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

Mazor 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.

The Mazor X navigation tracks the position of instruments, during spinal surgery, in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of a patient.

Device Description

The Mazor X system combines robotic trajectory guidance with navigated surgical instruments (either guided or free hand navigation) to enable the surgeon to precisely position surgical instruments and/or implants according to predefined planning. With the imaging capabilities of the system, the user can also visualize the implants on the patients CT. Same as the predicate device the modified Mazor X consists of a workstation with dedicated software, the surgical system, navigation camera, accessories, instruments and disposable kits. The modified Mazor X, the subject of this 510(k) application, introduces software and hardware modifications to the Mazor X System cleared in 510(k) K203005.

AI/ML Overview

The provided text is a 510(k) Summary for the Mazor X System (Mazor X Stealth Edition), detailing its substantial equivalence to a predicate device (K203005). The document focuses on comparing technological characteristics and asserting that modifications do not raise new safety or effectiveness concerns.

However, it does not contain a detailed study proving the device meets specific acceptance criteria in the manner requested by the prompt. This document is a regulatory submission demonstrating substantial equivalence, not a clinical study report with performance metrics like accuracy, sensitivity, or specificity against defined ground truth.

Therefore, many parts of your request for acceptance criteria and study details cannot be fulfilled from the provided text.

Here's what can be extracted and what is missing:

Device: Mazor X System (Mazor X Stealth Edition)

1. Table of Acceptance Criteria and Reported Device Performance

The document describes performance in terms of equivalence to a predicate device rather than specific acceptance criteria for a new study. The closest to "acceptance criteria" related to performance are the accuracy metrics established by the predicate device.

Characteristic	Acceptance Criteria (from predicate)	Reported Device Performance (Modified Mazor X)
Robotic Accuracy	< 1.5 mm mean accuracy	Mean accuracy < 1.5 mm
Navigation Accuracy (Positional Error)	< 2 mm mean positional error	Mean positional error < 2 mm
Navigation Accuracy (Trajectory Error)	< 2° mean trajectory error	Mean trajectory error < 2°
Robotic Depth Accuracy (Facet Decortication)	< 1.5 mm absolute robotic depth error	Absolute robotic depth error < 1.5 mm

Note: The document explicitly states: "A series of performance bench testing demonstrated that the absolute robotic depth error is smaller than ±1.5 mm and that the overall system accuracy is equivalent to the predicate device system accuracy. In addition, the navigation accuracy was tested and found to be equivalent to the navigation accuracy performance of the predicate device (mean positional error <2mm and mean trajectory error of 2°)."

2. Sample Size and Data Provenance

The document mentions "Bench testing" and "Non-Clinical Performance Data" but does not specify the sample size used for these tests (e.g., number of cadavers, phantoms, or clinical cases, if any).
Data Provenance (Country of Origin, Retrospective/Prospective): Not specified. The testing described appears to be laboratory/bench testing, not clinical data from patients.

3. Number of Experts and Qualifications for Ground Truth

Not applicable / Not stated. The ground truth for device accuracy (positional, trajectory, depth) would typically be established by highly precise measurement systems (e.g., optical tracking, CMM) during bench testing, not by human experts interpreting images for diagnostic purposes. The document doesn't describe any human expert review process for determining the accuracy metrics.

4. Adjudication Method for the Test Set

Not applicable. As the ground truth is established via precise measurements in a bench test setting for accuracy, an adjudication method for human interpretation is not relevant.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No evidence of MRMC study. The document describes a robotic and navigation system's accuracy, not a diagnostic or assistive AI system that requires human reader improvement analysis.

6. Standalone (Algorithm Only) Performance

Yes, implicitly. The performance data (robotic and navigation accuracy) are presented as inherent capabilities of the device itself, derived from "bench testing." This would be the "standalone" performance of the robotic system's guidance capabilities.

7. Type of Ground Truth Used

Based on the description of "bench testing" for "robotic depth mean accuracy," "system accuracy," and "navigation accuracy," the ground truth likely involves physical measurements using highly accurate instruments (e.g., CMM, optical trackers, etc.) on phantoms or test setups, calibrated against known standards. It is not expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

Not applicable / Not stated. This document describes a robotic surgical system, not a machine learning or AI model in the sense of one that learns from a "training set" of patient data (e.g., images for diagnosis). The software modifications mentioned are "enhancements to enable extended functionality" and "UX/UI improvements," rather than the introduction of a new AI algorithm requiring a large training dataset with labelled ground truth. The system relies on its inherent mechatronic precision, optical tracking, and image processing capabilities rather than patterns learned from a data training set.

9. How Ground Truth for Training Set Was Established

Not applicable. See #8. No training set is described for an AI/ML model that would require such ground truth establishment.

Summary

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April 7, 2023

Mazor Robotics Ltd. Marina Shkedy Sr. Regulatory Affairs Specialist 1 HaEshel Street (Building C) Caesarea Business Park, 3079830 Israel

Re: K230064

Trade/Device Name: Mazor X System (Mazor X Stealth Edition) Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO, LLZ Dated: December 29, 2022 Received: January 9, 2023

Dear Marina Shkedy:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Shumaya Ali-S

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230064

Device Name Mazor X System (Mazor X Stealth Edition)

Indications for Use (Describe)

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

Mazor X 3D imaging capabilities provide a processing and conversion of 2D fluoroscopic prom standard Carms into a volumetric 3D image. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of high contrast objects.

The Mazor X navigation tracks the position of instruments, during spinal surgery, in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of a patient.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

Applicant name:	Mazor Robotics Ltd.1 HaEshel Street (Building C)Caesarea business Park 3079830, Israel
Contact person(s):	Primary: Marina ShkedyRole: Sr. Regulatory Affairs SpecialistEmail: marina.shkedy@medtronic.comPhone: +972507848810Secondary: Sophie GoraliRole: Regulatory Affairs SpecialistEmail: sophie.gorali@medtronic.com

Date Prepared: April 6th, 2023

Name of Device: Mazor X System (Mazor X Stealth Edition)

Classification Name: Stereotaxic instrument

Classification Code: OLO and LLZ

Device class: II

Regulation number: 882.4560

Panel: Orthopedic

Predicate Devices: Mazor X System (Mazor X Stealth Edition) (K203005)

Intended Use / Indications for Use

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

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The Mazor X navigation tracks the position of instruments, during spinal surgery, in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of a patient.

Device Description

Technological Characteristics

The modified Mazor X device is similar in its technological features to its predicate device, the cleared Mazor X. Both the subject and predicate systems combine robotic and navigation technologies to enable the precise positioning and tracking of surgical instruments or spinal implants during general spinal surgery. Both systems allow registration of image data with patient anatomy by registering the pre-operative CT scan to the intra-operative fluoroscopic scans, and by localizing the position of the 3D patient volume to the robotic system. In both systems, the positioning of surgical instruments and their trajectories are guided by the system in accordance with the planning conducted by the surgeon on the pre-operative CT image. In both systems, the navigation feature provides the option of tracking the surgical instruments during the procedure. Both systems include very similar hardware and software components, including the workstation, the surgical system, navigation camera, accessories, instruments, and disposable kits. The modifications to the cleared Mazor X System, that are the subject of this premarket application,

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include software enhancements to enable extended functionality, compatibility with additional, previously cleared, surgical tools and some minor hardware changes.

However, as explained in more detail below, these differences do not raise new or different questions of safety or effectiveness since the principal technology remains very similar and, in both instances, the key question is whether the robotic and navigation functionalities are accurate. The bench performance testing and human factors validation demonstrated that the modified Mazor X is safe and effective as the predicate device.

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Comparison of the Proposed Mazor X to the Cleared Mazor X System (K203005) is provided below:

Table 0-1: Comparison of the Proposed Mazor X to the Cleared Mazor X System (K203005)

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Technological	Mazor X System		Comparison
Characteristic	Mazor Robotics Ltd.	Mazor Robotics Ltd.
		K203005 (predicate device)
Human Factors	The Mazor X System simplifies theplanning and surgical procedure (pre-intra-operative planning) and providesthe user with additional imagingmodalities (3D Define Scan, AutoSegmentation Process, etc.). Mazor XPlanning facilitates performingmeasurements and calculating angleswithin a specific spinal region ofinterest, in accordance with standardclassifications.	The Mazor X System simplifies theplanning and surgical procedure (pre-intra-operative planning) and providesthe user with additional imagingmodalities (3D Define Scan, AutoSegmentation Process, etc.). Mazor XAlign facilitates performingmeasurements and calculating angleswithin a specific spinal region ofinterest, in accordance with standardclassifications.	Identical

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Substantial Equivalence

The modified Mazor X is as safe and effective as the cleared Mazor X. The modified Mazor X has the same intended uses and indications for use and similar technological characteristics, and principles of operation as its predicate device. The minor technological differences between the modified Mazor X and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the modified Mazor X is as safe and effective as its predicate device. Thus, the Mazor X is substantially equivalent.

Non-Clinical Performance Data

The following testing was conducted to evaluate the device:

Software major level of concern verification and validation testing was conducted as a) required by IEC 62304 and FDA Guidance on General Principles of Software Validation, January 11, 2002.
b) Bench testing was conducted to verify that the design outputs meet the design inputs. The functionality of the new or modified features was tested to ensure that system requirements, software requirements and user needs were met as defined. Specifically, the updated Spine Segmentation feature, the addition of Facet Decortication capability, the integration compatibility of the Medicrea UNiD (K212005) and the Planning mode UX / UI improvements were verified and validated through testing.

Conclusions

The modified Mazor X is substantially equivalent to its predicate, the cleared Mazor X. The modified Mazor X has the same intended use and indications for use and similar technological characteristics, and principles of operation as its predicate device. The minor technological differences between the modified Mazor X and is predicate device, raise no new issues of safety or effectiveness. Non-clinical performance data demonstrate that the Mazor X performs as expected and in a manner that is substantially equivalent to its predicate device. Thus, the Mazor X is substantially equivalent.

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).

TechnologicalCharacteristic	Mazor X SystemMazor Robotics Ltd.	Mazor X SystemMazor Robotics Ltd.K203005 (predicate device)	Comparison
Product Code,Class	OLO and LLZ,Class II	OLO and LLZ,Class II	Identical
Indications forUse	The Mazor X is indicated for precisepositioning of surgical instruments orspinal implants during general spinalsurgery. It may be used in open orminimally invasive or percutaneousprocedures.Mazor X 3D imaging capabilitiesprovide a processing and conversion of2D fluoroscopic projections fromstandard C-arms into a volumetric 3Dimage. It is intended to be usedwhenever the clinician and/or patient	The Mazor X is indicated for precisepositioning of surgical instruments orspinal implants during general spinalsurgery. It may be used in open orminimally invasive or percutaneousprocedures.Mazor X 3D imaging capabilitiesprovide a processing and conversion of2D fluoroscopic projections fromstandard C-arms into a volumetric 3Dimage. It is intended to be usedwhenever the clinician and/or patient	Identical
Technological	Mazor X System	Mazor X System	Comparison
Characteristic	Mazor Robotics Ltd.	Mazor Robotics Ltd.
		K203005 (predicate device)
	benefits from generated 3D imaging ofhigh contrast objects.	benefits from generated 3D imaging ofhigh contrast objects.
	The Mazor X navigation tracks theposition of instruments, during spinalsurgery, in relation to the surgicalanatomy and identifies this position ondiagnostic or intraoperative images of apatient.	The Mazor X navigation tracks theposition of instruments, during spinalsurgery, in relation to the surgicalanatomy and identifies this position ondiagnostic or intraoperative images of apatient.
TargetPopulation	Orthopedic patients	Orthopedic patients	Identical
AnatomicalSites	Spine	Spine	Identical
EnvironmentUsed	Hospital setting (operating room)	Hospital setting (operating room)	Identical
Technological	Mazor X System	Mazor X System	Comparison
Characteristic	Mazor Robotics Ltd.	Mazor Robotics Ltd.
		K203005 (predicate device)
Main system	The Mazor X System consists of the	The Mazor X System consists of the	Identical
components	following components:	following components:
	Workstation	Workstation
	Surgical System 3Define	Surgical System 3Define
	Camera: SR300 model	Camera: SR300 model
	Bed Connecting Unit (e.g., Bed Frame)	Bed Connecting Unit (e.g., Bed Frame)
	Device accessories for spine application	Device accessories for spine application
	Mazor X Navigation Camera and accessories	Mazor X Navigation Camera and accessories
Mechanism of	Computer assisted Stereotaxy:	Computer assisted Stereotaxy:	Identical
Action	Instrument position and trajectory	Instrument position and trajectory
	calculation based on image data &	calculation based on image data &
	instrument tracking based on optical	instrument tracking based on optical
TechnologicalCharacteristic	Mazor X SystemMazor Robotics Ltd.	Mazor X SystemMazor Robotics Ltd.K203005 (predicate device)	Comparison
	navigation. Motorized positioning ofthe Surgical Arm (spine) with toolguide through 6 axes.	navigation. Motorized positioning ofthe Surgical Arm (spine) with toolguide through 6 axes.
Compatibilitywith Medtronicinstruments andtools	Mazor X is compatible with thefollowing Medtronic tools andinstruments:Medtronic Spineinstruments(K182121) Medtronic Navigation NavLockTrackers (K182104) Medtronic Stealth-Midas andStealth Midas MR8 navigateddrill systems (K160713,K183644)	Mazor X is compatible with thefollowing Medtronic tools andinstruments:Medtronic Spineinstruments(K182121) Medtronic Navigation NavLockTrackers (K182104) Medtronic Stealth-Midas andStealth Midas MR8 navigateddrill systems (K160713,K183644)	Similar.Compatibility withadditional, cleared tomarket, Medtronicinstruments and toolsusing the samenavigation technology,enabling tracking theposition of theinstruments in relation tothe surgical anatomy andidentify this position onthe patient images.
TechnologicalCharacteristic	Mazor X SystemMazor Robotics Ltd.	Mazor X SystemMazor Robotics Ltd.K203005 (predicate device)	Comparison
	Medtronic navigated surgical instruments - Trials trackers,Inserters and Disc PrepInstruments (K131425, K163581, K150231) andMedtronic Pedicle Probe (K050438) Medicrea UNiD Analyzer (K212005) Stealth-Midas Rex Drill System (K202552) Medtronic Navigated Anterolateral Disc PrepInstruments (K211441)	Medtronic navigated surgical instruments - Trials trackers,Inserters and Disc PrepInstruments (K131425, K163581, K150231) andMedtronic Pedicle Probe (K050438)	The compatibility with additional, cleared tomarket, tools, does not change the systemindications for use, design or its principles ofoperation and do not raise new questions ofsafety and efficacy.
TechnologicalCharacteristic	Mazor X SystemMazor Robotics Ltd.	Mazor X SystemMazor Robotics Ltd.K203005 (predicate device)	Comparison
	Medtronic Adaptix Interbody System with Titan nanoLOC Surface Technology (K201267) Medtronic CD HORIZO NTM Spinal System (K211596) Medtronic Catalyft PL (K214011) Medtronic Anteralign TL and Voyager FNS (K214011) Anteralign LS (K222383), Capstone PTC implants and Enhanced (size 36, length of 36 mm) Capstone implants (K172199).
TechnologicalCharacteristic	Mazor X SystemMazor Robotics Ltd.	Mazor X SystemMazor Robotics Ltd.K203005 (predicate device)	Comparison
Features	The Mazor X System consists of thefollowing features:• Preoperative planning andoperation• Advanced 3D Visualization(volume rendering)• Robotic guidance and opticalnavigation of surgical tools	The Mazor X System consists of thefollowing features:• Preoperative planning andoperation• Advanced 3D Visualization(volume rendering)• Mazor X Align• Robotic guidance of surgicaltools	Identical
ImagingModalities	• CT and Fluoro based imaging• X-ray based imaging (Planning)	• CT and Fluoro based imaging• X-ray based imaging (planning)	Identical
RegistrationFeatures	• CT-Fluoro Merge Registration• Automatic 3D ImageRegistration (Scan and Plan)	• CT-Fluoro Merge Registration• Automatic 3D ImageRegistration (Scan and Plan)	Identical
TechnologicalCharacteristic	Mazor X SystemMazor Robotics Ltd.	Mazor X SystemMazor Robotics Ltd.K203005 (predicate device)	Comparison
Planning	• Plan Entry and Target Selection	• Plan Entry and Target Selection	Identical
Features	• 3D Model Building	• 3D Model Building
Medical DeviceInterfaces	• O- arm Imaging System• 2D C-Arm• 3D C-Arm	• O- arm Imaging System• 2D C-Arm• 3D C-Arm	Identical
Dimensions	Workstation 1.85 x 1.20 x 0.64 m (6.07 x 3.94 x 2 ft)Surgical System 0.92 x 0.63 x 0.58 m (3.02 x 2.07 x 1.9 ft)Mazor X Navigation Camera (NDI Vega Polaris) 1.9 x 0.65 x 0.61 m (6.2x2.1 x 2 ft)	Workstation 1.85 x 1.20 x 0.64 m (6.07 x 3.94 x 2 ft)Surgical System 0.92 x 0.63 x 0.58 m (3.02 x 2.07 x 1.9 ft)Mazor X Navigation Camera (NDI Vega Polaris) 1.9 x 0.65 x 0.61 m (6.2x2.1 x 2 ft)	Identical
Weight	• Workstation - 185 kg (408 lbs)• Surgical System – 25 kg (55.1 lbs)	• Workstation - 185 kg (408 lbs)• Surgical System – 25 kg (55.1 lbs)	Identical
TechnologicalCharacteristic	Mazor X SystemMazor Robotics Ltd.	Mazor X SystemMazor Robotics Ltd.K203005 (predicate device)	Comparison
	Mazor X Navigation Camera(NDI Vega Polaris) - 75Kg(165.3lbs)	Mazor X Navigation Camera(NDI Vega Polaris) - 75Kg(165.3lbs)
Performance	Mazor X System mean accuracy <1.5mm Navigation Accuracy mean positional error <2mm and mean trajectory error of 2°. Mazor X will also provide Facet Decortication depth accuracy within 1.5mm.	Mazor X System mean accuracy <1.5mm Navigation Accuracy mean positional error <2mm and mean trajectory error of 2°.	Similar. A requirementfor robotic depth meanaccuracy (along thetrajectory) was added forthe Facet Decorticationprocedure since in theFD procedure the roboticarm serves as amechanical stopper. Thecriterion for accuracy isthe same as in thecleared device <1.5 mm.
TechnologicalCharacteristic	Mazor X SystemMazor Robotics Ltd.	Mazor X SystemMazor Robotics Ltd.K203005 (predicate device)	Comparison
A series of performancebench testingdemonstrated that theabsolute robotic deptherror is smaller than ±1.5mm and that the overallsystem accuracy isequivalent to thepredicate device systemaccuracy. In addition, thenavigation accuracy wastested and found to beequivalent to thenavigation accuracyperformance of thepredicate device (meanpositional error <2mm
TechnologicalCharacteristic	Mazor X SystemMazor Robotics Ltd.	Mazor X SystemMazor Robotics Ltd.K203005 (predicate device)	Comparison
			and mean trajectory errorof 2°). The performancetests demonstrated thatthe modified Mazor Xdevice keeps the samerobotic and navigationaccuracy as in thepredicate device and theaddition of accuracyrequirement along thetrajectory doesn't raisenew questions of safetyand efficacy.

TechnologicalCharacteristic	Mazor X SystemMazor Robotics Ltd.		Comparison
	Mazor Robotics Ltd.	K203005 (predicate device)
Cybersecurity	Mazor X system contains externalwired communication interface(ethernet). Mazor X system isdeveloped in accordance with theCybersecurity design controls toensure Mazor X Cybersecurity andmaintain safety and effectiveness,similarly to the currently cleareddevice.	Mazor X system contains externalwired communication interface(ethernet). Mazor X system isdeveloped in accordance with theCybersecurity design controls toensure Mazor X Cybersecurity andmaintain safety and effectiveness,similarly to the currently cleareddevice.	Identical
Standards Met	IEC 62304	IEC 62304	Identical
TechnologicalCharacteristic	Mazor X SystemMazor Robotics Ltd.	Mazor X SystemMazor Robotics Ltd.K203005 (predicate device)	Comparison
Materials	Ultem 1000HU Carbon Fiber Zacton 350 Ketron LSG PEEK NaturalBlack/ TECAPEEK Stainless Steel Aluminum 6061 Polyethylene MedikoteTM C12 (Me-DLC)	Ultem 1000HU Carbon Fiber Zacton 350 Ketron LSG PEEK NaturalBlack/ TECAPEEK Stainless Steel Aluminum 6061 Polyethylene MedikoteTM C12 (Me-DLC)	Identical
Biocompatibility	Materials are biocompatible	Materials are biocompatible	Identical
CompatibilityWith theEnvironment	The Mazor X is compliant with the IEC60601-1-2 (EMC Compatibility)standard.	The Mazor X is compliant with the IEC60601-1-2 (EMC Compatibility)standard.	Identical
TechnologicalCharacteristic	Mazor X SystemMazor Robotics Ltd.	Mazor X SystemMazor Robotics Ltd.K203005 (predicate device)	Comparison
and OtherDevices
Sterility	No new sterilization methods orproducts have been introduced in theMazor X.The reusable accessories are sterilizedby steam sterilization, single-usedisposable kits by gamma radiation,and sterile covers (e.g., Sterile Sleevefor Surgical Arm) by ETO sterilization.Mazor X navigation tools are sterilizedwith the Medtronic Sofamor Danekspine instruments(K182121) andMedtronic Navigation NavLock tools(K182104).	No new sterilization methods orproducts have been introduced in theMazor X.The reusable accessories are sterilizedby steam sterilization, single-usedisposable kits by gamma radiation,and sterile covers (e.g., Sterile Sleevefor Surgical Arm) by ETO sterilization.Mazor X navigation tools are sterilizedwith the Medtronic Sofamor Danekspine instruments(K182121) andMedtronic Navigation NavLock tools(K182104).	Identical
TechnologicalCharacteristic	Mazor X SystemMazor Robotics Ltd.	Mazor X SystemMazor Robotics Ltd.K203005 (predicate device)	Comparison
Electrical Safety	Power Requirements:• 110-120 VAC, 60 Hz• 220-240 VAC, 50 Hz• 100 VAC, 50/60 Hz• Maximum Power = 1000 VAThe Mazor X System is compliant withthe IEC 60601-1 (Electrical Safety) std.	Power Requirements:• 110-120 VAC / 60 Hz• 220-240 VAC / 50 Hz• Maximum Power = 1000 VAThe Mazor X System is compliant withthe IEC 60601-1 (Electrical Safety) std.	Extended power range tosupport additionalmarkets
MechanicalSafety	The Mazor X System is compliant withthe IEC 60601-1 (Electrical Safety)standard.	The Mazor X System is compliant withthe IEC 60601-1 (Electrical Safety)standard.	Identical
Chemical Safety	Not Applicable	Not Applicable	Identical
Thermal Safety	The Mazor X System is compliant withthe IEC 60601-1 standard.	The Mazor X System is compliant withthe IEC 60601-1 standard.	Identical
Technological	Mazor X System	Mazor X System	Comparison
Characteristic	Mazor Robotics Ltd.	Mazor Robotics Ltd.
		K203005 (predicate device)
RadiationSafety	The Mazor X System is compliant withthe IEC 60601-1-2 (EMC) standard.	The Mazor X System is compliant withthe IEC 60601-1-2 (EMC) standard.	Identical
Laser Safety	The Mazor X System is compliant withIEC 60825-1 (2014) (Safety of laser)standard.	The Mazor X System is compliant withIEC 60825-1 (2014) (Safety of laser)standard.	Identical