(90 days)
The Elekta Neuromag 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™ is an upgraded version of the currently available Neuromag Vectorview (K984401). The Elekta Neuromag™ does not change the intended use or the fundamental scientific technology of the Neuromag Vectorview.
The Elekta Neuromag™ integrates 306 sensor elements, including planar gradiometers and and magnetometers, with computers and data acquisition and data analysis software in order to measure the differences in the magnetic signals generated by the intracellular dendritic currents. These detectors are positioned in a helmet shaped array that gives the user the ability to record the electrical activity of the entire surface of the brain simultaneously without having to move the position of the measuring device.
The provided document is a 510(k) summary for the Elekta Neuromag™ device, which describes its substantial equivalence to a predicate device, rather than presenting a performance study against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and performance metrics cannot be found in this document.
The document states that the Elekta Neuromag™ is an upgraded version of the currently available Neuromag Vectorview (K984401) and that it does not change the intended use or the fundamental scientific technology of the Neuromag Vectorview. It also asserts that the Elekta Neuromag™ is substantially equivalent to its predicate device the Omega Whole-Cortex MEG System (K030737) in safety and effectiveness.
Here's a breakdown of what can and cannot be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. This document is a 510(k) summary focused on substantial equivalence to a predicate device, not a performance study report with specific acceptance criteria and detailed device performance metrics. The demonstration of "safety and effectiveness" for a 510(k) is typically done by showing equivalence to a legally marketed predicate device, rather than fulfilling explicit, predefined performance criteria from a new clinical study.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document does not describe a performance study with a test set. The claim of substantial equivalence is based on the device's technical characteristics being similar to the predicate device.
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)
- Cannot be provided. No ground truth establishment is described as there is no specific performance study against a test set in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No adjudication method is mentioned as there is no performance study described.
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
- Cannot be provided. The Elekta Neuromag™ is a magnetoencephalographic (MEG) device, not an AI-powered diagnostic tool. No MRMC study is mentioned, nor is there any AI component described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Cannot be provided. This is not an algorithmic device in the context of an "algorithm only" performance study. It's a medical device for measuring brain signals.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. No specific ground truth is mentioned. The device's use is to help localize active areas which are "interpreted by trained physicians," suggesting that clinical interpretation and correlation with other diagnostic data form the basis of its utility, not a single, predefined "ground truth" used for a direct performance assessment in this 510(k) submission.
8. The sample size for the training set
- Cannot be provided. This document does not describe a machine learning algorithm or a training set.
9. How the ground truth for the training set was established
- Cannot be provided. As above, no training set or ground truth for it is mentioned.
Summary of Device and Equivalence:
The Elekta Neuromag™ is a magnetoencephalographic (MEG) device that measures brain signals. It is an upgraded version of a previously cleared device (Neuromag Vectorview K984401) and claims substantial equivalence to another legally marketed predicate device, the Omega Whole-Cortex MEG System (K030737). The basis for this equivalence is that the Elekta Neuromag™ does not change the intended use or fundamental scientific technology of the predicate, and its fundamental technical characteristics are similar. The document explicitly states that the device is substantially equivalent in safety and effectiveness to its predicate.
§ 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).