(55 days)
The PFR95TM Particulate Filter Respirator and Surgical Masks are intended for use by operating room personnel and other health care workers to protect both the patients and the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials.
Respirator consisting of nonwoven inter facing, filter media(s), and an outer facing. It covers the nose and mouth of the wearer, and is held in place with two synthetic elastic headbands, conforming to the curvature of the wearer's nose with a malleable nosepiece.
The provided 510(k) summary for the Tecnol PFR95™ Particulate Filter Respirator and Surgical Mask (K974068) describes the device, its intended use, and performance data from non-clinical tests. Since this is a submission for a physical medical device (particulate filter respirator/surgical mask) and not a software-as-a-medical-device (SaMD), many of the requested criteria (such as sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable or typically reported for this type of submission. The information provided focuses on material properties and physical performance rather than AI/algorithm performance.
Here's an analysis of the available information based on the prompt's request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated Requirements/Standards) | Reported Device Performance |
|---|---|
| Filtration Efficiency: | |
| - Meet NIOSH required sodium chloride test | Met NIOSH required sodium chloride test with 0.3 micron particles. |
| - Filtration efficiency not drop below 95% | At no time did the filtration efficiency drop below 95%. |
| Fluid Resistance: | |
| - Resist splash and splatter of blood and body fluids | Subject device samples were challenged with 2cc of synthetic blood at a speed simulating release of blood from an artery. (Implied successful resistance, as no failure is reported and a conclusion of "safe and effective" is made). |
| Face Fit: | |
| - Not explicitly stated quantitative criteria, but implicitly requires acceptable fit for protection. | Subject device samples were tested using a qualitative fit test. (Implied successful fit, as no failure is reported and a conclusion of "safe and effective" is made). |
| Ease of Breathing (Airflow Resistance): | |
| - NIOSH airflow resistance test requirement: Initial resistance (inhalation) less than 35mm H2O. | Subject device samples met the requirements of the NIOSH airflow resistance test, with initial resistance (inhalation) less than 35mm H2O. |
| Biocompatibility: | |
| - Meet requirements of ISO-10993, Part 1: Evaluation and Testing. | Subject device meets the requirements of ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document refers to "Subject device samples" for each test. For physical device testing like this, the sample size would typically be defined by the relevant standards (e.g., NIOSH, ISO).
- Data Provenance: Not specified. This would be laboratory testing conducted on the manufactured device, not data from human subjects or clinical records.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. The "ground truth" for this type of device is established through performance against objective, standardized physical and chemical tests (e.g., NIOSH standards for filtration, ISO standards for biocompatibility). There is no human expert consensus for defining ground truth in this context.
4. Adjudication Method for the Test Set
- Not Applicable. As ground truth relies on objective laboratory measurements against defined standards, there is no need for an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study is relevant for diagnostic imaging or similar scenarios where human readers interpret medical data, often with and without AI assistance. This is a physical device, so such a study is not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- No. This is not a software algorithm; it is a physical medical device. Therefore, a "standalone algorithm performance" study is not applicable. The performance described is the standalone performance of the physical device itself.
7. The Type of Ground Truth Used
- Standardized Test Results/Compliance with Regulatory Standards. The "ground truth" is adherence to established national and international standards (e.g., NIOSH for filtration, airflow resistance, and fluid resistance; ISO-10993 for biocompatibility). These standards define objective, measurable pass/fail criteria.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. This is not an AI/ML device that requires a training set.
§ 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.