(18 days)
The Elekta Neuromag® with Maxwell Filter non-invasively measures the magnetoencephalographic (MEG) signals (and, optionally, electroencephalographic (EEG) signals) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed, and may then be interpreted by trained physicians to help localize these active areas. The locations may then be correlated with anatomical information of the brain. MEG is routinely used to identify the locations of visual, auditory, somatosensory, and motor cortex in the brain when used in conjunction with evoked response averaging devices. MEG is also used to non-invasively locate regions of epileptic activity within the brain. The localization information provided by MEG may be used, in conjunction with other diagnostic data, in neurosurgical planning.
The Elekta Neuromag with Maxwell Filter adds support for separating brain signals from external disturbances and reducing mcasurements artifacts.
The provided text does not contain a study that proves the device meets specific acceptance criteria. Instead, it is a 510(k) summary for the Elekta Neuromag® with Maxwell Filter, seeking substantial equivalence to a predicate device. This document describes the device, its intended use, and indications for use, but not a clinical or performance study with defined acceptance criteria and results.
Therefore, I cannot populate the table or answer most of the questions as the requested information (performance data, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not present in the provided text.
The document focuses on demonstrating that the new device has "similar fundamental technical characteristics" to the predicate device to establish substantial equivalence.
Here's what can be extracted based on the document's content:
1. A table of acceptance criteria and the reported device performance
The provided document does not contain specific acceptance criteria or reported device performance metrics from a study. It is a 510(k) summary for substantial equivalence, not a performance study report.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not mentioned or described in the document. The device is a MEG system, not an AI-assisted diagnostic tool for human readers in the context of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable in the context of this device as described. The Elekta Neuromag® with Maxwell Filter is a diagnostic device that measures MEG/EEG signals to be interpreted by trained physicians. It's not an algorithm operating in a standalone capacity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not provided in the document.
8. The sample size for the training set
Not applicable/provided. This document is not describing a machine learning or AI algorithm with a training set.
9. How the ground truth for the training set was established
Not applicable/provided. This document is not describing a machine learning or AI algorithm with a training set.
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).