(21 days)
The Willson® ONE-Fit™ Flat-Fold™ Healthcare Particulate Respirator and Surgical Masks (HC-NB095F & HC-NB295F) are NIOSH-approved N95 single use respirators intended for use by healthcare personnel during medical/surgical procedures to protect both the wearer and the patient by protecting the wearer against the spatter of blood and other potentially infectious materials and reducing the transfer of microorganisms and other airborne particulate matter.
The Willson ONE-Fit Flat-Fold masks also meet the CDC guidelines for TB exposure control within healthcare facilities and are intended for use as an isolation mask.
The Willson ONE-Fit Flat-Fold Healthcare Particulate Respirator and Surgical Masks are flat-fold style particulate respirator and surgical masks. The only difference between the two models is the number of straps; one has a single strap, the other a double strap.
The inner layer of the mask is constructed of spunbonded polypropylene, the middle layer is a filtration layer made of melt blown polypropylene and the outer layer is a covering of spunbonded polypropylene. The two halves that comprise the flat-fold facepiece are ultrasonically sealed together. The lower halves and is/are ultrasonically welded into the corners of the mask. The perimeter edges of the mask that contact the wearer's face are also ultrasonically sealed to provide reinforcement of the edges.
The Willson ONE-Fit Flat-Fold Healthcare Particulate Respirator and Surgical Masks are approved by NIOSH in accordance with 42 CFR 84 as N95 particulate respirators. NIOSH has issued approvals TC-84A-4372 (single strap) and TC-84A-4371 (dual strap).
The provided text describes a 510(k) submission for the Willson® ONE-Fit™ Flat-Fold™ Healthcare Particulate Respirator and Surgical Masks. This is a submission for a medical device (respirator/surgical mask) and not an AI/ML (Artificial Intelligence/Machine Learning) powered device. Therefore, the information requested regarding acceptance criteria and performance metrics for AI/ML devices is not applicable to this document. The document focuses on demonstrating substantial equivalence to a predicate device through performance testing against standardized tests for physical characteristics and biocompatibility.
Here's an analysis based on the information provided, clearly stating what is not applicable for an AI/ML device:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Fluid Resistance | Standardized tests for fluid resistance (implied to meet relevant standards for surgical masks). | Passed standardized tests for fluid resistance. |
| Filter Efficiency | Standardized tests for filter efficiency (implied to meet relevant standards for N95 respirators, which is generally ≥95% filtration efficiency for 0.3 micron particles). | Passed standardized tests for filter efficiency. Additionally, the device is "NIOSH-approved N95 single use respirators" in accordance with 42 CFR 84, meaning it meets the N95 filtration criteria. |
| Bacterial Filtration Efficiency | Standardized tests for bacterial filtration efficiency (implied to meet relevant standards for surgical masks, typically ≥95% or ≥98% bacterial filtration efficiency). | Passed standardized tests for bacterial filtration efficiency. |
| Flammability | Standardized tests for flammability (implied to meet relevant standards). | Passed standardized tests for flammability. |
| Breathing Resistance | Standardized tests for breathing resistance (implied to meet relevant standards, ensuring user comfort and safety). | Passed standardized tests for breathing resistance. |
| Biocompatibility | Determined to be biocompatible by cytotoxicity, sensitization, and skin irritation testing. | Determined to be biocompatible by cytotoxicity, sensitization and skin irritation testing (materials "virtually identical" to predicate, which were also determined to be biocompatible). |
| NIOSH Approval (N95) | Approval by NIOSH in accordance with 42 CFR 84 as N95 particulate respirators. | Approved by NIOSH (TC-84A-4372 for single strap, TC-84A-4371 for dual strap). |
| CDC Guidelines for TB Exposure Control | Meets CDC guidelines for TB exposure control within healthcare facilities. | Meets the CDC guidelines for TB exposure control within healthcare facilities. |
| Protection against blood spatter | Protects the wearer against the spatter of blood and other potentially infectious materials (implied by fluid resistance and surgical mask classification). | Indicated for use "to protect the wearer against the spatter of blood and other potentially infectious materials." |
| Reduction of microorganism transfer | Reduces the transfer of microorganisms and other airborne particulate matter (implied by filter efficiency and bacterial filtration efficiency). | Indicated for use "reducing the transfer of microorganisms and other airborne particulate matter." |
| Design Differences (if any) | The only difference between the two models is the number of straps (one has a single strap, the other a double strap). The materials used in the mask are "virtually identical" to the predicate. Construction method (ultrasonically sealed) and specific materials (spunbonded polypropylene, melt blown polypropylene) are described. | The only difference between the two models is the number of straps; one has a single strap, the other a double strap. The inner layer is spunbonded polypropylene, middle layer is melt blown polypropylene, outer layer is spunbonded polypropylene. Halves are ultrasonically sealed, and perimeter edges are ultrasonically sealed for reinforcement. Materials are virtually identical to the predicate. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each individual performance test (fluid resistance, filter efficiency, etc.). It states that the "Flat-Fold masks have been performance tested in an identical manner to the predicate, and passed standardized tests." The data provenance is related to laboratory testing of physical materials and device performance under controlled conditions. No patient or human subject data is referenced.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for this device is established by objective engineering and laboratory performance standards and physical material properties, not expert clinical interpretation.
4. Adjudication method for the test set
Not applicable. The tests are based on objective pass/fail criteria against established standards, not on human adjudication of ambiguous cases.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML device, and no human reader studies are mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
The ground truth is based on objective engineering and laboratory performance standards (e.g., specific filtration percentages, resistance to fluid penetration, flammability ratings) and material biocompatibility testing as defined by regulatory bodies like NIOSH and FDA-recognized standards.
8. The sample size for the training set
Not applicable. This is not an AI/ML device and does not involve a "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device and does not involve establishing ground truth for 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.