(110 days)
The ClearPoint® Array 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 ® Array 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 ClearPoint Array System is comprised of a workstation laptop with workstation software, the SMARTGrid™ MRI-Guided Planning Grid, the SMARTFrame™ Array MRI-Guided Trajectory Frame, SmartFrame Array Reducer Tube Kit, the ClearPoint™ Accessory Kit, the SMARTFrame™ Array Thumb Wheel Extension Set, and the MRI Neuro Procedure Drape.
A pre-alignment may be used when it is desired to obtain an approximate alignment using a Surgical Navigation System prior to performing final alignment and device placement in the MR Scanner using real-time MR Images. Pre-alignment using an SNS is not intended to provide accurate stereotactic placement. The final alignment and insertion must be performed using real-time MR images with ClearPoint Array software prior to inserting a device in the brain. The SMARTGrid™ MRI-Guided Planning Grid 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™ Array MRI-Guided Trajectory Frame is an adjustable trajectory frame that provides the quidance and fixation for neurosurgical tools. MRI visible fluids in the Targeting Stem along with the fiducial markers in the frame allows for trajectory feedback when the physician views the MR images, makes changes and confirms the subsequent MR images. The ClearPoint Array 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) (supplied by scanner manufacturers) that meet the physician's desired imaging quality. ClearPoint Neuro also supplies an optional head fixation frame that can be used with the ClearPoint Array System.
The ClearPoint System Array Workstation includes the following:
- ClearPoint Workstation Software (for trajectory planning and monitoring)
- Laptop Computer
The hardware components of the ClearPoint Array System are the SMARTFrame Array and accessories. They are all single use devices that are provided sterile. They include the following:
1 SMARTFrame Array Pack
a. SMARTFrame Array (adjustable trajectory frame to guide and hold the neurosurgical tools, includes Probe Adapter and Tracker Rod)
b. SMARTFrame Array Scalp Mount Base (includes fiducials, titanium screws, and support pins)
c. Entry Point Locator
d. Targeting Stem
e. Centering Device
f. Dock
g. Device Lock (2 different diameters)
h. Screwdriver
i. 2.1-mm Guide Tube
j. 4.5 Center Drill Guide
k. 4.5 Offset Drill Guide
l. 3.4-mm Drill Reducer Tube
m. Center Insertion Guide
n. Offset Insertion Guide
2 SmartFrame Array Thumb Wheel Extension Set for the trajectory frame
3 SmartFrame Array Guide Tube Kit
a. 1.7-mm Guide Tube
b. 2.5-mm Guide Tube and Device Lock
c. 3.2-mm Guide Tube and Device Lock
4 SmartFrame Array Guide Tubes (sold seperately)
a. 7.9mm Center and Offset Device Guides
b. 5.4mm Center and Offset Device Guides
Common components to ClearPoint System include:
- SMARTGrid Pack (interacts with the Software to determine the desired location of the burr hole):
a. Marking Grid
b. Marking Tool - Accessory pack:
a. Peel away sheath
b. Stylet
c. Depth Stop
d. Ruler - MRI Neuro Procedure Drape
The provided text, a 510(k) Summary for the ClearPoint Array System (version 1.1), focuses on demonstrating substantial equivalence to a predicate device, primarily due to a software update. While it mentions 'Targeting Accuracy' as an acceptance criterion and states a specific performance, it does not provide a detailed study design as might be found in a clinical trial report.
Here's an attempt to extract and infer the information based on the provided text:
Acceptance Criteria and Reported Device Performance
The key acceptance criterion mentioned, which is related to the device's accuracy, is:
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Targeting Accuracy | ≤ 2.0 mm |
Study Proving Device Meets Acceptance Criteria
The document states: "The company completed new software validation for the ClearPoint Array version 1.1 software update, which includes the addition of the preoperative planning module."
While this indicates that a validation study was performed, the document does not provide details for many of the requested items (2-9) about the study design, sample size, expert involvement, or ground truth establishment. This is typical for a 510(k) submission showing substantial equivalence, where detailed de novo clinical study results are often not required if the changes are minor and do not raise new questions of safety and effectiveness, and performance is demonstrated through established engineering and software validation principles.
Based on the provided text, the following information is not available:
- Sample size used for the test set and the data provenance: Not specified. The document implies software validation was done, but details on the "test set" (e.g., number of image sets, countries of origin, retrospective/prospective) are absent.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
- Adjudication method for the test set: Not specified.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not specified. This type of study is typically done for AI/ML-driven diagnostic devices that assist human readers in interpretation. The ClearPoint Array System is a stereotaxic guidance system, and the software update is for a preoperative planning module, rather than a diagnostic AI. Therefore, an MRMC study is unlikely to be relevant or performed for this device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly detailed. The "Targeting Accuracy" metric suggests an objective, standalone measurement of the system's precision, but the methodology for this measurement (e.g., phantom study, cadaver study) is not provided.
- The type of ground truth used: Not explicitly stated. For a stereotaxic system, ground truth for accuracy studies would typically involve precise physical measurements on phantoms or cadavers, or comparison to a gold-standard imaging or navigation system. The document does not elaborate on this.
- The sample size for the training set: Not applicable based on the information provided. The software update is described as "incorporat[ing] an update" and "new software validation," implying traditional software development and testing, rather than an AI/ML model that requires a "training set" in the machine learning sense. The preoperative planning module might involve algorithms, but the text doesn't suggest a deep learning model requiring a large training dataset.
- How the ground truth for the training set was established: Not applicable, as no training set (in the AI/ML context) is mentioned or implied.
In summary, the document provides the acceptance criterion for targeting accuracy (≤ 2.0 mm) and states that the device meets this, but it does not detail the specific study methodology (e.g., sample size, ground truth establishment, expert involvement, or comparative effectiveness studies) beyond "new software validation." This level of detail is usually not included in a 510(k) summary focused on substantial equivalence for a non-AI/ML device where the change is primarily a software update to a planning module.
§ 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).