The Renaissance System is indicated for precise positioning of surgical instruments or implants during general spinal surgery. It may be used in either open 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 device modification of the TenZing system (K102130). which is comprised of the original SpineAssist System and the C-InSight System.

The SpineAssist application enables the surgeon to precisely position surgical instruments or implants during general spinal surgery. This is achieved through preoperation planning and virtual placement of the surgical instrument or implant (e.g., a screw) based on the patients' CT data. During the surgical procedure the pre-planned instrument or implant positions are located and projected on Fluoroscopy images relative to the SpineAssist device position while the SpineAssist arm is then guided to the actual position. The SpineAssist is described in previously cleared 510(k) submissions K033413, K051676, K063607 and K073467.

The C-InSight application is a software based product, which converts a sequence of two-dimensional fluoroscopy images into a 3D volumetric image, intraoperatively. The C-InSight computer is connected to a traditional C-Arm in the operating room and grabs all images from the C-Arm. Using a tracking algorithm, the C-InSight software is able to convert a continuous scan around the region of interest into a 3D image, intra-operatively. The C-InSight is described in the previously cleared 510(k) submission K081672.

The TenZing System cleared in 510(k) submission K102130 is a workstation which contains both the C-InSight and SpineAssist components in one workstation. This allows the physician to perform SpineAssist procedures and C-InSight procedures as independent applications, but using the same workstation console. Furthermore, the TenZing System allows the surgeon to perform SpineAssist procedures and obtain an intra-overative 3D verification image using the C-InSight application. Thus, the surgeon can obtain real time feedback regarding instrument and/or implant positioning.

The modified system is called the Renaissance System. The device modifications include a newly designed workstation (hardware change), a slightly modified SpineAssist Guiding Device (with colored LED lights), and modified software with improved GUI for the original TenZing software (software change) and the ability to perform CT-Fluoroscopy registration using the fluoroscopy images obtained from the C-InSight application (i.e., CT to C-InSight registration).

AI/ML Overview

The provided text describes the Renaissance System, a robotic surgical guidance system for spinal surgery. Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Metric	Reported Device Performance
Software validation (in accordance with FDA Guidance)	Passed: "Software validation testing in accordance with the FDA Guidance for the Premarket Submissions for Software Contained in Medical Devices (January 11, 2002)." (Implicitly, the device met the requirements of this guidance.)
CT to C-InSight Registration Accuracy	Not explicitly stated as an "acceptance criterion" with a specific threshold in the provided text. However, it was a "Performance Test" that the device presumably passed for clearance: "CT to C-InSight Registration Accuracy Testing." (The document implies this test was successfully completed, but specific accuracy metrics are not included in this summary.)
Electrical and Mechanical Safety (IEC 60601-1)	Passed: "IEC 60601-1 Electrical and Mechanical Safety Testing." (Implicitly, the device met the requirements of this standard.)
Electromagnetic Compatibility (IEC 60601-1-2)	Passed: "IEC 60601-1-2 Electromagnetic Compatibility Testing." (Implicitly, the device met the requirements of this standard.)
Substantial Equivalence to Predicate Device (TenZing System K102130)	Achieved: "The technological characteristics, e.g., overall design, materials, mechanism of action, mode of operation, performance characteristics, etc., and the intended use of the Renaissance device are substantially equivalent to the predicate device cited above." (This is the overarching "acceptance" for 510(k) clearance, implying that all performance criteria are consistent with or improved over the predicate.) The FDA confirmed substantial equivalence in the clearance letter.

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

The provided text mentions "Performance Testing" but does not specify the sample size for the CT to C-InSight Registration Accuracy Testing. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective) for any of the performance tests.

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

The document does not provide information regarding the number of experts, their qualifications, or their role in establishing ground truth for any of the performance tests. The focus is on technical compliance and equivalence.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss the effect size of human readers with or without AI assistance. The testing described is primarily focused on the device's technical specifications and safety rather than its impact on human performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The performance testing listed ("Software validation testing," "CT to C-InSight Registration Accuracy Testing," "IEC 60601-1 Electrical and Mechanical Safety Testing," and "IEC 60601-1-2 Electromagnetic Compatibility Testing") primarily describes standalone algorithm and system performance in a technical context. The "CT to C-InSight Registration Accuracy Testing" would specifically assess the algorithm's ability to accurately register CT and C-InSight data without direct human intervention impacting the registration process itself.

7. The Type of Ground Truth Used

For the "CT to C-InSight Registration Accuracy Testing," the type of ground truth is implicit. Typically, such accuracy testing would involve:

Phantom studies: Using a known physical phantom with measurable fiducials where the "true" positions are precisely known.
Reference standard imaging: Using a gold-standard imaging modality (e.g., a highly accurate CT scan) as the 'true' representation against which the system's registration of fluoroscopic images to CT is compared.
The document does not explicitly state whether expert consensus, pathology, or outcomes data were used as ground truth for any of the tests reported here.

8. The Sample Size for the Training Set

The document does not provide any information about a training set or its sample size. The focus is on verification and validation of the modified device rather than the development of a new AI model with training data.

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

Since no information on a training set is provided, there is no information on how its ground truth was established. This device submission is for a modification of an existing system (TenZing) and primarily focuses on technical and safety testing of the modifications, not the development of a new AI algorithm requiring a specific training dataset and ground truth establishment methodology.

Summary

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K110911

SECTION 7 - SUMMARY OF SAFETY AND EFFECTIVENESS

APR 28 2011

(Premarket Notification [510(k)] Number)

1. Submitter Information

Manufacturer Name & AddressMazor Robotics Ltd.7 HaEshel Str.P.O.B. 3104Southern Caesarea Industrial Park, 38900ISRAEL	Official CorrespondentAhava SteinA. Stein - Regulatory Affairs Consulting Ltd.20 Hata'as St.Kfar Saba 44425Israel
2. Date Prepare:	March 2011
3. Device Name
Proprietary Name:	Renaissance System
Common / UsualName:	Combination of:1. Spinal Stereotaxic instrument; and2. 3-D Reconstruction Tool for Mobile X-Ray Devices
FDA ClassificationName:	1. 21 CFR 882.4560; Stereotaxic instrument2. 21 CFR 892.2050; System, image Processing, Radiological

Class II, Product Code HAW and LLZ FDA Classification:

4. Predicate Devices

The Renaissance System is substantially equivalent to the following device:

Manufacturer	Device	510(k)	Date Cleared
Mazor Robotics	TenZing	K102130	08/26/2010

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5. Device Description

The Renaissance system is a device modification of the TenZing system (K102130). which is comprised of the original SpineAssist System and the C-InSight System.

6. Intended Use / Indications

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

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7. Performance Standards

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

8. Performance Testing

The following Performance tests were performed on the Renaissance System:

Software validation testing in accordance with the FDA Guidance for the . Premarket Submissions for Software Contained in Medical Devices (January 11, 2002).
CT to C-InSight Registration Accuracy Testing .
IEC 60601-1 Electrical and Mechanical Safety Testing �
IEC 60601-1-2 Electromagnetic Compatibility Testing ●

Technological Characteristics Compared to Predicate Device 9.

The technological characteristics, e.g., overall design, materials, mechanism of action, mode of operation, performance characteristics, etc., and the intended use of the Renaissance device are substantially equivalent to the predicate device cited above.

Image /page/2/Figure/10 description: The image contains the number 615 followed by a period. The number is written in a clear, legible font. The number is the main focus of the image.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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 Regulatory Affairs Consulting 20 Hata'as St., Kfar Saba, 44425 ISRAEL

APR 2 8 2011

Re: K110911

Trade/Device Name: Renaissance System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW and LLZ Dated: March 27, 2011 Received: March 31, 2011

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 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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major 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 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence 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.

Mary S Pastel

Mary S. Pastel, Sc.D. 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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SECTION 1 - INDICATIONS FOR USE

510(k) Number (if known):

Device Name:

Renaissance System

Intended Use Statement:

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

Prescription Use V (Per 21 C.F.R. 801 Subpart D) Over-The-Counter Use

(Optional Format Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (CDDB) ○Д / ○

Minny Stadel

Office of In

510K. K110911

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).