(109 days)
The Surgical Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.
The proposed device, is a three-layer, single-use, flat-pleated mask. The inner and outer layers of the mask are made of spun-bonded nonwoven polypropylene, and the middle layer is made of melt-blown nonwoven polypropylene. The proposed devices are available in two types, ear-loop and Tie-on. The ear loops are made of nylon and spandex, and the ties are made of spun-bonded nonwoven polypropylene. The ear loops/tie-on is held in place over the users' mouth and nose by ear loops/ties welded to the mask. The nose clip is made of Medical polypropylene+Q235. Users can adjust the nose clip according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. Both the ear loop and tie-on masks are available in different sizes to provide more options for user. The proposed device can be provided in sterile and non-sterile two types.
The document you provided is a 510(k) Premarket Notification for Surgical Face Masks. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a clinical or standalone study.
Therefore, the information requested in your prompt (acceptance criteria, details of a study proving device performance, sample sizes, expert involvement, ground truth establishment, etc.) is not present in this document. This 510(k) primarily relies on non-clinical performance testing and a comparison of technological characteristics to a predicate device.
Specifically:
- No clinical study was conducted or included in this submission. The document explicitly states this in Section 7: "No clinical study is included in this submission."
- The "acceptance criteria" for a 510(k) are typically met by demonstrating that the new device performs "as well as" or "better than" the predicate device in relevant non-clinical tests or by meeting recognized consensus standards. The document shows tables of test results (e.g., Bacterial Filtration Efficiency, Particulate Filtration Efficiency, Fluid Resistance) against, or in comparison to, the predicate device and relevant standards (e.g., ASTM F2100 Level 2).
- There is no mention of human experts establishing ground truth for a test set, adjudication methods, or MRMC studies because there was no clinical study.
However, I can extract information related to the device performance and testing that was done to support the 510(k) clearance, framed as "reported device performance" against relevant "acceptance criteria" derived from the standards and predicate comparison:
The provided 510(k) Premarket Notification for Surgical Face Masks (K202843) demonstrates substantial equivalence to a predicate device (K173062) by relying on non-clinical performance testing rather than a clinical study. Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of human data, expert adjudication, or MRMC studies is not applicable to this submission.
Instead, the device meets "acceptance criteria" by demonstrating performance in laboratory tests in accordance with recognized consensus standards (e.g., ASTM F2100 Level 2) and by showing that its technological characteristics are substantially equivalent to the predicate device.
Here's an interpretation of the requested information based on the provided document, focusing on the non-clinical testing performed:
1. Table of Acceptance Criteria (as per standards/predicate comparison) and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria (based on ASTM F2100 Level 2 or predicate) | Reported Device Performance (K202843) |
|---|---|---|
| Fluid Resistance | Pass at 120 mmHg (Same as Predicate) | Pass at 120 mmHg |
| Particulate Filtration Efficiency (PFE) | Meet requirements for Level 2 (~98.98% for predicate) - Note: ASTM F2100 Level 2 minimum PFE is ≥ 98% at 0.1 µm. | Average 98.98% |
| Bacterial Filtration Efficiency (BFE) | Meet requirements for Level 2 (~99.4% for predicate) - Note: ASTM F2100 Level 2 minimum BFE is ≥ 98%. | Average 98.92% |
| Differential Pressure (Delta P) | Meet requirements for Level 2 (Average 2.7 $mmH_2O/cm^2$ for predicate) - Note: ASTM F2100 Level 2 maximum Delta P is |
§ 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.