The Renaissance System is indicated for precise positioning of surgical instruments or spinal implants during general spinal and brain surgery. It may be used in open or minimally invasive or percutaneous procedures.

Renaissance 3D imaging capabilities provide a processing and conversion of 2D fluoroscopic projections from standard C-Arms into volumetric 3D image. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of high contrast objects.

Device Description

The Renaissance System is a computer controlled miniature medical image-guided surgery (IGS) system which serves as a technological platform for solutions that provide accuracy, precision and accessibility in performing general spinal and brain procedures. The Renaissance System is designed to assist surgeons in precisely guiding handheld surgical tools and/or implants (in spinal surgery) according to a computerized, image-based, pre-operative plan along a given traiectory. The Renaissance System Brain Application was developed based on the same principles of operation for image guided brain surgeries. The Renaissance System Brain Application processes MRI and CT images via proprietary algorithms and based on the preoperative plan the RBT Device is programmed to position its articulating arm and thus the surgical instrument at the desired coordinates. Using a special skull attachment component (i.e., the RBT Base), the RBT Device attaches to the skull in the area where the procedure is being performed, and assists surgeons in precisely positioning the handheld surgical tools according to the computerized, image-based, pre-operative plan.

The main components of the Renaissance System Brain Application include:

A. The RBT Device
B. Workstation Console in the OR and Planning PC Workstation in the physician's office
C. Renaissance Brain Application Accessories including RBT Base, Skull Screws, Guiding Arm, Star Marker, Base Screwdriver, etc.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the Renaissance System with Brain Application, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Predefined Device Specifications)	Reported Device Performance (as stated in the document)
Accuracy of registration process met predefined device specifications.	The accuracy assessment was performed on a human head phantom. The accuracy of the registration process met the predefined device specifications.
Overall mean accuracy of less than 1.5mm in both target plane and target depth (Bench Accuracy Study)	The Renaissance System Brain Application demonstrated an overall mean accuracy of less than 1.5mm in both target plane and target depth.
Overall mean accuracy of less than 1.5mm in both target plane and target depth, and repeatable performance (Cadaver Accuracy Study)	The Renaissance System Brain Application demonstrated an overall mean accuracy of less than 1.5mm in both target plane and target depth, as well as repeatable performance.
Stability of the anchoring system to the skull, with minimal shift and pull-resistance.	The results demonstrated that the anchoring of the Renaissance System Brain Application is stable and pull-resistance.
Software validation according to IEC 60601-1-4 and FDA Guidelines for Pre-Market Submissions for Software	Validation of the device software was performed according to the IEC 60601-1-4 standard and the FDA Guidance for the Content of Pre-Market Submissions for Software Contained in Medical Devices. Each software validation document was written according to the relevant IEEE standard.

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

The document does not explicitly state a specific numerical sample size for a "test set" in the traditional clinical trial sense. The performance evaluations were conducted using:

Human head phantom: Used for the Registration Accuracy Test.
Cadaver brain: Used for the Cadaver Accuracy Study.

The data provenance is not explicitly stated in terms of country of origin of the data. Both studies (phantom and cadaver) would be considered pre-clinical performance evaluations rather than retrospective or prospective clinical studies involving human patients.

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

The document does not mention the use of experts to establish ground truth for the test set. The ground truth for the accuracy studies (phantom and cadaver) would have been established by physical measurements and the known "targets" within these models.

4. Adjudication Method for the Test Set

Not applicable, as there is no mention of human-reviewed ground truth or a need for adjudication in these performance studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of Human Reader Improvement

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission focuses on the performance of the device itself (standalone accuracy and stability) rather than its impact on human reader performance.

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

Yes, standalone performance studies were done. The "Bench Accuracy Study" and "Cadaver Accuracy Study" directly assess the algorithmic and mechanical accuracy of the Renaissance System Brain Application without a human-in-the-loop interacting with the system's output for diagnostic or decision-making purposes. These studies measured the device's ability to precisely guide instruments to a target.

7. The Type of Ground Truth Used

The ground truth used for the performance studies was based on:

Known physical measurements/targets: For the Bench Accuracy Study, the ground truth would be the pre-defined target coordinates and depth in the testing setup.
Known anatomical locations/targets: For the Cadaver Accuracy Study, the ground truth would be specific, identifiable anatomical points or simulated targets within the cadaver brain.
Imaging truth: For the Registration Accuracy Test, the ground truth would be the known spatial relationship between features in the different imaging modalities (MRI, CT) against which the fusion/registration accuracy is measured.

8. The Sample Size for the Training Set

The document does not provide information on the sample size for a training set. This submission is for a medical device that assists in surgery through image guidance and robotics, not a machine learning model that requires a separate training set in the typical sense. The "proprietary algorithms" mentioned would likely have been developed and refined using engineering principles and simulated (or possibly internal, unmentioned) data, but the specific "training set" size is not relevant or disclosed in this context.

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

Not applicable, as a conventional "training set" with established ground truth in the context of machine learning is not discussed or relevant to the information provided for this device submission. The underlying principles for the algorithms would have been established through engineering design, physics, and mathematical modeling, rather than through a labeled training dataset.

Summary

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SECTION 5

510(K) SUMMARY OF SAFETY & EFFECTIVENESS

RENAISSANCE SYSTEM

(WITH BRAIN APPLICATION)

510(k) Number K__(2 08 |2 ﺳﮯ

Applicant's Name:

Company name:	Mazor Robotics Ltd.
Address:	7 HaEshel St.
	PO Box 3104
	Caesarea Park South 38900
	Israel
Tel:	+972-4-6187100
Fax:	+972-4-6187111
E-mail:	ayelet@mazorrobotics.com

Contact Person:

Official Correspondent: Ahava Stein Company name: A. Stein - Regulatory Affairs Consulting Address: Beit Hapaamon (Suite 213) 20 Hata'as Str. (Box 124) Kfar Saba 44425 Israel Tel: + 972-9-7670002 Fax: +972-9-7668534 E-mail: ahava@asteinrac.com

Date Prepared: March 6, 2012

Name of the device: Renaissance System

Trade or proprietary name, if applicable: Renaissance System

Common or usual name: Image Guided Surgery

Establishment Registration No .: 3005075696

Classification Name:

Combination of:

a. Stereotaxic Instrument; and
b. System, Image Processing, Radiological

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Classification: The subject of this 510(k) is the Renaissance System, with the CFR classification sections 882.4560; Stereotaxic Instrument with product code HAW and 892.2050; System, Image Processing, Radiological and product code LLZ.

Predicate Device: The Renaissance System with Brain Application is substantially equivalent to the original Renaissance system (manufactured by Mazor Robotics Ltd., and the subject of 510(k) document no. K113228 and K110911) and to the StealthStation System (manufactured by Medtronic and the subject of 510(k) document no K050438). A comparison table and detailed discussion are presented in Section 12 of this application.

Device Description: The Renaissance System is a computer controlled miniature medical image-guided surgery (IGS) system which serves as a technological platform for solutions that provide accuracy, precision and accessibility in performing general spinal and brain procedures. The Renaissance System is designed to assist surgeons in precisely guiding handheld surgical tools and/or implants (in spinal surgery) according to a computerized, image-based, pre-operative plan along a given traiectory. The Renaissance System Brain Application was developed based on the same principles of operation for image guided brain surgeries. The Renaissance System Brain Application processes MRI and CT images via proprietary algorithms and based on the preoperative plan the RBT Device is programmed to position its articulating arm and thus the surgical instrument at the desired coordinates. Using a special skull attachment component (i.e., the RBT Base), the RBT Device attaches to the skull in the area where the procedure is being performed, and assists surgeons in precisely positioning the handheld surgical tools according to the computerized, image-based, pre-operative plan.

The main components of the Renaissance System Brain Application include:

A. The RBT Device
B. Workstation Console in the OR and Planning PC Workstation in the physician's office
C. Renaissance Brain Application Accessories including RBT Base, Skull Screws, Guiding Arm, Star Marker, Base Screwdriver, etc.

The RBT Device and Workstation Console were previously cleared under K113228 and K110911. This 510(k) submission describes the addition of the new accessories (RBT Base, Skull Screws, Guiding Arm, Star Marker, Base Screwdriver, etc.) which enable increased accessibility for the RBT Device over the skull and the changes in the SW application.

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Indication for Use:

Comparison of Technological Characteristics with the predicate device:

The modified Renaissance System with Brain Application is similar to the original Renaissance System (K113228 and K110911) and to the StealthStation System and Software (K050438) regarding indications for use. All of these devices are intended for precise positioning of surgical tools during surgery and all of these devices may be used in either open or percutaneous (i.e., minimally invasive) procedures. Furthermore, all of the above devices may be used in a surgical procedure where reference to a rigid anatomical structure, such as the spine, skull, hip, etc., can be identified relative to a CT, MR, fluoro or other image. The purpose of this 510(k) was to extend the indications for use of the original Renaissance System to include Brain Application, and thus include brain surgery procedures in which the skull (as the rigid anatomical structure) can be identified, similar to the StealthStation System. The target population (i.e., orthopedic and neurology patients), anatomical sites (i.e., any rigid anatomical structure, such as the spine or skull) and environment of use (i.e., hospital setting) are the same in the new Renaissance System with Brain Application and in the predicate devices.

The modified Renaissance System with Brain Application is identical to the original Renaissance System regarding components, design, materials, and basic scientific technology. The design of the Renaissance System with Brain Application is similar to the design of the original Renaissance System and the StealthStation System, as all systems consist of a planning and execution application and the ability to receive and merge multi-image scans. All of these devices use the same mechanism of action, i.e., computer assisted stereotaxy. The components of the modified Renaissance System with Brain Application are similar to the original Renaissance System, with the addition of new accessories to enable the brain approach, including the RBT Base, Skull Screws, Guiding Arm, Star Marker, Base Screwdriver, etc. The combination of these accessories allows trajectories and range of operation for the device in general brain surgeries. The device features and operational procedure are the same as in the original Renaissance System. Additionally, software modifications were implemented to enable the new brain approach, including a software change enabling fusion/registration between MRU and CT scans for brain procedures. The accuracy of the Renaissance System with Brain Application is the same as previously cleared Renaissance System for spine procedures, i.e., <1.5mm. The new indications for use and the technological modifications including fusion/registration between MRI and CT scans are also substantially equivalent to the StealthStation System (K050438).

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Non-Clinical Performance Data

The following performance tests were conducted on the Renaissance System with Brain Application:

Software validation testing (IEC 60601-1-4 & FDA Guidelines) . 1.

Validation of the device software was performed according to the IEC 60601-1-4 standard and the FDA Guidance for the Content of Pre-Market Submissions for Software Contained in Medical Devices. Each software validation document was written according to the relevant IEEE standard.

The software validation documentation has been prepared for the Renaissance System with Brain Application and software version 3.4.

2. Stability Test

The objective of the Stability Test was to validate the stability of the anchoring system to the skull. The anchoring system consists of the RBT Base mounted on the skull using three Skull Screws. The stability was validated by applying forces in three different planes and measuring the resulting shift in the position of the RBT Base, as well as the pull-out force. The results demonstrated that the anchoring of the Renaissance System Brain Application is stable and pull-resistance.

3. Registration Accuracy Test

The goal of the study was to measure the accuracy of the registration method of the multimodality medical images for the Renaissance System Brain Application. The modalities in question are various types of Magnetic Resonance Imaging (MRI) scans (e.g. proton-density, T1-weighted, T2-weighted) and X-ray Computed Tomography (CT). The accuracy assessment was performed on a human head phantom. The accuracy of the registration process met the predefined device specifications.

Bench Accuracy Study 4.

The objective of the study was to quantify the accumulative error of the system. This was measured based on the deviation of the tool tip from the center of the target, as well as, the measurement of the tip depth. The Renaissance System Brain Application demonstrated an overall mean accuracy of less than 1:5mm in both target plane and target depth.

ર. Cadaver Accuracy Study

The aim of this study was to evaluate the system accuracy and repeatability in simulated clinical conditions, i.e., on a cadaver brain. The Renaissance System Brain Application demonstrated an overall mean accuracy of less than 1.5mm in both target plane and target depth, as well as repeatable performance.

Performance Standards:

There are no performance standards under the Federal Food. Drug and Cosmetic Act, for this type of device.

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Clinical Performance Data

Not Applicable

Conclusions Drawn from Non-Clinical and Clinical Tests:

The performance tests demonstrate that Renaissance System with Brain Application may be safely and effectively used in brain surgical procedures requiring precise positioning of surgical instruments during brain surgery. The software validation and accuracy performance tests demonstrate that the Renaissance System with Brain Application meets its design and performance specifications and is substantially equivalent to the previously cleared Renaissance System.

Substantial Equivalence:

In summary, the indications for use of the modified Renaissance System with Brain Application are substantially equivalent to a combination of the original Renaissance system and the StealthStation device. Furthermore, the basic technological characteristics of the modified Renaissance System with Brain Application are identical to the original Renaissance System and similar in many respects to the StealthStation device. The differences in the technological characteristics do not raise new questions of safety and effectiveness. Consequently, the Renaissance System with Brain Application is substantially equivalent to the predicate devices.

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Mazor Robotics Ltd. % Ms. Ahava Stein Official Correspondent A. Stein - Regulatory Affairs Consulting Beit Hapaamon (Suite 102) 20 Hataas Str. (P.O. Box 124) 444425 KFAR SABA ISRAEL

Re: K120812

Trade/Device Name: Renaissance System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW and LLZ Dated: July 4, 2012 Received: July 9, 2012

Dear Ms. Stein:

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 for ass bared in 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, de Moos that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, dicrororo, marrov also act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such 11 your device is classified (ooo as regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 1 loase of advised that 1 Dr resume that your device complies with other requirements of the Act that I Drimas intact a and regulations administered by other Federal agencies. You must of any I catal statutes and regaranents, including, but not limited to: registration and listing (21 Comply will and the 11th 31et 31equirements, 801 and 809); medical device reporting of

JUL 12 2012

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice mouivents as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirences as begin marketing your device as described in your Section 510(k) premarket with anow you to begally many of your ence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 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/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known):

Device Name: Renaissance System

Indications for Use Statement:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 C.F.R. 801 Subpart D) C)

Over-The-Counter Use (Optional Format Subpart

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Radiological Device: Office of Ir Evaluation and 510K

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).