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The Medivis NeuroAlign device is stereotaxic image guidance system intended to be used with the Microsoft HoloLens headset for the spatial positioning and orientation of neurosurgical instruments employed by surgeons. This device is specifically intended for cranial surgery, where reference to a rigid anatomical structure can be identified, without the need for a frame or fixation of a navigated instrument guide to the patient. The system is intended for use in various surgical settings, including operating rooms, intensive care units, and interventional procedure suites.

The Medivis NeuroAlign device is a software application that processes and visualizes anatomical images for surgical navigation. It works in conjunction with off-the-shelf hardware and surgical instruments, including an IGS workstation, touchscreen monitor, and a 3D tracking system, along with IR trackable surgical instruments. The device uses pre-acquired patient data, which can be transferred from the hospital's PACS or local files. It operates with a network-based software interface for data downloading and supports image upload for custom visualization. The device's data transfer is unidirectional. It provides various image display options and manipulation features, primarily controlled through the touchscreen monitor. An HMD serves as an adjunct heads-up display and functions as an optical 3D tracking component for patient and surgical tool localization. The device registers patient data to the surgical environment through IR tracking, but it does not overlay data onto the surgical site. It cannot integrate with intra-operative image sources like surgical microscopes or ultrasound devices.

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The SOLOPASS 2.0 System is a tool that obtains ultrasound images and positional data to provide intra-procedural, image guided localization and navigation, to aid in the frontal placement of an intraventricular catheter.

The SOLOPASS® 2.0 System is a neuronavigational system that collects intraoperative ultrasound imaging referenced to a skull mounted fixation device, allowing the user to plan the desired placement for external ventricular drain (EVD). The system utilizes two-dimensional imaging data with simultaneously captured location data to build a three-dimensional model of the anatomy without the use of preoperative imaging. Once the user has chosen a catheter placement location, the fixation device is locked in place to guide a catheter towards the intended anatomic location.

The SOLOPASS® 2.0 System consists of three main sub-systems:

1. The Patient Interface Device (PID): A skull-mounted fixation device that translates mechanical motion into digital position and secures the Ultrasound Probe and Catheter Guide.
2. The Ultrasound Probe "The Probe": A custom cranial "burr-hole" style probe used to collect intraoperative ultrasound image data from the patient.
3. The Workstation: A custom, portable unit that includes a dedicated operating system, imaging software application, and 27" monitor for displaying the User Interface. The Workstation is the primary interface of the other subsystems and is controlled by the included foot pedal.

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The Ball Joint Guide Array (BJGA) 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 Ball Joint Guide Array (BJGA) is a skull-mounted, single use stereotactic neurosurgical guidance device. It is manually operated and facilitates trajectory planning and guides instruments or devices to a specific location within the brain. The ball joint system can be used to support a wide range of surgical trajectories into the brain. An image-guided neuronavigational system is used to register cranial landmarks and utilize presurgical neuroimaging data to align the BJGA with an optimal skull entry point to achieve the planned trajectory. Once aligned, the BJGA assembly is securely attached to the skull and locked in position to provide a stable instrument/device guide. Intraoperative magnetic resonance imaging (MRI) is then used to confirm intraoperative trajectory alignment with the planned trajectory and make additional trajectory adjustments, as needed, prior to insertion of the neurosurgical instrument, guided via the BJGA, into the brain.

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Phasor EZ-Fiducials is intended to provide fixed reference point(s) in patients requiring stereotactic surgery in conjunction with CT imaging with the included screws placed using the included EZ-Driver (electric screwdriver) or manual screwdriver exclusively for each.

Phasor EZ-FIDUCIALS™ provide fixed reference points during neurosurgical procedures. The device is composed of 3 items, all single-use, provided gamma-sterilized, and placed within the same primary packaging (sealed Tyvek tray within a shelf carton):

1. Screws: Each of the four provided titanium screws is identical, with specific dimensions of each EZ-Fiducials screw as follows: screwhead circular shape screwhead with square-shaped engagement, non-threaded shaft diameter 2.9mm and length 15mm, threaded shaft diameter (major threads) 1.98mm, thread length 5mm; no protective caps are provided, and the screws should exclusively be utilized in conjunction with the screwdrivers (manual or EZ-Driver) provided together in the same tray (and with no other screwdriver);

2. Manual Screwdriver: handheld, to be solely used with the screws provided, not intended for use with any other screws;

3. EZ-driver: (electric, handheld, non-rechargeable battery-operated screwdriver, without software, single-use for solely tightening or loosening the provided screws exclusively, not intended for use with any other screws).

The provided FDA 510(k) clearance letter and summary for EZ-Fiducials focuses primarily on substantial equivalence to predicate devices based on technological characteristics and bench testing, rather than a clinical study with acceptance criteria based on human-in-the-loop performance or algorithm-only performance against a defined ground truth.

Therefore, for aspects related to "device performance," "acceptance criteria," "sample size," "expert ground truth," "adjudication methods," "MRMC studies," "standalone performance," and "ground truth for training/test sets," the available document does not provide this information. The submission relies on bench testing to demonstrate equivalence.

Here's an analysis of what information is provided and what explicitly is not provided based on your request:

Acceptance Criteria and Device Performance (Based on Available Information)

The document does not present a table of acceptance criteria and reported device performance in the manner typically seen for clinical or AI/algorithm performance studies (e.g., sensitivity, specificity, accuracy). Instead, it relies on demonstrating compliance with an ASTM standard and general performance adequacy, often by comparison to predicate devices' known characteristics.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

Study Proving Device Meets Acceptance Criteria

The study proving the device meets acceptance criteria is primarily bench testing. No clinical study data is presented.

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

• See table above. This is inferred from the discussion of performance testing. Explicit quantitative acceptance criteria (e.g., "deflection must be less than X mm") are not detailed, but compliance with ASTM F543-23 and "adequate performance" are stated.

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

• Sample Size: Not explicitly stated for bench testing. The testing refers to "bone simulant" but the quantity of fiducials, screws, or instances tested is not specified.
• Data Provenance: Not applicable in terms of patient data. The testing is bench testing using "bone simulant." There is no indication of retrospective or prospective data or country of origin, as it's not a clinical study.

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

• Not applicable. This was a bench study, not a study requiring expert ground truth for clinical cases. The "ground truth" for the bench testing would be physical measurements and compliance with engineering standards.

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

• Not applicable. There was no human interpretation or subjective assessment of clinical data that would require 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. An MRMC study was not done. The device is a physical fiducial system and an electric screwdriver, not an AI or software device that assists human readers.

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

• Not applicable. This is not an AI algorithm. The device performance here refers to the physical characteristics and functionality of the fiducials and screwdriver.

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

• Bench Testing Data/Engineering Standards. The ground truth for this submission's performance assessment is the physical performance and measurements of the device (deflection) and compliance with industry standards (ASTM F543-23).

8. The sample size for the training set:

• Not applicable. This device does not use machine learning or AI, so there is no training set.

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

• Not applicable. As above, no training set.

Summary of the Study:

The "study" referenced in the 510(k) for EZ-Fiducials is a series of bench tests focusing on:

• Biocompatibility of materials.
• Sterility validation.
• Packaging integrity.
• Performance of the screws (e.g., deflection characteristics, compliance with ASTM F543-23 when inserted into bone simulant).
• Performance of the electric screwdriver (its ability to drive screws adequately).

The clearance is based on the argument that these bench tests demonstrate the device's substantial equivalence in terms of safety and effectiveness to the predicate device (Medtronic Navigus Unibody Fiducial Marker System) and a reference device (OsteoMed Pinnacle Driver), even with some technological differences (e.g., screwdriver speed, sterilization method). The document explicitly states: "No clinical testing was needed or performed otherwise." The predicate device was also "cleared based upon bench testing alone."

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Stereotaxic Guiding Surgical Devices, NaoTrac S is intended for the spatial positioning and orientation of instrument holder or instrument tool to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode). The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be appropriate.

Stereotaxic Guiding Surgical Devices, NaoTrac S is a robotized platform for the guidance of neurosurgical instruments compatible with the diameter of instrument adaptor provided by Brain Navi Biotechnology Co., Ltd.

Stereotaxic Guiding Surgical Devices, NaoTrac S is composed of a compact robotic arm and display screen mounted on a wheeled trolley. Different types of instruments may be attached to the end of the arm and changed according to the requirements of the procedure to be completed.

The display screen permits to ensure the communication between NaoTrac S and its user by indicating the realizable actions as well as by proposing various commands. NaoTrac S is an aid for locating anatomical structures in either open or percutaneous procedures.

The provided FDA 510(k) Clearance Letter for the Stereotaxic Guiding Surgical Devices, NaoTrac S (K242575) includes details on acceptance criteria and supporting studies.

Here's an analysis of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes "Accuracy Testing" which includes "systematic accuracy," but it does not specify the sample size for this test set (e.g., number of measurements, number of trajectories).

The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given the nature of a medical device accuracy test, it is typically conducted in a controlled environment (e.g., lab setting) rather than with patient data.

3. Number of Experts Used and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth for the "Accuracy Testing." This type of accuracy evaluation for a stereotaxic device typically relies on metrology (precise measurement instruments and setups) to define the true position and angle, not human expert interpretation.

4. Adjudication Method for the Test Set

Since the ground truth for accuracy testing is established through metrological measurements rather than human interpretation, an adjudication method like 2+1 or 3+1 is not applicable and not mentioned in the document.

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

The document does not indicate that a Multi Reader Multi Case (MRMC) comparative effectiveness study was done. The NaoTrac S is a robotic guiding surgical device, not an imaging diagnostic tool that typically involves human reader interpretation for comparative effectiveness studies. The primary evaluation focuses on the device's accuracy in guidance.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop)

The "Accuracy Testing" results (Positional Error and Trajectory Angle Error) represent the standalone performance of the NaoTrac S device. These metrics evaluate how accurately the robotic arm positions and orientates instruments without direct human intervention in the final positioning step that is being measured. The device's function is to guide the neurosurgeon, but its intrinsic accuracy is a standalone measure.

7. Type of Ground Truth Used

For the accuracy testing, the ground truth was metrological measurements. The document states that the tests were conducted "according to internally defined methods" for "systematic accuracy," comprising "position accuracy and angular accuracy." This implies the use of highly precise measurement tools and techniques to determine the true position and angle against which the device's performance was compared.

8. Sample Size for the Training Set

The document does not specify a sample size for a training set. The NaoTrac S is a robotic guidance system, and its accuracy is primarily determined by its mechanical design, control algorithms, and calibration, rather than a machine learning model trained on a dataset in the way a diagnostic AI would be. While there are software components, the "Software Verification and Validation" section refers to standard software development lifecycle processes, not specifically to training a machine learning model.

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

Since a machine learning training set is not explicitly mentioned or implied for the core function of the NaoTrac S in its accuracy evaluation, the method for establishing its ground truth is not applicable and not discussed in the document.

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Navient is a computerized surgical navigation system intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical procedures.

The Navient system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT, MR based model of the anatomy.

Indications:

Example procedures include but are not limited to:

• Cranial Procedures:
• Tumor resections
• · Cranial biopsies
• · Craniotomies
• · Pediatric Catheter Shunt Placement
• General Catheter Shunt Placement

Navient is an image quided navigational system intended to assist with preoperative planning and real-time positioning of surgical tools during stereotaxic procedures via (infrared) tracking technology. The system is essentially composed of a computerized main unit (computer), a Navient IR CameraBox, Navient cart, Navient navigation software, and corresponding accessory sets intended for specific clinical applications.

Navient's quidance function is based on the patient images acquired prior to the procedure, combined with optical measurements of the pose of navigated instruments relative to the patient's anatomy. To enable navigation, the reference instrument/accessory is attached to the patient to enable tracking of the patient's anatomy. The patient images are then spatially registered with the patient's anatomy by matching landmark locations marked on both the image and the patient, followed by matching a path traced by the user on the patient's anatomy with a model of patient's anatomical surface automatically generated from the image data.

Depending on the desired clinical application, the Navient system also includes the following instrument/accessory kits. These reusable instruments are intended to be sterilized/disinfected prior to use.

• Cranial Accessory Kit (955-NC-AKC) o
• Biopsy Accessory Kit (955-NC-AKB) O

Disposable tracker instruments are also available based on user preference.

The provided document is a 510(k) summary for the ClaroNav Navient Image Guided Navigation System, Cranial. This document describes the device, its intended use, technological characteristics, and performance data to demonstrate substantial equivalence to a predicate device.

Acceptance Criteria and Device Performance:

The primary acceptance criteria for the Navient system is its accuracy, specifically in terms of positional and angular error. The document states: "Navient has been validated to a mean positional error of ≤ 2.0 mm and a mean anqular error of ≤ 2.0deq."

Here's a table summarizing the acceptance criteria and reported device performance:

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is described under the "Performance Data" section, specifically "Full system accuracy bench testing (overall accuracy)".

1. A table of acceptance criteria and the reported device performance:
(See table above)

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

• Sample Size for the Test Set: The document does not explicitly state the numerical sample size (e.g., number of measurements or trials) for the "Full system accuracy bench testing." It mentions using "representative phantoms."
• Data Provenance: The data is based on bench testing using phantoms. The country of origin of the data is not specified, but the applicant is from Canada. The study is a prospective experimental study conducted by the manufacturer to demonstrate performance.

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

This is a bench testing study, not an AI or human-in-the-loop clinical study where expert review of images or clinical outcomes would establish ground truth. The "ground truth" for this accuracy testing would be the known, precise measurements and positions of the targets on the phantoms. Therefore, no external experts are typically involved in establishing this type of ground truth for a physical device's mechanical/measuring accuracy. The expertise lies in the engineering and quality control personnel performing the measurements.

4. Adjudication method for the test set:

Not applicable in the context of bench testing device accuracy. Adjudication typically refers to resolving discrepancies among multiple human readers or ground truth experts.

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 done. This document pertains to the clearance of a surgical navigation system, which primarily aids surgeons in real-time positioning based on pre-acquired images. It is not an AI-based diagnostic tool intended to assist human readers in interpreting medical images or improving diagnostic accuracy.
• The study described is a bench study evaluating the physical accuracy of the navigation system, not the diagnostic performance or reader improvement.

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

• Yes, in a sense, the "Full system accuracy bench testing" represents the standalone performance of the device's navigational accuracy. The measurements of positional and angular error were likely performed by the device and then compared against the known ground truth of the phantom. This is the performance of the algorithm and hardware working together in a controlled environment.
• It's important to differentiate this from "standalone AI performance" if the device were an AI diagnostic algorithm. Here, "standalone" refers to the device's ability to accurately track and report positions, irrespective of a surgeon's subjective assessment.

7. The type of ground truth used:

The ground truth used for the full system accuracy bench testing was engineered ground truth based on known, precise measurements of target points on "representative phantoms." These phantoms are designed with known spatial relationships that serve as the gold standard for accuracy verification.

8. The sample size for the training set:

• Not applicable. This document describes a surgical navigation system, not an AI algorithm that undergoes machine learning training. Therefore, there is no "training set" in the context of deep learning models.
• The "training" for such a device involves calibration, manufacturing processes, and software development, which are different from data-driven machine learning training.

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

• Not applicable. As stated above, there is no "training set" in the machine learning sense for this device.
• For the development and calibration of the device, the inherent accuracy of manufacturing, calibration tools, and metrology standards would serve as the "ground truth" for ensuring the device performs as designed.

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Alignment System Cranial is intended to plan and to achieve a trajectory with surgical instruments during cranial stereotactic procedures.

The indications for use are biopsy of intracranial lesions, placement of stereoelectroencephalography (SEEG) electrodes and placement of anchor bolts for laser interstitial thermal therapy (LITT).

The subject device Alignment System Cranial is an image guided surgery system intended to support the surgeon to plan and to achieve a trajectory with surgical instruments during cranial stereotactic procedures using optical tracking technology.

For this purpose, the Alignment System Cranial consists of a combination of hardware and software. The Alignment Software Cranial with LITT 2.1 is installed on an Image Guided Surgery (IGS) platform (Curve, Curve Navigation 17700, Kick 2 Navigation Station or Buzz Navigation) consisting of a computer unit, a touch display and an infrared tracking camera. During surgery, the software tracks the position of instruments in relation to the patient anatomy and identifies this position on pre- or intraoperative images. The position of the surgical instruments is continuously updated on these images by optical tracking. This position information is used by the software to align either passive or active positioning devices to a planned trajectory for subsequent surgical steps.

The Alignment System Cranial has different configurations of hardware devices depending on which positioning device is used and which indication is performed. The Alignment Software Cranial with LITT 2.1 supports the active positioning devices Surgical Base System 1.4 and Cirq Arm System 2.0 (+ Cirq Robotic Alignment Module + Cirq Robotic Disposable Kinematic Unit) as well as the passive positioning device VarioGuide. Both types of positioning devices consist of articulated arms with different joints where additional devices and surgical instruments can be attached to for further manual or robotic alignment to a defined trajectory.

In addition, the subject device offers a set of indication specific instruments to support biopsy, sEEG and LITT procedures. This instrumentation consists of instrument holders, tracking arrays, guide tubes, reduction tube, bone anchors, drill bits and depth stops. None of the instruments is delivered sterile. All patient contacting materials consist of different alloys of stainless steel.

The Alignment Software Cranial with LITT has the following accessories:

• Automatic Registration providing an automatic registration for subsequent use.
• Automatic Registration iMRI providing an automatic image registration for intraoperatively . acquired MR images.

The provided text is a 510(k) summary for the "Alignment System Cranial," which includes "Alignment Software Cranial with LITT." It details the device's indications for use, description, and comparison to predicate devices, along with performance data to demonstrate substantial equivalence.

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

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

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

• Sample Size for Test Set:
  • Number of registrations: 6
  • Total number of samples: 37 (This likely refers to individual measurements taken over the 6 registrations)
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, the study was conducted as "System accuracy testing" to evaluate the device in "a realistic clinical setup and representative worst case scenarios," suggesting it was a controlled, prospective study performed by the manufacturer.

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

The document does not provide information on the number of experts or their qualifications used to establish ground truth for this system accuracy testing. This type of testing typically relies on metrology standards and physical measurements rather than clinical expert consensus for ground truth.

4. Adjudication method for the test set

The document does not specify an adjudication method. For system accuracy testing based on physical measurements, an adjudication process involving human experts is generally not applicable in the same way it would be for image-reading or diagnostic AI.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The performance data presented is for the system accuracy of the device concerning its ability to align instruments, not for a diagnostic AI algorithm that human readers would interact with. The document explicitly states: "No clinical testing was needed for the Subject Device since optical tracking technology in the scope of image guided surgery for the included indications for use is well established in the market."

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

The performance study was for the system's accuracy (hardware + software components), which is a key aspect of its standalone functionality in terms of guiding instruments. While it's not an "algorithm only" study in the sense of a pure AI diagnostic tool, it measures the precision of the device's output without direct human interpretation in the loop of the measurement itself. The "Automatic Registration" features (including one for iMRI) are mentioned as accessories, implying an algorithmic component, but specific performance criteria for these AI/ML-based features are not detailed beyond the general system accuracy. The document mentions that "There have been no changes to the AI/ML algorithm" for surface matching for patient registration, implying its prior validation.

7. The type of ground truth used

The ground truth for the system accuracy testing ("positional and angular navigation accuracy") would have been established through precise physical measurements using calibrated instruments and metrological standards (e.g., a coordinate measuring machine or similar setup to establish a true target position against which the device's reported position is compared). It is not based on expert consensus, pathology, or outcomes data, as this is a measurement of mechanical and software precision.

8. The sample size for the training set

The document does not provide information on the sample size for the training set for any embedded AI/ML components (e.g., the AI/ML based model for landmark delivery in surface matching). The focus of this 510(k) summary is on the system accuracy for the LITT indication, and asserts "no changes to the AI/ML algorithm" for patient registration.

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

The document does not provide information on how the ground truth for any training set was established for embedded AI/ML components. It only mentions that an existing AI/ML algorithm for surface matching landmarks has not changed.

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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 device is intended to aid in locating anatomical structures and for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons for navigating compatible surgical instruments in open or percutaneous procedures. The device is indicated for any neurosurgical procedure in which stereotactic neurosurgery may be appropriate and where reference to a rigid anatomical structure, such as the skull, can be identified relative to anatomy images.

Geniant Cranial is a hardware platform that supports real-time surgical navigation using medical patient images. The application software reprocesses the CT or MR images of the patient acquired before surgery. It displays the contents on the software screen in various fluoroscopy directions (axial, sagittal and coronal). Before surgery, the surgeon can create and save one or more surgical routes to simulate. The surgeon may create and manipulate one or more 3D models of human anatomy before the surgery. During surgery, the system tracks the position of special surgical tools in the patient's anatomy and continuously updates the positions of the surgical tools in these images. The application software can also show you how the actual position and path during surgery relate to the pre-operative plan and guide the surgeon to follow the planned trajectory. The real-time location information obtained through Genial can help guide the surgeon's decision and the surgical route.

This document describes the acceptance criteria and the study proving the device meets them for the "Geniant Cranial (Navigated Neurosurgical Positioning Robot)".

1. Table of Acceptance Criteria and Reported Device Performance

Detailed Performance Results for Geniant Cranial:

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

The document does not specify the exact sample size for the test set used in the accuracy testing. It states that "Koh Young Technology considered all parameters that may influence the stereotactic procedure, which include the different devices, accessories, and components of Geniant Cranial, other influencing devices used in the procedure that are validated to be compatible with Genial, and other elements of the surgical environment" and that the testing was performed "Under the representative worst-case configuration considering an actual clinical procedure".

The data provenance is not explicitly stated as retrospective or prospective, nor does it specify the country of origin. However, given that these are non-clinical performance and accuracy tests, the data likely originates from internal lab testing conducted by the manufacturer, Koh Young Technology Inc. (Republic of Korea).

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

The document does not provide information on the number of experts used or their qualifications for establishing the ground truth for the non-clinical accuracy test set. As this is a non-clinical, performance-based test measuring instrument accuracy, the ground truth would likely be established through precise metrological measurements rather than human expert interpretation of medical images.

4. Adjudication Method for the Test Set

The document does not mention an adjudication method as it pertains to clinical interpretation or consensus. The described testing is a technical accuracy assessment, and thus, typical clinical adjudication methods (like 2+1, 3+1) are not applicable.

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

No. The provided document does not mention any multi-reader multi-case (MRMC) comparative effectiveness study evaluating human reader improvement with or without AI assistance. The device is a "Navigated Neurosurgical Positioning Robot," which falls under the category of surgical navigation systems and is not an AI-assisted diagnostic imaging interpretation tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone performance study was conducted. The accuracy testing detailed in "Table 3 – Accuracy Testing Result" presents the inherent accuracy of the Geniant Cranial device itself (robot and navigation system) in simulating spatial positioning and trajectory guidance. This testing measures the device's ability to achieve specific positional and angular accuracy independent of a human operator's varying performance, by comparing its output against a known, precise "ground truth" established during the test setup.

7. Type of Ground Truth Used

The ground truth used for the accuracy studies was established through precise physical measurements to determine the true 3D positional and trajectory angle targets. These are technical benchmarks for device performance, not clinical pathology or outcomes data. The study references "ASTM F2554-18 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems" and "ISO 9283:1998 Manipulating industrial robots - Performance criteria and related test methods," indicating that the ground truth was based on metrological standards for robotic and computer-assisted system accuracy.

8. Sample Size for the Training Set

The document does not specify a sample size for a training set. As this device is a surgical navigation robot and not a machine learning/AI diagnostic tool that requires image-based training, the concept of a "training set" in the context of data-driven algorithm development for image interpretation is not directly applicable here. The device's functionality is based on real-time tracking, image reprocessing, and robotic guidance, relying on established geometric and kinematic principles rather than statistical learning from a large training dataset.

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

As explained in point 8, the document does not indicate the use of a "training set" in the context of machine learning. The device's operational principles rely on precise engineering and calibration rather than data-driven training. Therefore, the establishment of ground truth for a training set is not discussed or relevant to the reported performance evaluation.

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FLASH EVD is a stereotactic image guidance system intended for the spatial positioning and orientation of neurosurgical instruments. The device is only indicated for cranial surgery where reference to a rigid anatomical structure can be identified, does not require rigid fixation of the patient, and does not require fixation of a navigated instrument guide to the patient.

FLASH EVD System is a stereotactic image guided surgical navigation system during cranial procedures. The FLASH EVD software assists in guiding surgeons during external ventricular drainage (EVD) catheter placement procedure, also known as a ventriculostomy, is prescribed to relieve elevated intracranial pressure when there is a disruption in the normal flow of cerebrospinal fluid (CSF) within the brain.

The provided text describes the 7D Surgical FLASH EVD System and its 510(k) submission for clearance. However, it does not contain the detailed information necessary to fully answer all aspects of your request, particularly regarding specific acceptance criteria metrics and a multi-reader, multi-case (MRMC) comparative effectiveness study.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application, K192945) through non-clinical testing.

Here's a breakdown of what can be extracted and what information is missing based on your prompts:

1. Table of Acceptance Criteria and Reported Device Performance

The document specifies "System Accuracy Requirement" for the predicate device, which the FLASH EVD System also adopts as "Same as K192945." These are the closest things to acceptance criteria mentioned.

Note: The document states that "Device performance tests were performed to verify the absolute accuracy and repeatability of the accuracy of the device, and the navigation accuracy according to ASTM F2554-10." It also mentions "Target Registration Error (TRE) and Trajectory Angular Error (TAE) have been used to evaluate the clinical accuracy of the system on phantom models in a clinical simulated environment." However, the specific numerical results for these tests are not provided in the summary, only a general "All accuracy specifications have been met." conclusion.

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

• Test Set Sample Size: Not explicitly stated. The testing was described as "Non-Clinical Performance Surgical Simulations Conducted on Phantom Models."
• Data Provenance: The testing was conducted on "phantom models" in a "clinical simulated environment." The origin of data for clinical performance (i.e., human subject data) is not applicable as a clinical trial was not required. The manufacturer is 7D Surgical ULC, located in Toronto, ON, Canada, which suggests the development and non-clinical testing likely occurred there.
• Retrospective or Prospective: Not applicable, as the testing was on phantom models, not patient data in a retrospective or prospective manner.

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

• This information is not provided. The ground truth for the non-clinical accuracy testing (TRE and TAE on phantom models) would typically be established through precise physical measurements or a CAD model of the phantom, rather than expert consensus on medical images.

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

• Not applicable. Adjudication methods like 2+1 or 3+1 are primarily used for reviewing patient images by multiple experts to establish ground truth for AI model performance. Since the testing was non-clinical on phantom models, this type of adjudication is not 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

• No, an MRMC comparative effectiveness study was explicitly NOT done. The document states: "A clinical trial was not required to demonstrate the safety and effectiveness of FLASH EVD. Clinical validation is unnecessary as FLASH EVD does not introduce new indications for use, and device features are equivalent to the previously cleared predicate device identified."
• Therefore, there is no information on how much human readers improve with or without AI assistance, as AI assistance in the context of improving human reader performance on imaging interpretation does not appear to be the primary function or study objective of this surgical navigation system. The system guides surgeons, but it's not described as an AI diagnostic aid for image interpretation.

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

• Yes, the "Non-Clinical Accuracy" testing (System accuracy, TRE, TAE) on phantom models represents a form of standalone performance evaluation of the device's navigation capabilities. The results concluded that "All accuracy specifications have been met."

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

• For the "Non-Clinical Accuracy" tests, the ground truth was based on:
  • Physical measurements/known phantom geometry: "TRE and TAE evaluate the error discrepancy between the position reported by the image guided surgery system and the ground truth position measured physically or otherwise."
  • ASTM F2554-10 Standard: This standard provides a method for objectively measuring positional accuracy.

8. The sample size for the training set

• Not applicable/Not provided. This device is a surgical navigation system, not an AI/ML model for image interpretation that typically requires a large training set of labeled images. While the system uses "preoperatively acquired tomographic data," this is for patient-specific registration and navigation, not for training a generalizable AI model in the typical sense of deep learning. The document describes it as "displaying the locations of tracked navigation tools relative to the patient" and linking "Position and orientation data of the tracked navigation tools to the preoperative image data."

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

• Not applicable/Not provided for the reasons stated in point 8.

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