(214 days)
The ISIS MER System / Elekta MER System is intended to be used during neurosurgery to record and stimulate brain motor and sensory neurons to aid in the placement of depth electrodes.
During neurosurgical interventions the ISIS MER System / Elekta MER System is used for optimal extra cellular recording and deep brain stimulation. The system operates the integrated neurostimulator that delivers impulses similar to the effect of an implanted electrode. Recording and stimulation of up to five channels are possible simultaneously. A sixth channel may be used for EMG recording for optimal patient surveillance.
The provided text is a 510(k) summary for the Inomed GmbH ISIS MER System / Elekta MER System. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. It typically focuses on comparing the new device's technological characteristics, safety, and effectiveness to its predicate.
Based on the provided text, there is no information available regarding acceptance criteria, a specific study proving the device meets those criteria, or details regarding the methodologies listed in your request (sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, training set details, etc.).
Here's why and what information is present:
- Type of Submission: This is a Traditional 510(k). The primary goal of a 510(k) is to establish substantial equivalence to a predicate device, not necessarily to set new performance acceptance criteria or conduct extensive clinical effectiveness studies in the same way a PMA (Premarket Approval) would require.
- Focus of the Document: The document explicitly states: "The functionality for the ISIS MER System / Elekta MER System are equivalent to its predicate devices... in safety and effectiveness. The fundamental technical characteristics are similar to those of the predicate devices and are listed on the comparison charts provided in this 510k submission." This indicates a focus on comparing technical specifications and intended use rather than presenting novel performance studies against defined acceptance criteria.
- Information Absent:
- No table of acceptance criteria or reported device performance for newly established metrics.
- No mention of a dedicated "study" to prove specific performance targets.
- No details on sample sizes for test sets or training sets.
- No information about data provenance, expert panels, adjudication methods, or ground truth establishment.
- No discussion of MRMC studies or standalone AI algorithm performance, as this device (depth electrode recording system) is not an AI-driven diagnostic tool in the sense of image analysis.
Conclusion:
The provided 510(k) summary does not contain the information required to answer your questions about acceptance criteria and a specific study proving the device meets those criteria. The submission aims to demonstrate substantial equivalence to predicate devices (Axon Guideline System 3000A and Dantec / Medtronic Keypoint / Leadpoint system) based on similar technological characteristics, safety, and effectiveness, rather than establishing new performance benchmarks with detailed study results. The device itself is a depth electrode system for neurosurgery, not an AI-based diagnostic tool, which typically would involve the extensive validation studies you are asking about.
§ 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).