The VUZE System is intended to enable users to load pre-operative 3D images and planning data and register and overlay this data in real time with intra-operative 2D radiographic images of the same anatomy to support device guidance during interventional spinal procedures. The system also offers pre-operative surgical planning including implant sizing, entry location, and trajectory determination along with intra-operative guidance and tool trajectory / position confirmation.

Device Description

The VUZE System (the "System") enables users to load 3D images and planning data then register and overlay this data in real time with intra-operative 2D radiographic images of the same anatomy. The System supports device quidance during minimally invasive spinal surgery, including the stabilization of the spine by means of fixation. fixation coupled with fusion, vertebroplasty or kyphoplasty. Applicable vertebrae are within the range of S1 through T7.

The System offers optional pre-operative surgical planning including implant sizing, entry location and trajectory determination, along with intra-operative guidance and tool trajectory/position confirmation by displaying a graphical representation of a tool tracked by intra-operative 2D images onto a patient's pre-operative 3D images.

The System's main components include:

A workstation running the VUZE Planning and Procedure software (pre-installed)
A housing for the workstation, with a front door for user access as well as a back service door
A 32" touchscreen
A mouse
An isolation transformer
An internal video acquisition device (frame grabber)
A minimal-footprint, wheeled cart on which the above-listed items are placed.
DVI cable with galvanic isolator
An optional standalone planning station (planning software running on a commercial PC with identified specifications)
Optional C-arm orientation sensors (3), charger, and associated Bluetooth dongle (Note: The orientation sensor may also be referred to under an acronym of IMU)
Optional OTS foot pedal and associated Bluetooth dongle

AI/ML Overview

Acceptance Criteria and Study for the VUZE System (K232976)

Based on the provided FDA 510(k) summary, the VUZE System is a medical imaging system for spinal interventions. The submission focuses on evaluating the substantial equivalence of a modified VUZE System to its predicate device (original VUZE System K210830). The performance data presented primarily assesses the quantitative accuracy of the system's core function: registering pre-operative 3D images with intra-operative 2D radiographic images to guide surgical tools.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are established as Root Mean Square (RMS) specification limits and quantile limits for various accuracy parameters. The reported device performance is based on testing at "Recommend Angles" and "Minimal Angle Difference" scenarios.

Parameter	Acceptance Criteria	Reported Device Performance (Recommend Angles)	Status	Reported Device Performance (Minimal Angle Difference)	Status
RMS Specification Limits
Direction error [deg]	≤ 3°	0.3094°	Pass	0.4537°	Pass
Tip deviation from GT trajectory [mm]	≤ 2 mm	0.2833 mm	Pass	0.4107 mm	Pass
Predicted tip deviation from GT trajectory [mm]	≤ 2 mm	0.3572 mm	Pass	0.5199 mm	Pass
Depth error [mm]	≤ 4 mm	0.8196 mm	Pass	1.0194 mm	Pass
Quantile Specification Limits (95% / 2.5% & 97.5%)
Direction error [deg]	< 5.7° (95th percentile)	0.545° (95th percentile estimate)	Pass	0.851° (95th percentile estimate)	Pass
Tip deviation from GT trajectory [mm]	< 2 mm (95th percentile)	0.479 mm (95th percentile estimate)	Pass	0.798 mm (95th percentile estimate)	Pass
Predicted tip deviation from GT trajectory [mm]	< 2 mm (95th percentile)	0.615 mm (95th percentile estimate)	Pass	0.995 mm (95th percentile estimate)	Pass
Depth error [mm] Lower	> -6.5 mm (2.5th percentile)	-1.371 mm (2.5th percentile estimate)	Pass	-1.939 mm (2.5th percentile estimate)	Pass
Depth error [mm] Upper	< 6.5 mm (97.5th percentile)	1.920 mm (97.5th percentile estimate)	Pass	2.394 mm (97.5th percentile estimate)	Pass

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

The document does not explicitly state the numerical sample size (e.g., number of cases or images) used for the quantitative accuracy testing. It mentions "all combinations of X-Ray machines and CT/CBCT data" were used.

Data Provenance: Not explicitly stated as "retrospective" or "prospective." The testing described is "Simulated Use / Quantitative Accuracy," suggesting it was conducted in a controlled environment as part of verification and validation, rather than directly from real-world patient data. The provenance of the CT/CBCT data and X-ray images used for these simulations (e.g., from a specific country or derived from anonymized patient data) is not specified.

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

The document does not provide information on the number of experts or their qualifications for establishing the ground truth for the test set. The ground truth (GT) is referred to in "Tip deviation from GT trajectory" and "Predicted tip deviation from GT trajectory," implying a reference standard was used, but details about its establishment are absent. Given the type of accuracy metrics (e.g., tip deviation, direction error), it's highly likely a physical phantom or controlled simulation with precisely known geometries served as the ground truth.

4. Adjudication Method for the Test Set

The document does not mention an adjudication method (like 2+1, 3+1, or none) for the test set. This type of adjudication is typically used for image interpretation tasks involving multiple human readers, which is not the primary focus of the performance data presented here (which is quantitative accuracy of registration and tool trajectory).

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described in the provided text. The performance data focuses on the standalone quantitative accuracy of the device's algorithmic functions rather than assessing the improvement of human readers with AI assistance.

6. Standalone (Algorithm Only) Performance

Yes, the performance data presented is a standalone (algorithm only) performance evaluation. The tables show the accuracy of the VUZE System in calculating direction error, tip deviation, predicted tip deviation, and depth error against a "GT trajectory" and specifications. This assesses the algorithmic output itself without specifying human interaction in the measurement of these specific performance metrics.

7. Type of Ground Truth Used

The type of ground truth used is implied to be a precisely defined geometric reference or simulated trajectory (e.g., from a phantom or highly accurate simulation model). The metrics "Tip deviation from GT trajectory" and "Depth error from GT" strongly suggest a known, exact reference point or path that the system's output is being compared against. It is not expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

The document does not explicitly state the sample size for the training set. It describes "modifications to the CT to X-ray registration algorithm" and a "Deprecation of the previous ML algorithm... Same functionality is now done by a traditional algorithm." This implies that prior algorithms might have used training data, but the current submission's focus is on the modified algorithms and their direct performance. If the current critical algorithms are "traditional" (i.e., not machine learning based), then training data in the conventional sense might be less relevant for this submission, although development of such algorithms could involve extensive testing against diverse data.

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

Since the document does not specify a training set sample size or details about a machine learning algorithm's training, it does not provide information on how the ground truth for a training set was established.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the agency's name, "U.S. Food & Drug Administration," in blue text.

VUZE Medical Ltd. % Clay Anselmo Principal Quality and Regulatory Consultant Shriner & Associates, Inc. 429 Whitepine Creek Road Trout Creek, Montana 59874

May 9, 2024

Re: K232976

Trade/Device Name: VUZE System Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: April 2, 2024 Received: April 2, 2024

Dear Clay Anselmo:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

Jessica Lamb

Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K232976

Device Name VUZE System

Indications for Use (Describe)

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

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510(k) Summary – K232976

Introduction:

This document contains the 510(k) Summary for the VUZE Medical - VUZE System. The content of this summary is based on the requirements set forth in 21 CFR 807.92(c).

Submitter Information:

Applicant / ManufacturerName and Address	VUZE Medical Ltd.3/84 Rav Ashi St.Tel Aviv 6939537, Israel
510(k) Submitter / Preparer	Clay AnselmoPrincipal Quality and Regulatory ConsultantShriner & Associates429 Whitepine Creek RoadTrout Creek, MT 59874clay.anselmo@shrinerandassociates.com
510(k) Contact Person	David TolkowskyVUZE Medical, Ltd.3/84 Rav Ashi St.Tel Aviv 6939537, Israeldavidt@vuzemedical.com+972-(0)733983000
Date prepared	08-May-2024
Device Identification
Trade names	VUZE System
Common name	VUZE Medical Imaging System for spinalinterventions
Classification name	Medical Image Management andProcessing System
Regulation Number	21 CFR Part 892.2050
Classification	Class II
Product Code	Primary: LLZ

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Predicate Device

Trade names:	VUZE System
510(k) number:	K210830

Device Description:

The System's main components include:

A workstation running the VUZE Planning and Procedure software (pre-installed) ●
A housing for the workstation, with a front door for user access as well as a back ● service door
A 32" touchscreen ●
A mouse ●
An isolation transformer ●
An internal video acquisition device (frame grabber) ●
A minimal-footprint, wheeled cart on which the above-listed items are placed. ●
DVI cable with galvanic isolator ●
An optional standalone planning station (planning software running on a ● commercial PC with identified specifications)
Optional C-arm orientation sensors (3), charger, and associated Bluetooth dongle ● (Note: The orientation sensor may also be referred to under an acronym of IMU)
. Optional OTS foot pedal and associated Bluetooth dongle

Indications for Use:

The VUZE System is intended to enable users to load pre-operative 3D images and planning data and register and overlay this data in real time with intra-operative 2D radiographic images of the same anatomy to support device guidance during interventional spinal procedures. The system also offers pre-operative surgical planning including implant sizing, entry location, and trajectory determination along with intra-operative quidance and tool trajectory / position confirmation.

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Technological Characteristics Comparison:

Substantial Equivalence: The VUZE System is substantially equivalent to the original VUZE System (a.k.a. original device) K210830.

The 510(k) Substantial Equivalence Decision-making Process (detailed) from FDA Guidance - The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] was followed as described below:

. The modified VUZE System has the same intended use and the same indications for use as the Predicate device (original version of the VUZE System).
. The VUZE System uses identical fundamental technology as the Predicate device and very similar detailed technological solutions.
. The following summary of technological changes from the originally cleared device and the modified VUZE System are being made through this 510(k):

Planning Software: O

Added option for planning-only station that contains only the planning . software which runs on commercial PC meeting certain specified requirements. Option includes export to USB functionality for transferring planning data to VUZE System.
I Elimination of the need to generate pre-operative data during planning. New feature allows DRR generation in real-time during procedure.
트 Addition of a new feature incorporating horizontal line angle control into the Coronal cross-section, supplementing the existing Sagittal cross-section controls.
트 Add a check of 3D scan slice thickness to ensure it is equal to or greater than slice interval. Discard scans that do not meet this requirement.
트 Add feature that requires the user to indicated whether the skin level is visible in the axial view or not.
Add support for loading DICOM-CTs generated by 3D C-arm machines (CBCT).
트 Minor graphical user interface improvements for usability (e.g. view zoom, display simplifications, display pixel spacing, reset button addition, button re-arrangement).
Resolution of non-safety related software anomalies.

ം VUZE System and Procedure Software

Implement a modification to the CT to X-ray registration algorithm to replace . the reliance on pre-operative data for generating the initial-guess registration. This algorithm performs in real-time similar calculations that were previously done preoperatively.
. Implement a registration success score to assess the System's confidence in the CT to X-ray registration result. This score assesses the System's confidence in the registration and establishes a specific threshold to determine registration failure.
Addition of a Bluetooth C-arm orientation sensor and associated Bluetooth dongle to allow compatibility with additional X-ray systems.

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. Deprecation of the previous ML algorithm for determining window size parameters. Same functionality is now done by a traditional algorithm that calculates the filter for several window sizes and chooses the best one.
트 Add option to load CT images and planning data from USB media.
. Add support for additional C-arm systems for 2D X-ray image acquisition: * Philips Zenition 70
- - GE: OEC Elite CFD
- � Ziehm: Vision FD and Vision RFD 3D (2 different Flat Detector types)
트 Add support for Siemens NXS protocol for image acquisition via a LAN connection as an alternative to using a frame grabber. This option is available only the Siemens Cios Spin C-arms.
Add a new "live DRR" display, also known as "Simulated X-ray view" that activates when the C-arm rotates and displays a 2D projection image derived from the 3D CT / CBCT scan data in accordance with the current angles of the C-arm.
트 Add a verification and associated alert to ensure that tool length marking is not shorter than 40mm and that the position of the marked tool is not further than 200 pixels from that marked in the planning data.
Add a feature to enable users to instantly view the newly acquired X-ray image prior to its processing, with no dark background.
. Add a feature that allows the user to verify proper positioning of all the tools (e.g. k-wires prior to screw placement) with two additional AP X-ray images capturing all the tools at once.
. Add a feature that allows the System to be used in an offline mode so that newly acquired X-ray images aren't input and analyzed by the VUZE System.
. Generate cross-sections in the background. If generation fails, the software will suggest acquiring images from different C-arm angles, in advance. If the generation is successful, the user can then view the generated crosssections within the software by pressing "Generate Cross-Sections".
. Addition of a system verification that alerts the user when the tool trajectory changes significantly from what was previously accepted.
Addition of an optional Bluetooth foot pedal with associated Bluetooth dongle for the System as an input device that activates the default action from the GUI at the time of activation.
. Upgrade GPU model from RTX-2080 to RTX-3090 to support faster CT to X-ray registration.
. Addition of DVI galvanic Isolator and replace existing optical video cable with DVI cable.
. Minor graphical user interface improvements for usability (e.g., snap to tool, screenshot tool, magnification view, display incision site, C-arm angles display in title bar, always provide next image angle suggestions, text changes).
. Resolution of non-safety related software anomalies.
The differences in technology do not raise different questions of safety or . effectiveness and were evaluated through comprehensive bench verification and validation testing including a usability study. The results of testing provide assurance that the device is as safe and effective as the Predicate.

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For a more detailed comparison refer to the Substantial Equivalence comparison table included below.

Performance Data:

There are no identified special controls or performance standards for this device.

The modified VUZE System was verified and validated in accordance with 21 CFR 820.30. The following tests assessed comprehensively the changes in the system and were completed to demonstrate substantial equivalence and that any technological differences do not raise new or different questions of safety and effectiveness. The device successfully completed all of the evaluations and testing shown below. The standards shown in the following section were used, where applicable, to conduct testing and evaluate results.

Hardware component / assembly functional verification ●
Software Verification / Validation at the unit, integration and system levels (full ● execution of all software-based testing from original 510(k) with protocol modifications where necessary to fully test changes)
Electrical Safety and EMC
Full system functional verification against inputs and specifications .
Simulated Use / Quantitative Accuracy
Formative Usability Validation ●

As listed above, quantitative accuracy performance of the VUZE System was evaluated in comparison to its performance specifications and found to meet all specifications. The following tables present the results of this performance testing.

Parameter
CT Angle Settings	Directionerror[deg]	Tipdeviationfrom GTtrajectory[mm]	Predictedtipdeviationfrom GTtrajectory[mm]	Deptherror[mm]
VUZE System Recommended Angles	0.3094	0.2833	0.3572	0.8196
Minimal Angle Difference (worst case)	0.4537	0.4107	0.5199	1.0194
RMS specification limit	$\u22643\u00b0$	$\u22642$ mm	$\u22642$ mm	$\u22644$ mm
All results within RMS specification limit	Pass	Pass	Pass	Pass

Results of the Root Mean Square (RMS) analysis at Recommend and Minimal Angle Differences between X-ray Images

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Parameter	Specification	Quantile	TestResult	Using VUZESystemRecommendedAngles		Using MinimalAngle Difference
				QuantileEstimate	95% Conf.Limit ofQuantile	QuantileEstimate	95% Conf.Limit ofQuantile
Direction error [deg]	< 5.7°	95%	Pass	0.545	0.556	0.851	0.892
Tip deviation from GT trajectory [mm]	< 2 mm	95%	Pass	0.479	0.490	0.798	0.824
Predicted tip deviation from GT trajectory[mm]	< 2 mm	95%	Pass	0.615	0.627	0.995	1.035
Depth error [mm] Lower	> -6.5 mm	2.5%	Pass	-1.371	-1.424	-1.939	-2.053
Depth error [mm] Upper	< 6.5 mm	97.5%	Pass	1.920	1.976	2.394	2.580

Summary of results for all combinations of X-Ray machines and CT/CBCT data.

No animal or human clinical data were needed to demonstrate substantial equivalency.

The device has been designed and tested in conformance to the following voluntary recognized consensus standards and continues to comply in its modified form. Note: The standard set below represents the current versions of the standards for which the original version of the VUZE system declared conformity.

ANSI / AAMI / IEC 60601-1: 2005 /(R)2012 +A1:2012 + A2:2021: Medical ● Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance (FDA Recognition #19-46)
IEC 60601-1-2:2020 Edition 4.1, Medical Electrical Equipment Part 1-2: General ● Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Compatibility - Requirements and Tests (FDA Recognition #19-36).
IEC 62304:2006/A1:2016, Medical Device Software Software Lifecycle ● Processes (FDA Recognition #13-79)
IEC 62366-1:2015 + AMD1:2020: Medical devices Part 1: Application of usability ● engineering to medical devices (FDA Recognition #5-129)
. ISO 10993-1:2018: Biological evaluation of Medical Devices, Part 1: Evaluation and Testing within a Risk Management Process (FDA Recognition #2-258)
IEC 60601-1-6:2013-10 Edition 3.1: Medical Electrical Equipment Part 1-6: . Collateral Standard - Usability (FDA Recognition #5-89)
ISO 14971:2019 Medical Devices: Application of Risk Management to Medical ● Devices (FDA Recognition #5-125)
ISO 15223:2021 Medical devices Symbols to be used with medical devices ● labels, labeling, and information to be supplied - Part 1: General requirements (FDA Recognition #5-134)

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VUZE System, K232976: 510(k) Summary

ISO 20417:2021 Medical devices Information to be supplied by the manufacturer . (FDA Recognition #5-135)
NEMA PS 3.1 3.20 (2021) Digital Imaging and Communications in Medicine ● (DICOM) Set (FDA Recognition #12-342)
ASTM D4169-16 Standard Practice for Performance Testing of Shipping ● Containers and Systems (FDA Recognition #14-499)
. IEC 62133-2:2017 Secondary cells and batteries containing alkaline or other nonacid electrolytes - Part 2: Lithium systems (FDA Recognition #19-33)
UN/DOT 38.3 5th Edition, Amendment 1: Recommendations on the Transport of . Dangerous Goods
UL 2054 2nd Edition House and Commercial Batteries .

Substantial Equivalence Comparison:

Device	Modified VUZE System	Original VUZE system
Characteristic	(Subject Device)	(Predicate, K210830)	Conclusion
Intended Use	Intended as an imaging aid forinterventional procedures to allowcomparison of planned tool pathsagainst actual tool placement	Intended as an imaging aid forinterventional procedures to allowcomparison of planned tool pathsagainst actual tool placement	Identical toPredicate
Indications for Use	The VUZE System is intended to enable usersto load pre-operative 3D images and planningdata and register and overlay this data in realtime with intra-operative 2D radiographicimages of the same anatomy to supportdevice guidance during interventional spinalprocedures. The system also offers pre-operative surgical planning including implantsizing, entry location, and trajectorydetermination along with intra-operativeguidance and tool trajectory / positionconfirmation.	The VUZE System is intended to enable users toload pre-operative 3D images and planning dataand register and overlay this data in real time withintra-operative 2D radiographic images of thesame anatomy to support device guidance duringinterventional spinal procedures. The system alsooffers pre-operative surgical planning includingimplant sizing, entry location, and trajectorydetermination along with intra-operative guidanceand tool trajectory / position confirmation.	Identical toPredicate
Device Class	II	II	Identical toPredicate
Procodes	LLZ	LLZ	Identical toPredicate
Anatomy	Thoracic and Lumbar Spine	Thoracic and Lumbar Spine	Identical toPredicate
Surgical Access Type	Percutaneous	Percutaneous	Identical toPredicate
Patient Population	General Spine Surgery	General Spine Surgery	Identical toPredicate
Target User	Interventional Spine Surgeon	Interventional Spine Surgeon	Identical toPredicate

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VUZE System, K232976: 510(k) Summary

Device	Modified VUZE System	Original VUZE system
Characteristic	(Subject Device)	(Predicate, K210830)	Conclusion
Environment	Surgical Suite	Surgical Suite	Identical toPredicate
Procedure HardwarePlatform	Dedicated Workstation	Dedicated Workstation	Identical toPredicate
Planning HardwarePlatform	Commercial PC meeting specificrequirements and not containexternal software	Planning was performed on dedicatedworkstation performing both planningand procedure functions.	Substantiallyequivalentto Predicate
Work-Flow	3D imaging, planning, 2D imaging,3D to 2D co-registration,intervention, confirmation	3D imaging, planning, 2D imaging, 3Dto 2D co-registration, intervention,confirmation	Identical toPredicate
3D Image Data Source	CT / CBCT	CT	Substantiallyequivalentto Predicate
Interoperative ImageCo-Registration	3D image to X-ray using DigitallyReconstructed Radiographs (DRR's)	3D image to X-ray using DigitallyReconstructed Radiographs (DRR's)	Identical toPredicate
Tool Use	Free hand	Free Hand	Identical toPredicate

Conclusion:

The results of the comparison of the modified VUZE System to the predicate device, in conjunction with the successful performance testing data gathered and described above, shows the VUZE system has the same intended use, similar technological characteristics, and that the differences in technological characteristics do not raise different questions of safety and effectiveness. Therefore, it is concluded the VUZE System is substantially equivalent to the original VUZE system (K210830).

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).