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. The REMI™ Robotic Navigation System is indicated for assisting the surgeon in placing pedicle screws in the posterior lumbar region (LI-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 outlines the FDA 510(k) clearance for the REMI Robotic Navigation System, focusing on its substantial equivalence to a predicate device. However, it does not contain a detailed study report or explicit acceptance criteria with reported device performance metrics in the format requested.

The document primarily focuses on demonstrating that the updated REMI system, with additional compatible 3D imaging systems, is substantially equivalent to its predicate. The "Performance Testing - Bench" section mentions tests conducted but does not provide specific numerical acceptance criteria or performance results.

Therefore, much of the requested information cannot be extracted directly from the provided text. I will indicate where information is missing or inferred.

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Accuracy (Bench) - Worst Case	0.74 ± 0.36 mm (95% CI: 1.46mm) - This is the reported performance of the predicate device, which the subject device is stated to be "Same as Predicate."
Image Quality (with added 3D imagers)	Stated to be "equivalent" to the predicate's performance with the Medtronic O-arm. (No specific metric provided)
Image Transfer Speed (with added 3D imagers)	Stated to be "equivalent" to the predicate's performance with the Medtronic O-arm. (No specific metric provided)
Image Registration Speed (with added 3D imagers)	Stated to be "equivalent" to the predicate's performance with the Medtronic O-arm. (No specific metric provided)
Registration Accuracy (with added 3D imagers)	Stated to be "equivalent" to the predicate's performance with the Medtronic O-arm. (No specific metric provided)
Usability Validation	Testing was done to ensure the risk profile was maintained. (No specific metric or outcome provided)
Compatibility with PSIS Pins	Biocompatibility assessment for Ti6Al4V ELI (used in PSIS pins) included in K190360 (referring to a previous clearance for the pedicle screws).
Robot collision avoidance/detection	Manual movement of Trajectory Platform to gross location. Small fine tuning of Trajectory Platform location is automatic but is current limited to cease when platform encounters a force greater than 9lbs. (This is for the predicate, and again, the subject device is "Same as Predicate.")

Study Details from the provided text:

Sample size used for the test set and the data provenance:
- The document mentions "Performance Testing - Bench" and "Verification and validation testing" but does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It suggests bench testing was primarily used for equivalence.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- No information provided. The "performance testing" described appears to be technical validation against specified equivalence factors rather than expert review of clinical outcomes or images.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- No information provided.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC study was not described. This device is a robotic navigation system for spinal surgery, not an AI-assisted diagnostic imaging interpretation tool that would typically involve human readers. Its purpose is to aid surgeons in pedicle screw placement.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The document does not explicitly describe a "standalone" algorithmic performance test in the context of an AI-only system. The device is a navigation system that guides a human surgeon. Its performance metrics, like accuracy, are inherently tied to the system's ability to guide to a planned trajectory, which can be measured quantitatively in bench tests. The bench testing mentioned covers aspects like "Accuracy," "Image Quality," "Image Transfer Speed," and "Image Registration Speed."
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Based on the description of "Performance Testing - Bench" and "Accuracy verification on anatomical landmarks" (for the predicate), the ground truth for accuracy testing would typically involve precisely measured physical points or targets on a phantom or model, measured by a highly accurate reference system (e.g., CMM). For image quality, transfer, and registration speed, the ground truth would be objectively defined technical specifications or measurements.
The sample size for the training set:
- No information provided about a "training set." The REMI system is a robotic navigation system, not described as a deep learning or machine learning-based algorithm that typically requires a large training dataset for model development. The system uses pre-programmed logic, image processing, and control algorithms.
How the ground truth for the training set was established:
- Not applicable, as no training set for an AI/ML model is mentioned.

Summary

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October 28, 2022

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

Re: K223070

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: September 29, 2022 Received: September 30, 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.

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

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Indications for Use

510(k) Number (if known) K223070

Device Name REMITM Robotic Navigation 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

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	10/28/2022
Classification Reference	21 CFR 882.4560
Product Code	OLO
Common/Usual Name	Stereotaxic Instrument
Trade/Proprietary NamePredicate Device(s)	Remi Robotic Navigation SystemPractical Navigation Surgical GuidanceSystem (K202184)

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.
1. TThe Registration Array is affixed to the Targeting Platform and positioned over the planned surgical site.

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1. The appropriate area of spine (L1-S1) is scanned with a validated 3D imaging system.
1. The scans are transferred to the Remi system workstation, which reconstructs the images and uses the registration array image 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 planned on the workstation.
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

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. The Remi Robotic Navigation System is indicated for assisting the surgeon in placing pedicle screws in vertebrae in the posterior lumbar region (L1-S1). The system is designed for lumbar pedicle screw placement with the patient in the prone position and is compatible with the Accelus LineSider® Spinal System.

Substantial Equivalence

The proposed Remi Robotic Navigation System (Remi) is considered substantially equivalent to the Remi Surgical Guidance System that was cleared as the Practical Navigation Surgical Guidance System (K202184). A comparison to the predicate device is provided in the table below.

Devices	Subject DeviceRemi Robotic Navigation System	Predicate DevicePractical Navigation SurgicalGuidance System [K202184]
Indications for Use	The Remi Robotic Navigation System isintended for use as an aid for preciselylocating anatomical structures and for thespatial positioning and orientation of a toolholder or Guide Tube to be used by surgeonsfor navigating and/or guiding compatiblesurgical instruments in open or	The Practical Navigation Surgical GuidanceSystem is intended for use as an aid forprecisely locating anatomical structures andfor the spatial positioning and orientation of atool holder or Guide Tube to be used bysurgeons for navigating and/or guidingcompatible surgical instruments in open orpercutaneous
	percutaneous spinal procedures in referenceto rigid patient anatomy and fiducials thatcan be identified on a 3D Imaging scan. TheREMI Robotic Navigation System is indicatedfor assisting the surgeon in placing pediclescrews in vertebrae in the posterior lumbarregion (LI-S1). The system is designed forlumbar pedicle screw placement with thepatient in the prone position and iscompatible with the Accelus LineSider SpinalSystem.	spinal procedures in reference to rigid patientanatomy and fiducials that can be identifiedon a O-arm scan. The REMI RoboticNavigation System is indicated for assistingthe surgeon in placing pedicle screws invertebrae in the posterior lumbar region (LI-S1). The system is designed for lumbarpedicle screw placement with the patient inthe prone position and is compatible with theAccelus LineSider Spinal System.
Product Code	OLO	OLO
Principles ofOperation	Same as Predicate.	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 C-arm Ziehm FD Vision 3D Stryker Airo 3D	3D Intraoperative images Medtronic O-arm
Trajectory planningparameters	Same as Predicate.	Entry point, target point, length of theinstrument, diameter
Localization method	Same as Predicate.	Optical System (infrared Camera)
Camera system	Same as Predicate.	Monocular
Controller	Same as Predicate.	Manual macro adjustmentsForce-controlled movement of Targetingplatform
Patient RegistrationMethod	Same as Predicate.	Registration fixture in place during 3Dintraoperative images
Accuracyverification onanatomicallandmarks	Same as Predicate.	Yes
Real time display ofinstrument position	Same as Predicate.	Yes
InstrumentGuidance	Same as Predicate.	Trajectory and location set by Targetingplatform. Instruments are manuallypositioned by the surgeon through the guidetube on the Targeting Platform.
Patient fixation	Same as Predicate.	Tracking Camera is fixed to OR table andthe patient's iliac crest.
Positioningaccuracy (bench	Same as Predicate.	$0.74 \pm 0.36$ mm (worst case)95% CI: 1.46mm (worst case)
Robot collisionavoidance/detection	Same as Predicate.	Manual movement of Trajectory Platformto gross location. Small fine tuning ofTrajectory Platform location is automaticbut is current limited to cease whenplatform encounters a force greater than9lbs.

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PSIS Pin Addition

Two PSIS pins were added for this submission: 150mm x 6mm PSIS Pin (PN6025) and 100mm x 6mm (PN6026). The PSIS pins are made of titanium (Ti6Al4V ELI PER ASTM F136). This material is used by Integrity Implants (d/b/a Accelus) in their LineSider Spinal System pedicle screws cleared in K190360. The biocompatibility assessment for Ti6Al4V ELI is included in K190360.

Performance Testing - Bench

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

3D Imager Accuracy Software Test Verification
Usability Validation

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 GE OEC 3D C-arm (K203346), Stryker Airo (K160126) and Ziehm Vision 3D C-arm (K202360) with the Remi system is equivalent to the use of the Medtronic O-arm. The following factors were used to show equivalence.

Image Quality
Image Transfer Speed
Image Registration Speed
Registration Accuracy

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Conclusions

The subject device, Remi Robotic Navigation System, described in this submission has the same intended use and the same technological characteristics as the predicate device, Remi Robotic Navigation System (K202184). The primary difference between the subject device and the predicate is the addition of other validated 3D imaging systems and the subsequent modification of the indications for use.

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 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 Remi Robotic Navigation System (K202184).

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).