The NeuroMate Stereotactic System is intended to be used in a stereotactic neurosuroical operating room for the spatial positioning and onlentation of an instrument holder or tool guide to be used by the surgeon to manually guide standard neurosurgical instruments.

The NeuroMate Stereotactic System, the BRW Stereotactic System and the Compass Stereotactic System are intended for the sterectactic spatial positioning and onlentation of an instrument or tool guide to be used by a surgeon to manually guide standard neurosurgical instruments.

Device Description

The NeuroMate Stereotactic System is a computer controlled image-quided electromechanical multijointed arm. NeuroMate is intended to be used in a stereotactic neurosuroical operating room for the spatial positioning and onlentation of an instrument holder or tool guide to be used by the surgeon to manually guide standard neurosurgical instruments (Figure 1).

NeuroMate assists the surgeon in its operating tasks by providing a stable, accurate, and reproducible mechanical guidance for surgical instruments, while not directly entering in contact with the patient's head. The instrument holder's sterectactic soatial positioning and orientation are determined by the neurosurgeon using an "external" (i.e., not provided by IMMI Inc.) imaging software for stereotactic planning and specific to the intended clinical application.

The NeuroMate Stereotactic System acts like a motorized stereotactic frame driven by the external imaging software supported by a PC or a computer workstation providing visualization of anatomical structures and brain targets specific for the intended application (e.g., 3-D image databases from CT, MR, DSA, PET, SPECT),

Following a carefully prepared stereotactic treatment plan, at the neurosumeon request. the NeuroMate Stereotactic System slowly moves and subsequently nointains an instrument holder proximal to the patient's head: NeuroMate automatically and accurately insure the correct stereotactic angular and spatial positioning of surgical instruments, thereby reducing potential human errors. During most of the duration of a neurosurgical procedure, NeuroMate is motionless and the instrument holder rigidly holds the surgical instrument chosen by the neurosurgeon prior to initiating stereotactic surgery. Only when changing spatial position and/or orientation does NeuroMate actually move. Finally, NeuroMate must be used in conjunction with a stereotactic head ring.

The device operates from a 110V supply, with all of its structure grounded; the device is equipped with a double-insulation 110V/220V transformer. Its main components are:

electronic and PC circuit boards powered by switching power supplies: .
an electromechanical 5-axis multiliointed arm displaced by 24V DC motors: .
a RS-232 computer interface enabling communications with external 4 computers or workstations which operate the external imaging software driving the NeuroMate Stereotactic System.

The NeuroMate Stereotactic System's controller has been specifically developed for surgical applications. It includes several functions at the mechanical and software levels, which, in case of dysfunction, quarantee the patient safety and the medical staff safety.

NeuroMate Stereotactic System's controller is a "distributed controller" comprising the following elements:

an axis controller for each joint: .
a main controller module coordinating NeuroMate's motion; it performs the . necessary transformations between the Cartesian space and joint space;
a field bus linking the main controller to the axis controllers; .
a supervisor module performing all functions related to user interface, and . generating the motion orders for the NeuroMate Stereotactic System to navigate in Cartesian space.

AI/ML Overview

The provided document describes the NeuroMate Stereotactic System and its performance.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" but rather "performance specifications." These are presented as the results of different testing sequences. Based on the "Performance Data" section and Table A (Continued), the following can be constructed:

Performance Metric	Acceptance Criteria (Implicit from Predicate Devices / Performance Specifications)	Reported Device Performance (NeuroMate Stereotactic System)
Location Accuracy	< 1.5 mm (Based on BRW) or < 0.7 mm (Based on COMPASS)	< 0.75 mm (Measured: 0.73 mm)
Angular Accuracy	< 0.5° (Based on BRW)	< 0.14° (Measured: 0.14°)
Repeatability	(Not explicitly stated for predicate devices, but for NeuroMate)	< 0.15 mm (Measured: 0.136 mm)

Note: The acceptance criteria are inferred from the performance data of the predicate devices (BRW and COMPASS) and the "performance specifications" mentioned in the text against which NeuroMate's measured performance is compared. The document states, "The results of these measurements are well within the performance specifications of the device."

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

The document describes pre-clinical testing ("Overall performances... were assessed as a result of different testing sequences") and clinical testing.

Pre-clinical Test Set: No specific sample size (e.g., number of measurements) is explicitly stated for the pre-clinical tests that measured accuracy and repeatability. It's implied these were laboratory measurements.
Clinical Test Set:
- Sample Size: A cohort of 45 patients (16 females; 29 males, mean age 42 years, range 8-75).
- Data Provenance: Prospective, conducted between September 1995 and April 1996, at the Neurosurgery Department of Grenoble University Hospital in France.

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

For the clinical test set: The ground truth for the device's performance in patient procedures was established by the neurosurgeons at Grenoble University Hospital. The document states, "The treatment strategy... are entirely left under the neurosurgeon's control," and "NeuroMate performed as intended and successfully positioned the instrument holder at the required stereotactic spatial and angular position," and "following readjustment judged clinically necessary by X-ray control in-situ." It also mentions " deviations between requested positioning and clinically optimal positioning were < 2mm in 65% of the cases without simulation, and increased to 97% with treatment simulation." This indicates that neurosurgeons made the clinical judgments and assessed the "clinically optimal positioning."
Number of Experts: Not explicitly stated, but it would have been the neurosurgical staff involved in the 45 cases.
Qualifications of Experts: They are referred to as "neurosurgeons" at a university hospital, implying specialized medical training and expertise in neurosurgery. No specific years of experience are provided.

4. Adjudication Method for the Test Set

For the clinical test set: The document implies a form of clinical judgment/adjudication by the operating neurosurgeon(s). The decision for "readjustment judged clinically necessary by X-ray control in-situ" implies the surgeon(s) assessed the initial positioning and decided if it met clinical requirements, potentially using X-ray feedback for confirmation. There is no mention of an independent adjudication panel or a specific numeric rule (like 2+1 or 3+1).

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

There is no MRMC comparative effectiveness study described in the document. The study described is a clinical trial assessing the performance of the NeuroMate Stereotactic System itself, not a comparison of human readers with vs. without AI assistance. The NeuroMate assists the surgeon in positioning, but the decision-making remains with the surgeon. No effect size for human reader improvement with AI assistance is provided.

6. Standalone (Algorithm Only) Performance

The document describes the performance of the device (NeuroMate Stereotactic System) as a standalone system in terms of its mechanical accuracy and repeatability (0.73 mm positioning accuracy, 0.14° angular accuracy, 0.136 mm repeatability). The device "acts like a motorized stereotactic frame driven by the external imaging software." While external software provides the plan, the NeuroMate's physical movement and positioning capabilities (the electromechanical arm) are assessed independently from direct human interaction for its core mechanical performance metrics. However, its clinical effectiveness is still within the human-in-the-loop surgical context.

7. Type of Ground Truth Used

For pre-clinical performance (accuracy, repeatability): The ground truth was known locations in space or the ability to return to the same position, measured in a controlled laboratory setting (likely using precision measurement tools).
For clinical performance: The ground truth was based on clinical assessment and judgment by neurosurgeons, often supported by X-ray control in-situ to determine "clinically optimal positioning" and whether "readjustment" was needed.

8. Sample Size for the Training Set

The document does not mention a training set in the context of machine learning or AI algorithm development. The NeuroMate system is described as a "computer controlled image-guided electromechanical multijointed arm" driven by "external imaging software." While such software might have been developed using training data, the document focuses on the device's mechanical and clinical performance, not the training of an internal AI component.

9. How Ground Truth for the Training Set Was Established

Since no training set for an AI algorithm is described, this information is not applicable based on the provided document. The NeuroMate itself is a robotic arm, not an AI diagnostic/prognostic algorithm that requires a training set in the typical sense.

Summary

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K963256
MAY 9, 1997

SMDA Summary of Safety and Effectiveness - 510(k) Summary

A. Sponsor Information
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Innovative Medical Machines International, Inc. 70 Wainut Street Wellesley, MA 02181 Telephone: 617 239 8108 Contact Person: Dr. Jean-Luc Boulnois President

B. Device Identification

Common/Usual Name: Proprietary Name:

Stereotactic Instrument NeuroMate Stereotactic Svstem

C. Identification of Predicate Device(s)

The NeuroMate Stereotactic System is substantially equivalent to the following previously cleared and currently marketed devices:

BRW Stereotactic System (Radionics: K811452) .
COMPASS Stereotactic System (Stereotactic Medical Systems; K871046) .

D. Device Description

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Image /page/1/Picture/0 description: The image shows a robotic arm in a dark setting. The arm is white and has several joints, giving it flexibility. The arm is positioned in a way that suggests it is reaching out or manipulating something. There is a rectangular object to the right of the arm, which could be a sensor or another part of the robotic system.

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Joint Axis

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Figure 1 : NeuroMate Stereotactic System Geometry

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The treatment strategy, including the choice of the entry point on the patient's head and the associated rectilinear route to reach a pre-selected brain target, are entirely left under the neurosurgeon's control. NeuroMate enables the surgeon to spatially position a surpleal instrument along a virtually infinite number of angular onentations centered onto a pre-selected brain target point.

The device operates from a 110V supply, with all of its structure grounded; the device is equipped with a double-insulation 110V/220V transformer. Its main components are:

electronic and PC circuit boards powered by switching power supplies: .
an electromechanical 5-axis multiliointed arm displaced by 24V DC motors: .
a RS-232 computer interface enabling communications with external 4 computers or workstations which operate the external imaging software driving the NeuroMate Stereotactic System.

NeuroMate Stereotactic System's controller is a "distributed controller" comprising the following elements:

an axis controller for each joint: .
a main controller module coordinating NeuroMate's motion; it performs the . necessary transformations between the Cartesian space and joint space;
a field bus linking the main controller to the axis controllers; .
a supervisor module performing all functions related to user interface, and . generating the motion orders for the NeuroMate Stereotactic System to navigate in Cartesian space.

Performance Data ui

Overall performances of the NeuroMate Stereotactic System were assessed as a result of different testing sequences designed to:

verify the device's technical and functional characteristics . .
verify the operation of the device's safety systems, and .
measure the accuracy and repeatability performances in spatial positioning and . orientation of the multi-jointed arm carrying a specific payload.

The results of these measurements are well within the performance specifications of the device and provide a clear indication of the relatively high spatial accuracy of the NeuroMate Stereotactic System.

t Accuracy may be defined as the success of the device in reaching a known location in space: the measured positioning accuracy was 0.73 mm, and the measured angular accuracy was 0.14°
Repeatability is the ability of the device to return to the same position in space . repeatedly: the measured repeatability was 0.136 mm.
u Clinical Testing

Between Sept. 1995 and Apr. 1996, the NeuroMate Stereotactic System was tested at the Neurosurgery Department of Grenoble University Hospital in France. The objectives of the clinical testing were to establish that the NeuroMate Stereotactic System could

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position an instrument in any required stereotactic spatial position corresponding to predetermined entry and a target points, as determined by the neurosurgeon.

A cohort of 45 patients (16 females; 29 males) with a mean age of 42 years (range 8-75) underwent various stereotactic procedures with the assistance of NeuroMate. The procedures were as follows: biopsy (11 cases), cystemostomy (4 cases), turnoral cyst (1 case), Parkinson (17 cases), electro-encephalogram stimulation for the treatment of acute epilepsy (12 cases).

The stereotactic approaches used included single oblique, double oblique, frontal, lateral, and parietal trajectories corresponding to standard accesses around the patient's head. In all cases, NeuroMate performed as intended and successfully positioned the instrument holder at the required stereotactic spatial and angular position.

As a result of these clinical tests, the benefits of using the NeuroMate Stereotactic System for the positioning of an instrument holder can be summarized as follows:

NeuroMate can access any part of the patient's head for single or multiple . traiectories without the mechanical limitations encountered in the use of frames;
the choice of optimal trajectories adapted to anatomical, functional, and surgical ● considerations is facilitated by the accessibility provided by NeuroMate;
NeuroMate was successful in directly positioning its instrument holder at the . appropriate stereotactic location in 75% of the cases; following readjustment judged clinically necessary by X-ray control in-situ, the requested positioning was achieved in every case (100%);
NeuroMate's simulation capabilities, particularly when bi-planar X-rays are . available in the Operating Room, can significantly enhance the clinical effectiveness of the instrument holder positioning: deviations between requested positioning and clinically optimal positioning were < 2mm in 65% of the cases without simulation, and increased to 97% with treatment simulation;
NeuroMate positioning readjustment immediately prior to surgical treatment . could be easily performed and was judged clinically satisfactory in 94% of cases at the first request, and in all cases at the second request.

G. Substantial Equivalence

The IMMI's NEUROMATE Stereotactic System is substantially equivalent to the BRW Stereotactic System (Radionics; K811452) and the Compass Sterectactic System (Stereotactic Medical Systems; K871046) in terms of its performance data and intended uses. A direct comparison of significant performance data for these predicate devices and for the NeuroMate Stereotactic System is summarized in Table A. A direct comparison of the intended uses is summarized in Table B.

The technical characteristics of the NeuroMate Stereotactic System are equivalent to those of the BRW and Compass Stereotactic Systems. Differences that exist between these devices, relating to technical specifications, materials, physical appearance, and control systems, do not affect the relative safety and effectiveness of NeuroMate,

Image /page/3/Picture/13 description: The image shows a handwritten number "301" at the top, with the number "000049" printed below it. The handwritten number is slightly slanted to the right. The printed number is in a simple, sans-serif font and appears to be part of a document or label.

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Manufacturer	RADIONICS	Stereotactic Medical Systems, Inc.	IMMI, Inc.
Model	BRW CT Stereotactic System	COMPASS StereotacticPositioning System	NEUROMATE StereotacticSystem
K-Number	K811452	K871046
Class	II	II
Head Ring Assembly	Yes (BRW-HR)	Yes	Yes: from other existingmanufacturers
Localizer Ring	Yes (BRW-LR)	Yes	No: use other existingmanufacturer localizers forimages
Rigid connection to table	Yes (Mayfield Assembly)	Yes (Stereotactic Headframe)	Yes: with mechanical frame
Arc System	Yes (BRW-AS: based on AP, LAT,and VERT coordinates convertedinto angular coordinates)	Yes (3-D slide & arc quadrant)	Multi-jointed electro-mechanicalarm; rigid spatial positionlocking
Instrument Holder	Yes (set on Arc System: BRW-AS)	Yes (set on Arc Carrier)	Yes: mounted on 5th joint; rigidinstrument holding
Calibration	Yes	Yes	Yes: register on head ring
Phantom assembly forcalibration	Yes (BRW-PB)	Yes	No
Isocentric target position	Yes	Yes	Yes: Isocentric stereotactictargeting
Trajectory through 2 points	Yes (set up from computer solutionproviding BRW-AS stereotacticsettings)	Yes (set up from computersolution providing precisestereotactic headframe settings)	Yes: different types of possiblemotions

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Table A. Performance Data: Stereotactic Systems

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Manufacturer	RADIONICS	Stereotactic Medical Systems, Inc.	IMMI, Inc.
Model	BRW CT Stereotactic System	COMPASS StereotacticPositioning System	NEUROMATE StereotacticSystem
K-Number	K811452	K871046
Class	II	II
Location accuracy:
Position:Angle:Repeatability:	Position: 1.5 mmAngle: 0.5°	Position: 0.7 mm	Position: < 0.75 mmAngular: < 0.14°Repeatability: < 0.15 mm
Computer and Software	Yes: Calculate target coordinatesrelative to Head Ring from imagedata; calculate arc angles fordesired probe trajectory	Yes: Computer AssistedStereotaxy; calculate headframesettings from image data fordesired trajectory	Yes: Computer AssistedStereotaxy; calculate trajectoryand instrument orientation fromimage data
Motorized Motion	No	Yes: Motorized motion of theheadframe along X, Y,Z through3 stepper motor slides	Yes: Motorized motion of theinstrument holder throughelectro mechanical, 5 axis,multi-jointed arm

Table A (Continued). Performance Data: Stereotactic Systems

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Manufacturer	RADIONICS	Stereotactic MedicalSystems, Inc.	IMMI, Inc.
Model	BRW CT Stereotactic System	COMPASS StereotacticPositioning System	NEUROMATE Stereotactic System
K-Number	K811452	K871046
Class	II	II
Accessibility	From any suitable direction(rotatable head posts on HeadRing)	From any suitable direction	From any suitable direction:displace multi-jointed arm aroundpatient's head avoiding pre-programmed forbidden volumes
Multiple targets	Yes: through one burr hole	Unknown	Yes: through one burr hole
Conventional stereotaxyaccess	Yes	Yes	Yes: universal approachany trajectory
Transnasal pituitary access	Yes	Unknown	Yes
Posterior fossa access	Yes (cervical approaches bylowered/tilted Head Ring)	Unknown	Yes
Full lateral access	Yes	Yes: lateral access	Yes: universal approach
Sterile draping	Yes	Yes	Yes

用品 ്ക് അമ്പ

Table B . Intended Uses: Stereotactic Systems

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Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).