(105 days)
The MR Conditional Cup and Webb Electrodes are intended for use in the recording of the Electroencephalogram (EEG), the evoked potential (EP), or as a ground and reference in an EEG or EP recording. This device is non-sterile for Single Patient Use Only and may remain on the patient in a MRI environment under specific conditions.
The device consists of ABS molded disk-shaped Cup or Webb style cutaneous electrodes coated with Ag/AgCl. The electrodes are affixed to 18cm long conductive leadwires. Up to 10 leadwires are connected to a multipin touch proof connector to form an electrode array assembly, which is labeled "MR Conditional." Up to 4 electrode arrays can be used simultaneously on a patient. The device design and leadwire length have been engineered for both 1.5T (64MHz) and 3.0T (128 MHz) MRI environments. An extension cable, 1.0 to 3.0m long, is included to attach the electrode array to monitoring equipment. The extension cable is clearly labeled with "MR Unsafe" symbols on both ends, and is NOT intended to be in the MR environment. This enables users to quickly disconnect the MR Unsafe extension cable and leave the MR Conditional electrodes in place on the patient for MRI procedures.
The provided text is a 510(k) Pre-Market Notification for a medical device (MR Conditional Cup Electrode, MR Conditional Webb Electrode). It describes the device, its intended use, and comparative testing performed to demonstrate substantial equivalence to a predicate device.
Crucially, this document does NOT describe the acceptance criteria and study that proves a device meets acceptance criteria for an AI/ML-based medical device. Instead, it is focused on demonstrating the physical and functional safety and performance of a conventional medical electrode in an MRI environment compared to a previously approved device.
Therefore, I cannot extract the information required for a study proving an AI/ML device meets acceptance criteria from this document. The concepts of "test set," "ground truth," "expert consensus," "human readers," "AI assistance," "effect size," and "standalone performance" are not applicable to the type of device and testing described in this 510(k) summary.
The document states:
- "No Clinical Tests were conducted as referenced in 21 CFR 807.92(b)(2)."
- "The functional performance equivalency was determined by mechanical and electrical benchtop testing..."
- "The MR safety and performance equivalency of the MR Conditional Cup and Webb Electrodes were determined using the same test methodology as the predicate device..."
The acceptance criteria here pertain to physical safety and functional performance (e.g., thermal limits in MRI, signal quality) as demonstrated by benchtop and computational testing, not diagnostic performance based on algorithms or human interpretation of data.
If you have a document describing the study for an AI/ML device, please provide that, and I will be happy to assist.
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).