ClearPoint System

• K Number: K142505
• Device Name: ClearPoint System
• Manufacturer: MRI INTERVENTIONS, INC.
• Date Cleared: 2015-10-21 ( 411 days)
• Product Code: HAW , ORR
• Regulation Number: 882.4560
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: K111073

Intended Use

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.

Device Description

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 Traiectory Frame (ATF) that provides the quidance 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 following:

1. ClearPoint Workstation Software (for trajectory planning and monitoring)
2. 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 following:

1. SMARTGrid Pack (interacts with the software to determine the desired location of the burr hole)
   a. Marking Grid
   b. Marking Tool
2. SMARTFrame Pack (SMARTFrame or SMARTFrame XG)
   a. SMARTFrame ("ATF") with Base
   b. Centering Tool
   c. Dock
   d. Device Lock (2 different diameters)
   e. Screwdriver
   f. Roll Lock Screw and Washer
3. Rescue Screws (Extra Titanium Screws)
4. Hand Controller (for use with the ATF) and Thumbwheel Extension
5. Accessory Pack
   a. Peel-away Sheath
   b. Stylet
   c. Lancet
   d. Depth Stop
   e. Ruler
6. Scalp Mount Base
7. Guide Tube and Device Guide Packs (Guide Cannulas)
8. SmartTip MRI Hand Drill and Drill Bit Kit
9. MRI Neuro Procedure Drape, with Marker Pen and Cover
10. MR Camera Fiberscope Accessory Kit
11. SmartFrame MR Fiducial

AI/ML Overview

The ClearPoint System is intended to provide stereotactic guidance and operation of instruments or devices during planning and operation of neurological procedures within the MRI environment and in conjunction with MR imaging.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Targeting Accuracy	Less than 1.5 mm at ≤ 125 mm

2. Sample Size and Data Provenance:

• Test Set Sample Size: The document repeatedly mentions "a cadaver study" and "a water phantom" for accuracy testing. No specific number for the cadaver or water phantom samples is provided.
• Data Provenance: The studies appear to be conducted by the manufacturer, MRI Interventions, Inc., in a controlled testing environment, rather than being derived from patient data or clinical trials in specific countries. The testing methodology suggests a lab-based, pre-clinical assessment.

3. Number of Experts and Qualifications:

• The document does not mention the use of experts to establish ground truth for the test set. The validation seems to rely on physical measurements and technical verification rather than human interpretation or expert consensus.

4. Adjudication Method:

• No adjudication method is mentioned as the ground truth establishment for the test set does not involve human interpretation requiring adjudication.

5. MRMC Comparative Effectiveness Study:

• No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The device is a stereotactic guidance system, not an AI diagnostic or assistive tool that would typically be evaluated in an MRMC study comparing human readers with and without AI assistance.

6. Standalone Performance:

• The performance described is for the device itself (hardware and software working together to achieve targeting accuracy). However, the "standalone" context for AI usually refers to algorithm-only performance without human input. In this case, the ClearPoint System is the standalone device providing guidance. The accuracy testing detailed assesses the device's ability to achieve its intended targeting without human "correction" during the measurement of accuracy. The system's performance is independently verified, as the outcome (targeting accuracy) is a direct measure of the system's output.

7. Type of Ground Truth Used:

• The ground truth for the accuracy testing was established through physical measurements and phantom studies. Specifically, a water phantom and a cadaver study were used to measure the deviation of the device's guided trajectory from the intended target. This is a form of measurement ground truth.

8. Sample Size for the Training Set:

• The document describes a hardware and software system for stereotactic guidance. It does not explicitly mention a "training set" in the context of machine learning or AI model development. The software capabilities are described more as an integral part of the system's function (e.g., trajectory planning and monitoring) rather than a continuously learning AI. Therefore, a traditional "training set" as understood in AI validation is not applicable or explicitly mentioned.

9. How Ground Truth for Training Set Was Established:

• As a traditional "training set" is not explicitly mentioned or applicable to the device's description, the method for establishing its ground truth is not detailed. The software's development likely followed standard software engineering verification and validation processes against pre-defined specifications and requirements, rather than through a machine learning training paradigm.

Regulation Number and Section

§ 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).