(314 days)
The Disposable Surgical Masks are intended to be worn to protect both the patient and healthcare personnel 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. The Disposable Surgical Masks are single use, disposable device, provided non-sterile.
Disposable Surgical Mask is composed of three layers and is flat-pleated. The mask materials consist of an outer layer (spun-bond polypropylene), a middle layer, between the outer layer and inner layers (melt-blown polypropylene), and an inner layer (spun-bond polypropylene). Each mask contains ear loops to secure the mask over the users' mouth and face and includes a malleable nose piece (High-density Polyethylene) to provide a firm fit over the nose. There are four models for Disposable Surgical Mask with different colors and sizes. All six models are Ear Loop type in blue or white colors and two sizes including 145mm×90mm and 175×95mm.
The provided document is a 510(k) summary for a Disposable Surgical Mask (K210042). It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets acceptance criteria in the context of an AI/ML medical device. The document details performance testing for physical and material properties of the surgical masks.
Therefore, most of the requested information regarding AI/ML device testing (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC studies, standalone performance, training set details) is not applicable to this type of device and submission.
However, I can extract the relevant acceptance criteria and performance data for the Disposable Surgical Mask as presented in the document.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical/Material Performance):
This table is directly from the "IX. PERFORMANCE DATA" section of the document. The acceptance criteria and results refer to the physical and barrier performance of the surgical mask material.
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Bacterial Filtration Efficiency | To determine the bacterial filtration efficiency (BFE) | Level 2 ≥ 98% | 32/32 Passed at ≥99.9% |
| Particulate Filtration Efficiency | To determine the particle filtration efficiency (PFE) | Level 2 ≥ 98% | 32/32 Pass at ≥99.5% |
| Differential Pressure (delta-P) | To measure breathability/resistance to airflow | Level 2 |
§ 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.