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510(k) Data Aggregation
(286 days)
Neuron AccuPoint™ Electrodes are intended for use in intraoperative recording of single unit neuronal activity or intraoperative stimulation of neural elements in the brain.
The AccuPoint™ Electrode is used for monitoring, recording, or microstimulation during intraoperative procedures to map the electrical activity of single unit neurons at subsurface levels of the brain. Intraoperative microelectrode recording (MER) and microstimulation equipment is utilized with depth electrodes during stereotactic surgery to assist in localization for further applications such as permanent implant placement.
The MER or microstimulation equipment which connects to the AccuPoint Electrode are supplied by other manufacturers and is not sold by MicroProbes for Life Science, Inc. The AccuPoint Electrode is produced with standard connectors to connect with other manufacturers' cables that then connect to MER and microstimulation equipment.
The AccuPoint Electrode is a long, extremely thin metal needle insulated with a Parylene C coating. This needle will be composed of either tungsten or a platinum-iridium alloy, depending on the preference of the clinician. The tip of this needle is exposed using either an electric arc or laser process, to create an electrode. The tip exposure length can be carefully controlled to imbue the electrode with a particular impedance. This core needle electrode is situated within a stainless steel and polyimide cannula, with the electrode and cannula being employed together as an integrated unit. The electrode will be capable of sliding within the cannula. allowing the clinician to extend the tip during use, or retract the tip back within the cannula during handling and storage. The rear portion of the cannula will be equipped with a "stop collar", or a thick stainless steel ring which assures proper placement of the electrode within the surgical frame. A laver of stainless steel within the cannula will serve as a second electrode or "reference contact". The electrode may or may not be equipped with an outer stainless steel shield. The electrode will be equipped with two gold pin connectors on the back end, which allow the electrode to be connected to the cable leading to the MER or microstimulation equipment possessed by the surqeon. The model number of each electrode configuration was chosen to be analogous to the comparable predicate electrode model from one of two other manufacturers (FHC and Alpha Omega), allowing clinicians to easily adopt the AccuPoint Electrode with minimal confusion. Only a length within 5 cm of the AccuPoint Electrode comes into direct contact with patient tissue.
Accessories include stainless steel spacer and insertion tubes and stylets which are used during stereotaxic functional neurosurgical procedures to accurately guide a microelectrode or instrument into the brain. The insertion tubes with the stylet inserted are initially placed through the stereotaxic frame access locations for determining the estimated depth of the target location to then insert the depth electrode (AccuPoint Electrode).
The AccuPoint Electrodes and Accessories will be sold sterile, for single patient use, and will be disposable.
The provided document K162459 for the Accupoint Electrode does not contain information about studies specifically designed to prove the device meets acceptance criteria related to a diagnostic or AI-driven performance measure. This document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria for a novel diagnostic or AI functionality.
The "Summary of Testing" section (page 5) details the types of tests performed for the AccuPoint Electrode, but these are primarily engineering and biocompatibility tests to ensure the device's basic safety and function, and its equivalence to the predicate device. They do not involve clinical performance metrics like sensitivity, specificity, or reader improvement with AI assistance.
Therefore, many of the requested elements of the acceptance criteria and study information cannot be extracted from this document, as they are not relevant to the type of device and its regulatory submission.
However, I can provide the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't present acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity). Instead, it focuses on demonstrating that the device's characteristics are comparable to the predicate device and that it meets basic safety and performance requirements for an electrode.
| Characteristic / Test | Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (K162459) |
|---|---|---|
| Indications For Use | Same as predicate device (FHC microTargeting Electrode) | "Neuron AccuPoint™ Electrodes are intended for use in intraoperative recording of single unit neuronal activity or intraoperative stimulation of neural elements in the brain." (Matches predicate) |
| Material Biocompatibility | Meets ISO 10993-1 requirements; no cytotoxicity | Cytotoxicity testing completed, compliance maintained with known biocompatible materials and validated sterilization processes. |
| Electrode Impedance | Within specified range (0.5 MΩ-Megohms (+/-30%) to 1 MΩ-Megohms (+/-20%) Measured at 1 kHz or 220 Hz) | Tested for electrode impedance. (No specific numerical results reported in this summary, but implied to meet criteria for substantial equivalence). |
| Continuity and Insulation Integrity | Functionally sound, no breaks in continuity or insulation defects | Tested for continuity and insulation integrity. (Implied to meet criteria). |
| Dynamic Impedance | No short circuiting between inner and outer electrodes | Tested for dynamic impedance to detect short circuiting. (Implied to meet criteria). |
| Sterilization Method | Ethylene Oxide, Non-pyrogenic | Matches predicate (Ethylene Oxide, EO, Non-pyrogenic) |
| Physical and Dimensional Attributes (e.g., Overall Length, Core Electrode Diameter, Tip Style, Tip Taper) | Match predicate device (FHC microTargeting Electrode) | Ranges and descriptions provided match the predicate device. |
| Shelf Life | At least one year | One (1) Year (Aging study ongoing to obtain longer expiration date). Predicate has Three (3) Years. |
The following points cannot be addressed by the provided document as they are related to AI/diagnostic studies, which are not applicable to this device and its submission type:
2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/diagnostic device study. The "testing" mentioned refers to engineering and biocompatibility tests, not clinical evaluations with a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth established for a test set in the context of diagnostic performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable. No training set for an AI model.
9. How the ground truth for the training set was established: Not applicable.
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