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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 an operating room environment and in conjunction with MR and/or CT imaging. During planning, the system is intended to provide functionality for the automatic identification, labeling, visualization of segmentable brain structures from a set of loaded MR images. 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) (asleep or awake) lead placement. When used in an MRI environment, the system is intended for use only with 1.5 and 3.0 Tesla MRI scanners and MR Conditional implants and devices.

The updated ClearPoint Software Version 3.0 introduces modifications to support a new clinical workflow using intraoperative CT imaging when compared to the previous ClearPoint Software Version 2.2 (K233243). The ClearPoint System described in this submission is essentially identical from a technological standpoint to the cleared predicate device described in K233243 (ClearPoint System version 2.2). As mentioned above, since the prior clearance, the company has implemented software features to enable usage of the ClearPoint System during CT-guided procedures, in addition to MR-guided procedures supported in the predicate device. The hardware components are unchanged from the device described in K233243 and minor changes were made to the indications for use.

The ClearPoint System is comprised of a workstation laptop with software, the SMARTGrid Planning Grid, the SMARTFrame 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 trajectory planning software. The SMARTFrame is an Adjustable Trajectory Frame (ATF) that provides the guidance and fixation for neurosurgical tools. The image-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 intraoperatively acquired images, makes changes and confirms with subsequent image acquisitions. Optionally, the ClearPoint System can be used with any head fixation frame to immobilize the patient's head with respect to the scanner table. ClearPoint Neuro also supplies an optional head fixation frame 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 current ClearPoint System are the SMARTFrame and Accessories. They are all single use devices that are provided sterile and include the SMARTGrid Planning Grid (Marking Grid, Marking Tool), SMARTFrame Pack (SMARTFrame or SMARTFrame XG, Centering Device and Wharen Centering Guide, Dock, Device Lock, Screwdriver, Roll Lock Screw and Washer), Rescue Screws (Extra Titanium Screws), Thumbwheel Extension, Accessory Kit (Peel-away Sheath, Stylet, Lancet, Depth Stop, Ruler), Scalp Mount Base, and Guide Tubes and Device Guide Packs (Guide Cannulas). In addition, the ClearPoint System is used with the 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, and SmartFrame Fiducial.

The provided document (K243657) is a 510(k) Premarket Notification for the ClearPoint System (Software Version 3.0), which is a stereotaxic instrument. The document primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the non-clinical testing performed.

Based on the provided text, here's a description of the acceptance criteria and the study that proves the device meets the acceptance criteria, addressing each point as much as possible:

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

The document provides accuracy specifications in tables:

Table 1: ClearPoint System Accuracy Specifications - MRI Guidance (Unchanged from predicate)

Note: The table layout in the original document for MRI accuracy is a bit unusual with duplicated rows for positional error, and it's not explicitly labelled as "acceptance criteria." However, it presents the validated performance.

Table 2: ClearPoint System Accuracy Specifications - CT Guidance (New for v3.0)

Explicit Acceptance Criteria (from "Targeting Accuracy" row in Table 3 comparison):

• Targeting Accuracy: ± 1.5 mm @ ≤125mm (This appears to be the primary specified acceptance criterion for overall targeting accuracy, presumably applying across both MRI and CT guidance given its placement in the general comparison table).

Reported Device Performance:

• MRI Guidance: Positional Error (99% CI) 0.44 mm, 0.60 mm, 0.10 mm. Angular Error (99% CI) 0.46°. These values are well within the ± 1.5 mm overall targeting accuracy.
• CT Guidance: Positional Error (99% CI Upper Bound) 0.93 mm. Trajectory Angle Error (99% CI Upper Bound) 0.37°. These values are also well within the ± 1.5 mm overall targeting accuracy.

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

The document states:

• "Accuracy testing was performed using an MRI scanner to confirm that modifications included in the ClearPoint System 3.0 did not cause any unexpected changes in the accuracy specifications of the software, with successful results."
• "Additionally, accuracy testing was performed in a CT scanner to validate the CT-guided clinical workflow that is new to the ClearPoint 3.0 software and establish new ground-truth accuracy specifications."

However, the document does not specify the sample size for either the MRI or CT accuracy test sets.
The data provenance is also not specified regarding country of origin or whether it was retrospective or prospective. Given the nature of accuracy testing for a stereotaxic device, these are typically phantom-based, prospective tests conducted in a controlled lab or clinical environment, rather than patient data studies.

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)

The document does not mention human experts for establishing ground truth for the accuracy tests. The accuracy testing described appears to be technical validation against a known physical ground truth (e.g., phantom measurements), as is common for stereotaxic instrument validation. Therefore, expert consensus on images is not relevant for this type of accuracy assessment.

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

Not applicable, as the accuracy testing described is a technical validation against a physical ground truth, not a study evaluating human interpretation or a scenario requiring adjudication.

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

The document does not mention any MRMC comparative effectiveness study or any evaluation of human readers (even though the device has "automatic identification, labeling, visualization" of structures). The testing detailed is primarily focused on the system's technical accuracy in guidance, not on AI assistance for human image interpretation.

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

Yes, the accuracy testing described in Section 6, "Non-Clinical Testing," and detailed in Tables 1 and 2, represents standalone (algorithm only) performance testing against a technical ground truth. It evaluates the system's precision and accuracy in positional and angular measurements.

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

The ground truth used for the accuracy tests appears to be physical measurements from a phantom or test setup, given the context of "Positional Error" and "Angular Error" in millimeters and degrees. The document refers to "establish new ground-truth accuracy specifications" in relation to the CT testing, implying a precise, measurable standard. This is typical for the technical validation of stereotaxic guidance systems.

8. The sample size for the training set

The document does not specify a sample size for a "training set." The ClearPoint System 3.0 software introduces features like "automatic identification, labeling, visualization, and quantification of segmentable brain structures" and "Algorithms to automatically locate and identify marking grid, targeting frame components, cannula, and device tip from both MR and CT image sets." While these imply the use of machine learning or advanced algorithms that would require training data, the submission focuses on the validation of these features' accuracy, not on the details of their development (including training data specifics).

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

Since the document does not discuss a training set, there is no information provided on how its ground truth was established. For the algorithms processing anatomical structures or hardware components, the ground truth for training data would typically involve manually annotated medical images by qualified personnel (e.g., radiologists, neurosurgeons, or trained annotators under expert supervision).

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. During planning, the system is intended to provide functionality for the automatic identification, labeling, visualization and quantification of segmentable brain structures from a set of loaded MR images. The ClearPoint System is intended as an integral part of procedures that have traditionally used stereotactic methodology. These procedures include biopsies, catheter and electrode 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 updated ClearPoint Software Version 2.2 integrates the ClearPoint Neuro Maestro Brain Model software (K213645) into the previous ClearPoint Software Version 2.1 (K222519). The ClearPoint Maestro™ Brain Model product is a stand-alone software application for automatic labeling, visualization, and quantification of segmentable brain structures from a set of MRI images and has been incorporated into the ClearPoint System software. The ClearPoint System described in this submission is essentially identical from a technological standpoint to the cleared predicate device described in K222519 (ClearPoint System). As mentioned above, since the prior clearance, the company has integrated the Maestro Brain Model into the software of the predicate device. Specifically, the company has released an updated version of software 2.1, which was part of the last clearance, and has now been upgraded to software 2.2.

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 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 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) (supplied by scanner manufacturers) that meet the physician's desired imaging quality. ClearPoint Neuro 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 and 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

Each of the above packs is sold separately and is intended to be used with the ClearPoint Workstation. Each of the components has been described in detail in previous submissions. The ClearPoint System described in this 510(k) is a modification to the company's cleared ClearPoint System (K222519).

The provide document primarily focuses on the substantial equivalence of the ClearPoint System (Software Version 2.2) to its predicate device (ClearPoint System Software Version 2.1) and the integration of functionalities from another cleared device (ClearPoint Maestro Brain Model K213645). While it mentions "Accuracy testing" and "acceptance criteria," the level of detail provided is insufficient to fully answer all aspects of your request, particularly regarding specific performance metrics for the integrated Maestro Brain Model functionalities, the study design for establishing ground truth, or details of multi-reader studies.

However, based on the information provided, here's what can be extracted and inferred:

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

The document mentions "Accuracy testing was performed to confirm that modifications included in ClearPoint System 2.2 did not cause any unexpected changes in the accuracy specifications of the software, with successful results." The Table 2, "ClearPoint System Accuracy Specifications," appears to represent the device's demonstrated performance against an underlying (but unstated) acceptance criterion for accuracy.

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

The document does not explicitly state the sample size used for "Accuracy testing" or for the validation of the Maestro Brain Model functionalities. It broadly states "ClearPoint Neuro performed extensive Non-Clinical Verification Testing." No information on data provenance (country of origin, retrospective/prospective) is provided.

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

The document does not provide details on the number or qualifications of experts used to establish ground truth for the test set. It mentions "Workflow for verifying the brain structure segmentation results" for the Maestro Brain Model functionality, which implies a human review process, but no specifics are given.

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

The document does not specify any adjudication method used for the test set.

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

The document does not mention any multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on the integration of an existing cleared software and ensuring the overall system's accuracy specifications are maintained. The AI component (automatic segmentation of brain structures) is integrated, but its comparative effectiveness with human readers is not detailed.

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

Yes, a standalone validation of the "Maestro Brain Model" functionality was likely already done as part of its original 510(k) clearance (K213645). The current submission states, "The inclusion of the Maestro Brain Model functionalities incorporates the functions of a standalone software product that has previously been subject of a cleared 510(k), (K213645)."

While the specific standalone performance metrics for K213645 are not reproduced in this document, the fact that it was a "stand-alone software application for automatic labeling, visualization, and quantification of segmentable brain structures" implies that its performance as an algorithm-only component was evaluated during its initial clearance.

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

The document does not explicitly state the type of ground truth used. For "Accuracy testing" related to positional and angular error, it typically involves phantom studies or precisely measured landmarks. For the brain structure segmentation, the "Maestro Brain Model" clearance (K213645) would have established its own ground truth, likely involving expert-drawn segmentations or anatomical atlases. The current submission only refers to the pre-existing clearance.

8. The sample size for the training set

The document does not provide any information regarding the sample size for the training set for any of the software's components, including the Maestro Brain Model.

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

The document does not provide any information on how the ground truth for the training set was established. This information would typically be part of the original 510(k) submission for the Maestro Brain Model (K213645), which is referenced as a predicate, but not detailed here.

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 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 System is comprised of a workstation laptop with software, the SMARTGrid™ MRI Guided Planning Grid, the SMARTFrame™ MRI-Guided Traiectory 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 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 frame allows for trajectory feedback when the physician views the MRI images, makes changes and confirms with subsequent MR images. The modified ClearPoint Software is used to provide stereotactic quidance for the insertion of one or more devices into the brain within a magnetic resonance imaging (MRI) environment, using hardware provided by ClearPoint Neuro, Incorporated. The software will guide the end user through a set of discrete workflow steps for identifying localization hardware mounted onto the patient, planning one or more trajectory paths into the brain, quiding the alignment of one or more stereotactic frames along each of the planned trajectories, and monitoring the insertion of one of more devices into the brain. The software also supports workflow for creating pre-operative plans prior to carrying out the intraoperative procedure. The software will be installed on a physical laptop computer situated inside the MRI Suite during the intra-operative procedure. There, it will be used in conjunction with a MRI scanner, the SMARTFrame adjustable trajectory frame (ATF), and associated disposable hardware kits provided by ClearPoint Neuro to guide the user through the insertion of one or more devices into the brain. Throughout the procedure, in instances where specific scans are required, the software application will prescribe scan plane parameters detailing the position and angulation of a desired image acquisition necessary to proceed with the workflow. In these cases, users are required to enter the parameters prescribed by the software manually on the MRI scanner console to carry out the appropriate image acquisition. 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. ClearPoint Neuro also supplies an optional head fixation frame that can be used with the ClearPoint System.

The provided document describes a 510(k) premarket notification for a software update (version 2.1) to the ClearPoint System. The primary focus of the submission is to demonstrate that the updated software is substantially equivalent to the predicate device (ClearPoint System with software 2.0).

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

Key Finding: The document explicitly states that the hardware and Indications for Use are unchanged from the predicate device. The updates are limited to the software of the ClearPoint System. Therefore, the "study" described focuses on software verification and validation, primarily demonstrating that the new software does not degrade performance or introduce new risks compared to the previous version, rather than establishing direct clinical effectiveness or an acceptance criteria for a new device.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this submission is for a software update to an already cleared device, the acceptance criteria are framed in terms of ensuring the continued performance and safety of the device, rather than establishing initial performance benchmarks against a specific clinical threshold. The core acceptance criterion for this 510(k) is substantial equivalence to the predicate device.

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

• Sample Size for Test Set: The document describes "test cases" and "data inputs" used for various software tests, but does not provide a specific number of cases or patients/procedures used in these tests. It refers to "previously acquired test image data" for manual verification tests.
• Data Provenance: Not explicitly stated, but the mention of "previously acquired test image data" suggests the use of existing, likely retrospective, data for some manual testing. No specific country of origin is mentioned. The integrated system testing involved "reproducing clinical usage" with an MRI scanner, implying simulated or real-world data akin to clinical scenarios.

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

• Number of Experts: Not applicable in the traditional sense of clinical experts establishing ground truth for a diagnostic AI. The document describes "two different testers" for manual verification tests.
• Qualifications of Experts: The qualifications of these "testers" are not specified beyond their role in executing tests. Given the nature of a software update, these would likely be software quality assurance or engineering personnel rather than medical professionals.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly described as an adjudication method for ground truth, as the testing focuses on software functionality rather than clinical interpretation. For "manual verification bench tests," it states "Tests were executed independently by two different testers using the same build of software." This implies a form of independent verification but not a concensus-based adjudication of a medical "ground truth."

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

• MRMC Study: No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not performed. This submission is for a software update to a stereotaxic guidance system, not a diagnostic AI intended to assist human readers in interpreting medical images. Therefore, a study to measure human reader improvement with AI assistance is not relevant to this type of device and submission.

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

• Standalone Performance: The testing described focuses on the software's functional correctness and its ability to maintain the system's "defined accuracy specifications" when integrated with hardware and MRI scanners.
  • Automated Tests: These "exercise all the underlying segmentation algorithms in isolation outside the application against a range of data inputs" and "exercise low-level math and other libraries in isolation." This broadly represents a form of standalone performance testing for specific algorithmic components. However, this is not a measurement of diagnostic accuracy but rather functional validation.
  • The "Targeting Accuracy" of the system is stated as "±1.5mm @ ≤125mm," which is a performance specification for the entire system, not just the software in isolation. The integrated system tests verify that the software contributes to maintaining this accuracy.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the software verification and validation, the "ground truth" is implied by the expected output of the software (e.g., consistency with predicate software, known expected results for algorithms, or adherence to the system's accuracy specifications). It is not based on expert consensus, pathology, or outcomes data in a clinical sense. It's a technical "ground truth" derived from software requirements and direct comparison to the previous, cleared software version.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable/Not provided. This document describes a software update for a medical device that provides stereotactic guidance. It is not an AI/ML device that requires a "training set" in the context of machine learning model development. The software updates are described as "updates" and "upgraded," implying feature changes or bug fixes rather than re-training of a learned model.

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

• Ground Truth for Training Set: Not applicable. As stated above, this is a software update for a medical device, not an AI/ML application that involves a training set and associated ground truth establishment for model learning.

Ask a specific question about this device

The ClearPoint System is intended to provide stereotactic quidance 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 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) (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. Thumbwheel Extension
4. Accessory Kit
   a. Peel-away Sheath (2)
   b. Stylet
   c. Lancet
   d. Depth Stop (2)
   e. Ruler
5. Scalp Mount Base
6. Guide Tubes and Device Guide Packs (Guide Cannulas).

MRI Interventions Devices that can also be used with ClearPoint

1. SmartTip Drill Bit Kit
2. MRI Hand Drill
3. SmartFrame MR Fiducial
4. MRI Neuro Procedure Drape
5. Camera Fiberscope Accessory Kit
6. ClearPoint Pursuit

The provided text describes a 510(k) premarket notification for a medical device called the "ClearPoint System." This submission is a modification to a previously cleared predicate device (K181195). The document does not contain information about an AI/ML-driven device or a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. Instead, it focuses on physical and performance testing of hardware modifications.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" related to AI/ML performance, human reader improvement, and ground truth establishment for AI training/test sets are not applicable to this document.

However, I can extract information related to the performance data and the general nature of the testing described.

Here's the information based on the provided document:

Acceptance Criteria and Reported Device Performance

The document states: "Design Verification was performed relative to these specifications [Design inputs provided the requirements for the respective product specifications] with acceptable results. These tests included verification of physical, performance, and safety requirements, as well as benchtop accuracy testing."

While explicit numerical acceptance criteria values are not provided in tabular form, the general acceptance criteria can be inferred as meeting the requirements of the design specifications, ensuring physical, performance, and safety requirements, and demonstrating acceptable benchtop accuracy.

Study Information (Based on provided text)

• Sample size used for the test set and the data provenance: Not explicitly stated as a "test set" in the context of an AI/ML study. The studies conducted are described as "Design Verification" tests, "physical, performance, and safety requirements" tests, and "benchtop accuracy testing." The "samples" would refer to the modified device components themselves. No information on data provenance (country of origin, retrospective/prospective) is provided, as it's not a clinical data study.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI/ML study requiring expert ground truth for clinical image interpretation. The "ground truth" for the device's performance would be engineering specifications and measurements.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This refers to consensus among human readers for AI/ML studies, which is not described.
• 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 study was not done or described. This document pertains to hardware modifications, not AI assistance for human readers.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm-only performance assessment described, as this is a physical device undergoing modifications.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this engineering verification study would be the established design specifications, physical measurements, and functional requirements. It is not clinical ground truth like pathology or outcomes data.
• The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no training set.
• How the ground truth for the training set was established: Not applicable. As there is no training set for an AI/ML device described.

In summary: The document is a 510(k) summary for hardware modifications to a stereotactic guidance system. The "study" refers to design verification, performance, safety, and benchtop accuracy testing of these hardware components against engineering specifications. It does not involve AI/ML components, clinical data collection for algorithm training/testing, or human reader studies.

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, 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.

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, 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 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.

Ask a specific question about this device

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 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

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:

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.

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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