(102 days)
Medline's Smoke Evacuation Shroud is a single use, sterile product. Its intended use is as an electrosurgical accessory to attach to a standard cautery pencil. The shroud removes surgical procedures. The product is used inside the sterile field.
Medline's Smoke Evacuation Shroud is a single use, sterile product.
I apologize, but the provided text from the FDA 510(k) clearance letter for the "Medline Smoke Evacuation Shroud" does not contain the information necessary to answer your request about acceptance criteria and a study proving device performance as it relates to AI/machine learning devices.
The document is a standard FDA 510(k) clearance letter for a Class II medical device (a smoke evacuation shroud, which is a physical accessory for electrosurgical pencils) and primarily addresses regulatory compliance and substantial equivalence to predicate devices. It does not discuss:
- Acceptance criteria for an AI/ML algorithm.
- Performance studies involving AI/ML.
- Sample sizes for test or training sets.
- Expert involvement in establishing ground truth.
- Adjudication methods.
- MRMC studies or effect sizes for human readers.
- Stand-alone algorithm performance.
- Types of ground truth.
Therefore, I cannot populate the table or provide any of the requested details based on the given input. This document is not relevant to the kind of AI/ML device performance study you are asking about.
§ 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.