(90 days)
The Disposable Medical Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. They are in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
The Disposable Medical Surgical Masks are green color, three-layer, flat-folded masks with nose piece and ear loops. The green colorant is polypropylene (PP) master batch.
The inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.
The ear loops are held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loops are not made with natural rubber latex or fiberglass, but nylon and spandex.
The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of Iron core coated with Polyethylene.
The Disposable Medical Surgical Masks are sold non-sterile and are intended to be single use, disposable devices.
The provided document is a 510(k) Premarket Notification from the FDA for a Disposable Medical Surgical Mask. It details the device's technical specifications, intended use, and comparison to a predicate device, as well as the results of non-clinical performance and biological safety tests.
However, the request asks for specific information related to acceptance criteria and a study proving a medical device meets these criteria, particularly focusing on aspects like AI assistance, human reader performance improvement, ground truth establishment, sample sizes for training and test sets, and expert involvement. The document describes a surgical mask, which is a physical product, not a medical device that would involve AI, image analysis, or human reader performance in the context of the questions asked.
Therefore, many of the questions asked (e.g., about AI, human readers, ground truth for training/test sets, MRMC studies) are not applicable to the information provided in this document, which pertains to the physical and biological performance of a surgical mask.
I will interpret the request as asking about the acceptance criteria and proof of performance as presented in this document for a surgical mask, acknowledging that many of the AI/image analysis specific questions are not relevant here.
Here's an analysis based on the provided document:
Acceptance Criteria and Study Proving Device Meets Criteria (for a Disposable Medical Surgical Mask)
The study described in this document is a non-clinical performance and biological safety evaluation conducted to demonstrate substantial equivalence of the Disposable Medical Surgical Mask to a legally marketed predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | To demonstrate the functionality of the subject device. | 29 out of 32 pass at 160 mmHg for Level 3 | 31 out of 32 pass at 160 mmHg, 3 lots; PASS |
| Particulate Filtration Efficiency (ASTM F2299) | To demonstrate the functionality of the subject device. | ≥ 98% | 98.8%; 98.8%; 98.8%; PASS |
| Bacterial Filtration Efficiency (ASTM F2101) | To demonstrate the functionality of the subject device. | ≥ 98% | 99.8%; 99.8%; 99.8%; PASS |
| Differential Pressure (Delta P) (EN 14683 Annex C) | To demonstrate the functionality of the subject device. |
§ 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.