(90 days)
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
| Test Standard | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ISO 10993-05 | Cytotoxicity | 3.5 sec (Class 1) | IBE for all 14 test articles in each of 3 lots (42 total test articles) |
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.
§ 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.