(30 days)
The ClearPoint System is intended to provide stereotactic guidance and operation of instruments or devices during the 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. The System is intended for use only with 1.5 and 3.0 Tesla MRI scanners.
The ClearPoint System is comprised of a workstation laptop with software, the SMARTGrid™ MRI-Guided Planning Grid, the SMARTFrame™ MRI-Guided Trajectory Frame, the SMARTFrame™ Accessory Kit and the SMARTFrame™ Hand Controller. The SMARTGrid and associated Marking Tool are designed to assist the physician to precisely position the entry hole as called out in the trajectory planning software. The SMARTFrame is an Adjustable Trajectory Frame (ATF) 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 allows 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 and imaging coil(s) that can be used with the ClearPoint System. The ClearPoint Workstation includes the ClearPoint Workstation Software (for trajectory planning and monitoring) and a 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 SMARTGrid Pack (Marking Grid, Marking Tool), SMARTFrame Pack (SMARTFrame or SMARTFrame XG, Centering Tool, Wharen Centering Guide, Dock, Device Lock, Screwdriver, Roll Lock Screw and Washer), Rescue Screws, Hand Controller and Thumbwheel Extension, Accessory Pack (Peel-away Sheath, Stylet, Lancet, Depth Stop, Ruler), Scalp Mount Base, Guide Tube and Device Guide Packs (Guide Cannulas), SmartTip MRI Hand Drill and Drill Bit Kit, SmartTwist MRII Hand Drill and 4.5mm/6.0mm Drill Guide, MRI Neuro Procedure Drape, with Marker Pen and Cover, and SmartFrame MR Fiducial.
Here's an analysis of the provided text regarding the acceptance criteria and study for the ClearPoint System, structured as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Measure) | Reported Device Performance |
|---|---|
| Targeting Accuracy | ± 1.5mm @ ≤ 125mm |
| Functionality of Wharen Centering Guide | Confirmed to hold Centering Tool and maintain selected entry point |
| Functionality of 4.5mm and 6.0mm Drill Guides | Acceptable results (functions as intended) |
| Compliance with Biological Evaluation | Adheres to AAMI/ANSI/ISO 10993-1 |
| Compliance with Sterilization Process | Adheres to ANSI/AAMI/ISO 11135-1 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for test sets (e.g., number of phantom targets, physical products tested) for the functionality tests. The studies described are bench and phantom testing. Data provenance is implied to be from laboratory testing rather than human clinical data. The document does not provide information on the country of origin or whether the data was retrospective or prospective, as it pertains to bench and phantom testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for the bench and phantom testing. The "ground truth" for these tests would likely be the known dimensions or positions in the phantom or bench setup.
4. Adjudication Method for the Test Set
The document does not describe any adjudication methods, as the tests performed are technical performance verification rather than clinical outcomes requiring expert review.
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 document describes bench and phantom testing for device modifications, not a comparative clinical study involving human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device described is a medical instrument system, not an AI algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" does not apply in the context of this 510(k) submission. The ClearPoint System requires a human operator for its intended use "to provide stereotactic guidance and operation of instruments or devices during the planning and operation of neurological procedures."
7. The Type of Ground Truth Used
For the performance data mentioned (Targeting Accuracy, functionality of new components):
- Targeting Accuracy: The ground truth would be the known, precise target location within the phantom used for testing, typically established through precise measurement tools or engineering specifications.
- Functionality of Wharen Centering Guide and Drill Guides: The ground truth would be the intended functional behavior and design specifications of these components as verified through engineering tests.
8. The Sample Size for the Training Set
The document does not mention any "training set" as it relates to machine learning or AI models. The ClearPoint System is a hardware/software system for surgical guidance, not an AI/ML device that requires training data in the typical sense.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a "training set" in the context of AI/ML, this question is not applicable to the provided document. The "training" for such a device would relate to the design and development processes for the hardware and software components, following engineering and quality system standards.
§ 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).