(30 days)
The Magnes®3600 WH MEG is intended for use in diagnostic procedures that require the measurement and display of extracranial magnetic fields and information about the electrical activity in the brain as inferred from those fields.
The Magnes® 3600 WH MEG consists of a magnetic sensor for detecting and measuring magnetic fields produced by the human brain, along with auxiliary equipment required to perform the measurements in a conventional medical facility environment and to display the results of the measurements to physicians in a variety of ways.
The provided document states that no performance data was required for the Magnes® 3600 WH MEG because its specifications, performance characteristics, and intended uses are the same as the legally marketed predicate device, the Magnes® 2500 WH MEG.
Therefore, the document does not contain any information regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for a test set.
- Data provenance.
- Number of experts or their qualifications for establishing ground truth.
- Adjudication method for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for a training set.
- How ground truth for a training set was established.
The basis for the 510(k) clearance was a claim of substantial equivalence to a predicate device, meaning the new device is considered as safe and effective as a legally marketed device without the need for new clinical performance studies.
§ 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).