ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate.

Device Description

ROSA Surgical Device is a computer controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments.

AI/ML Overview

Acceptance Criteria and Study for ROSA Surgical Device

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mean accuracy for in vitro application	Below 2 mm (for both fiducial markers and optical registration)

The acceptance criterion for the ROSA Surgical Device was that its in vitro application accuracy should be below 2 mm, which is stated to be equivalent to other commonly used surgical localization systems. The device met this criterion for both fiducial markers and optical registration methods.

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

Sample Size: A total of 45 measurements were collected for fiducial markers and another 45 measurements for optical registration. This sums to 90 measurements for the test set.
Data Provenance: The data was collected "in vitro," implying it was generated in a controlled laboratory setting using a phantom skull. There is no information regarding the country of origin of the data provided in the document. The study was prospective in the sense that the tests were specifically designed and executed to evaluate the device's performance.

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

The document does not indicate the involvement of human experts to establish the ground truth for the test set. The ground truth was established by precise measurements using a portable CMM (Coordinate Measuring Machine) with a known accuracy.

4. Adjudication Method for the Test Set

No human adjudication method (e.g., 2+1, 3+1) was used for the test set, as the ground truth was established mechanically through a CMM.

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

No MRMC comparative effectiveness study was mentioned. The study focused on the standalone performance of the device and not on human readers' improvement with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was conducted. The "Device performance tests" were explicitly performed to validate the absolute accuracy and repeatability of the robot arm and the application accuracy for both fiducial markers and optical registration. This involved the algorithm and mechanical system alone, without human-in-the-loop performance being assessed in this specific accuracy study.

7. Type of Ground Truth Used

The ground truth used was based on physical, objective measurements of target points in a phantom skull using a high-accuracy mechanical device. Specifically:

A phantom skull featuring small metallic balls was used to materialize target points.
A portable CMM (FARO Titanium arm) with a 50 µm single point accuracy was used to measure the distance between the targeted point and the attained instrument tip position.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for the training set. The ROSA Surgical Device is an electromechanical arm and navigation system, and while it's computer-controlled and uses "calculations," the typical concept of a "training set" for machine learning algorithms (as might be present in AI/ML medical devices) is not explicitly detailed or indicated as relevant for its core accuracy validation in this submission. The validation described is for the precision of the mechanical and navigational components.

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

As no training set is explicitly described or detailed in terms of its ground truth establishment, this information is not available in the provided text. The accuracy study focuses on the device's performance against a known physical ground truth, rather than validating an AI model's training.

Summary

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PREMARKET NOTIFICATION 510(K) SUBMISSION

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ROSA SURGICAL DEVICE

5 - 510(K) SUMMARY

[As Required by 21 CFR 807.92] Summary of Safety and Effectiveness

1	Submitter	MedTech S.A Parc Euromédecine Bâtiment 8 1006 rue de la Croix Verte 34090 Montpellier France
	Contact Person	Bertin NAHUM, President Phone number : (+33) 467 107 740 Fax number : (+33) 467 597 418
	Preparation date	June 10, 2010
	Revision date	July 20, 2010
	Revision date	August 18, 2010
	Revision date	September 02, 2010
2	Device name
	Trade Name	ROSA Surgical Device
	Common Name	Computer-assisted surgical device
	Code product and classification name	Stereotaxic Instrument (HAW), 21 CFR Section 882.4560
3	Predicate devices	ROSA Surgical Device, manufactured by MedTech SAS, K092239, cleared November 17, 2009
		StealthStation Treatment Guidance Platform, manufactured by Medtronic Surgical Navigation Technologies, K001801, cleared June 30, 2000
		VectorVision Cranial / ENT, manufactured by BrainLAB AG, K023651, cleared February 17, 2004
		Frameless Neuromate Stereotactic System, manufactured by Integrated Surgical Systems, Inc., K991081, cleared June 25, 1999
4	Description	ROSA Surgical Device is a computer controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide.
		Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration.
		The system is intended for use by neurosurgeons to guide standard neurosurgical instruments.

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PREMARKET NOTIFICATION 510(K) SUBMISSION ROSA SURGICAL DEVICE

Explanation of how the device operates

ROSA Surgical Device assists the neurosurgeon in planning the position of instruments relative to preoperative images.

Adequate position of the instrument holder is obtained from three-dimensional calculations performed from desired surgical planning parameters and registration of spatial positions of patient head with fiducial markers or a laser telemeter.

When using the fiducial markers registration, ROSA Surgical Device can be shifted into a "cooperative mode" during which the surgeon can manually move the arm anywhere in the operating field by simply grabbing the tip. Pinpoint collection of fiducial markers is carried out with ROSA and its navigation probe with the cooperative mode.

When using the optical registration, ROSA Surgical Device can be shifted into a "cooperative mode" during which the surgeon can manually move the arm with the laser telemeter at its end and digitize selected anatomical landmarks on the patient's head. Then, the robot arm automatically scans an appropriate surface of the patient's head.

ROSA Surgical Device provides a stable, accurate and reproducible mechanical guidance of neurosurgical instruments in accordance with a preoperative planning.

a computer-controlled ROSA Surgical Device is electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide.

Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments.

It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate.

Intended use

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Performance data 6

Testing was carried out to assure compliance with recognized electrical safety standards: IEC 60601-1 standard for electrical safety and IEC 60601-1-2 standard for electromagnetic compatibility.

Tests were also carried out to satisfy the requirements of the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and IEC 62304 (Medical Device Software - Life Cycle Process).

Device performance tests were performed to validate the absolute accuracy and repeatability of the device (robot arm).

Device performance tests were performed to validate the application accuracy of the device for fiducial markers and optical registration.

The test bench permits to simulate a neurosurgical procedure. Test consists in thoroughly following the ROSA stereotactic procedure and measuring the distance between the targeted point and the attained instrument tip position. Equipment for this test includes a phantom skull featuring small metallic balls that materialize target points and a portable CMM for the measures (FARO Titanium arm, 50 um single point accuracy). Application accuracy is computed as the mean distance error for the N targets.

Expected results for ROSA surgical device for an in vitro application should yield a mean accuracy equivalent to other commonly used surgical localization systems: below 2 mm.

For fiducial markers: The mean target localization accuracy was evaluated in vitro on a total of 45 measurements collected by approaching nine targets distributed within a volume comparable to a human head. Average in vitro application accuracy is below than 2 mm.

For optical registration: The mean target localization accuracy was evaluated in vitro on a total of 45 measurements collected by approaching various targets distributed within a volume comparable to a human head. Average in vitro application accuracy is below than 2 mm.

ROSA application accuracy with optical registration ાંક equivalent to the application accuracy of the previous cleared ROSA (below than 2 mm).

Testing protocol

Tests results .

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PREMARKET NOTIFICATION 510(K) SUBMISSION ROSA SURGICAL DEVICE

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7 summary

Substantial equivalence The technological characteristics, features, specifications, materials, mode of operation, and intended use of the ROSA Surgical Device are substantially equivalent to the predicate devices cited above.

The differences that exist between the devices do not raise new issues of safety or effectiveness regarding the ROSA Surgical Device.

COMPARISON TABLE
Reference	FramelessNeuromateStereotacticSystemK991081	VectorVisionCranial / ENTK023651	ROSA SurgicalDeviceK092239	StealthStationTreatmentGuidancePlatformK001801	ROSA SurgicalDevice (for newsubmission)
Design
General devicedescription	Computer controlledelectromechanicalmulti-jointed armindicated for use as astereotacticinstrument	Neuronavigationsystem providinglocalization means forneurosurgicalinstruments	Computercontrolledelectromechanicalmulti-jointed armindicated for use asa stereotacticinstrument	Neuronavigationsystem providinglocalization means forneurosurgicalinstruments	Computercontrolledelectromechanicalmulti-jointed armindicated for use asa stereotacticinstrument
Localization means	Robot arm absoluteencoders	Infrared cameras	Robot arm absoluteencoders	Infrared cameras(NDI Polaris system)	Robot arm absoluteencoders
Image-guided	Yes	Yes	Yes	Yes	Yes
Integrated planningsoftware	No(third-party software)	Yes	Yes	Yes	Yes
Registrationmethod	Bone-mountedultrasound device	Fiducial markers"Softouch"mechanical probesystemLaser scanningdevice (Z-touchsystem)	Fiducial markers	Fiducial markers"Tracer" mechanicalprobe systemLaser registrationdevice (Fazer)	Fiducial markersOptical registrationdevice
Instrumentation	Laser pointerTool holder	ProbesFrameless biopsysystem	Navigation probeTool holder	ProbesFrameless biopsysystem	Navigation probeTool holderLaser pointer
Instrument fixation	Instruments aremounted onto robotarm's flange.	Freehandinstruments.A localizer is attachedto each navigatedinstrument.	Instruments aremounted onto robotarm's flange.	Freehandinstruments.A localizer is attachedto each navigatedinstrument.	Instruments aremounted onto robotarm's flange.
Instrumentcalibration method	Factory calibration	Intra operative	Factory calibration	Intra operative	Factory calibration
Systemimmobilizationbetween the patientand the device	Yes	Not necessarilyA localizer is attachedto the head holder asa reference	Yes	Not necessarilyA localizer is attachedto the head holder asa reference	Yes
PatientImmobilization(head holder)	Yes	Yes	Yes	Yes	Yes
Planning & Navigation Software
Path planning andcontrol Software	VoXimTM(IVS Solutions AG)	VectorVision Flex(BrainLAB)	ROSANNA(MedTech)	StealthStation(Medtronic)	ROSANNA(MedTech)
CT, & MRImodalities	Yes	Yes	Yes	Yes	Yes
Merge images	Yes	Yes	No	Yes	Yes
Save/load path	Yes	Yes	Yes	Yes	Yes
Reference	FramelessNeuromateStereotacticSystemK991081	VectorVisionCranial / ENTK023651	ROSA SurgicalDeviceK092239	StealthStationTreatmentGuidancePlatformK001801	ROSA SurgicalDevice (for newsubmission)
Fiducial markersregistration withpointer probe	No	Yes	Yes	Yes	Yes
Optical registrationwith lasertelemeter	No	Yes	No	Yes	Yes
Registration basedon ultrasoundmeasures	Yes	no	No	No	No
Cooperativemovement	No	No	Yes	No	Yes
Accuracyverification onanatomicallandmarks	Yes (laser pointer)	Yes (pointer probe)	Yes (navigationprobe)	Yes (pointer probe)	Yes (navigationprobe, laser beam)
Display real-timeinstrument positionon preoperativeimages	Yes	Yes	Yes	Yes	Yes
Provide mechanicalguidance forsurgicalinstruments	Yes	No	Yes	Only with theframeless biopsy	Yes
Instrument guideposition adjustment	Automatic (robotized)	Manual	Automatic(robotized)	Manual	Automatic(robotized)
Surgeon carries outfinal gesturethrough theinstrument guide	Yes	Yes	Yes	Yes	Yes
Indication(s) for use
Indication for use	Stereotactic spatialpositioning andorientation of aninstrument holder ortool guide to be usedby a surgeon tomanually guidestandardneurosurgicalinstruments (biopsyneedle, stimulation orrecording electrode,endoscope).	Intended as an aid forprecisely locatinganatomical structuresin either open orpercutaneousprocedures. Indicatedfor any medicalcondition in which theuse of stereotacticsurgery may beappropriate, andwhere a reference toa rigid anatomicalstructure can beidentified to a CT orMR based model.	Intended to be usedin the operatingroom for the spatialpositioning andorientation of aninstrument holderor tool guide. Thesystem is intendedto be used byneurosurgeons toguide standardneurosurgicalinstruments (biopsyneedle, stimulationor recordingelectrode).Indicated for anyneurosurgicalcondition in whichthe use ofstereotactic surgerymay beappropriate.	Intended as an aid forprecisely locatinganatomical structuresin either open orpercutaneousprocedures. Indicatedfor any medicalcondition in which theuse of stereotacticsurgery may beappropriate, andwhere a reference toa rigid anatomicalstructure can beidentified to a CT orMR based model.	Intended to be usedin the operatingroom for the spatialpositioning andorientation of aninstrument holderor tool guide. Thesystem is intendedto be used byneurosurgeons toguide standardneurosurgicalinstruments (biopsyneedle, stimulationor recordingelectrode,endoscope).Indicated for anyneurosurgicalcondition in whichthe use ofstereotactic surgerymay beappropriate.
Anatomical site	Head	Head, ENT	Head	Head, Spine, ENT	Head
User	Neurosurgeon	Neurosurgeon	Neurosurgeon	Neurosurgeon	Neurosurgeon
Associatedequipments	Sterile drapes	Sterile drapesFiducial markersNeurosurgical headholder	Sterile drapesFiducial markersNeurosurgical headholderLight source (forvisualization)	Sterile drapesFiducial markersNeurosurgical headholderSurgical microscope	Sterile drapesFiducial markersNeurosurgical headholderLight source (forvisualization)

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100 2007 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000 1000000000000000000000000000000000000000000000000000000000000000000000000000000000000

PREMARKET NOTIFICATION 510(K) SUBMISSION ROSA SURGICAL DEVICE

Page 10 of 45

・

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SIMILARITIES AND DIFFERENCES

Similarities

All five devices are intraoperative stereotactic instruments used by neurosurgeons for assisting in the spatial positioning and orientation of a neurosurgical instrument.

ROSA Surgical device is substantially equivalent to:

the Neuromate, StealthStation and VectorVision devices for assisting the spatial positioning and orientation of an endoscope (neurosurgical instrument).

the cleared ROSA, Neuromate, StealthStation and VectorVision devices concerning the preoperative planning process. All five take as input data CT or MRI DICOM 3.0 medical images. The neurosurgeon performs its preoperative plan by defining entry and target points on 3D and 2D views. Preoperative plan can be performed the day before surgery.

the cleared ROSA, StealthStation and VectorVision devices concerning the manual registration processes. It uses the same Image Guided Surgery multi-modality fiducial markers and is based on the same mathematical computations (3D rigid transformation). The application accuracy is substantially equivalent.
the StealthStation and VectorVision devices with regard to the optical registration processes. It uses the same Image Guided Surgery multi-modality and is based on the same mathematical computations (3D rigid transformation). The application accuracy is substantially equivalent.
the StealthStation which uses a laser telemeter for the optical registration.
the Neuromate device which provides a laser system for the navigation and accuracy verification.
the cleared ROSA and Neuromate devices as it provides mechanical guidance for neurosurgical instruments and allows optimal access according to patient anatomy. Both are computer controlled electromechanical multi-jointed arms with factory calibrated instruments.
the cleared ROSA Surgical Device as it provides cooperative movement where the surgeon can - the cleared ROOA Ourgour Dowlod in preating field simply by directing the surgical instrument attached to the robot arm.

ROSA Surgical Device combines the planning and registration functionalities of the Neuromate, NOOA Gurgiour Donio combines the pechanical guidance functionality of the cleared ROSA system and Neuromate.

DIFFERENCES

StealthStation and VectorVision devices use a Polaris system (infrared cameras) for locating it Steath Olation and vocuryical and registration instruments held by the surgeon, a localizer is position of the instrument. ROSA and Neuromate devices provide mechanical guidance for attached to the instruments, both are computer controlled electromechanical multijointed arms with embedded sensors to locate the position of instruments.

StealthStation device uses a Polaris system for locating the position of laser telemeter held by the Steath Diation device association. While the VectorVision device uses a Polaris system for locating the position of the laser spot on the patient face.

Neuromate device uses a registration method based on ultrasound measures. Rosa, StealthStation and VectorVision devices provide an optical registration method based on laser measures.

ROSA and Neuromate devices use a mechanical immobilization system between the head holder ROSA and Neuromate devices use a mechanion immobilization one vices provide a localizer attached to the patient head.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Medtech SAS c/o Ms. Cécile Genevieve Quality Regulation Affairs Manager Parc Euromedecine, Bâtiment 8 1006, rue de la croix verte 34090 Montpellier France

Re: K101791

Trade/Device Name: Rosa Surgical Device Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: August 19, 2010 Received: August 23, 2010

Dear Mr. Nahum:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

SEP 2 3 2010

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Rathm of

Malvina B. Eydelman, M.D. Director Division of Ophthalmic. Neurological. and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4 - INDICATIONS FOR USE

510(k) Number (if known): K101791

2 3 2010

Device Name:

ROSA Surgical Device

ROSA Surgical Device is a computer-controlled electromechanical Indications for Use: arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide.

Guidance is based on a pre-operative plan developed with threedimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments.

It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate.

× Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Michael Herman

(Division Sig Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K101791

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).