(22 days)
The Grass MR Conditional/CT Cup Electrodes and Arrays 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 an MRI or CT environment under specific conditions.
Grass® MR Conditional/CT Cup Electrodes are for surface monitoring EEG, electromyogenic and physiologic data signals commonly recorded on the chest, extremities, head and faces of patients. Grass® MR Conditional/CT Array Cup Electrodes are also used in electrocardiography, evoked potentials, and polysomnography. The Grass® MR Conditional/CT Array Cup Electrodes are MR conditional/CT. The included extension cables are MR/CT Unsafe.
The Operating Principle and technological characteristics of the Grass MR Conditional Cup Electrodes are identical to the predicate device (K171102), with a few dimensional and material modifications that have been assessed to be equivalent to the predicate and therefore do not affect the fundamental scientific technology, safety, or effectiveness of the device (reference Substantial Equivalence of Technological Characteristics table, below). The test methods were identical to those used to assess the predicate device.
The provided text describes the 510(k) premarket notification for the Grass® MR Conditional/CT Cup Electrodes. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria for AI/ML performance. As such, many of the requested details regarding AI/ML device performance studies (e.g., sample sizes for test/training sets, expert consensus for ground truth, MRMC studies, standalone performance) are not applicable or present in this specific regulatory submission.
The document primarily details the physical and functional characteristics of the electrodes and their compliance with safety standards and predicate device equivalency, particularly concerning MR conditional features.
However, I can extract the closest applicable information related to "acceptance criteria" and "device performance" based on the provided text, interpreting "performance" in the context of the device's electrical and physical properties as assessed for medical device regulatory submission.
Here's an attempt to fill in the table and answer the questions based on the provided non-AI/ML medical device submission:
Acceptance Criteria and Reported Device Performance (Non-AI/ML Device)
| Acceptance Criteria (Target Performance) | Reported Device Performance |
|---|---|
| Electrical Resistance (Singles) | ** |
§ 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).