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The ClearPoint Array System (Version 1.2) 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 in conjunction with MR imaging. The ClearPoint Array System (Version 1.2) 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 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. The ClearPoint Array Workstation includes the following:

1. ClearPoint Array Workstation Software (for trajectory planning and monitoring)
2. Laptop Computer
   The hardware components of the ClearPoint Array System are the SMARTFrame Array and accessories, and are listed below. They are all single use devices provided sterile. Beyond the changes described above, there have been no modifications to the hardware compared to the last cleared version of the device (K214040).
3. SMARTFrame Array Pack
   a. SMARTFrame Array (adjustable trajectory frame to guide and hold the neurosurgical tools, includes Probe Adapter, Tracker Rod)
   b. SMARTFrame Array Scalp Mount Base (includes fiducials, titanium screws, and titanium standoff pins)
   c. Entry Point Locator
   d. Targeting Stem
   e. Centering Device
   f. Dock
   g. Device Lock (2 different diameters)
   h. Screwdriver
   i. 2.1-mm Guide Tube
   j. 4.5 Center Drill Guide
   k. 4.5 Offset Drill Guide
   l. 3.4-mm Drill Reducer Tube
   m. Center Insertion Guide
   n. Offset Insertion Guide
4. SmartFrame Array Thumb Wheel Extension Set for the trajectory frame.
5. SmartFrame Array Guide Tube Kit
   a. 1.7-mm Guide Tube
   b. 0.5-mm Guide Tube and Device Lock
   c. 3.1-mm Guide Tube and Device Lock
   d. SmartFrame Array Guide Tubes (sold separately)
   e. 7.9mm Center and Offset Device Guides
   f. 5.4mm Center and Offset Device Guides
   Common Components to the ClearPoint System are listed below. These components have not been modified since their clearance (K214040, K200097, K100836, K091343).
6. SMARTGrid Pack (interacts with the Software to determine the desired location of the burr hole) (K100836)
   a. Marking Grid
   b. Marking Tool
7. Accessory Pack (K200097)
   a. Peel away sheath
   b. Stylet
   c. Depth Stop
   d. Ruler
8. MRI Neuro Procedure Drape (K091343)

The provided text describes the ClearPoint Array System (Version 1.2) and its non-clinical testing for substantial equivalence to a predicate device. It primarily focuses on software modifications and accuracy specifications.

Here's an analysis of the acceptance criteria and study proving the device meets them, based only on the provided text:

Key Takeaway: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical testing. It does not describe a clinical study comparing human reader performance with and without AI, or a standalone AI performance study. The "device meets acceptance criteria" refers to the non-clinical performance benchmarks.

1. A table of acceptance criteria and the reported device performance

The document presents performance validation data as part of the non-clinical testing, which serves as the acceptance criteria for the accuracy of the system.

Note on Acceptance Criteria: The document states, "The results of all testing met the acceptance criteria and demonstrated that the modified ClearPoint Array Software complies with all design specifications and performs as expected." However, the specific numerical acceptance criteria thresholds (e.g., "positional error must be less than X mm") are not explicitly listed in a separate column from the reported performance. Instead, the reported performance (especially the 99% CI) is the validation against which the "acceptance criteria" were met. The implication is that these measured values fell within the pre-defined acceptable limits for each parameter.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: The document mentions "Accuracy testing was performed," but does not specify the sample size (e.g., number of measurements, number of trajectories, or number of cases) used for this testing.
• Data Provenance: Not specified. Given it's non-clinical testing for a medical device 510(k), it's typically laboratory-based simulation/phantom data, not patient data from a specific country or collected retrospectively/prospectively.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This was non-clinical accuracy testing of a stereotaxic guidance system, not a study involving human interpretation of medical images or expert adjudication of clinical outcomes. The "ground truth" for positional and angular accuracy would have been established by engineering measurements against known physical references.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable. This was non-clinical accuracy testing, not a study requiring human adjudication of results.

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, an MRMC comparative effectiveness study was not conducted or described. The document focuses on the mechanical/software accuracy of the stereotactic guidance system, not on AI assistance for human image readers. The "AI" concept as typically understood in medical image analysis (e.g., for detection or diagnosis) is not relevant to this device's described function as a stereotaxic instrument.

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

• A form of "standalone" testing was done, but it's for the software components of a stereotaxic guidance system, not a diagnostic AI algorithm. The document states:
  • "ClearPoint Neuro performed extensive Non-Clinical Verification Testing to evaluate the safety and performance of the software components of ClearPoint Array System (Version 1.2)."
  • Specific tests included: "Automated Verification," "Integrated System Verification," "Localization Verification," and "Regression Test Verification."
  • "Accuracy testing was performed to confirm that modifications included in ClearPoint Array 1.2 did not cause any unexpected changes in the accuracy specifications of the software, with successful results."
  • This "accuracy testing" (Table 5-1) represents the "algorithm only" performance for positional and angular accuracy of the guidance system's calculations.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The ground truth for the non-clinical accuracy testing would have been physical measurements or known engineering specifications from a controlled test environment (e.g., phantom studies with precisely known target locations and trajectories). It would not be expert consensus, pathology, or outcomes data, as this is a device for guidance during neurological procedures, not for diagnosis.

8. The sample size for the training set

• Not applicable. The document describes non-clinical verification testing of a stereotaxic guidance system's software and hardware, not a machine learning model that requires a "training set."

9. How the ground truth for the training set was established

• Not applicable. As no training set was described, there's no ground truth establishment for it.

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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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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.

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