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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.

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:

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

1. SMARTGrid MRI Planning Grid (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 Device and Wharen Centering Guide
   c. Dock
   d. Device Lock (2 different diameters)
   e. Screwdriver
   f. Roll Lock Screw and Washer
3. Rescue Screws (Extra Titanium Screws)
4. Thumbwheel Extension
5. Accessory Kit
   a. Peel-away Sheath
   b. Stylet
   c. Lancet
   d. Depth Stop
   e. Ruler
6. Scalp Mount Base
7. 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":

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.

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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.

Ask a specific question about this device

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. The System is intended for use only with 1.5 and 3.0 Tesla MRI scanners.

The hardware and software components of the SurgiVision ClearPoint System. The hardware and software components of the SurgiVision ClearPoint System 37 are identical to the predicate device. The sole purpose of this 510(k) application is to expand the indications for the ClearPoint System to 3.0 Tesla MRI scanners. The ClearPoint System 3T is intended to provide trajectory planning, guidance and fixation of neurosurgical tools during minimally invasive stereotactic surgical procedures in the brain conducted in the MR suite. The System itself provides no therapeutic or diagnostic functionality. The ClearPoint Stereotactic System is comprised of two separate device groups, a hardware and a software group. The software group is known as the ClearPoint Workstation. It includes the following: ClearPoint Workstation Software (for trajectory planning and . monitoring) Laptop Computer . The hardware device group under the ClearPoint Stereotactic System umbrella is known as the SmartFrame and Accessories.

Here's an analysis of the provided text regarding the SurgiVision ClearPoint System 3T, focusing on the acceptance criteria and the study proving it meets those criteria:

The K111073 submission for the ClearPoint System 3T is a 510(k) to expand the indications for use of the previously cleared ClearPoint System (K100836) to include 3.0 Tesla MRI scanners. Therefore, the primary "acceptance criterion" being evaluated is the device's performance and safety within the 3T MRI environment, specifically demonstrating it is substantially equivalent to the predicate device operating in a 1.5T environment.

Acceptance Criteria and Reported Device Performance

Details of the Study

1. Sample Size used for the test set and the data provenance:

   • The document does not specify a "sample size" in terms of number of patients or cases. The testing described is bench testing only.
   • Data Provenance: Not applicable in the context of patient data, as the tests were bench tests.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. The ground truth for bench testing is typically based on engineering specifications and metrology, not expert clinical consensus from patient data.

3. Adjudication method for the test set:

   • Not applicable, as this was bench testing against engineering standards, not a clinical study requiring adjudication of expert interpretations.

4. 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 or comparative effectiveness study was performed. The device, a neurological stereotaxic instrument, is a guidance system, not an AI-driven diagnostic or interpretative tool that would typically involve human readers or AI assistance in the way described.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • The "testing" described is inherently standalone in nature, as it's bench testing of the system alone for its physical and functional characteristics (force, torque, heating, accuracy, etc.) within the 3T MRI environment. While the system is used with a human in the loop during surgery, the specific tests mentioned here evaluate the device's technical performance.

6. The type of ground truth used:

   • Bench Test Ground Truth: Engineering specifications, physical measurements, and established safety standards for medical devices in an MRI environment (e.g., limits for heating, artifact generation, and system accuracy specifications from the predicate device).

7. The sample size for the training set:

   • Not applicable. This device is a sterotactic guidance system; there is no mention of a machine learning component requiring a "training set" of data.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set mentioned or implied for this device.

Ask a specific question about this device

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. The System is intended for use only with 1.5 Tesla MRI scanners.

The ClearPoint System is comprised of a workstation laptop with workstation software, the SMARTGrid™ MRI-Guided Planning Grid, the SMARTFrame™ MRI-Guided Trajectory Frame, the SMARTFrame Accessory Kit, the SMARTFrame Handcontroller, and the MR Neuro Procedure Drape. The MR Neuro Procedure Drape was cleared for market via a separate 510(k) notice (K091343).

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 allows for trajectory feedback when the physician views the MR 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.

Here's a breakdown of the acceptance criteria and study information for the ClearPoint System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Test Set Sample Size:
  • MRI Test Device Accuracy Testing: Not explicitly stated, but implies multiple tests were conducted with a "Test Device representative of the devices to be used."
  • System Accuracy Comparison in a Skull Phantom: Not explicitly stated, but involved the ClearPoint System and the predicate Navigus II MR/NeXframe MR.
  • System Accuracy Comparison in a Cadaver: One cadaver was used.
• Data Provenance: The studies were internal validation studies conducted by SurgiVision, Inc., using phantoms and a cadaver. No information is provided regarding country of origin or whether it was retrospective or prospective in the context of clinical patient data, as these were pre-clinical validation studies.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

The document does not explicitly state the number or qualifications of experts used to establish ground truth for the test set. The studies described are technical performance assessments against pre-defined targets (phantoms) or comparisons to a predicate device in a cadaver, rather than diagnostic assessments requiring expert interpretation.

4. Adjudication Method (Test Set)

The document does not describe a formal adjudication method for ground truth in the test set. For the phantom studies, the ground truth was presumably the known pre-determined target or the expected performance based on the predicate device. For the cadaver study, it involved comparing the ClearPoint System's performance against the predicate Navigus II MR, likely using objective measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The provided text refers to comparative effectiveness studies against a predicate device (Navigus II MR) and its performance, and user ratings on procedure-related assessments by a user, but not an MRMC study comparing human readers with and without AI assistance.

6. Standalone Performance (Algorithm Only)

Yes, a standalone performance assessment was conducted for the device's accuracy and functionality. The "ClearPoint System Accuracy Testing" and "System Accuracy Comparison in a Skull Phantom" sections describe tests of the system's ability to precisely position instruments and achieve targeting accuracy. These tests are focused on the device's inherent mechanical and software performance.

7. Type of Ground Truth Used

• For Accuracy Testing:
  • MRI Test Device Accuracy Testing: A "known pre-determined target in a phantom."
  • System Accuracy Comparison in a Skull Phantom: Comparison against data previously obtained for the predicate Navigus II MR/NeXframe MR using the same model system. The predicate device's performance would serve as a de-facto ground truth or benchmark, assuming its accuracy had been previously established.
  • System Accuracy Comparison in a Cadaver: Comparison against the predicate Navigus II MR/NeXframe MR's performance in accessing targets in a cadaver head.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for a "training set." The studies described are validation studies for the device's performance against established benchmarks or a predicate, not studies involving an AI or machine learning model that requires a dedicated training set.

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

Not applicable, as no training set for an AI or machine learning model is mentioned in the provided text. The device is a "Neurological Stereotaxic Instrument" with associated software, not explicitly an AI-driven diagnostic or treatment planning system that would typically have a training set.

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