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

Renaissance X 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 X System hosts guidance for spine procedures and intraoperative 3D image processing capabilities. It enables the surgeon to precisely position surgical instruments and/or implants. The planning of the surgical procedure and virtual placement of surgical instruments and/or implants (e.g., a screw) can be achieved through pre-operation planning based on the patient's CT scan or intra-operative planning based on Renaissance X 3D Scan image or on a 3D image uploaded from an external 3D image acquiring system. With the imaging capabilities of the system the user can also visualize the implants on the patients CT.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Mazor Robotics Ltd.'s Renaissance System, but it does not contain information about acceptance criteria or a specific study proving the device meets those criteria, especially in the context of AI performance metrics like sensitivity, specificity, or AUC.

The document primarily focuses on regulatory approval, substantial equivalence to a predicate device, and general performance testing (software validation, accuracy/repeatability, rigidity, collision avoidance). These are device-level safety and functional tests, not typically clinical performance studies that establish detailed acceptance criteria for diagnostic or AI-driven performance.

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

Missing Information (and why it's missing from this document):

A table of acceptance criteria and the reported device performance: This document does not specify quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy). The "Accuracy and Repeatability Testing" mentioned would likely have internal, engineering-level acceptance criteria (e.g., +/- X mm deviation), but these are not disclosed.
Sample sized used for the test set and the data provenance: Not mentioned, as no specific clinical performance study for an AI component is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method: Not mentioned.
Multi Reader Multi Case (MRMC) comparative effectiveness study: Not mentioned. The focus is on the device's functionality, not how it improves human reader performance with AI assistance.
Standalone (i.e. algorithm only without human-in-the loop performance) study: Not mentioned.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not mentioned.
The sample size for the training set: Not mentioned.
How the ground truth for the training set was established: Not mentioned.

What can be inferred/extracted from the document regarding "performance testing" (though not directly "acceptance criteria" in the AI sense):

The document lists "Performance Testing" undertaken, which includes:

Software validation testing: "demonstrate that the modified software version meets its design requirements."
Accuracy and Repeatability Testing: "demonstrate that the Renaissance X System has maintained the required accuracy, as specified in the device design requirement. These tests have established that the system is accurate every time as an integrated system, including the full assembly as will be performed in the Operating Room, and that it is able to repeatedly perform in the same standard when required." (No specific metrics or acceptance values are given).
Rigidity Testing: "These tests demonstrate the mechanical integrity of the Renaissance X System. It shows that the system's design meets the functional requirements with safety margins."
Collision Avoidance Testing: "these tests validates the system's ability to avoid collisions in the operating field, both with the patient and various objects used during the operation."

Summary of what's provided vs. requested:

The provided document details the regulatory clearance (510(k)) of the Renaissance System, emphasizing its substantial equivalence to a predicate device and its overall safety and functional performance tests. It states that "dence X 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." However, it does not delineate specific (AI-related) acceptance criteria or detailed study results for its imaging or surgical guidance capabilities in the way a clinical trial or AI validation study would. The performance tests listed are general engineering and software validation tests, not clinical performance metrics against a defined ground truth.

Summary

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

September 10, 2014

Mazor Robotics Ltd. % Ahava Stein Regulatory Consultant A. Stein-Regulatory Affairs Consulting Ltd. 20 Hata'as St. (Beit Hapaamon, Suite 102) Kfar Saba 44425 Israel

Re: K140167

Trade/Device Name: Renaissance System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO, HAW, LLZ Dated: August 3, 2014 Received: August 11, 2014

Dear Ahava 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. 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

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(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 (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 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/Resourcesfor You/Industry/default.htm. 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 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,

Lori A. Wiggins -S

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

K140167 510(k) Number (if known):

Device Name:

Renaissance System

Indications for Use:

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

Over-The-Counter Use (Optional Format Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

K140167

(Premarket Notification [510(k)] Number)

1. Submitter Information Manufacturer Name and Address Official Correspondent Mazor Robotics Ltd. Ahava Stein PO Box 3104, A. Stein - Regulatory Affairs Consulting Ltd. 7 HaEshel St., 20 Hata'as St. (Beit Hapaamon, Suite 102) Caesarea Park South 38900, Kfar Saba 44425, Israel Israel 2. Date Prepared: July 28, 2014 3. Device Name Renaissance X System Proprietary Name: Renaissance X System Common Name: Combination of: Spinal/Orthopedic Stereotaxic instrument; and 1. 2. System, Image Processing, Radiological FDA Classification 21 CFR 882.4560; Stereotaxic instrument Name:

FDA Classification: Class II, Product Code OLO, HAW and LLZ

4. Predicate Devices

The Renaissance System is substantially equivalent to the following devices:

Manufacturer	Device	510(k)	Date Cleared
Mazor Robotics Ltd.	Renaissance System	K113228	December 1, 2011

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ട്. Device Description

Indications for Use 6.

7. Performance Standards

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

8. Performance Testing

The following Performance tests were performed on the Renaissance X System:

Software validation testing in accordance with the FDA Guidance for the ● Premarket Submissions for Software Contained in Medical Devices (May 11, 2005). The software validation tests demonstrate that the modified software version meets its design requirements.
. Accuracy and Repeatability Testing - these tests demonstrate that the Renaissance X System has maintained the required accuracy, as specified in the device design requirement. These tests have established that the system is accurate every time as an integrated system, including the full assembly as will be performed in the Operating Room, and that it is able to repeatedly perform in the same standard when required.
Rigidity Testing - these tests demonstrate the mechanical integrity of the Renaissance X System. It shows that the system's design meets the functional requirements with safety margins.
. Collision Avoidance Testing - these tests validates the system's ability to avoid collisions in the operating field, both with the patient and various objects used during the operation.

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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 indications for use of the modified Renaissance X System are substantially equivalent to the predicate device cited above.

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).