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

Device Description

The ROSA Brain device is a robotized platform providing guidance of any neurosurgical instruments compatible with the diameter of the adaptors supplied by Medtech (for example, a biopsy needle). The device is composed of a compact robotic arm and a touch screen mounted on a robot stand. Different types of instruments may be attached to the robot arm and changed according to the requirements of the procedure to be completed. ROSA Brain is an image-guided device that assists the surgeon in planning the position of instruments or implants on preoperative or intraoperative images. It provides a stable, accurate and reproducible mechanical guidance in accordance with the planning.

AI/ML Overview

The provided document is a 510(k) premarket notification for the ROSA Brain device. It does not describe a study proving the device meets specific acceptance criteria in the context of diagnostic or AI performance.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (ROSA Surgical Device K101797) based on technological characteristics and non-clinical performance data, primarily related to safety, electrical compatibility, and software validation.

Therefore, many of the requested items (e.g., table of acceptance criteria vs. reported performance, sample sizes for test/training sets, expert ground truth, MRMC study, standalone performance) are not applicable or extractable from this specific document, as it pertains to a different type of device clearance (stereotaxic instrument rather than an AI/diagnostic device).

Here's a breakdown of what can be extracted or inferred from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table of quantitative performance acceptance criteria with corresponding device results in the way it would for an AI or diagnostic device (e.g., sensitivity, specificity, accuracy thresholds). The "performance data" provided relates to compliance with standards and successful software verification/validation.

Acceptance Criteria (related to general device function/safety)	Reported Device Performance
Biocompatibility requirements met (ISO-10993)	Met
Electrical safety (IEC 60601-1)	Complied
Electromagnetic compatibility (IEC 60601-1-2)	Complied
Software Verification & Validation (FDA Guidance, IEC 62304)	Verification activities performed, conformity with user needs/intended use
Mechanical and Acoustic Testing (general function)	Not explicitly detailed in criteria/results but implied by device description and predicate comparison

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

Not applicable in the context of an AI/diagnostic test set. The document refers to "software tests" and "verification tests," but these are functional and safety tests, not performance evaluations against a labeled dataset for an AI algorithm.

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

Not applicable in the context of an AI/diagnostic test set. The device is a surgical guidance robot, not an AI diagnostic tool requiring expert-labeled ground truth for performance evaluation.

4. Adjudication Method for the Test Set:

Not applicable.

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

No. The document explicitly states: "The 510(k) does not contain clinical information for the ROSA Brain." and "The 510(k) does not contain animal study test results for the ROSA Brain." An MRMC study would fall under clinical information.

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

Not applicable for a surgical robotic system. The device is inherently "human-in-the-loop," assisting a surgeon. Its performance is evaluated through functional metrics and its ability to accurately position instruments, not as a standalone diagnostic algorithm.

7. The Type of Ground Truth Used:

For the software verification and validation, the "ground truth" would be the predefined functional requirements and expected outputs of the software modules. The "Conformity of software with the user needs and intended use of the device" serves as the ultimate validation.

For the mechanical and electrical performance, the ground truth is the established standards (e.g., IEC 60601-1) and the physical measurements/outputs of the device to ensure it meets specifications (e.g., accuracy of positioning).

8. Sample Size for the Training Set:

Not applicable. This device is not an AI model that undergoes "training" on a dataset in the conventional sense. The "training" in this context would be the development and testing of the software and hardware components following engineering principles.

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

Not applicable. As above, there's no "training set" in the context of an AI algorithm. The validation of the device's components and system is against design specifications, functional requirements, and established safety/performance standards. The "ground truth" for each specific test during development and verification would be defined by those specifications and the expected, correct behavior or output.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

December 18, 2015

Medtech S.A. Ms. Colette Maurin Regulatory Affairs Director ZAC Eurêka 900 rue du Mas de Verchant 34000 Montpellier, France

Re: K151359

Trade/Device Name: ROSA Brain Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: November 16, 2015 Received: November 20, 2015

Dear Ms. Colette Maurin:

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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 yours,

Carlos L. Pena -S

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K151359

Device Name ROSA Brain

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

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

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Image /page/3/Picture/0 description: The image shows the logo for Medtech. The logo is in blue and consists of the word "medtech" in a sans-serif font. Below the word "medtech" is the phrase "INNOVATIVE SURGICAL TECHNOLOGY" in a smaller font. The logo is simple and modern.

510(k) Summary

This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part §807.92.

SUBMITTER I

Medtech S.A. ZAC Eurêka 900 rue du Mas de Verchant 34000 Montpellier, France Tel +33 (0)4 67 10 77 40 Fax +33 (0)4 67 59 74 18

Contact Person: Colette Maurin Requlatory Affairs Director c.maurin@medtechsurgical.com

Dated prepared: December 17, 2015

II DEVICE

Name of device: ROSA Brain Common Name: Computer-assisted surgical device Classification name: Stereotaxic Instrument (21CFR 882.4560) Requlatory class: II Code product: HAW

III PREDICATE DEVICE

ROSA Surgical Device, manufactured by Medtech S.A., K101797, cleared September 23, 2010

DEVICE DESCRIPTION IV

The ROSA Brain device is a robotized platform providing quidance of any neurosurqical instruments compatible with the diameter of the adaptors supplied by Medtech (for example, a biopsy needle).

The device is composed of a compact robotic arm and a touch screen mounted on a robot stand. Different types of instruments may be attached to the robot arm and changed according to the requirements of the procedure to be completed.

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Image /page/4/Picture/0 description: The image shows the logo for Medtech. The logo is in blue and consists of the word "medtech" in a stylized font. Below the word "medtech" is the phrase "INNOVATIVE SURGICAL TECHNOLOGY" in a smaller font. The logo is simple and modern, and it conveys a sense of innovation and technology.

The touch screen ensures the communication between the device and its user by indicating the actions to be done as well as by offering various commands.

ROSA Brain is an image-quided device that assists the surgeon in planning the position of instruments or implants on preoperative or intraoperative images. It provides a stable, accurate and reproducible mechanical guidance in accordance with the planning.

An image acquisition of the patient's head (MRI / CT images) is performed prior to surgery and loaded into the device.

In the preoperative phase, the surgeon carries out the surgical planning on the patient images using the device software. The desired surgical parameters for positioning of the surgical instruments are defined (for example: target point, entry point and instrument length).

During surgery, the device provides accurate and rigid quidance of the required instrument according to the previously completed planning.

> INDICATIONS FOR USE

The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurosurqical procedure in which the use of stereotactic surgery may be appropriate.

VI COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Device	ROSA Surgical Device(K101791)	ROSA Brain(submission subject)
Indications for use	Intended to be used in the operatingroom for the spatial positioning andorientation of an instrument holder ortool guide. The system is intended tobe used by neurosurgeons to guidestandard neurosurgical instruments(biopsy needle, stimulation orrecording electrode, endoscope).Indicated for any neurosurgicalcondition in which the use ofstereotactic surgery may beappropriate.	DifferentJustification:Minor rewordingIntended for the spatial positioning andorientation of instrument holders or toolguides to be used by neurosurgeons toguide standard neurosurgical instruments(biopsy needle, stimulation or recordingelectrode, endoscope). The device isindicated for any neurosurgical procedurein which the use of stereotactic surgerymay be appropriate
Where used	Neurosurgical operating room	Identical
User	Neurosurgeon	Identical
General device description	Computer controlledelectromechanical 6-axis multi-jointed arm	Identical
Device	ROSA Surgical Device(K101791)	ROSA Brain(submission subject)
Principle of operation	• Preoperative images• Surgical planning• Patient registration• Guidance of instruments	Identical
	Preoperative images & surgical planning
Preoperative images	3D MRI / CT	Identical
DICOM compliance	DICOM 3.0	Identical
Multimodality fusion	Yes (MRI/CT)	Identical
Planning software	ROSANNA 2.0 (Medtech)	DifferentJustification:Minor changes – Upgraded versionROSANNA BRAIN 3.0 (Medtech)
Integrated planningsoftware	Yes	Identical
Define regions of interest(ROI)	Yes	Identical
Trajectory definition(stereotactic module)	Parameters for planning trajectories:entry point, target point, instrumentlength, diameter, name, color	Identical
Trajectory definition(endoscopy module)	Parameters for planning trajectories:entry point, target point, instrumentlength, diameter, name, securityradius (10mm by default), securityaperture (10° by default)	Identical
Save/load planning	Yes	Identical
	Patient registration
Localization means	Robot arm absolute encoders	Identical
Controller	Axis controller for each jointKinematic transformation betweenthe Cartesian space and joint spaceSupervisor module	Identical
Registration methods	• Fiducial markers• Optical registration device	DifferentJustification:• Fiducial markers• Optical registration device• Stereotactic frame (fiducials mountedon the frame)
Fiducial markersregistration with pointerprobe	Yes	Identical
Optical registration withlaser telemeter	Yes	Identical
Laser class for opticalregistration	2 (complies with 21 CFR 1040.10)	Identical
Cooperative movement	Yes	Identical
Accuracy verification onanatomical landmarks	Yes (navigation probe, laser beam)	Identical
Device	ROSA Surgical Device(K101791)	ROSA Brain(submission subject)
Instruments guidance
Image-guided	Yes	Identical
Display real-timeinstrument position onpreoperative images	Yes	Identical
Mechanical guidance forsurgical instruments	Yes	Identical
Instrument guide positionadjustment	Automatic (robotized)	Identical
Surgeon carries out finalgesture through theinstrument guide withtraditional surgicalinstrument	Yes	Identical
Instrument fixation	Instruments are mounted onto robotarm's flange	Identical
Instrument calibrationmethod	Factory calibration	Identical
Components	Navigation probe Standard tool holder Endoscope holder Optical sensor Fiducial markers Head holder Stereovision system 3D visualization headset Light source	DifferentJustification:Navigation probe Standard tool holder Endoscope holder Optical sensor Fiducial markers Head holder Microdrive holder Leksell frame registration plates The stereovision system, headset andlight source are not part of the device.Registration plates were designed for thestereotactic frame registration method.
Patient immobilization	Yes - The device is attached to thehead holder or the frame via anadaptor	DifferentJustification:Same principle with minor redesign of thehead holder and frame adaptors
Device mobility	Yes - Mobile stand with wheels,immobilized with 3 stabilization feet	DifferentJustification:Same principle with 4 stabilization feetinstead of 3
Vigilance system	Yes - hand control	DifferentJustification:1-pedal footswitch

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Image /page/5/Picture/0 description: The image shows the logo for Medtech. The logo is in blue and consists of the word "medtech" in a sans-serif font. Below the word "medtech" is the phrase "INNOVATIVE SURGICAL TECHNOLOGY" in a smaller, sans-serif font. The logo is simple and modern.

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Image /page/6/Picture/0 description: The image shows the logo for Medtech. The logo is in blue and consists of the word "medtech" in a stylized font. Below the word "medtech" is the phrase "INNOVATIVE SURGICAL TECHNOLOGY" in a smaller font. The logo is simple and modern, and it conveys a sense of innovation and technology.

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Image /page/7/Picture/0 description: The image shows the logo for Medtech, a company that specializes in innovative surgical technology. The logo is in blue and features the company name in a bold, sans-serif font. Below the company name is the tagline "Innovative Surgical Technology" in a smaller font. The logo is simple and modern, and it conveys a sense of innovation and expertise.

PERFORMANCE DATA VII

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

The biocompatibility evaluation for ROSA Brain device has been conducted in accordance with blue book memorandum #G95-1 entitled "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part-1: Evaluation and Testing", May 1, 1995. The evaluation reveals that biocompatibility requirements are met by the ROSA Brain device.

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on ROSA Brain. The device complies with recognized electrical safety standards: IEC 60601-1 standard for electrical safety and IEC 60601-1-2 standard for electromagnetic compatibility.

Software Verification and Validation Testing

Software tests were conducted to satisfy the requirements of the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and IEC 62304 Standard (Medical Device Software - Life Cycle Process). The software was considered as a "major" level of concern, since a failure of the software could result in serious injury or death to the patient.

Software verification activities were performed during the "Design, coding & testing" and "Verification" phases of software lifecycle. Outputs generated during these phases include:

Code walkthroughs ●
Unit test reports
Integration test reports
. System test reports
Overall software test report ●
Verification test reports
Overall software verification report (see ROSA3-052A)

Code inspections and software tests at the unit, integration and system levels were performed according to the Software Test Plan. Verification tests were performed for each software requirements according to the Software Verification Plan.

Conformity of software with the user needs and intended use of the device were performed through the "Validation" phase of the ROSA Brain device.

Mechanical and acoustic testing

The 510(k) does not contain clinical information for the ROSA Brain.

Animal study

The 510(k) does not contain animal study test results for the ROSA Brain.

Clinical Studies

The 510(k) does not contain clinical information for the ROSA Brain.

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Image /page/8/Picture/0 description: The image shows the logo for Medtech. The logo is in blue and consists of the word "medtech" in a sans-serif font. Below the word "medtech" is the phrase "INNOVATIVE SURGICAL TECHNOLOGY" in a smaller font. The logo is simple and modern.

CONCLUSIONS VI

The non-clinical data support the safety of the device and the hardware verification and validation demonstrate that the ROSA Brain Device should perform as intended in the specified use conditions. The non-clinical data demonstrate that the ROSA Brain Device performs comparably to the predicate device that is currently marketed for the same intended use.

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).