(236 days)
The NeuroNav System / NeuroSmart System, incorporated the installed HaGuide software, is intended to be used in assisting neurosurgeons, in the operating functional neurosurgery, and to record from and stimulate brain motor and sensory neurons and to aid in the placement of depth electrode.
The NeuroNav Drive is intended to be used in assisting neurosurgeons, in the operating room during functional neurosurgery, to aid in the placement of depth electrodes.
Alpha Omega's NeuroNav System is an accurate electrodes navigation system to aid the neurosurgeon in placement of DBS electrodes. The system is designed to be used in the operating room during neurosurgery.
The NeuroNav Drive system is designed for compatibility with Alpha Omega's Microprobes (NeuroProbes K120098) or with other manufacturers' compatible electrodes, and is compatible with all the existing Stereotactic Frames and Frameless procedures.
NeuroNav system can record signals from the brain cells (Micro-Electrode Recording -MER) or stimulate the brain target zone during movement disorders neurosurgery procedure.
In addition, the NeuroNav system is planned to include additional sub model, will be traded as "NeuroSmart", this sub model is identical to the NeuroNav system, the subject device, and incorporated the installed HaGuide software, will be elaborated hereunder.
The installed HaGuide software is a user option tool, which is a real-time software solution designed to accurately detects the Sub Thalamic Nucleus region, its entrance and exit boundaries as well gives the user a stimulation location recommendation.
The HaGuide software robustly detects intra STN detection of Dorso lateral Oscillatory Region (DLOR) and Ventro Medical Non-Oscillatory Region (VMNR) boundary.
The provided text describes a 510(k) premarket notification for the NeuroNav System, NeuroSmart System, and NeuroNav Drive. The key focus for this request is the "HaGuide Clinical Study" which assesses the performance of the HaGuide software module.
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria for the HaGuide software's performance, but rather presents the results of a single-arm study evaluating its accuracy against expert measurements. Based on the "Primary Effectiveness Endpoint Analysis" and "Results" section of the HaGuide Clinical Study, an implicit acceptance goal was likely a high percentage agreement and strong correlation.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| High Percent agreement between HaGuide software measurements and expert Neurosurgeon/Electrophysiologist measurements for STN entry point vs. exit point depth. | Percent agreement between HaGuide and Neurosurgeon/Electrophysiologist expert is 90.34% (95% CI, 85.27, 93.85 %). |
| Strong Correlation between HaGuide measurements and expert Neurosurgeon/Electrophysiologist measurements in depth of STN entry site and exit site. | Correlation between the HaGuide measurements and expert Neurosurgeon/Electrophysiologist measurements in depth of STN entry site and exit site was very strong (coefficient = 0.9492 and 0.9317 respectively and both lower 95% Confidence Limit >0.91). |
| Low average difference between HaGuide and expert measurements (Bland-Altman analysis) for STN entry and exit points. | Bland-Altman analysis of average against the difference between HaGuide and expert measurements for the location of STN entry was 0.18 mm (95% CI, -0.9, 1.2 mm) and exit points was -0.15 mm (95% CI, -1.25, 1 mm). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 81 patients, leading to 105 surgeries and 213 electrodes evaluated.
- Data Provenance: Retrospective, Multi-centre, with data collected from both the United States and Outside United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not explicitly stated as a number, but referred to as "qualified user (Neurosurgeon/Electrophysiologist)".
- Qualifications of Experts: Neurosurgeon/Electrophysiologist. No specific years of experience are provided, but they are described as "qualified users."
4. Adjudication Method for the Test Set
The document implicitly describes the adjudication method as a direct comparison between the "HaGuide software measurements" and "expert Neurosurgeon/Electrophysiologist measurements." There is no mention of a formal multi-reader adjudication process like 2+1 or 3+1; the expert opinion is considered the "gold standard."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study focuses on the accuracy of the algorithm (HaGuide software) compared to expert opinion (the "gold standard"), not on how human readers' performance improves with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone study was done. The "HaGuide Clinical Study" specifically evaluates the "HaGuide software module accuracy" by comparing its measurements directly against expert measurements, indicating that the algorithm's performance was assessed independently of active human-in-the-loop use.
7. The Type of Ground Truth Used
The ground truth used was expert consensus/opinion. The document states that "The reference against which the accuracy of HaGuide mapping was compared is the gold standard being the qualified user (Neurosurgeon/Electrophysiologist) concluding about the location of the entry and exit points of the sub-thalamic nucleus (STN) from the visual and audio recording patterns."
8. The Sample Size for the Training Set
The document does not provide information regarding the sample size for the training set used to develop the HaGuide software. The "HaGuide Clinical Study" describes a clinical validation of the software, implying it was already developed when this study was performed.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for the training set was established, as details about the software's development (including training data and ground truth establishment) are not covered in this 510(k) summary.
§ 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).