(140 days)
The ClearPoin® 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 insettion 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. Some of the accessories are common components with the ClearPoint System (K200079). 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
q. Device Lock (2 different diameters)
h. Screwdriver
i. 2.1-mm Guide Tube
j. Center Drill Guide
k. Offset Drill Guide
- 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
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 document is a 510(k) premarket notification summary for the ClearPoint Array System. This type of submission focuses on demonstrating "substantial equivalence" to a predicate device, rather than proving a device "meets acceptance criteria" in the way one might for a novel AI/ML device or a device with new performance claims.
Therefore, the document does not contain the typical information required to answer all parts of your request, such as a multi-reader multi-case study, detailed ground truth establishment for a test set, or separate training set details, as these are more common for AI/ML device submissions with explicit performance claims against real-world clinical outcomes.
However, based on the information available, I can extract what is relevant to performance and "acceptance":
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the format of a pre-defined performance goal that the device must achieve (e.g., "sensitivity must be >X%"). Instead, it provides performance validation values for key navigational accuracy metrics, which likely represent measurements taken to demonstrate the device's capabilities and support its substantial equivalence claim. The predicate device's targeting accuracy serves as a benchmark for comparison.
| Metric (ClearPoint Array System) | Reported Performance | Predicate Device Performance (Acceptance Benchmark/Comparison) |
|---|---|---|
| Positional Error (Mean) | 0.78 mm (x,y,z) | ≤ 1.5 mm |
| Positional Error (99% CI) | 1.14 mm (x,y,z) | - |
| Angular Error (Mean) | 0.67° | - |
| Angular Error (99% CI) | 0.85° | - |
(Note: The second row for positional error (1.52, 0.46, 1.94, and -1.41, 0.73, -2.08) appears to be additional data points for positional error (potentially x, y, z components or separate measurements), but the document does not clarify their exact meaning beyond being under 'Positional Error (mm)' and 'Mean', 'Std. Dev', '99% CI'. For clarity, I'm using the first row as the primary 'overall' mean positional error provided.)
The primary "acceptance criterion" implicit in this type of submission is that the performance of the new device is substantially equivalent to the predicate device, especially considering the predicate's stated "Targeting Accuracy ≤ 1.5 mm." The reported mean positional errors (0.78mm and other values) are well within this 1.5 mm threshold, indicating that this aspect of performance is considered acceptable and equivalent or improved.
2. Sample size used for the test set and the data provenance
The document states: "Design Verification and Validation was performed relative to these specifications and with acceptable results. These tests included verification of physical, performance, and safety requirements, as well as benchtop accuracy testing."
- Sample Size: The document does not explicitly state the sample size (number of measurements or trials) used for the benchtop accuracy testing.
- Data Provenance: The data is described as "benchtop accuracy testing." This implies controlled laboratory conditions, not human subject data from a specific country or clinical setting. It is not retrospective or prospective clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For a stereotactic guidance system, "ground truth" for accuracy is typically established by precise measurement tools and phantoms in a controlled engineering or physics lab setting, rather than by expert human interpretation of images. The device's performance is measured against known physical coordinates or angles.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as ground truth is established via physical measurements and not human adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This type of study is typically performed for diagnostic AI/ML devices where the AI provides assistance to a human reader, to demonstrate improvement in reader performance. The ClearPoint Array System is a surgical guidance device, not a diagnostic AI/ML tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in a sense. The "Performance Data" table ("Positional Error" and "Angular Error") represents the standalone performance of the device in a controlled, benchtop setting, measuring its inherent accuracy in guiding and positioning. It's the device's mechanical and software accuracy demonstrated without a human actively interpreting images or making a diagnostic decision in a clinical context.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The ground truth for the "Performance Data" (positional and angular accuracy) would be based on physical precision measurements using highly accurate instruments (e.g., optical trackers, coordinate measuring machines) in a controlled laboratory environment with phantoms that have known, precise target locations.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set in the typical sense for machine learning. The software modifications mentioned are likely re-engineering and feature additions for workflow and UI, not learning algorithms.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set for machine learning.
§ 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).