(74 days)
The Racal N95 Respirator and Surgical Mask will be used for the health care practitioner from blood and body fluids and particulates and to meet the NIOSH / CDC TB Prevention Guidelines.
RACAL N95 RESPIRATOR AND SURGICAL MASK is indicated for respiratory proceetive device. This disposable Surgical mask is a one-piece, light weight half mask with filter material forming the mask. The component includes an inner scrim layer, netting material forming the mask. The component includes an inner scrim layer, netting layer, meltblown protection layer and elastic band. RACAL N95 RESPIRATOR AND SURGICAL MASK is NIOSH approved (Approval #IC-84A-0008) and has a filtration efficiency level of 95% and is effective against particulate aerosols free of oil. RACAL NYS RESPIRATOR AND SURGICAL MASK is available in four sizes, extra small, medium and large, The nose clip and elastic headband ensures effective face to mask seal.
Here's an analysis of the provided text regarding the acceptance criteria and study for the RACAL N95 RESPIRATOR AND SURGICAL MASK:
This submission details a medical device (N95 respirator and surgical mask) rather than an AI-powered diagnostic tool. Therefore, many of the typical questions related to AI device performance evaluation (such as expert adjudication, MRMC studies, effect size of AI assistance, training set details, etc.) are not applicable to this document. The evaluation of this device is based on physical performance criteria and equivalence to predicate devices, not on data analysis or diagnostic accuracy.
Here's the information extracted and adapted to the context of this medical device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria / Standard Met | Reported Device Performance |
|---|---|
| Respiratory Protection (NIOSH N95 Class) | |
| Filtration Efficiency (42 CFR Part 84) | 95% effective against particulate aerosols free of oil |
| Regulatory Approval | |
| NIOSH Approval Number | TC-84A-0008 |
| Meets CDC Guidelines for Preventing Transmission of Mycobacterium Tuberculosis | Device is intended to meet these guidelines. |
| Physical Characteristics / Intended Use | |
| Fluid Resistant Barrier | Present |
| Wire Nose Clip | Present |
| Foam Nose Piece Inside Mask | Present |
| Elastic Headband | Present |
| Multi-Layer Filtering Media | Present |
| Intended Use: Respiratory protection of healthcare workers from blood and body fluids and particulates. | Aligned with device description. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify a sample size for performance testing or details about the provenance of such test data. The performance claims (e.g., 95% filtration efficiency) are stated as facts met by the design and approval process rather than results from a specific study detailed in this summary. These would typically be part of the NIOSH approval process based on standardized testing protocols.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is evaluated against physical performance standards (e.g., filtration efficiency) and regulatory compliance (NIOSH N95 approval), not against expert clinical diagnoses.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. There is no "ground truth" established by expert adjudication for this type of device. Performance is determined by standardized laboratory tests.
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 is not an AI-powered diagnostic device, and therefore, human reader improvement with AI assistance is not a relevant metric.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is established by:
- Standardized Performance Specifications: Primarily derived from the Code of Federal Regulations, Title 42, Part 84 for N95-class of Respiratory Protective Devices, which outlines specific testing methodologies and passing criteria for filtration efficiency, breathability, and fit.
- Regulatory Body Approval: NIOSH (National Institute for Occupational Safety and Health) approval (TC-84A-0008) serves as the ultimate validation that the device meets the required performance standards.
- CDC Guidelines: Compliance with CDC guidelines for preventing Mycobacterium tuberculosis transmission.
8. The sample size for the training set
Not applicable. This is a manufactured physical good, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set is involved for this 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.