. This device is not made from any natural rubber latex. The product is sold non-sterile and intended to be disposable for single-use.

The provided text describes the acceptance criteria and the study conducted for the DWFritz ASM2000 surgical face mask. It does not contain information about an AI/ML powered device, human readers, or ground truth establishment by experts for image analysis. Therefore, I will extract and present the information relevant to the provided text about the surgical mask.

Device: DWFritz ASM2000 Surgical Face Mask

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes Used for the Test Set and Data Provenance

The sample sizes for the testing (not an AI/ML test set) are provided within the table above:

• Particulate Filtration Efficiency (PFE): 32 test articles in each of three lots (96 total test articles).
• Synthetic Blood Fluid Resistance: 32 test articles in each of three lots (96 total test articles).
• Differential Pressure (Delta P): 32 test articles in each of three lots (96 total test articles).
• Flammability: 14 test articles in each of 3 lots (42 total test articles).

The provenance of this data is not explicitly stated in terms of country of origin or whether it was retrospective/prospective, but it refers to non-clinical testing performed on the manufactured device.

3. Number of Experts and Qualifications for Ground Truth Establishment

This information is not applicable as the document describes a physical medical device (surgical mask) and its performance testing, not an AI/ML device requiring expert-established ground truth from medical images.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3. Testing involves objective measurements against established standards.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

This information is not applicable as the document describes a physical medical device (surgical mask) and its performance testing, not an AI/ML device that assists human readers.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

This information is not applicable as the document describes a physical medical device (surgical mask), not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this medical device is established by objective measurements against recognized industry standards (e.g., ISO, ASTM, MIL specifications, CFR codes) for physical and biological properties. This is not derived from expert consensus, pathology, or outcomes data in the context of diagnostic performance.

8. Sample Size for the Training Set

This information is not applicable as there is no mention of a training set, as the device is a physical product and not an AI/ML algorithm.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8.

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