(175 days)
The FHC microTargeting® Electrodes are intended for use in intra-operative recording of single unit neuronal activity or intra-operative stimulation of neural elements in the brain.
The FHC microTargeting® Electrode is for intra-operative single unit recording and stimulation during functional neurosurgery.
This document (K033173) is a 510(k) summary for a medical device called the microTargeting® Electrode. It's a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, not a study proving the device meets specific acceptance criteria as you'd find in clinical trials for complex AI/machine learning devices.
Therefore, many of the requested categories (such as acceptance criteria, reported performance, sample size for test set, expert qualifications, adjudication method, MRMC study, standalone performance, ground truth types, training set size, and ground truth establishment for training set) are not applicable in this context.
This document describes a traditional medical device (an electrode) seeking clearance based on technological characteristics and intended use similar to existing products, rather than a device with an algorithm that requires performance metrics against a defined ground truth.
Here's what can be extracted from the provided text based on your request, with the understanding that the nature of the device and submission type means many fields will be "N/A":
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Demonstrating that the device is as safe and effective as legally marketed predicate devices. | The FDA determined the device is substantially equivalent (K033173). |
| Intended Use | The device is intended for intra-operative recording of single unit neuronal activity or intra-operative stimulation of neural elements in the brain. | The FHC microTargeting® Electrodes are intended for use in intra-operative recording of single unit neuronal activity or intra-operative stimulation of neural elements in the brain. (Matches) |
| Technological Characteristics | Differences from predicate devices do not affect relative safety and effectiveness. | "Differences that exist between these devices, relating to technical specifications, physical appearance, and design do not affect the relative safety and effectiveness of the microTargeting® Electrodes." (Statement of claim) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A: This 510(k) submission does not present data from a clinical test set in the way an AI/ML device would. It relies on demonstrating substantial equivalence to predicate devices based on design, materials, manufacturing, and intended use, rather than specific performance metrics from a clinical study.
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)
- N/A: No ground truth establishment by experts for a test set is described or required for this type of 510(k) submission for a non-AI/ML device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A: No adjudication method is described as there is no test set for performance evaluation in this context.
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
- N/A: This is not an AI-assisted device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A: This is not an algorithm-based device. No standalone performance study was performed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A: No explicit "ground truth" as a reference standard for performance evaluation is mentioned or required for this device. The regulatory submission focuses on substantial equivalence to existing devices.
8. The sample size for the training set
- N/A: The device is a physical electrode. There is no concept of a "training set" as would be used for an AI/ML algorithm.
9. How the ground truth for the training set was established
- N/A: As there is no training set, this is not applicable.
§ 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).