(307 days)
The Surgical Face Mask is intended to be worn to protect both the patient and healthcare persomel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided non-sterile.
The Surgical Face Mask is 3-layer, and it is two model is HSD-TYP2R (Ear loops) and HSD-TYP2RT (Tie-On). Flat-folded masks constructed of nonwoven polypropylene materials. The mask is provided with ear loops (spandex and polyester) or tie tapes (spun-bond polypropylene). A malleable nose clip is placed in the layers of facemask for comfort and individualized fit. The surgical face mask color is blue. Product is Level 3 based on ASTM F2100-19. The surgical face mask is single-use, disposable devices, provided non-sterile.
This document is a 510(k) Premarket Notification from Wuhan Huashida Protective Products Co., Ltd. for their Surgical Face Mask. It is a submission to the FDA demonstrating that their device is substantially equivalent to a legally marketed predicate device.
The premise of a 510(k) submission is to demonstrate "substantial equivalence' to a legally marketed device, not necessarily to prove the device's independent safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval) application. For a device like a surgical face mask, the FDA generally relies on performance testing against recognized standards rather than clinical studies, especially if the device is similar in design and materials to existing cleared devices.
Therefore, the information provided below is based on the provided document and tailored to how a 510(k) submission addresses "acceptance criteria" through non-clinical testing.
Here's an analysis of the provided text in relation to your request about acceptance criteria and the study proving the device meets them:
1. A table of acceptance criteria and the reported device performance
The document provides a table of acceptance criteria and results from non-clinical performance and biocompatibility testing.
| Items | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| For Surgical Face Mask Performance | |||
| Fluid Resistance Performance | The purpose of the performance testing is to demonstrate the functionality of the subject device | 29 out of 32 pass at 160 mmHg | Pass |
| Particulate Filtration Efficiency | (Implied: To demonstrate the mask's ability to filter particulate material) | $\geq$ 98% | Pass |
| Bacterial Filtration Efficiency | (Implied: To demonstrate the mask's ability to filter microorganisms) | $\geq$ 98% | Pass |
| Differential Pressure | (Implied: To measure the breathability of the mask) | =98% is the target). There are no human "experts" establishing a subjective ground truth like in a diagnostic AI study. The results are quantitative measurements. |
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable for non-clinical performance and biocompatibility testing. Adjudication methods like 2+1 or 3+1 are used in studies where human readers (e.g., radiologists) are involved in interpreting medical images or data, and their disagreements need to be resolved to establish a "ground truth" or reference standard. This document pertains to physical device testing.
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 is not applicable. An MRMC study is relevant for evaluating the performance of AI-assisted diagnostic tools where human interpretation plays a role. This submission pertains to a surgical face mask, which is a physical barrier device, not an AI diagnostic tool. The document explicitly states: "No clinical study is included in this submission."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This question refers to the performance of an AI algorithm in isolation. The product is a surgical face mask, not an algorithm. The testing performed is standalone in the sense that it's the mask's performance being measured directly against established standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is based on pre-defined, quantitative performance specifications established by relevant industry standards and regulatory guidance. For example:
- Fluid Resistance: Resistance to penetration by synthetic blood at a specified pressure (ASTM F1862).
- Filtration Efficiency (Particulate & Bacterial): Percentage of particles/bacteria filtered out (ASTM F2299, ASTM F2101).
- Differential Pressure: How easily air can pass through (EN 14683).
- Flammability: A classification based on burn rate (16 CFR 1610).
- Biocompatibility: Absence of cytotoxic, irritating, or sensitizing effects as per ISO 10993 standards.
These standards define the 'truth' or expected performance for a surgical mask of a certain level.
8. The sample size for the training set
This is not applicable. This device is a manufactured medical product, not an AI algorithm that requires a "training set."
9. How the ground truth for the training set was established
This is not applicable, as there is no "training set" for this type of device submission.
§ 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.