(161 days)
The Makrite Model 910-N95 Healthcare Particulate Respirator and Surgical Mask is a no fiberglass, fluid resistant single-use mask 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. This device also meets CDC Guidelines for TB Exposure Control.
The Makrite Type N95 Healthcare Particulate Respirator and Surgical Mask Model 910-N95 is constructed from a white nonwoven material used in the inner and outer shell. The polypropylene melt blown filter media is layered between the inner and outer shell. The headband is made of rubber stapled to the mask. The inside noseviece utilizes a closed cell foam and the outside nosepiece which conforms to the nose is made of aluminum.
Here's a breakdown of the acceptance criteria and study information for the Makrite Model 910-N95 Healthcare Particulate Respirator and Surgical Mask, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test Name | Performance Requirement (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Particulate Filtration Efficiency (NIOSH N95 Certification) | 95% efficiency against 0.3 micron diameter challenge | Meets requirements for TC-84A-3323 (N95 certification) |
| Resistance to Synthetic Blood Penetration (ASTMF1862-00) | Resistant to synthetic blood | Resistant to synthetic blood |
| Breathing Resistance (NIOSH 30 CFR11 section 11.140-9 / 42CFR84) | Meets prescribed test criteria for breathing resistance | Meets prescribed test criteria |
| Irritation: Primary Skin FHSA & Skin Sensitization | Not explicitly stated, but passes the test | Passes the tests (implied by inclusion in performance tests and conclusion) |
| Meets CDC Guidelines for TB Exposure Control | Meets CDC Guidelines | Meets CDC Guidelines for TB Exposure Control |
Note: The document emphasizes substantial equivalence to a predicate device (Gerson Isolair APR Type N95 Mask Model 2735, K960778) as the primary proof of safety and effectiveness, meaning the new device performs comparably to an already approved device.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document refers to "the use of 0.3 micron diameter challenge" for filtration efficiency testing, and tests performed by NIOSH and Nelson Laboratories. It does not specify the number of masks or trials involved in these tests.
- Data Provenance: The tests were conducted by recognized testing laboratories: NIOSH (National Institute for Occupational Safety and Health) and Nelson Laboratories. The data is prospective, as it involves active testing of the Makrite device. The country of origin for these testing bodies is the United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a physical product, and its performance is assessed through objective, standardized laboratory tests, not subjective expert evaluation of data. Therefore, there is no "ground truth" established by human experts in the context of image interpretation or medical diagnosis. The "ground truth" is defined by the objective measurement standards of the relevant test protocols (e.g., 95% filtration efficiency for N95).
4. Adjudication Method for the Test Set
Not applicable. As noted above, the evaluation relies on objective laboratory test results, not expert consensus or adjudication of subjective interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of images or other data, where the goal is to evaluate the impact of a new tool (like AI) on physician performance. The Makrite Model 910-N95 is a physical protective device, not a diagnostic tool requiring human interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, in a sense, the performance of the device itself (the "algorithm" in this analogy) was tested in a standalone manner. The tests reported (filtration efficiency, breathing resistance, synthetic blood penetration, irritation) are all direct measurements of the mask's physical properties and performance without human interaction beyond conducting the test.
7. The Type of Ground Truth Used
The ground truth used is based on objective, standardized test criteria and regulatory requirements. For example:
- NIOSH N95 certification: The ground truth is defined by the NIOSH 42 CFR 84 standard, which specifies 95% efficiency against 0.3 micron particles.
- Synthetic Blood Penetration: The ground truth is defined by the ASTMF1862-00 standard for resistance.
- Breathing Resistance: The ground truth is defined by NIOSH 30 CFR11 section 11.140-9.
These are established benchmarks for performance, not subjective expert opinions or clinical outcomes.
8. The Sample Size for the Training Set
Not applicable. The Makrite Model 910-N95 is a manufactured product, not a machine learning model. Therefore, there is no "training set" in the context of AI or algorithm development. Its performance is inherent in its design and manufacturing materials, verified through testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device.
§ 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.