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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.

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The Arcus Head Fixation Frame is intended for use as a device to clamp and hold the patient's head in a particular position for procedures requiring Magnetic Resonance Imaging (MRI) of the brain structure and targets.

The Arcus Head Fixation Frame is a re-usable, non-sterile device designed to clamp and hold the patient's head in a particular position for procedures requiring Magnetic Resonance Imaging (MRI) of the brain structure and targets. It consists of a Ring that secures the patient's skull with skull pins, a Base that secures the Ring, and Posts that hold Fixation Screws. The device is secured to the scanner table. It is designed for use with specific Siemens MRI Scanners. The device is MR Conditional and contains brass inserts and titanium pin tips.

This document describes a 510(k) premarket notification for the Arcus Head Fixation Frame. It does not contain information about the acceptance criteria and study designs that are typically associated with artificial intelligence/machine learning (AI/ML) powered medical devices. The device described in this document is a physical medical device (neurosurgical head holder/skull clamp), not an AI/ML algorithm.

Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI/ML device based on this text.

However, I can extract the relevant performance data and comparisons for the physical device as presented in the document:

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

The document does not explicitly present "acceptance criteria" in a tabular format as would be seen for an AI/ML device's performance metrics (e.g., sensitivity, specificity thresholds). Instead, it states that "Testing confirmed the Arcus HFF met the Product Specification Requirements." The performance data is primarily focused on demonstrating equivalence to a predicate device and confirming basic functionalities and safety for an MRI environment.

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

This information is not applicable and therefore not provided in the document, as it pertains to a physical device evaluation through bench testing, not an AI/ML algorithm trained and tested on data.

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)

This information is not applicable as this is a physical device submission without data-driven ground truth. The "ground truth" for this device would be its physical properties and performance under specific test conditions, established through engineering and safety standards.

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

This information is not applicable as it is a physical device evaluation, not a clinical study involving reader performance or expert 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

This information is not applicable as the device is a physical head fixation frame, not an AI-powered diagnostic or assistive tool.

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

This information is not applicable as the device is a physical head fixation frame, not a standalone AI algorithm.

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

For this physical device, the "ground truth" is established through:

• Engineering specifications and design: The device is designed to meet certain physical and mechanical criteria.
• Regulatory standards: Adherence to recognized consensus standards like ISO 10993-1, ASTM F2052, and ASTM F2119-07, which define acceptable physical and biological performance.
• Bench testing: Direct experimental verification of physical properties (e.g., securing head, MR safety properties).
• Predicate device comparison: The performance and safety of the device are judged largely against the established performance and safety of a legally marketed predicate device.

8. The sample size for the training set

This information is not applicable as the device is a physical head fixation frame, not an AI/ML algorithm that undergoes training.

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

This information is not applicable for the same reason as above.

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The V-TAG is intended to assist with stereotactic guidance, placement, and fixation for the operation of surgical instruments or devices during the planning and operation of neurological procedures performed in conjunction with preoperative and perioperative MR imaging. These procedures include laser coagulation, biopsies, catheter placement and electrode placement procedures.

The V-TAG™ device is a single-use, skull-mounted, rigid trajectory array guide used in stereotactic surgical procedures. The V-TAG can be manipulated to provide a wide range of surgical trajectories into the head. An image-quided neuronavigational system loaded with a stereotactic surgical plan is used to align the V-TAG to the planned trajectory; once aligned, the V-TAG is securely locked to provide a stable instrument guide. After positioning of the V-TAG, magnetic resonance imaging (MRI) is used to confirm alignment with the planned trajectory. Adjustment of the V-TAG may be performed in the MRI scanner to refine or change the trajectory based on updated intraoperative imaging. Intracranial placement of a neurosurgical device or surgical instrument using the V-TAG device is only to be performed after MRI confirmation of the trajectory.

The provided text describes a 510(k) premarket notification for the V-TAG (Voyager Trajectory Array Guide) device, a modification to a previously cleared predicate device (K180854). The core purpose of this submission is to modify the instructions for use to allow for trajectory adjustments in the MRI scanner based on intraoperative imaging.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document states, "For each trial, the beginning alignment was intentionally set to an error greater than 10mm." It does not explicitly state the total number of "trials" or "placements" conducted. It implies multiple trials but lacks a specific numerical count for the test set.
• Data Provenance: Not specified. The document does not mention the country of origin of the data or whether it was retrospective or prospective. Given the context of a 510(k) summary for a medical device, it is highly likely to be prospective testing specifically for this submission.

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

• This information is not provided in the document. The testing described appears to be a technical accuracy assessment (measuring alignment deviations) rather than an expert-adjudicated clinical outcome study.

4. Adjudication Method for the Test Set:

• This information is not provided and is not applicable in the context of the described technical accuracy testing. There's no indication of human expert adjudication for the "ground truth" errors, as the errors were likely directly measured against the planned trajectory.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• An MRMC comparative effectiveness study was not conducted. This device is a surgical guidance tool, not an AI-assisted diagnostic or interpretation system that would typically warrant such a study. The study focuses on the device's physical accuracy in guiding instruments.

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

• This question is not directly applicable as the V-TAG is a physical surgical guidance device, not primarily an algorithm or software that operates in a "standalone" fashion. While it works in conjunction with an image-guided neuronavigational system, the performance evaluation here is on the V-TAG's physical accuracy when manipulated by a human in a simulated or real surgical setting, confirmed by imaging. The "algorithm only" concept usually applies to diagnostic interpretations or automated decision-making.

7. The Type of Ground Truth Used:

• The ground truth for the accuracy testing appears to be the pre-planned trajectory of the center lumen to the target. The "projected errors were then calculated," implying a measurement of deviation from this intended target.

8. The Sample Size for the Training Set:

• This information is not applicable as the described study is a performance validation of a physical device's mechanical accuracy, not a machine learning model that requires a training set.

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

• This information is not applicable as there is no training set mentioned or implied for this type of device validation.

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The MR Compatible Aspiration System is used for controlled aspiration of blood, cystic components of tumors, abscess, colloid cysts, and cerebrospinal fluid using a manual syringe during surgery of the Ventricle System or Cerebrum.

The MCA Kit is an accessory to the cleared ClearPoint System (K171257). The MCA Kit consists of a MCA device guide, guide sheath, stylet, depth stops, cannula (with attached tube) and adapter. The MCA Kit is designed to aid a physician in the removal of specific tissue or fluid types from the brain during image guided surgery. It is MR safe, as all materials are non-metallic. The MCA Kit is comprised of single use only, sterile-packaged disposable components that are packaged together.

The provided document describes the MRI Interventions, Inc.'s MR Compatible Aspiration Kit (MCA Kit) and the studies performed to demonstrate its substantial equivalence to a predicate device, the Penumbra Apollo System (K152699).

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document sometimes indirectly states the "acceptance criteria" by describing what the results demonstrated/met. For the "Flow and Leak Testing" and "MCA-Kit Device–SmartFrame XG Compatibility," the specific numerical acceptance criteria were not explicitly detailed in the provided text, but the document states they were met.

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

• Accuracy Testing: The specific numerical sample size (number of placements) for the accuracy test is not explicitly stated. It mentions that "Placements were performed using the 12 Fr x 30 cm and 16 Fr x 30 cm MCA Kits," representing the smallest and largest outer diameter sizes. However, the total number of repetitions or distinct placements is not given.
• MCA-Kit Device Guide – SmartFrame XG Compatibility: Not specified.
• Flow and Leak Testing: Not specified.
• Aspiration Test: "Twelve Fr. and 16 Fr. Cannulas that have undergone worst-case conditioning were used for this test." The exact number of cannulas tested is not specified beyond indicating both sizes were used.

Data Provenance: This was a bench testing study, not involving human subjects. Therefore, data provenance in terms of country of origin or retrospective/prospective is not applicable in the typical clinical sense. The data was generated through controlled laboratory experiments.

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

Not applicable. This device is a mechanical instrument (aspiration kit). The ground truth for its performance (e.g., accuracy, flow, leak, aspiration capacity) was established via engineering measurements and predefined physical/mechanical standards, not by expert medical interpretations.

4. Adjudication Method for the Test Set

Not applicable. As this was bench testing based on physical measurements and predefined criteria, there was no need for expert adjudication of results.

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

No, an MRMC comparative effectiveness study was not done. This device is an aspiration kit, not an imaging or diagnostic device that relies on human reader interpretation. The effectiveness studies focused on the physical performance of the device.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Yes, the studies described are standalone performance tests of the device itself (e.g., accuracy, flow, aspiration), without human interaction as part of the measured performance metric, although human operators would have performed the tests. The device does not involve an algorithm.

7. Type of Ground Truth Used

The ground truth used was based on:

• Predefined engineering specifications and limits (e.g., 2mm and 2° accuracy limits for stereotaxic devices).
• Quantitative physical measurements (e.g., mean error in mm, angular error in degrees, aspiration pressure in inHg, change in inner diameter in percentage).
• Qualitative observations of physical integrity (e.g., "without leaking or collapsing," "remains undamaged").

8. Sample Size for the Training Set

Not applicable. This device does not involve machine learning or artificial intelligence, so there is no training set in the typical sense.

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

Not applicable, as there is no training set.

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The ClearPoint System is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures within the MRI environment and in conjunction with MR imaging. The ClearPoint System is intended as an integral part of procedures that have traditionally used stereotactic methodology. These procedures include biopsies, catheter and electrode insertion, including deep brain stimulation (DBS) lead placement. The System is intended for use only with 1.5 and 3.0 Tesla MRI scanners.

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

The SMARTGrid and associated Marking Tool are designed to assist the physician to precisely position the entry hole as called out in the traiectory planning software. The SMARTFrame is an Adjustable Trajectory Frame (ATF) that provides the quidance and fixation for neurosurqical tools. The MRI visible fluids of the Targeting Cannula along with the fiducial markers in the base of the frame allows for trajectory feedback when the physician views the MRI images, makes changes and confirms with subsequent MR images.

The ClearPoint System can be used with any MRI-compatible head fixation frame to immobilize the patient's head with respect to the scanner table, as well as with any imaging coil(s) (supplied by scanner manufacturers) that meet the physician's desired imaging quality. MRI Interventions also supplies an optional head fixation frame that can be used with the ClearPoint System.

The ClearPoint Workstation includes the following:

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

The hardware components of the current ClearPoint System are the SMARTFrame and Accessories. They are all single use devices that are provided sterile. They include the following:

1. SMARTGrid MRI Planning Grid (interacts with the software to determine the desired location of the burr hole)
   a. Marking Grid
   b. Marking Tool
2. SMARTFrame Pack (SMARTFrame or SMARTFrame XG)
   a. SMARTFrame ("ATF") with Base
   b. Centering Device and Wharen Centering Guide
   c. Dock
   d. Device Lock (2 different diameters)
   e. Screwdriver
   f. Roll Lock Screw and Washer
3. Rescue Screws (Extra Titanium Screws)
4. Thumbwheel Extension
5. Accessory Kit
   a. Peel-away Sheath
   b. Stylet
   c. Lancet
   d. Depth Stop
   e. Ruler
6. Scalp Mount Base
7. Guide Tubes and Device Guide Packs (Guide Cannulas)

In addition, the ClearPoint System is used with the following separately cleared or Class I, 510(k)exempt products:
SmartTip MRI Hand Drill and Drill Bit Kit
MRI Neuro Procedure Drape, with Marker Pen and Cover
SmartFrame MR Fiducial
Camera Fiberscope Accessory Kit

The provided text is a 510(k) summary for the ClearPoint System, focusing on software updates. It describes the device, its intended use, and comparative technological characteristics with a predicate device. The "Performance Data" section outlines the verification testing performed.

Here's an analysis of the provided information to answer your questions, with the caveat that detailed study methodologies are often abridged in 510(k) summaries:

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

The summary doesn't explicitly present a table of acceptance criteria for each test with numerical targets, but it states "Pass. The design has been verified to satisfy all acceptance criteria" and provides performance details within the results.

Here's a table attempting to construct this from the provided "Performance Data":

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

• Integrated System Test: "Nine device placements were evaluated."
• Regression Test: "This test used data from the predicate device..."
• Verification Test: "This test used data from the predicate device..."
• Automated UI Test: No specific sample size of "data" is mentioned, as it simulates user input to test functionality.

The data provenance is not specified regarding country of origin, nor is it explicitly stated whether the tests were retrospective or prospective, though "live scanner connection" and "data from the predicate device" suggest a mix of methodologies, likely a combination of new prospective testing for the integrated system and retrospective analysis of existing data for regression/verification.

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

The 510(k) summary does not provide any information on the number or qualifications of experts used to establish ground truth for the test set. The tests described are primarily focused on software and system functionality (e.g., accuracy of device placement, consistency with previous versions), rather than clinical performance based on expert interpretation of medical images.

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

The summary does not describe any adjudication methods. This type of detail is typically relevant for studies involving human interpretation or subjective assessments, which are not the primary focus of the engineering verification tests described here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study involving human readers and AI assistance is mentioned or implied. The study focuses on the device's functional performance, not its impact on human reader performance.

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

The "Integrated System Test" involves "interoperation with scanner and disposable hardware kit," and the "Regression" and "Verification" tests analyze software output. While not explicitly framed as "algorithm only" performance, these tests evaluate the software's functional output and accuracy without explicitly describing a human-in-the-loop scenario for primary performance evaluation. The "accuracy of 1.0 mm or less" in the Integrated System Test is a measure of the system's precision in device placement.

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

For the Integrated System Test, the "ground truth" for evaluating accuracy (1.0 mm or less) would likely be based on physical measurements of the actual device placement in reference to a target, possibly confirmed through imaging, but the exact method isn't detailed. It's an engineering ground truth related to physical-system accuracy.

For Regression and Verification Tests, the "ground truth" is the expected behavior and output based on the software's requirements and the previously released predicate device's performance.

8. The sample size for the training set

The 510(k) summary does not provide information on training set sample size. This is because the submission is for an updated version of a stereotactic guidance system software, which typically relies on established algorithms and engineering principles rather than a "trained" machine learning model in the sense of deep learning that requires large training datasets. The changes are described as modifications to visualization toolkits, DICOM handling, image fusion, and UI workflow.

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

As there is no mention of a traditional "training set" in the context of machine learning, there is no information on how its ground truth was established. The "ground truth" for the software's development would be based on engineering specifications, medical imaging physics, and clinical requirements for stereotactic accuracy.

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The ClearPoint System is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures within the MRI environment and in conjunction with MR imaging. The ClearPoint System is intended as an integral part of procedures that have traditionally used stereotactic methodology. These procedures include biopsies, catheter and electrode insertion, including deep brain stimulation (DBS) lead placement. The System is intended for use only with 1.5 and 3.0 Tesla MRI scanners and MR Conditional implants and devices. The user should consult the "Navigational Accuracy" section of the User's Guide to assess if the accuracy of the system is suitable for their needs.

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

The SMARTGrid and associated Marking Tool are designed to assist the physician to precisely position the burr hole as called out in the trajectory planning software. The SMARTFrame is an adjustable trajectory frame that provides the guidance and fixation for neurosurgical tools. The MRI visible fluids of the Targeting Cannula along with the fiducial markers in the base of the frame allow for trajectory feedback when the physician views the MRI images, makes changes, and confirms with subsequent MR images.

The ClearPoint System can be used with any MRI-compatible head fixation frame to immobilize the patient's head with respect to the scanner table, as well as with any imaging coil(s) that meet the physician's desired imaging quality. MRI Interventions also supplies an optional head fixation frame that can be used with the ClearPoint System.

The ClearPoint Workstation includes the following:

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

The hardware components of the ClearPoint System are the SMARTFrame and Accessories. They are all single use devices that are provided sterile. They include the following:

1. SMARTGrid Pack (interacts with the Software to determine the desired location of the burr hole)
   a. Marking Grid
   b. Marking Tool
2. SMARTFrame Pack
   a. SMARTFrame (adjustable trajectory frame ("ATF") to guide and hold the neurosurgical tools, includes fiducials, Targeting Cannula, & titanium screws)
   b. Centering Device
   c. Dock
   d. Device Lock (2 different diameters)
   e. Screwdriver
3. Rescue Screws (Extra Titanium Screws)
4. Thumbwheel Extension
5. Accessory Pack
   a. Peel away sheath
   b. Stylet
   c. Lancet
   d. Depth Stop
   e. Ruler
6. Scalp Mount Base
7. Guide Tube and Device Guide Packs (Guide Cannulas)

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

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Study Details Proving Device Meets Acceptance Criteria

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

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

Here are the details extracted from the document:

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

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

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

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

4. Adjudication Method for the Test Set:

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

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

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

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

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

7. The Type of Ground Truth Used:

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

8. The Sample Size for the Training Set:

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

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

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

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The MRII Cranial Drill and Accessories are intended to provide access through the skull for ventriculostomy or other neurological procedures, such as biopsy or catheter placement, in or near an MR scanner of 3T maximum strength. The MRII Cranial Drill and Accessories are intended to be used only when the scanner is not performing a scan. The MRII Cranial Drill is intended for single use only.

The MRII Cranial Drill and accessories is composed of the MR Compatible Hand Drill and Drill Bit Kits, packaged separately and found substantially equivalent in K 122456. The packaging is identical to that of the predicate device. The MRII Cranial Drill is wrapped in CSR and then sealed in a Tyvek pouch. The Drill Bit Kits are packaged in a sealed tray within a sealed Tyvek pouch.

The provided document, a 510(k) summary for the MRII Cranial Drill and Accessories, details performance data and a risk analysis to demonstrate substantial equivalence to a predicate device. It primarily focuses on the device's mechanical performance and safety within an MRI environment, rather than the performance of an AI algorithm or a diagnostic tool. Therefore, many of the requested fields related to AI performance, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance with humans-in-the-loop, and training set information are not applicable to this device and document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: The document does not specify exact numerical sample sizes for each test in terms of individual devices. It generally refers to "All modified MRI Hand Drills" or "Each Chuck/Shaft sub-assembly." For certain tests like "Drilling Efficiency," it mentions using 3.2, 4.5, and 6.0 mm Drill bits with "each Hand Drill Tested," implying multiple permutations.
• Data Provenance: The data is generated from in-house design verification testing conducted by the company (MRI Interventions, Inc.). This is prospective data from controlled experiments. The country of origin is not explicitly stated but can be inferred as the United States, given the FDA submission.

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

• Not Applicable. This is a mechanical device performance study, not a medical imaging or diagnostic study requiring expert ground truth for interpretation. "User evaluation scores" are mentioned for "Smooth Operation and Vibration During Drilling," "Drill Bit Loading," and "Wet Glove usage," which implies subjective assessment by individuals, but their number and specific qualifications are not detailed beyond being users.

4. Adjudication method for the test set

• Not Applicable. As there is no expert consensus on ground truth, no adjudication method is relevant.

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

• Not Applicable. This is not an AI-powered diagnostic device, so an MRMC study comparing human readers with and without AI assistance is irrelevant.

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

• Not Applicable. This device does not involve an algorithm with standalone performance.

7. The type of ground truth used

• The "ground truth" for this device's performance is based on engineering specifications and measurable physical properties. For example, "0 mm slippage" for axial loading, "under 1 minute" for drilling efficiency, specific force and torque values, and reduction percentages for run-out and deflection. Some aspects involve "user evaluation scores" for subjective qualities like smooth operation and ease of handling.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device, so there is no training set. Design validation is based on physical testing and risk analysis.

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

• Not Applicable. No training set exists.

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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 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.

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The SmartTwist™ MRII Hand Drill and accessories are intended to provide access through the skull for ventriculostomy or other neurological procedures, such as biopsy or catheter placement, in or near an MR scanner of 3T maximum strength. The SmartTwist MRII Hand Drill and accessories are intended to be used only when the scanner is not performing a scan. The SmartTwist MRII Hand Drill is intended for single use only.

The SmartTwist MRII Hand Drill is a hand held manual drill with a 3:1 gear ration. It is intended for use with the drill kit accessory kits SmartTip Drill Kits for a 3.2mm, 4.5mm and 6.0mm drill bit, with lancet, depth stop and ruler.

The provided document is a 510(k) summary for the SmartTwist™ MRII Hand Drill, SmartTip™ MRII Drill Bit Kit, 4.5mm, 6.0mm, seeking substantial equivalence to the predicate device, the MRII Cranial Drill, K122456.

The document describes the performance data and acceptance criteria in terms of demonstrating substantial equivalence, rather than a traditional study with strict acceptance criteria and performance metrics for an AI/software device. This is a physical medical device, specifically a hand drill and drill bit kits.

Here's an breakdown based on the provided text, focusing on how the device meets "acceptance criteria" through comparison with its predicate:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (manual surgical drill), "acceptance criteria" are not reported as specific performance metrics (e.g., accuracy, sensitivity) like for diagnostics or AI. Instead, the acceptance is based on demonstrating substantial equivalence to a previously cleared predicate device, meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. The performance is therefore reported in terms of equivalence to the predicate and compliance with recognized standards.

Key Differences from Predicate (and how they meet criteria):

• Drill Bit Sizes: Predicate: 2.0mm, 3.2mm. Subject Device: 4.5mm, 6.0mm (addition of two new sizes).
  • Acceptance: This "addition of drill sizes is at the request of clinicians" and is deemed "equivalent in intended use, technological characteristics and principles of operation to the predicate MRII Cranial Drill."
• Packaging: Slight variation (Predicate: Drill is CSR Wrap in Tyvek Peel Pouch, Kit is Sterile, inside tray with Tyvek Lid and external Tyvek Pouch. Subject: Kit: Sterile, inside tray with Tyvek Lid and external Tyvek Pouch).
  • Acceptance: Not highlighted as a safety concern; assumes equivalent sterile barrier properties.

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

This document does not describe a clinical study in the sense of a test set with patient data for determining diagnostic accuracy or treatment outcomes. Instead, it refers to "Performance Data" from "Design Verification" and "Risk Analysis."

• Sample Size: Not specified in terms of patient data or number of devices tested in a formal sample size calculation. The verification likely involved destructive and non-destructive testing on a representative number of devices/components to ensure manufacturing quality and performance.
• Data Provenance: Not applicable in the context of patient data. The "performance data" would originate from internal lab testing, engineering assessments, and risk management activities conducted by MRI Interventions, Inc. in the USA. The data is retrospective in the sense that it's generated during the design and manufacturing process, not from a prospective clinical trial.

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

Not applicable. This is not a study assessing diagnostic performance or requiring expert ground truth in the traditional sense. The "ground truth" for demonstrating the device works as intended comes from established engineering principles, recognized consensus standards, and comparison to the predicate device's cleared performance. Clinician request for the new drill sizes implies clinical input, but not as part of a formal ground truth adjudication.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" requiring adjudication by multiple experts, as this is a physical device clearance based on substantial equivalence and engineering verification.

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

Not applicable. This is a manual surgical drill, not an AI/software device, and no MRMC study was conducted.

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

Not applicable. This is a manual surgical drill, not an algorithm, and its use inherently involves human interaction.

7. The Type of Ground Truth Used

The "ground truth" for this submission revolves around:

• Predicate Device Performance: The established safety and effectiveness of the legally marketed MRII Cranial Drill.
• Consensus Standards: Compliance with recognized international and national standards (e.g., ISO 10993-1 for biocompatibility, ISO 11135-1 for sterilization, ASTM F2052-05e1 for MRI safety).
• Design Verification Testing: Internal testing to ensure the device meets its own design specifications.
• Risk Analysis: Identification and mitigation of potential risks.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/machine learning algorithm, so there is no concept of a "training set."

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

Not applicable, as there is no training set for this type of device.

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