(308 days)
3M™ VFlex™Health Care Particulate Respirator and Surgical Mask 1805/1805S is 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.
The 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask 1805/1805S is an N95 particulate respirator. Particulate respirators help reduce wearer exposure to certain airborne particles, including those generated by electrocautery, laser surgery and other powered medical instruments. This respirator has a filter efficiency level of at least 95% against particulate aerosols free of oil . As a surgical mask, it is designed to be fluid resistant to splash and spatter of blood and other infectious materials+ and meets > 99% bacterial filtration efficiency (BFE) *. It is cleared to be worn in surgery. It can fit a wide range of face sizes. This respirator contains no components made from natural rubber latex.
The provided text is a 510(k) summary for the 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask, Model 1805/1805S. It describes the device and claims substantial equivalence to a predicate device (3M™ Health Care Particulate Respirator and Surgical Mask, Model 1870) rather than presenting a study to prove a device meets specific acceptance criteria based on novel performance.
Therefore, the information required for the requested output (acceptance criteria table, sample sizes, expert details, adjudication methods, MRMC studies, standalone studies, ground truth types, and training set information) is not applicable to this document as it details a substantial equivalence claim for regulatory clearance, not a performance study against predefined acceptance criteria for a novel device or AI algorithm.
The document focuses on comparing the new device's characteristics and performance to those of a previously cleared predicate device to assert that there are "no new questions of safety or effectiveness."
However, I can extract the comparison table that shows the specifications and performance characteristics of both the subject device and the predicate device, which implicitly defines the "acceptance criteria" in the context of substantial equivalence.
1. A table of acceptance criteria and the reported device performance
In the context of a 510(k) substantial equivalence claim, the "acceptance criteria" are implied by the performance characteristics of the predicate device. The new device is considered to "meet acceptance criteria" if its performance is substantially equivalent to the predicate device, such that there are no new questions of safety or effectiveness.
| Description | Predicate Device (3M™ Health Care Particulate Respirator and Surgical Mask, Model 1870 (K063023)) | Subject Device (3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask, Model 1805/1805S) |
|---|---|---|
| Intended Use | Surgical Mask/Respirator | Surgical Mask/Respirator |
| Materials Construction Technology | ||
| Outside cover web | Multi-Layer Polypropylene spunbond | Multi-Layer Polypropylene spunbond |
| Stiffener web | Polypropylene spunbond | NA |
| Filter web | Polypropylene | Polypropylene |
| Inner web | Polypropylene | Polypropylene |
| Nose-Clip | Aluminum | Aluminum |
| Staple | Steel | Steel |
| Headband | Polyisoprene | Polyisoprene |
| Nose foam | Polyurethane | NA |
| Specifications and Dimensions | ||
| Audit of NaCl Load Test | 99% (ASTM Standard Test Method for Bacterial Filtration Efficiency F2101) | > 99% (ASTM Standard Test Method for Bacterial Filtration Efficiency F2101) |
*This is a common performance standard for all N95 respirators, specified in the description but implied as a meeting criterion for both predicate and subject.
**This is a common performance standard for surgical masks, specified in the description but implied as a meeting criterion for both predicate and subject.
Key conclusions from the document:
- The subject device (3M™ VFlex™ 1805/1805S) is substantially equivalent to the predicate device (3M™ 1870).
- Both devices are fluid resistant (though at different pressure levels: predicate at 160 mmHg, subject at 120 mmHg), classified as Class I for flammability, and NIOSH certified with N95 filtration efficiency.
- The differences in materials ("Stiffener web" and "Nose foam" present in predicate but "NA" for subject) and fluid resistance pressure threshold did not raise new questions of safety or effectiveness in the FDA's determination.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document is a 510(k) summary for substantial equivalence, not a report of a clinical or performance study with a test set of data in the AI/medical device sense. The "tests" mentioned are standard industry tests for mask performance (e.g., NaCl load test, fluid resistance, flammability, NIOSH certification), which are typically done on samples of the manufactured product. Specific sample sizes for these manufacturing quality/performance tests are not detailed in this regulatory summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No ground truth establishment by experts for a test set is described, as this is not an AI/diagnostic device performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring expert adjudication is described.
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-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (respirator/surgical mask), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. Ground truth, in the context of AI or diagnostic device evaluation, is not relevant here. The "truth" for this device relates to meeting physical and performance specifications for filtration, fluid resistance, and flammability, tested by established laboratory methods.
8. The sample size for the training set
Not applicable. No training set is involved as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. No training set is involved.
§ 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.