(30 days)
To remove and filter smoke and aerosols from a surgical site produced during electrosurgical and laser procedures.
Not Found
I am sorry, but the provided text does not contain the information requested in your prompt regarding acceptance criteria and a study proving device performance for an AI/ML medical device.
The document is a 510(k) clearance letter from the FDA for a device named EvaQMax Smoke Evacuation System, product code FYD. This is a physical device used to remove and filter smoke and aerosols from a surgical site, not an AI/ML-driven device.
Therefore, I cannot provide details on:
- Acceptance criteria and reported device performance for an AI/ML device.
- Sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies related to AI/ML device validation.
The document discusses regulatory information for a non-AI/ML medical device, including its classification, regulations, and reporting requirements.
§ 878.5070 Air-handling apparatus for a surgical operating room.
(a)
Identification. Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient.(b)
Classification. Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.