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The ClearPoint Array System (Version 1.2) is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures within the MRI in conjunction with MR imaging. The ClearPoint Array System (Version 1.2) is intended as an integral part of procedures that have traditionally used stereotactic methodology. These procedures include biopsies, catheter and electrode insertion including deep brain stimulation (DBS) lead placement. The System is intended for use only with 1.5 and 3.0 Tesla MRI scanners and MR Conditional implants and devices.

The ClearPoint Array System is comprised of a workstation laptop with workstation software, the SMARTGrid™ MRI-Guided Planning Grid, the SMARTFrame™ Array MRI-Guided Trajectory Frame, SmartFrame Array Reducer Tube Kit, the ClearPoint™ Accessory Kit, the SMARTFrame™ Array Thumb Wheel Extension Set, and the MRI Neuro Procedure Drape. The ClearPoint Array Workstation includes the following:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

• No, an MRMC comparative effectiveness study was not conducted or described. The document focuses on the mechanical/software accuracy of the stereotactic guidance system, not on AI assistance for human image readers. The "AI" concept as typically understood in medical image analysis (e.g., for detection or diagnosis) is not relevant to this device's described function as a stereotaxic instrument.

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

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

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

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

8. The sample size for the training set

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

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

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

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The ClearPoint® Array 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 ® Array 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 Array System is comprised of a workstation laptop with workstation software, the SMARTGrid™ MRI-Guided Planning Grid, the SMARTFrame™ Array MRI-Guided Trajectory Frame, SmartFrame Array Reducer Tube Kit, the ClearPoint™ Accessory Kit, the SMARTFrame™ Array Thumb Wheel Extension Set, and the MRI Neuro Procedure Drape.

A pre-alignment may be used when it is desired to obtain an approximate alignment using a Surgical Navigation System prior to performing final alignment and device placement in the MR Scanner using real-time MR Images. Pre-alignment using an SNS is not intended to provide accurate stereotactic placement. The final alignment and insertion must be performed using real-time MR images with ClearPoint Array software prior to inserting a device in the brain. The SMARTGrid™ MRI-Guided Planning Grid 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™ Array MRI-Guided Trajectory Frame is an adjustable trajectory frame that provides the quidance and fixation for neurosurgical tools. MRI visible fluids in the Targeting Stem along with the fiducial markers in the frame allows for trajectory feedback when the physician views the MR images, makes changes and confirms the subsequent MR images. The ClearPoint Array 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 Array System.

The ClearPoint System Array Workstation includes the following:

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

The hardware components of the ClearPoint Array System are the SMARTFrame Array and accessories. They are all single use devices that are provided sterile. They include the following:
1 SMARTFrame Array Pack
a. SMARTFrame Array (adjustable trajectory frame to guide and hold the neurosurgical tools, includes Probe Adapter and Tracker Rod)
b. SMARTFrame Array Scalp Mount Base (includes fiducials, titanium screws, and support pins)
c. Entry Point Locator
d. Targeting Stem
e. Centering Device
f. Dock
g. Device Lock (2 different diameters)
h. Screwdriver
i. 2.1-mm Guide Tube
j. 4.5 Center Drill Guide
k. 4.5 Offset Drill Guide
l. 3.4-mm Drill Reducer Tube
m. Center Insertion Guide
n. Offset Insertion Guide
2 SmartFrame Array Thumb Wheel Extension Set for the trajectory frame
3 SmartFrame Array Guide Tube Kit
a. 1.7-mm Guide Tube
b. 2.5-mm Guide Tube and Device Lock
c. 3.2-mm Guide Tube and Device Lock
4 SmartFrame Array Guide Tubes (sold seperately)
a. 7.9mm Center and Offset Device Guides
b. 5.4mm Center and Offset Device Guides

Common components to ClearPoint System include:

1. SMARTGrid Pack (interacts with the Software to determine the desired location of the burr hole):
   a. Marking Grid
   b. Marking Tool
2. Accessory pack:
   a. Peel away sheath
   b. Stylet
   c. Depth Stop
   d. Ruler
3. MRI Neuro Procedure Drape

The provided text, a 510(k) Summary for the ClearPoint Array System (version 1.1), focuses on demonstrating substantial equivalence to a predicate device, primarily due to a software update. While it mentions 'Targeting Accuracy' as an acceptance criterion and states a specific performance, it does not provide a detailed study design as might be found in a clinical trial report.

Here's an attempt to extract and infer the information based on the provided text:

Acceptance Criteria and Reported Device Performance

The key acceptance criterion mentioned, which is related to the device's accuracy, is:

Study Proving Device Meets Acceptance Criteria

The document states: "The company completed new software validation for the ClearPoint Array version 1.1 software update, which includes the addition of the preoperative planning module."

While this indicates that a validation study was performed, the document does not provide details for many of the requested items (2-9) about the study design, sample size, expert involvement, or ground truth establishment. This is typical for a 510(k) submission showing substantial equivalence, where detailed de novo clinical study results are often not required if the changes are minor and do not raise new questions of safety and effectiveness, and performance is demonstrated through established engineering and software validation principles.

Based on the provided text, the following information is not available:

2. Sample size used for the test set and the data provenance: Not specified. The document implies software validation was done, but details on the "test set" (e.g., number of image sets, countries of origin, retrospective/prospective) are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
4. Adjudication method for the test set: Not specified.
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: Not specified. This type of study is typically done for AI/ML-driven diagnostic devices that assist human readers in interpretation. The ClearPoint Array System is a stereotaxic guidance system, and the software update is for a preoperative planning module, rather than a diagnostic AI. Therefore, an MRMC study is unlikely to be relevant or performed for this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly detailed. The "Targeting Accuracy" metric suggests an objective, standalone measurement of the system's precision, but the methodology for this measurement (e.g., phantom study, cadaver study) is not provided.
7. The type of ground truth used: Not explicitly stated. For a stereotaxic system, ground truth for accuracy studies would typically involve precise physical measurements on phantoms or cadavers, or comparison to a gold-standard imaging or navigation system. The document does not elaborate on this.
8. The sample size for the training set: Not applicable based on the information provided. The software update is described as "incorporat[ing] an update" and "new software validation," implying traditional software development and testing, rather than an AI/ML model that requires a "training set" in the machine learning sense. The preoperative planning module might involve algorithms, but the text doesn't suggest a deep learning model requiring a large training dataset.
9. How the ground truth for the training set was established: Not applicable, as no training set (in the AI/ML context) is mentioned or implied.

In summary, the document provides the acceptance criterion for targeting accuracy (≤ 2.0 mm) and states that the device meets this, but it does not detail the specific study methodology (e.g., sample size, ground truth establishment, expert involvement, or comparative effectiveness studies) beyond "new software validation." This level of detail is usually not included in a 510(k) summary focused on substantial equivalence for a non-AI/ML device where the change is primarily a software update to a planning module.

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The ClearPoin® Array 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® Array System is intended as an integral part of procedures that have traditionally used stereotactic methodology. These procedures include biopsies, catheter and electrode insettion including deep brain stimulation (DBS) lead placement. The System is intended for use only with 1.5 and 3.0 Tesla MRI scanners and MR Conditional implants and devices.

The ClearPoint Array System is comprised of a workstation laptop with workstation software, the SMARTGrid™ MRI-Guided Planning Grid, the SMARTFrame™ Array MRI-Guided Trajectory Frame, SmartFrame Array Reducer Tube Kit, the ClearPoint™ Accessory Kit, the SMARTFrame™ Array Thumb Wheel Extension Set, and the MRI Neuro Procedure Drape.

A pre-alignment may be used when it is desired to obtain an approximate alignment using a Surgical Navigation System prior to performing final alignment and device placement in the MR Scanner using real-time MR Images. Pre-alignment using an SNS is not intended to provide accurate stereotactic placement. The final alignment and insertion must be performed using real-time MR images with ClearPoint Array software prior to inserting a device in the brain. The SMARTGrid™ MRI-Guided Planning Grid 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™ Array MRI-Guided Trajectory Frame is an adjustable trajectory frame that provides the quidance and fixation for neurosurgical tools. MRI visible fluids in the Targeting Stem along with the fiducial markers in the frame allows for trajectory feedback when the physician views the MR images, makes changes and confirms the subsequent MR images. The ClearPoint Array 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 Array System.

The ClearPoint System Array Workstation includes the following:

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

The hardware components of the ClearPoint Array System are the SMARTFrame Array and accessories. Some of the accessories are common components with the ClearPoint System (K200079). They are all single use devices that are provided sterile. They include the following:
1 SMARTFrame Array Pack
a. SMARTFrame Array (adjustable trajectory frame to guide and hold the neurosurgical tools, includes Probe Adapter and Tracker Rod)
b. SMARTFrame Array Scalp Mount Base (includes fiducials, titanium screws, and support pins)
c. Entry Point Locator
d. Targeting Stem
e. Centering Device
f. Dock
q. Device Lock (2 different diameters)
h. Screwdriver
i. 2.1-mm Guide Tube
j. Center Drill Guide
k. Offset Drill Guide

1. 3.4-mm Drill Reducer Tube
   m. Center Insertion Guide
   n. Offset Insertion Guide
   2 SmartFrame Array Thumb Wheel Extension Set for the trajectory frame
   3 SmartFrame Array Guide Tube Kit
   a. 1.7-mm Guide Tube
   b. 2.5-mm Guide Tube and Device Lock
   c. 3.2-mm Guide Tube and Device Lock

Common components to ClearPoint System include:

1. SMARTGrid Pack (interacts with the Software to determine the desired location of the burr hole)
   a. Marking Grid
   b. Marking Tool
2. Accessory pack
   a. Peel away sheath
   b. Stylet
   c. Depth Stop
   d. Ruler
3. MRI Neuro Procedure Drape

The provided document is a 510(k) premarket notification summary for the ClearPoint Array System. This type of submission focuses on demonstrating "substantial equivalence" to a predicate device, rather than proving a device "meets acceptance criteria" in the way one might for a novel AI/ML device or a device with new performance claims.

Therefore, the document does not contain the typical information required to answer all parts of your request, such as a multi-reader multi-case study, detailed ground truth establishment for a test set, or separate training set details, as these are more common for AI/ML device submissions with explicit performance claims against real-world clinical outcomes.

However, based on the information available, I can extract what is relevant to performance and "acceptance":

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

The document does not explicitly state "acceptance criteria" in the format of a pre-defined performance goal that the device must achieve (e.g., "sensitivity must be >X%"). Instead, it provides performance validation values for key navigational accuracy metrics, which likely represent measurements taken to demonstrate the device's capabilities and support its substantial equivalence claim. The predicate device's targeting accuracy serves as a benchmark for comparison.

(Note: The second row for positional error (1.52, 0.46, 1.94, and -1.41, 0.73, -2.08) appears to be additional data points for positional error (potentially x, y, z components or separate measurements), but the document does not clarify their exact meaning beyond being under 'Positional Error (mm)' and 'Mean', 'Std. Dev', '99% CI'. For clarity, I'm using the first row as the primary 'overall' mean positional error provided.)

The primary "acceptance criterion" implicit in this type of submission is that the performance of the new device is substantially equivalent to the predicate device, especially considering the predicate's stated "Targeting Accuracy ≤ 1.5 mm." The reported mean positional errors (0.78mm and other values) are well within this 1.5 mm threshold, indicating that this aspect of performance is considered acceptable and equivalent or improved.

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

The document states: "Design Verification and Validation was performed relative to these specifications and with acceptable results. These tests included verification of physical, performance, and safety requirements, as well as benchtop accuracy testing."

• Sample Size: The document does not explicitly state the sample size (number of measurements or trials) used for the benchtop accuracy testing.
• Data Provenance: The data is described as "benchtop accuracy testing." This implies controlled laboratory conditions, not human subject data from a specific country or clinical setting. It is not retrospective or prospective clinical data.

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

Not applicable. For a stereotactic guidance system, "ground truth" for accuracy is typically established by precise measurement tools and phantoms in a controlled engineering or physics lab setting, rather than by expert human interpretation of images. The device's performance is measured against known physical coordinates or angles.

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

Not applicable, as ground truth is established via physical measurements and not human 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

No. This type of study is typically performed for diagnostic AI/ML devices where the AI provides assistance to a human reader, to demonstrate improvement in reader performance. The ClearPoint Array System is a surgical guidance device, not a diagnostic AI/ML tool.

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

Yes, in a sense. The "Performance Data" table ("Positional Error" and "Angular Error") represents the standalone performance of the device in a controlled, benchtop setting, measuring its inherent accuracy in guiding and positioning. It's the device's mechanical and software accuracy demonstrated without a human actively interpreting images or making a diagnostic decision in a clinical context.

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

The ground truth for the "Performance Data" (positional and angular accuracy) would be based on physical precision measurements using highly accurate instruments (e.g., optical trackers, coordinate measuring machines) in a controlled laboratory environment with phantoms that have known, precise target locations.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set in the typical sense for machine learning. The software modifications mentioned are likely re-engineering and feature additions for workflow and UI, not learning algorithms.

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

Not applicable, as there is no mention of a training set for machine learning.

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