(70 days)
The microTargeting® Guideline 4000 system is intended to assist in functional neurosurgical procedures where recording from and stimulation of brain motor and sensory neurons will aid in the placement of depth electrodes.
The microTargeting® Guideline 4000 is designed for intraoperative electrophysiological microelectrode recording, stimulation, data collection, analysis and storage.
The provided document (K071364 FHC 510(k) Summary) describes a medical device, the microTargeting® Guideline System 4000, and its substantial equivalence to predicate devices, but it does not contain a study that proves the device meets specific acceptance criteria in the format requested.
This 510(k) summary is a premarket notification to the FDA, asserting that the new device is as safe and effective as a legally marketed predicate device. The primary method of demonstrating this is through comparison of technological characteristics and intended use, rather than a clinical trial with acceptance criteria and statistical performance measures.
Here's why and what information is available:
1. Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: The document does not explicitly list quantitative acceptance criteria (e.g., target sensitivity, specificity, or accuracy thresholds).
- Reported Device Performance: Instead of performance metrics, the document states:
- "Specifications in every category are either the same, very similar, or improved [compared to predicate devices]."
- "Non-clinical review of the device shows the device meets similar performance specifications as the predicate devices."
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable. No clinical test set data or study is described in this 510(k) summary. The demonstration of substantial equivalence relies on non-clinical engineering and design comparisons.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:
- Not applicable. No clinical test set.
4. Adjudication Method for the Test Set:
- Not applicable. No clinical test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study was not described. The document does not mention human reader performance or AI assistance.
6. Standalone Performance Study (Algorithm Only):
- Not applicable. This device is an intraoperative neurophysiological recording and stimulating device, not an AI algorithm. Standalone performance for an algorithm is not relevant here.
7. Type of Ground Truth Used:
- Not applicable. No clinical test data requiring a ground truth determination is presented. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate devices.
8. Sample Size for the Training Set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable.
Summary of what the document does provide regarding "proof" of meeting criteria:
The "proof" in this 510(k) summary is the assertion of "Substantial Equivalence" to legally marketed predicate devices. This means the FDA has determined that the microTargeting® Guideline System 4000 is as safe and effective as the predicate devices (Axon Instruments, Inc. Guideline System 3000 K970943; Alpha Omega Neurotrek Physiological Navigation System K993622).
The criteria for this substantial equivalence are outlined as:
- Similar design, construction, materials, intended use, and performance characteristics.
- No new technology, materials, or manufacturing methods introduced.
- Specifications are "the same, very similar, or improved."
- No new issues of safety or effectiveness are introduced.
The "study" or evidence for this is a "Non-clinical review of the device," which presumably involves engineering tests, bench testing, and comparison of technical specifications against the predicate devices. The document does not elaborate on the specific details of this non-clinical review or present quantitative results from it, as is typical for a 510(k) summary. The full 510(k) submission would contain more detailed information.
§ 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).