(84 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. The System is intended for use only with 1.5 Tesla MRI scanners.
The ClearPoint System is comprised of a workstation laptop with workstation software, the SMARTGrid™ MRI-Guided Planning Grid, the SMARTFrame™ MRI-Guided Trajectory Frame, the SMARTFrame Accessory Kit, the SMARTFrame Handcontroller, and the MR Neuro Procedure Drape. The MR Neuro Procedure Drape was cleared for market via a separate 510(k) notice (K091343).
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 allows for trajectory feedback when the physician views the MR 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.
Here's a breakdown of the acceptance criteria and study information for the ClearPoint System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy (Radial/Depth Error) | "targeting accuracy observed was as expected" and "at least as accurate as the NeXframe MR (used in conjunction with software on a cleared MRI scanner) in terms of radial error and depth error" |
| Targeting Error | "error less than 1.5mm" |
| Functionality | "the device functioned as intended" |
| Safety (MRI Compatibility) | Device is "MRI Conditional as defined by ASTM F2503" with no added patient risk from electromagnetic fields, evidenced by verification testing for image distortion, force/torque, and RF heating. |
| Workflow Performance | "at least comparable to the NeXframe MR... in terms of both accuracy and user ratings on a variety of procedure-related assessments." |
2. Sample Sizes and Data Provenance
- Test Set Sample Size:
- MRI Test Device Accuracy Testing: Not explicitly stated, but implies multiple tests were conducted with a "Test Device representative of the devices to be used."
- System Accuracy Comparison in a Skull Phantom: Not explicitly stated, but involved the ClearPoint System and the predicate Navigus II MR/NeXframe MR.
- System Accuracy Comparison in a Cadaver: One cadaver was used.
- Data Provenance: The studies were internal validation studies conducted by SurgiVision, Inc., using phantoms and a cadaver. No information is provided regarding country of origin or whether it was retrospective or prospective in the context of clinical patient data, as these were pre-clinical validation studies.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
The document does not explicitly state the number or qualifications of experts used to establish ground truth for the test set. The studies described are technical performance assessments against pre-defined targets (phantoms) or comparisons to a predicate device in a cadaver, rather than diagnostic assessments requiring expert interpretation.
4. Adjudication Method (Test Set)
The document does not describe a formal adjudication method for ground truth in the test set. For the phantom studies, the ground truth was presumably the known pre-determined target or the expected performance based on the predicate device. For the cadaver study, it involved comparing the ClearPoint System's performance against the predicate Navigus II MR, likely using objective measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The provided text refers to comparative effectiveness studies against a predicate device (Navigus II MR) and its performance, and user ratings on procedure-related assessments by a user, but not an MRMC study comparing human readers with and without AI assistance.
6. Standalone Performance (Algorithm Only)
Yes, a standalone performance assessment was conducted for the device's accuracy and functionality. The "ClearPoint System Accuracy Testing" and "System Accuracy Comparison in a Skull Phantom" sections describe tests of the system's ability to precisely position instruments and achieve targeting accuracy. These tests are focused on the device's inherent mechanical and software performance.
7. Type of Ground Truth Used
- For Accuracy Testing:
- MRI Test Device Accuracy Testing: A "known pre-determined target in a phantom."
- System Accuracy Comparison in a Skull Phantom: Comparison against data previously obtained for the predicate Navigus II MR/NeXframe MR using the same model system. The predicate device's performance would serve as a de-facto ground truth or benchmark, assuming its accuracy had been previously established.
- System Accuracy Comparison in a Cadaver: Comparison against the predicate Navigus II MR/NeXframe MR's performance in accessing targets in a cadaver head.
8. Sample Size for the Training Set
The document does not provide information on the sample size used for a "training set." The studies described are validation studies for the device's performance against established benchmarks or a predicate, not studies involving an AI or machine learning model that requires a dedicated training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for an AI or machine learning model is mentioned in the provided text. The device is a "Neurological Stereotaxic Instrument" with associated software, not explicitly an AI-driven diagnostic or treatment planning system that would typically have a training set.
§ 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).