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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).

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

8. The sample size for the training set

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

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

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

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

The 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.

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ClearPoint Maestro™ Brain Model is intended for automatic labeling, visualization, volumetric and shape quantification of segmentable brain structures from a set of MR images. This software is intended to automate the process of identifying, labelling, and quantifying the volume and shape of brain structures visible in MRI images.

The ClearPoint Maestro™ Brain Model provides automated image processing of brain structures from T1-weighted MR images. Specifically, the device automates the manual process of identifying, labeling, and quantifying the volume and shape of subcortical structures to simplify the workflow for MRI segmentation.
The ClearPoint Maestro™ Brain Model consists of the following key functional modules.

• DICOM Read Module .
• Segmentation Module ●
• Visualization Module ●
• . Exporting Module
  The segmented brain structures are color coded and overlayed onto the MR images or be displayed as 3-D triangular mesh representation. The viewing capabilities of the device also provides anatomic orientation labels (left, right, inferior, superior, anterior, posterior), image slice selection, standard image manipulation such as contrast adjustment, rotation, zoom, and the ability to adjust the transparency of the image overlay.
  The output from ClearPoint Maestro™ Brain Model can also exported as a report in PDF format. The report also provides a comparison of segmented volume to normative values of brain structures based on reference data.

Here's a breakdown of the acceptance criteria and study details for the ClearPoint Maestro™ Brain Model, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The machine learning derived outputs (Cerebellum GM, Cerebellum WM, L Cortical GM, R Cortical GM, L Cortical WM, R Cortical WM) also met the acceptance criteria with Dice coefficients > 70% and mean relative volume differences < 0.3.

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

• Test Set Sample Size: 101 subjects for segmentation accuracy and relative volume difference validation.
• Reproducibility Test Set Sample Size: 20 "repeated scans" (implied as 20 subjects with repeated scans, but not explicitly stated as 20 distinct subjects or scans).
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The summary only states that the validation dataset was "completely independent from the training data created by Philips."

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

• Number of Experts: Not explicitly stated for the validation/test set. The document mentions "manually labeled data" was used as ground truth for the validation set, but does not specify how many experts created this manual labeling or their qualifications.
• Qualifications of Experts: Not specified for the test set ground truth.

4. Adjudication Method for the Test Set

The adjudication method for establishing ground truth for the test set is not explicitly mentioned. It states "manually labeled data" was used, but details on how consensus was reached (e.g., 2+1, 3+1, none) are absent.

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

No, an MRMC comparative effectiveness study was not explicitly stated as being performed. The study focuses on the standalone performance of the device against manually labeled data, not on its impact on human reader performance with or without AI assistance.

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

Yes, a standalone performance study was done. The study assesses the device's ability to segment, quantify, and reproduce results compared to manually labeled data, without human interaction with the device's output during the evaluation.

7. The Type of Ground Truth Used

The primary type of ground truth used for the validation (test set) was expert consensus / manual labeling ("manually labeled data T1-weighted MRI data").

8. The Sample Size for the Training Set

The sample size for the training set is not explicitly stated. It mentions: "The training data was created by the three technical experts at Philips Research Hamburg." This implies a dataset was used for training, but its size is not provided.

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

The ground truth for the training set was established by three technical experts at Philips Research Hamburg. The method (e.g., manual segmentation, specific tools, adjudication) is not detailed beyond this.

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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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