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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 and MR Conditional implants and devices. The user should consult the "Navigational Accuracy" section of the User's Guide to assess if the accuracy of the system is suitable for their needs.

The ClearPoint System is comprised of a workstation laptop with workstation software, the SMARTGrid™ MRI-Guided Planning Grid (previously cleared under K100836), the SMARTFrame™ MRI-Guided Trajectory Frame (K100836), the SMARTFrame™ Accessory Kit (K100836) and the SMARTFrame™ Thumbwheel Extension.

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 allow 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 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
   a. SMARTFrame (adjustable trajectory frame ("ATF") to guide and hold the neurosurgical tools, includes fiducials, Targeting Cannula, & titanium screws)
   b. Centering Device
   c. Dock
   d. Device Lock (2 different diameters)
   e. Screwdriver
3. Rescue Screws (Extra Titanium Screws)
4. 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)

Here's an analysis of the provided text regarding the ClearPoint System, focusing on the acceptance criteria and the study that proves the device meets those criteria:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Study Details Proving Device Meets Acceptance Criteria

The primary study mentioned to demonstrate device performance and suitability for new indications (explicitly including DBS lead placement) is a combination of:

• Literature and registry data for clinical use.
• Company's bench accuracy tests.

Here are the details extracted from the document:

2. Sample Size Used for the Test Set and Data Provenance:

• Clinical Data: Data from 1,259 procedures were available for accuracy placement. 828 of these procedures were specifically for DBS lead placement.
• Data Provenance: This was "literature and registry data," indicating retrospective collection from 35 institutions currently using the ClearPoint System. The country of origin is not explicitly stated but implies a multi-institutional, possibly international, or at least multi-state, context given the registry nature.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• This information is not explicitly stated for the clinical registry data. It's inferred that the "literature and registry data" would have involved physicians (likely neurosurgeons) performing the procedures and assessing outcomes, but the specific number and qualifications of experts for establishing ground truth on a per-case basis are not detailed.
• For the bench tests, no expert ground truth establishment is mentioned, as these are objective engineering measurements.

4. Adjudication Method for the Test Set:

• This information is not explicitly stated for the clinical registry data. Given it's registry data, it's unlikely a formal centralized adjudication method like 2+1 or 3+1 was used for each case's ground truth within the registry itself. The accuracy data likely came from post-operative imaging and physician assessment in individual clinical settings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, an MRMC comparative effectiveness study was not done. The document describes a study demonstrating device accuracy and clinical effectiveness based on existing use, not a comparison of human readers with and without AI assistance. The ClearPoint System is a stereotactic guidance system, not an AI-driven image interpretation tool for diagnostic purposes where MRMC studies are typical.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Yes, a form of standalone performance was done for the device's accuracy. The "company's bench accuracy tests" represent a standalone evaluation of the system's mechanical and software targeting capabilities, independent of real-time human interpretation or assistance during a procedure. The results (mean error, standard deviation, 99% confidence limits for linear and angular accuracy) are standalone measurements of the device's precision.

7. The Type of Ground Truth Used:

• Clinical Data: The ground truth for the clinical effectiveness (specifically placement accuracy) in the registry data would typically be derived from post-operative imaging analysis (e.g., MRI scans) to determine the actual final position of the placed instrument (e.g., DBS lead) relative to the planned target. This is effectively outcomes data related to the physical position of the device.
• Bench Tests: The ground truth for the bench accuracy tests would be metrological measurements against a precisely known reference target, using engineering methods to quantify linear and angular deviations.

8. The Sample Size for the Training Set:

• This information is not applicable/not provided in the context of this 510(k) summary. The ClearPoint System is a stereotactic guidance system. While its software (version 1.6.2) is mentioned, the document does not describe it as an AI/machine learning system that requires a "training set" in the conventional sense for image analysis or diagnostic prediction. The software likely relies on algorithms for trajectory planning, visualization, and guidance, which are developed and validated through engineering principles rather than data-driven machine learning training.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. As explained in point 8, the concept of a "training set" and associated "ground truth" for machine learning is not described or relevant to the information provided for the ClearPoint System. The device's software is based on established computational geometry and image processing principles for stereotactic guidance.

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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.

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 Trajectory Frame (ATF) 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 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 ClearPoint Workstation Software (for trajectory planning and monitoring) and a 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 SMARTGrid Pack (Marking Grid, Marking Tool), SMARTFrame Pack (SMARTFrame or SMARTFrame XG, Centering Tool, Wharen Centering Guide, Dock, Device Lock, Screwdriver, Roll Lock Screw and Washer), Rescue Screws, Hand Controller and Thumbwheel Extension, Accessory Pack (Peel-away Sheath, Stylet, Lancet, Depth Stop, Ruler), Scalp Mount Base, Guide Tube and Device Guide Packs (Guide Cannulas), SmartTip MRI Hand Drill and Drill Bit Kit, SmartTwist MRII Hand Drill and 4.5mm/6.0mm Drill Guide, MRI Neuro Procedure Drape, with Marker Pen and Cover, and SmartFrame MR Fiducial.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ClearPoint System, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify sample sizes for test sets (e.g., number of phantom targets, physical products tested) for the functionality tests. The studies described are bench and phantom testing. Data provenance is implied to be from laboratory testing rather than human clinical data. The document does not provide information on the country of origin or whether the data was retrospective or prospective, as it pertains to bench and phantom testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of experts to establish ground truth for the bench and phantom testing. The "ground truth" for these tests would likely be the known dimensions or positions in the phantom or bench setup.

4. Adjudication Method for the Test Set

The document does not describe any adjudication methods, as the tests performed are technical performance verification rather than clinical outcomes requiring expert review.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes bench and phantom testing for device modifications, not a comparative clinical study involving human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device described is a medical instrument system, not an AI algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" does not apply in the context of this 510(k) submission. The ClearPoint System requires a human operator for its intended use "to provide stereotactic guidance and operation of instruments or devices during the planning and operation of neurological procedures."

7. The Type of Ground Truth Used

For the performance data mentioned (Targeting Accuracy, functionality of new components):

• Targeting Accuracy: The ground truth would be the known, precise target location within the phantom used for testing, typically established through precise measurement tools or engineering specifications.
• Functionality of Wharen Centering Guide and Drill Guides: The ground truth would be the intended functional behavior and design specifications of these components as verified through engineering tests.

8. The Sample Size for the Training Set

The document does not mention any "training set" as it relates to machine learning or AI models. The ClearPoint System is a hardware/software system for surgical guidance, not an AI/ML device that requires training data in the typical sense.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a "training set" in the context of AI/ML, this question is not applicable to the provided document. The "training" for such a device would relate to the design and development processes for the hardware and software components, following engineering and quality system standards.

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