(157 days)
To record from and stimulate brain motor and sensory neurons to aid in the placement of depih electrodes.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the "Guideline System 3000" (GS3000). This document grants market clearance based on substantial equivalence to a predicate device and deals with regulatory aspects rather than detailed performance study reports.
Therefore, the document does not contain the acceptance criteria or the study details you are asking for. It does not describe:
- Acceptance criteria and reported device performance in a table.
- Sample sizes, data provenance, number of experts, qualifications of experts, or adjudication methods for a test set.
- Whether MRMC studies were done, or their effect sizes.
- Whether standalone performance was evaluated.
- The type of ground truth used.
- The sample size or ground truth establishment for a training set.
The document's purpose is to inform Axon Instruments, Inc. that their device is substantially equivalent to a legally marketed predicate device, allowing them to market it subject to general controls. It does not include the detailed technical or clinical study data that would typically be found in a Premarket Approval (PMA) application or a more comprehensive summary of safety and effectiveness data for a 510(k).
§ 882.1330 Depth electrode.
(a)
Identification. A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.(b)
Classification. Class II (performance standards).