neuromate Gen III by Renishaw Mayfield Sarl

Stereotactic spatial positioning and orientation of an instrument holder or tool guide to be used by a surgeon to manually guide standard neurosurgical instruments.

neuromate Gen III has been validated with the Leksell Stereotactic System Type G (comprising of head frame and CT Localizer).

Device Description

A stereotactic system with an electromechanical, multi jointed arm for spatial positioning and orientation of an instrument holder or tool-guide. Guidance is based on a preoperative plan developed with three-dimensional imaging software. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments.

AI/ML Overview

The provided text is a 510(k) Pre-market Notification for the neuromate Gen III device. It details the device's technical characteristics and compares it to a predicate device to establish substantial equivalence. However, the document does not include information about AI/ML models, multi-reader multi-case (MRMC) comparative effectiveness studies, or the types of clinical studies typically associated with proving the performance of AI-powered diagnostic devices.

The "study" referenced in the document is a performance validation of the mechanical accuracy of the stereotactic system, rather than an AI model.

Therefore, for your request, I will explain why many of the requested fields cannot be filled based on this document and address the parts that can be inferred.

This device (neuromate Gen III) is a stereotactic instrument, not an AI or imaging diagnostic device. The "validation" studies described relate to the mechanical accuracy and software performance of the medical device itself, not to the performance of an AI model in interpreting medical images or assisting human readers.

Acceptance Criteria and Device Performance (Based on "Performance Validation" of the Mechanical System)

The document describes "Performance Validation" of the neuromate Gen III system, focusing on its accuracy in the context of stereotactic surgery. This is about the mechanical accuracy of the robot.

Acceptance Criteria (Implied)	Reported Device Performance
Accuracy of the system for stereotactic positioning.	"The accuracy of the system complies with its claimed performances."
Equivalence in performance to the predicate system (K132755).	"is equivalent to those of the predicate system."
Specific Accuracy Claim (from Table comparison with predicate)	In Frame-based mode: < 2 mm (0.079 inches) and 2° between the position reached by the instrument and the actual target. (This is the "Overall positioning accuracy (including imaging)" for the neuromate Gen III.)

Explanation for Missing Information:

For the following points, the information is not present in the provided document because the device is a mechanical stereotactic system and not an AI-based diagnostic device where such information would typically be collected.

Sample size used for the test set and the data provenance: Not applicable. The "performance validation" here refers to testing the mechanical and functional accuracy of the device, not an AI model on a dataset of patient scans. The document mentions validation "with the Leksell Stereotactic System Type G (comprising of head frame and CT Localizer)," implying a physical setup for testing accuracy rather than a data set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a mechanical device's accuracy is established through engineering measurements and metrology, not expert review of images.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This device does not involve AI assistance for human readers in image interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no AI algorithm being evaluated for standalone performance. The device is a surgical robot guided by a surgeon.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the performance validation of this device would be precise mechanical measurements and engineering specifications for positioning accuracy, not medical diagnoses or pathology reports.
The sample size for the training set: Not applicable. This document describes a medical device, not a machine learning model, so there is no "training set."
How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission for a stereotactic surgical instrument, which is a mechanical robot used in neurosurgery. While it discusses software verification and validation (for the control software, including the new neuro|inspire planning software), it does not involve a study of an AI model's performance on medical imaging data or its impact on human readers. Therefore, the majority of the acceptance criteria and study details relevant to AI/ML devices cannot be found or inferred from this document. The "Performance Validation" mentioned pertains to the physical and computational accuracy of the robot's positioning capabilities.

Summary

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April 24, 2018

Renishaw Mayfield Sarl Stéphane Vinot Quality Assurance & Regulatory Affairs Manager 31. Rue Ampère Chassieu, 69680 Fr

Re: K180206

Trade/Device Name: neuromate Gen III Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: January 4, 2018 Received: January 24, 2018

Dear Stéphane Vinot:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.

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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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael J. Hoffmann -S

for 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) K180206

Device Name neuromate Gen III

Indications for Use (Describe)

Stereotactic spatial positioning and orientation of an instrument holder or tool guide to be used by a surgeon to manually guide standard neurosurgical instruments.

neuromate Gen III has been validated with the Leksell Stereotactic System Type G (comprising of head frame and CT Localizer).

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CEB 801 Subpart D)	Over-The-Counter Use (21 CER 801 Subpart C)

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510(k) SUMMARY

1. SUBMITTER:
  RENISHAW mayfield S.A.R.L. 31, rue Ampère 69680 Chassieu FRANCE 011-33 4 37 23 89 00 Phone: 011-33 4 78 90 75 22 Fax:

Contact person:

Stéphane Vinot Quality Assurance & Regulatory affairs Manager quality@renishawmayfield.com

Preparation date:

January 4th, 2018

2. DEVICE NAME:

Trade name:	neuromate® Gen III
Common name:	neuromate Gen III stereotactic system
Classification :	Regulation: 882.4560 Stereotaxic Instrument
Product Code:	HAW - Neurological Stereotaxic Instrument

3. PREDICATE DEVICE(s):

K132755 - neuromate Frameless Gen II - RENISHAW Mayfield S.A.R.L.

4. REFERENCE DEVICE:

K163666 - neuro | inspire™ - Renishaw plc.

Renishaw Mayfield sarl

31 rue ampère F-69680 Chassieu - France Téléphone +33 (0) 4 37 23 89 00 +33 (0) 4 78 90 75 22 Fax

RCS Lyon 480 820 307 SIRET 48082030700027 APE 3250A Nº identification TVA FR26 480 820 307 Capital : 250 000 €

Société Générale Lyon République Code Banque 30003 Code guichet 01200 Nº compte 00020839167 Clé 57 IBAN FR76 30003 01200 00020839167 57 BIC SOGEFRPP

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5. DEVICE DESCRIPTION:

6. INDICATION FOR USE:

Stereotactic spatial positioning and orientation of an instrument holder or tool guide to be used by a surgeon to manually guide standard neurosurgical instruments.

neuromate Gen III has been validated with the Leksell Stereotactic System Type G (comprising of head frame and CT Localizer).

7. COMPARISON WITH PREDICATE DEVICE:

The neuromate Gen III system (this submission) has the same intended use and the same fundamental scientific technology as the predicate device cleared under K132755.

The differences between the two devices are about the use of a new planning software named neuro|inspire (reference device K163666).

. Substitution of neuro|inspire planning software in the system:
The predicate device used a software package called VoXim as the planning software application. The neuromate Gen III (this submission) uses a planning software package called neuro|inspire (replacing Voxim). neuro|inspire contains a subset of functionalities of Voxim.

Moreover, the PC provided with the workstation has been changed to support the neuro|inspire software.

The proposed neuromate Gen III (this submission) is identical in design, intended use, construction and operation to the predicate K132755.

The itemised comparison between the device and its predicate is provided in the following paragraph 7 (Substantial Equivalence Summary) of this document.

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Device	neuromate Gen III (thissubmission)	neuromate Frameless Gen II(510(k) K132755)	SE
Manufacturer	RENISHAW mayfield	RENISHAW mayfield	Same
	Intended Use
Intended Use	Stereotactic spatialpositioning and orientation ofan instrument holder or toolguide to be used by asurgeon to manually guidestandard neurosurgicalinstruments.	Stereotactic spatial positioningand orientation of an instrumentholder or tool guide to be usedby a surgeon to manually guidestandard neurosurgicalinstruments.	Same
Indication for use
Indicationfor use	Stereotactic spatialpositioning and orientation ofan instrument holder or toolguide to be used by asurgeon to manually guidestandard neurosurgicalinstruments.neuromate Gen III has beenvalidated with the LeksellStereotactic System Type G(comprising of head frameand CT Localizer).	Stereotactic spatial positioningand orientation of an instrumentholder or tool guide to be usedby a surgeon to manually guidestandard neurosurgicalinstruments.	SE
Clinicalapplication	Neurological surgery	Neurological surgery	Same
Sites of use	Operating rooms	Operating rooms	Same
User	Neurosurgeon	Neurosurgeon	Same
Anatomicalsite	Head	Head	Same
Principle ofoperation	Patient imaging data isvisualized on the suppliedworkstation runningneuro inspire software. It isthe surgeon who chooses thetool, trajectory, point ofaccess and orientation.The data is communicated tothe robot which located thetool holder accordingly andaccurately.The surgeon performs theprocedure by inserting toolsthough the tool-holder, therobot ensures the continuedstability of the position.	Patient imaging data isvisualized on the suppliedworkstation running the VoXimsoftware. It is the surgeon whochooses the tool, trajectory,point of access and orientation.The data is communicated tothe robot which located the toolholder accordingly andaccurately.The surgeon performs theprocedure by inserting toolsthough the tool-holder, the robotensures the continued stabilityof the position.	SE
Registrationmethods	Framebased mode: thepatient wears a stereotacticframe and the frame isattached to the robot	Framebased mode: the patientwears a stereotactic frame andthe frame is attached to therobot (mechanical registration)Frameless mode: The patientwears a light-weight microphoneframe and the registration ismade by ultrasound.	SE
Frame typeindicated	Leksell StereotacticSystem Type G (head ringand CT localizer).	Leksell Stereotactic SystemType G (head ring, CT andMRI localizers from Elekta)+ CRW (head ring with MRIand CT localizers fromIntegra)+ Fischer (head ring with CTlocalizer from Inomed)	SE
Technical Characteristics
Generaldevicedescription	Computer-controlledelectromechanical multi-jointed arm	Computer-controlledelectromechanical multi-jointedarm	Same
System	• A robot, made of acomputer-controlled	• A robot, made of a computer-controlled articulated	Same
Architecture	articulated motorized armand the base that supportsit and contains the controlelectronics;• A workstation on whichruns software for scannedimage processing,procedure planning, robotconfiguration, robot controland system diagnostic;• A series of attachments toconnect the robot to thepatient, to perform patientregistration and to supportthe tools used by thesurgeon.	motorized arm and the basethat supports it and containsthe control electronics;• A workstation on which runssoftware for scanned imageprocessing, procedureplanning, robot configuration,robot control and systemdiagnostic;• A series of attachments toconnect the robot to thepatient, to perform patientregistration and to support thetools used by the surgeon.
Axis controltechnology	Incremental digital encodersAbsolute digital encoders	Incremental digital encodersAbsolute digital encoders	Same
Compliancewithvoluntarystandards	YesIEC 60601-1: 2005 + AC1 +AC2 + A1: 2012IEC 60601-1-2: 2007ISO 14971: 2007IEC 62304: 2006IEC 62366: 2007ISO 17665-1: 2006DICOM 3	YesIEC 60601-1: 2005 + AC1 +AC2 + A1: 2012IEC 60601-1-2: 2007IEC 60601-1-4: 2000ISO 14971: 2007IEC 62304: 2006IEC 62366: 2007ISO 17665-1: 2006DICOM 3	SE
Maximuminstrumentpayload	Maximum useful load: 5 kg(11 lb)1 kg (2.2 lb) for maximumaccuracy	Maximum useful load: 5 kg (11lb)1 kg (2.2 lb) for maximumaccuracy	Same
Workingvolume(subset of theabove inwhich thepositioningaccuracy isachived)	20 cm (~8") long, 18 cm (7")diameter horizontal cylinderorientedalong the robot axis and withitscentre 81 cm (~32") from thebase.	20 cm (~8") long, 18 cm (7")diameter horizontal cylinderorientedalong the robot axis and with itscentre 81 cm (~32") from thebase.	Same
Overallpositioningaccuracy(includingimaging)	In Frame-based mode: $< 2 mm (5/64")$ .maximum error: $2 mm (0.079")$ and $2°$ between theposition reached by theinstrument carried by the armand the actual target.	In Frame-based mode: $< 2 mm (5/64")$ .In Frameless mode: $< 3 mm (1/8")$	SE

8. SUBSTANTIAL EQUIVALENCE SUMMARY:

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9. NO CLINICAL TESTING

SoftwareVerificationandValidation	The neuromate Gen III software including neuro inspire planning weredesigned, verified and validated in accordance with IEC 62304: 2006and General Principles of Software Validation; Final Guidance forIndustry and FDA Staff.
	Verification and validation confirmed that the neuromate Gen IIIsoftware are safe and effective.
ElectricalSafetyVerification	The neuromate Gen III system was tested in accordance with IEC60601-1:2005 + AC1 + AC2 + A1: 2012.
	Test results confirmed that the neuromate Gen III complies with thisstandard.
PerformanceValidation	The neuromate Gen III system was validated with the LeksellStereotactic System Type G (comprising of head frame and CTLocalizer).
	The result of this validation confirmed that the accuracy of the systemcomplies with its claimed performances and is equivalent to those ofthe predicate system.
UsabilityValidation	The neuromate Gen III interface including neuroinspire was validatedin accordance with Usability Engineering standard IEC 62366: 2007.
	This validation confirmed that the use of the neuromate Gen III doesnot pose an unacceptable risk.

10. CONCLUSIONS FROM TESTING

Verification and validation activities were conducted to establish the performance and safety characteristics of the neuromate Gen III system.

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The results of these activities demonstrate that the neuromate Gen III is safe and effective and performs at least as safely and effectively as the predicate marketed device.

Therefore, the neuromate Gen III is considered substantially equivalent to the predicate device.

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).