(182 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.
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™ Thumbwheel Extension.
The SMARTGrid and associated Marking Tool are designed to assist the physician to precisely position the entry hole as called out in the traiectory planning software. The SMARTFrame is an Adjustable Trajectory Frame (ATF) that provides the quidance and fixation for neurosurqical 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) (supplied by scanner manufacturers) 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 current ClearPoint System are the SMARTFrame and Accessories. They are all single use devices that are provided sterile. They include the following:
- SMARTGrid MRI Planning Grid (interacts with the software to determine the desired location of the burr hole)
a. Marking Grid
b. Marking Tool - SMARTFrame Pack (SMARTFrame or SMARTFrame XG)
a. SMARTFrame ("ATF") with Base
b. Centering Device and Wharen Centering Guide
c. Dock
d. Device Lock (2 different diameters)
e. Screwdriver
f. Roll Lock Screw and Washer - Rescue Screws (Extra Titanium Screws)
- Thumbwheel Extension
- Accessory Kit
a. Peel-away Sheath
b. Stylet
c. Lancet
d. Depth Stop
e. Ruler - Scalp Mount Base
- Guide Tubes and Device Guide Packs (Guide Cannulas)
In addition, the ClearPoint System is used with the following separately cleared or Class I, 510(k)exempt products:
SmartTip MRI Hand Drill and Drill Bit Kit
MRI Neuro Procedure Drape, with Marker Pen and Cover
SmartFrame MR Fiducial
Camera Fiberscope Accessory Kit
The provided text is a 510(k) summary for the ClearPoint System, focusing on software updates. It describes the device, its intended use, and comparative technological characteristics with a predicate device. The "Performance Data" section outlines the verification testing performed.
Here's an analysis of the provided information to answer your questions, with the caveat that detailed study methodologies are often abridged in 510(k) summaries:
1. A table of acceptance criteria and the reported device performance
The summary doesn't explicitly present a table of acceptance criteria for each test with numerical targets, but it states "Pass. The design has been verified to satisfy all acceptance criteria" and provides performance details within the results.
Here's a table attempting to construct this from the provided "Performance Data":
| Test | Implied Acceptance Criteria (Inferred from outcomes) | Reported Device Performance |
|---|---|---|
| Integrated System Test | Correct interoperation with scanner and disposable hardware kit; satisfactory accuracy for device placements (Likely predefined numerical accuracy target, although not explicitly stated). | Pass. The design has been verified to satisfy all acceptance criteria. All functional requirements necessitating interfacing with a live MR scanner were satisfied and validated using the software. Nine device placements were evaluated and had accuracy of 1.0 mm or less. |
| Regression Test | Output consistent with the previously released software version (predicate device) for underlying system components. | Pass. The design has been verified to satisfy all acceptance criteria. The following underlying system components still produce output that is consistent with the previously released software version: image display/visualization, image transfer, network communication verification, segmentation library output, scan plane parameter computations, hardware adjustment computations and low-level math utilities. |
| Verification Test | All functional areas within the software behave as described in the requirements. | Pass. The design has been verified to satisfy all acceptance criteria. All functional areas within the software behaved as described in the requirements. |
| Automated UI Test | Software functions correctly when simulating user input. | Pass. The design has been verified to satisfy all acceptance criteria. The ClearPoint 2.0 Software has passed the Automated UI test protocol. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Integrated System Test: "Nine device placements were evaluated."
- Regression Test: "This test used data from the predicate device..."
- Verification Test: "This test used data from the predicate device..."
- Automated UI Test: No specific sample size of "data" is mentioned, as it simulates user input to test functionality.
The data provenance is not specified regarding country of origin, nor is it explicitly stated whether the tests were retrospective or prospective, though "live scanner connection" and "data from the predicate device" suggest a mix of methodologies, likely a combination of new prospective testing for the integrated system and retrospective analysis of existing data for regression/verification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The 510(k) summary does not provide any information on the number or qualifications of experts used to establish ground truth for the test set. The tests described are primarily focused on software and system functionality (e.g., accuracy of device placement, consistency with previous versions), rather than clinical performance based on expert interpretation of medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The summary does not describe any adjudication methods. This type of detail is typically relevant for studies involving human interpretation or subjective assessments, which are not the primary focus of the engineering verification tests described here.
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 MRMC comparative effectiveness study involving human readers and AI assistance is mentioned or implied. The study focuses on the device's functional performance, not its impact on human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The "Integrated System Test" involves "interoperation with scanner and disposable hardware kit," and the "Regression" and "Verification" tests analyze software output. While not explicitly framed as "algorithm only" performance, these tests evaluate the software's functional output and accuracy without explicitly describing a human-in-the-loop scenario for primary performance evaluation. The "accuracy of 1.0 mm or less" in the Integrated System Test is a measure of the system's precision in device placement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the Integrated System Test, the "ground truth" for evaluating accuracy (1.0 mm or less) would likely be based on physical measurements of the actual device placement in reference to a target, possibly confirmed through imaging, but the exact method isn't detailed. It's an engineering ground truth related to physical-system accuracy.
For Regression and Verification Tests, the "ground truth" is the expected behavior and output based on the software's requirements and the previously released predicate device's performance.
8. The sample size for the training set
The 510(k) summary does not provide information on training set sample size. This is because the submission is for an updated version of a stereotactic guidance system software, which typically relies on established algorithms and engineering principles rather than a "trained" machine learning model in the sense of deep learning that requires large training datasets. The changes are described as modifications to visualization toolkits, DICOM handling, image fusion, and UI workflow.
9. How the ground truth for the training set was established
As there is no mention of a traditional "training set" in the context of machine learning, there is no information on how its ground truth was established. The "ground truth" for the software's development would be based on engineering specifications, medical imaging physics, and clinical requirements for stereotactic accuracy.
§ 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).