(175 days)
The ClearPoint System is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures within the MRI environment and in conjunction with MR imaging. The ClearPoint System is intended as an integral part of procedures that have traditionally used stereotactic methodology. These procedures include biopsies, catheter and electrode insertion, including deep brain stimulation (DBS) lead placement. The System is intended for use only with 1.5 and 3.0 Tesla MRI scanners and MR Conditional implants and devices. The user should consult the "Navigational Accuracy" section of the User's Guide to assess if the accuracy of the system is suitable for their needs.
The ClearPoint System is comprised of a workstation laptop with workstation software, the SMARTGrid™ MRI-Guided Planning Grid (previously cleared under K100836), the SMARTFrame™ MRI-Guided Trajectory Frame (K100836), the SMARTFrame™ Accessory Kit (K100836) and the SMARTFrame™ Thumbwheel Extension.
The SMARTGrid and associated Marking Tool are designed to assist the physician to precisely position the burr hole as called out in the trajectory planning software. The SMARTFrame is an adjustable trajectory frame that provides the guidance and fixation for neurosurgical tools. The MRI visible fluids of the Targeting Cannula along with the fiducial markers in the base of the frame allow for trajectory feedback when the physician views the MRI images, makes changes, and confirms with subsequent MR images.
The ClearPoint System can be used with any MRI-compatible head fixation frame to immobilize the patient's head with respect to the scanner table, as well as with any imaging coil(s) that meet the physician's desired imaging quality. MRI Interventions also supplies an optional head fixation frame that can be used with the ClearPoint System.
The ClearPoint Workstation includes the following:
- ClearPoint Workstation Software (for trajectory planning and monitoring)
- Laptop Computer
The hardware components of the ClearPoint System are the SMARTFrame and Accessories. They are all single use devices that are provided sterile. They include the following:
- SMARTGrid Pack (interacts with the Software to determine the desired location of the burr hole)
a. Marking Grid
b. Marking Tool - SMARTFrame Pack
a. SMARTFrame (adjustable trajectory frame ("ATF") to guide and hold the neurosurgical tools, includes fiducials, Targeting Cannula, & titanium screws)
b. Centering Device
c. Dock
d. Device Lock (2 different diameters)
e. Screwdriver - Rescue Screws (Extra Titanium Screws)
- Thumbwheel Extension
- Accessory Pack
a. Peel away sheath
b. Stylet
c. Lancet
d. Depth Stop
e. Ruler - Scalp Mount Base
- Guide Tube and Device Guide Packs (Guide Cannulas)
Here's an analysis of the provided text regarding the ClearPoint System, focusing on the acceptance criteria and the study that proves the device meets those criteria:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Targeting Accuracy (Linear) | ± 1.5mm @ $\leq$ 125mm |
| Mean Error Across Device Configurations | Below 1mm |
| Highest Standard Deviation (Linear) | 0.45mm |
| Highest 99% Confidence Limit (Linear) | 1.52mm |
| Angular Accuracy | All below 1° |
| Highest Standard Deviation (Angular) | 0.55° |
| Highest 99% Confidence Limit (Angular) | 1.40° |
| Stereotaxic Device Limits | Below 2mm (linear error) and 2° (angular error) |
Study Details Proving Device Meets Acceptance Criteria
The primary study mentioned to demonstrate device performance and suitability for new indications (explicitly including DBS lead placement) is a combination of:
- Literature and registry data for clinical use.
- Company's bench accuracy tests.
Here are the details extracted from the document:
2. Sample Size Used for the Test Set and Data Provenance:
- Clinical Data: Data from 1,259 procedures were available for accuracy placement. 828 of these procedures were specifically for DBS lead placement.
- Data Provenance: This was "literature and registry data," indicating retrospective collection from 35 institutions currently using the ClearPoint System. The country of origin is not explicitly stated but implies a multi-institutional, possibly international, or at least multi-state, context given the registry nature.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not explicitly stated for the clinical registry data. It's inferred that the "literature and registry data" would have involved physicians (likely neurosurgeons) performing the procedures and assessing outcomes, but the specific number and qualifications of experts for establishing ground truth on a per-case basis are not detailed.
- For the bench tests, no expert ground truth establishment is mentioned, as these are objective engineering measurements.
4. Adjudication Method for the Test Set:
- This information is not explicitly stated for the clinical registry data. Given it's registry data, it's unlikely a formal centralized adjudication method like 2+1 or 3+1 was used for each case's ground truth within the registry itself. The accuracy data likely came from post-operative imaging and physician assessment in individual clinical settings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done. The document describes a study demonstrating device accuracy and clinical effectiveness based on existing use, not a comparison of human readers with and without AI assistance. The ClearPoint System is a stereotactic guidance system, not an AI-driven image interpretation tool for diagnostic purposes where MRMC studies are typical.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Yes, a form of standalone performance was done for the device's accuracy. The "company's bench accuracy tests" represent a standalone evaluation of the system's mechanical and software targeting capabilities, independent of real-time human interpretation or assistance during a procedure. The results (mean error, standard deviation, 99% confidence limits for linear and angular accuracy) are standalone measurements of the device's precision.
7. The Type of Ground Truth Used:
- Clinical Data: The ground truth for the clinical effectiveness (specifically placement accuracy) in the registry data would typically be derived from post-operative imaging analysis (e.g., MRI scans) to determine the actual final position of the placed instrument (e.g., DBS lead) relative to the planned target. This is effectively outcomes data related to the physical position of the device.
- Bench Tests: The ground truth for the bench accuracy tests would be metrological measurements against a precisely known reference target, using engineering methods to quantify linear and angular deviations.
8. The Sample Size for the Training Set:
- This information is not applicable/not provided in the context of this 510(k) summary. The ClearPoint System is a stereotactic guidance system. While its software (version 1.6.2) is mentioned, the document does not describe it as an AI/machine learning system that requires a "training set" in the conventional sense for image analysis or diagnostic prediction. The software likely relies on algorithms for trajectory planning, visualization, and guidance, which are developed and validated through engineering principles rather than data-driven machine learning training.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As explained in point 8, the concept of a "training set" and associated "ground truth" for machine learning is not described or relevant to the information provided for the ClearPoint System. The device's software is based on established computational geometry and image processing principles for stereotactic guidance.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).