Remi Robotic Navigation System by Fusion Robotics, LLC

The Remi Robotic Navigation System is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of a tool holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous spinal procedures in reference to rigid patient anatomy and fiducials that can be identified on a 3D imaging scan or 2D fluoroscopic images. The Remi Robotic Navigation System is indicated for assisting the surgeon in placing pedicle screws in the posterior lumbar region (L1-S1). The system is designed for lumbar pedicle screw placement with the prone position and is compatible with the Accelus LineSider Spinal System.

Device Description

The Remi Robotic Navigation System (Remi) is an image guided system primarily comprised of a computer workstation, software, a trajectory system, including a targeting platform, a camera, and various image guided instruments intended for assisting the surgeon in placing screws in the pedicles of the lumbar spine. The system operates in a similar manner to other optical-based image y systems.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Remi Robotic Navigation System (K223350). The submission focuses on demonstrating substantial equivalence to its predicate devices, particularly an earlier version of the Remi Robotic Navigation System (K223070) and the EXCELSIUS GPS (K171651). The key change in the subject device is the addition of compatibility with 2D fluoroscopic imaging systems for pedicle screw placement in the posterior lumbar region (L1-S1).

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics for the tested device. It broadly states that "The testing shows that the use of the 2D fluoroscopic images with the Remi system is equivalent to the use of the validated 3D imaging systems." and that the device "continues to meet design requirements, is as safe and effective as the predicate device, and performs according to its intended use."

However, the "POSITIONING ACCURACY (BENCH)" for the Primary Predicate Device is listed as: 0.74 ± 0.36 mm (worst case); 95% CI: 1.46mm (worst case). Since the subject device "Same as Primary Predicate" for this characteristic and the testing was done to demonstrate equivalence, it can be inferred that the acceptance criterion for accuracy for the new functionality is to maintain this level of accuracy or be equivalent to it.

Acceptance Criterion (Inferred from Predicate)	Reported Device Performance (Equivalent to Predicate)
Positioning Accuracy: ≤ 0.74 ± 0.36 mm (worst case), 95% CI: 1.46mm (worst case)	Maintained (Stated as "Same as Primary Predicate" and "equivalent to the use of the validated 3D imaging systems")
Software System Functionality	Met (Software System Test performed)
Navigation Accuracy	Verified (Navigation Accuracy Verification performed)
System Accuracy	Validated (System Accuracy Validation performed)
ASTM F2554 Compliance	Met (ASTM F2554 Accuracy Test performed)
Software Unit and Integration	Met (Software Unit and Integration Tests performed)

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

The document mentions "Performance Testing - Bench" was conducted, including "Navigation Accuracy Verification," "System Accuracy Validation," "Software System Test," "ASTM F2554 Accuracy Test," and "Software Unit and Integration Tests." However, specific sample sizes for these tests (e.g., number of cases, images, or measurements) are not provided.

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given that it is bench testing, it is likely that the data was generated in a controlled laboratory or testing environment rather than being derived from patient cases.

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

This information is not provided. The document describes bench testing, which typically uses defined physical standards or simulated scenarios to establish ground truth rather than expert consensus on clinical images/data.

4. Adjudication Method for the Test Set

This information is not provided. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation of clinical data and subsequent consensus determination. Since the testing described is bench testing, such an adjudication method is unlikely to apply.

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

No MRMC comparative effectiveness study is mentioned. The submission focuses on demonstrating substantial equivalence through bench testing, verifying that the added 2D fluoroscopy functionality maintains the device's accuracy and safety profiles compared to its predicate with 3D imaging. There is no information regarding human readers improving with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone (algorithm only) performance study was done. The performance testing described (Navigation Accuracy Verification, System Accuracy Validation, Software System Test, ASTM F2554 Accuracy Test, Software Unit and Integration Tests) are all characteristics of a standalone performance evaluation, focusing on the device's technical capabilities without human interaction determining performance outcomes within the tests themselves. The stated purpose was "to demonstrate that the updated requirement for this change was met and to ensure the risk profile of Remi was maintained," specifically concerning "the use of the 2D fluoroscopic images with the Remi system is equivalent to the use of the validated 3D imaging systems."

7. Type of Ground Truth Used

The ground truth for the bench testing would likely involve engineered physical phantoms, precisely manufactured test fixtures, and controlled experimental setups with known geometric parameters and validated measurements. For example, for "Navigation Accuracy Verification" and "System Accuracy Validation," physical measurements against a known standard or calibrated instruments would establish the ground truth. For "Software System Test" and "Software Unit and Integration Tests," the ground truth would be defined by the software's specified functional requirements and expected outputs.

8. Sample Size for the Training Set

The document does not provide information about a training set or its sample size. The submission is for a modification to an existing cleared device, specifically adding 2D fluoroscopic image compatibility. While the software was updated to support this, including an algorithm correcting distortion, the text implies that the evaluation focused on the performance of the system with the new capability rather than the development of a completely new AI algorithm requiring extensive training data. If machine learning was used for the distortion correction, details about its training would typically be in a separate section not provided here.

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

As no training set is explicitly mentioned, this information is not provided.

Summary

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Fusion Robotics, LLC % Sarah Braun Senior Regulatory Affairs Specialist Integrity Implants Inc. dba Accelus 354 Hiatt Drive Palm Beach Gardens, Florida 33418

Re: K223350

Trade/Device Name: Remi Robotic Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: November 22, 2022 Received: November 23, 2022

Dear Sarah Braun:

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.

Jesse Muir -S

For: 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) K223350

Device Name Remi Robotic Navigation System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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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

510(k) Owner	Fusion Robotics, LLC168 Centennial Parkway, Unit 170Louisville, CO 80027 USA
Contact Person	Sarah BraunSenior Regulatory Affairs SpecialistTel: 423-838-4454Email: sbraun@accelusinc.com
Date Prepared	11/22/2022
Classification Reference	21 CFR 882.4560
Product Code	OLO
Common/Usual Name	Stereotaxic Instrument
Trade/Proprietary Name	Remi Robotic Navigation System
Predicate Device(s)	Remi Robotic Navigation System (K223070)EXCELSIUS GPS (K171651)

1. The patient is placed in the appropriate position on the OR table.
1. The compact tracking Camera is rigidly affixed to the OR table using a multi-functional mechanical support arm in the appropriate position to track the surgical site.
1. The Camera is also affixed to a pin placed in the patient's iliac to provide a fixed location relative to the patient's spinal anatomy.
1. The Targeting Platform is affixed to the OR Table using a multi-functional mechanical support arm, ensuring that the Targeting Platform has sufficient range of motion to be placed over the surgical site.

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1. If a 3D imaging system is being used, the Registration Array is affixed to the Targeting Platform and positioned over the planned surgical site.
1. If 2D fluoroscopic system is being used, the C-Arm Grid Plate, 9900 9" is installed onto the fluoroscopic imaging system.
1. The appropriate area of spine (L1-S1) is Imaged with a validated imaging system.
1. The images are transferred to the Remi system workstation, which reconstructs the images and uses the registration array images) or the C-Arm Grid Plate Tracker image (for 2D fluoroscopic Images) to register the patient's spine relative to the Camera location.
1. The registration is confirmed by placing an image guided instrument with an Instrument Tracker at various points in the surgical field.
1. The surgical paths are then planned. If the procedure is using 3D images, this is done on the workstation. If the procedure is using 2D fluoroscopic images, the Planning Probe and workstation are utilized to capture the desired position for target pedicle screw placement.
1. The Targeting Platform is gross positioned manually close to the first surgical plan location.
1. The Targeting Platform is activated to set the fine location and the trajectory based on the surgical plan.
1. Instruments with tracking arrays can now be used through the tool guide of the Targeting Platform to prepare the pedicle and place a pedicle screw.

Intended Use/Indications for Use

Substantial Equivalence

The proposed Remi Robotic Navigation System (Remi) allows the use of a 2D fluoroscopic Imaging system. The system validated for this submission is the GE OEC 9900 Elite 9" Image Intensifier (K122234). The indications for use has been updated to add 2D fluoroscopic images for use with the Remi system. Four instruments were added: Long Reference Arm (PN1075), Planning Probe (PN1115), C-

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Arm Grid Plate, 9900 9" (PN1138), C-Arm Grid Plate Tracker (PN1139). The software was updated to support the use of 2D fluoroscopic images. Changes include compatibility with the new instruments and an algorithm which corrects the distortion of the 2D fluoroscopic image.

Performance Testing - Bench

The following tests were performed to support the substantial equivalence of the subject Remi Robotic Navigation System (Remi) to its predicates:

Navigation Accuracy Verification
. System Accuracy Validation
Software System Test
ASTM F2554 Accuracy Test
Software Unit and Integration Tests

Testing was done to demonstrate that the updated requirement for this change was met and to ensure the risk profile of Remi was maintained. The testing shows that the use of the 2D fluoroscopic images with the Remi system is equivalent to the use of the validated 3D imaging systems.

Devices	Subject Device	Primary Predicate Device	Secondary Predicate Device
	Remi Robotic NavigationSystem	Remi Robotic NavigationSystem [K223070]	EXCELSIUS GPS[K171651]
Indications forUse	The Remi Robotic NavigationSystem is intended for use asan aid for precisely locatinganatomical structures and forthe spatial positioning andorientation of a tool holder orguide tube to be used bysurgeons for navigatingand/or guiding compatiblesurgical instruments in openor percutaneous spinalprocedures in reference torigid patient anatomy andfiducials that can be identifiedon a 3D imaging scan or 2Dfluoroscopic images. The RemiRobotic Navigation System isindicated for assisting thesurgeon in placing pediclescrews in vertebrae in theposterior lumbar region (L1-S1). The system is designedfor lumbar pedicle screwplacement with the patient in	The Remi Robotic NavigationSystem is intended for use as anaid for precisely locatinganatomical structures and forthe spatial positioning andorientation of a tool holder orGuide Tube to be used bysurgeons for navigating and/orguiding compatible surgicalinstruments in open orpercutaneous spinal proceduresin reference to rigid patientanatomy and fiducials that canbe identified on a 3D Imagingscan. The Remi RoboticNavigation System is indicatedfor assisting the surgeon inplacing pedicle screws invertebrae in the posteriorlumbar region (L1-S1). Thesystem is designed for lumbarpedicle screw placement withthe patient in the prone position	The EXCELSIUS GPS™ is intendedfor use as an aid for preciselylocatinganatomical structures and forthe spatial positioning andorientation of aninstrument holder or guide tubeto be used by surgeons fornavigating and/orguiding compatible surgicalinstruments in open orpercutaneous proceduresprovided that the requiredfiducial markers and rigidpatient anatomy can beidentified on CT scans orfluoroscopy. The system isindicated for the placementof spinal and orthopedic bonescrews.
	the prone position and is compatible with the AccelusLineSider Spinal System.	and is compatible with the Accelus LineSider Spinal System.	and is compatible with the Accelus LineSider Spinal System.
Product Code	OLO	OLO	OLO
Principles ofOperation	Same as Predicates.	Intraoperative/preoperative images Patient registration Surgical planning Real-time tracking of navigated instruments Guidance of instruments	Intraoperative/preoperative images Patient registration Surgical planning Real-time tracking of navigated instruments Guidance of instruments
Input Images	3D Intraoperative images Medtronic O-arm GE OEC 3D Ziehm-Vision RFD 3D Stryker Airo TruCT 2D Fluoroscopic Images GE OEC 9900 Elite 9" Image Intensifier (K122234)	3D Intraoperative images Medtronic O-arm GE OEC 3D Ziehm-Vision RFD 3D Stryker Airo TruCT	3D pre-operative images3D intra-operative images2D intra-operative images
Trajectoryplanningparameters	Same as Primary Predicate.	Entry point, target point, length of the instrument, diameter	Unknown
Localizationmethod	Same as Primary Predicate	Optical System (infrared Camera)	Unknown
Camera system	Same as Primary Predicate	Monocular	Unknown
Controller	Same as Primary Predicate	Manual macro adjustmentsForce-controlled movement of Targeting platform	Unknown
PatientRegistrationMethod	Same as Primary Predicate	Registration fixture in place during 3Dintraoperative images	Intra-op CT: Registration fixturePre-op CT: Fluoroscopic to pre-op CT mergeFluoroscopy: Registration fixture
Accuracyverification onanatomicallandmarks	Same as Predicates.	Yes	Yes
Real timedisplay ofinstrumentposition	Same as Predicates.	Yes	Yes
InstrumentGuidance	Same as Primary Predicate.	Trajectory and location set byTargeting platform. Instrumentsare manually positioned by thesurgeon through the guide tubeon the Targeting Platform.	Yes, instruments are usedthrough the guide tube onthe robotic arm or aremanually positioned by thesurgeon.
Patient fixation	Same as Primary Predicate.	Tracking Camera is fixed to ORtable and the patient's iliaccrest.	Reference is fixed topatient's bony structuresuch as a long bone, iliaccrest, spinous process,vertebra, etc. for trackingsystem
Positioningaccuracy(bench	Same as Primary Predicate.	$0.74 \pm 0.36$ mm (worst case)95% CI: 1.46mm (worst case)	Unknown
Robot collisionavoidance/detection	Same as Primary Predicate.	Manual movement of TrajectoryPlatform to gross location. Smallfine tuning of TrajectoryPlatform location is automaticbut is currently limited to ceasewhen platform encounters aforce greater than 9lbs.	Unknown

Substantial equivalence analysis for Remi

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Conclusions

The subject device, Remi Robotic Navigation System, described in this submission shares a majority of the same technological characteristics as the primary predicate device, Remi Robotic Navigation System (K223070). The primary difference between the subject device and the primary predicate is the addition of validated 2D fluoroscopic imaging systems and the subsequent modification of the wording of the indications for use. Like the subject device, the secondary predicate, EXCELSIUS GPS (K171651) has the capability to rely on 2D intra-operative exam as the Input Images for the stereotaxic navigation of pedicle screw placement.

The verification and validation testing demonstrated that the characteristics of the subject Remi device are substantially equivalent to the predicate device. The subject device continues

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to meet design requirements, is as safe and effective as the predicate device, and performs according to its intended use. The information presented in this 510(k) premarket notification demonstrates that the subject device is substantially equivalent to the predicate devices.

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).