(217 days)
When properly worn, the surgical face mask is intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and airborne particles. This device is non-sterile and for single use only.
Ideal Med Pro 3-Ply Disposable Face Mask is a 3-ply, flat-pleated style surgical 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 elastic ear loops to secure the mask over the user's face and mouth with nose piece 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 is for a 510(k) summary for a "Ideal Med Pro 3-Ply Disposable Face Mask." This document focuses on demonstrating substantial equivalence to a predicate device through performance testing against established standards, rather than a clinical study involving human readers or a standalone AI algorithm. Therefore, many of the requested criteria regarding MRMC studies, expert adjudications, and AI performance are not applicable.
Here's the information extracted from the document:
1. A table of acceptance criteria and the reported device performance
| Test Standard | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM F2101 | Bacterial Filtration Efficiency (BFE) | 98% | 99.9% |
| ASTM F2299 | Particulate Filtration Efficiency (PFE) | 98% | 99.9% |
| ASTM F1862 | Synthetic Blood Fluid Resistance | 29 out of 32 pass at 120 mmHg | 30, 31, and 32 pass at 120 mmHg, out of 32 test articles in each of three lots (96 total test articles) |
| MIL-M-36954C | Differential Pressure (Delta P) | 3.5 sec (Class 1) | IBE for all 8 test articles in each of 3 lots (24 total test articles) |
2. Sample size used for the test set and the data provenance
- Bacterial Filtration Efficiency (BFE): Not explicitly stated, but typically involves a batch of test articles.
- Particulate Filtration Efficiency (PFE): Not explicitly stated.
- Synthetic Blood Fluid Resistance: 96 total test articles (32 test articles in each of three lots).
- Differential Pressure (Delta P): 24 total test articles (8 test articles in each of three lots).
- Flammability: 24 total test articles (8 test articles in each of 3 lots).
The origin of the test articles (e.g., country of origin, retrospective or prospective) is not specified in the provided document. These are product performance tests on manufactured devices, not clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. The "ground truth" for these tests is dictated by the standardized testing protocols themselves, not by expert consensus or clinical interpretation.
4. Adjudication method for the test set
This is not applicable. The tests are objective measurements against defined 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
This is not applicable. This document describes the performance of a disposable face mask, not an AI-assisted diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. This document describes the performance of a physical device (face mask), not an algorithm.
7. The type of ground truth used
The ground truth is established by the specified test standards (ASTM F2101, ASTM F2299, ASTM F1862, MIL-M-36954C, 16 CFR 1610) and their defined procedures and criteria.
8. The sample size for the training set
This is not applicable. There is no "training set" in the context of physical product performance testing for a face mask.
9. How the ground truth for the training set was established
This is not applicable.
§ 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.