(45 days)
The Willson® ONE-Fit™ HC-NB095 Healthcare Particulate Respirator and Surgical Mask is a NIOSHapproved N95 single use respirator 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 also meets the CDC guidelines for TB exposure control within healthcare facilities and is intended for use as an isolation mask.
The Willson ONE-Fit HC-NB095 Healthcare Particulate Respirator and Surgical Mask is a one size fits all, cup type, particulate respirator and surgical mask. The inner layer is constructed of polypropylene; the middle layer is a filtration layer made of polypropylene; and the outer layer is a covering of non woven polyester. The cup is thermoformed while the perimeter layers are heat sealed to form a small flange around the perimeter of the mask. Two latex free, synthetic elastic straps are stapled to the flange and are used to secure the mask to the wearer's face.
The Willson ONE-Fit HC-NB095 is approved by NIOSH in accordance with 42 CFR Part 84. NIOSH has issued certification number TC-84A-4357 as a type N95 Particulate Respirator. It is a single use, disposable device.
The provided document describes a 510(k) summary for a medical device, the Willson® ONE-Fit™ HC-NB095 Healthcare Particulate Respirator and Surgical Mask. However, it does not contain the specific details required to fully address all parts of your request regarding acceptance criteria and study methodologies.
The document highlights the device's performance through standardized tests and states that it passed these tests. It also mentions a comparison to predicate devices, noting that "Like the predicates, it has been performance tested and passed standardized tests for fluid resistance, filter efficiency, bacterial and viral filtration efficiency, flammability and breathing resistance." The materials used were also determined to be biocompatible.
Based on the information provided, here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Fluid Resistance | Meets standardized test criteria for fluid resistance. | Passed standardized tests for fluid resistance. |
| Filter Efficiency | Meets standardized test criteria for filter efficiency. | Passed standardized tests for filter efficiency. |
| Bacterial Filtration Efficiency (BFE) | Meets standardized test criteria for BFE. | Passed standardized tests for bacterial filtration efficiency. |
| Viral Filtration Efficiency (VFE) | Meets standardized test criteria for VFE. | Passed standardized tests for viral filtration efficiency. |
| Flammability | Meets standardized test criteria for flammability. | Passed standardized tests for flammability. |
| Breathing Resistance | Meets standardized test criteria for breathing resistance. | Passed standardized tests for breathing resistance. |
| Biocompatibility (Cytotoxicity) | Materials determined to be biocompatible (no significant cytotoxicity). | Materials determined to be biocompatible by cytotoxicity testing. |
| Biocompatibility (Sensitization) | Materials determined to be biocompatible (no significant sensitization). | Materials determined to be biocompatible by sensitization testing. |
| Biocompatibility (Skin Irritation) | Materials determined to be biocompatible (no significant skin irritation). | Materials determined to be biocompatible by skin irritation testing. |
| NIOSH Approval (N95) | Approved in accordance with 42 CFR Part 84. | Approved by NIOSH with certification number TC-84A-4357 as a type N95 Particulate Respirator. |
Missing Information: The specific numerical or qualitative acceptance criteria for these standardized tests are not detailed in this document. The document only states that the device "passed" them. To provide exact acceptance criteria, reference to the specific standards (e.g., ASTM F1862 for fluid resistance, 42 CFR Part 84 for NIOSH N95, etc.) would be needed, which are not included here.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided document. The document only mentions "performance tested" and "passed standardized tests" without detailing the number of units or samples tested for each criterion.
- Data Provenance: Not specified. The document does not indicate the country of origin of the test data or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the device is a physical product (respirator/surgical mask) and its performance is evaluated against objective engineering and biological standards, not through subjective assessment by human experts where "ground truth" would be established by consensus. The "ground truth" here is determined by the results of the standardized physical and biological tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used in studies involving subjective interpretation (e.g., medical image analysis) to resolve discrepancies among expert readers. The performance of a respirator is determined by objective measurements.
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
This section is not applicable. An MRMC study is relevant for diagnostic or interpretive devices, often involving AI assistance with human readers. This device is a passive protective medical device (respirator/surgical mask) and does not involve human readers or AI in its direct function or evaluation described here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. This device is not an algorithm or software. Its performance is inherent to its physical properties and construction.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established by objective measurements and observations from standardized physical and biological tests. Examples include:
- Measurement of filter penetration for filter efficiency.
- Observation of liquid penetration for fluid resistance.
- Microbiological challenge tests for bacterial and viral filtration efficiency.
- Flammability tests based on burn rate or extent.
- Pressure drop measurements for breathing resistance.
- Laboratory assays for cytotoxicity, sensitization, and irritation.
8. The sample size for the training set
This section is not applicable. The device is a physical product. The concept of a "training set" is relevant for machine learning algorithms or AI models, which are not part of this device's description. The manufacturing process is likely subject to quality control and statistical process control, but this is different from a "training set" for AI.
9. How the ground truth for the training set was established
This section is not applicable for the reasons stated in point 8.
§ 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.