CORI is indicated for use in surgical procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined.

These procedures include unicondylar knee replacement (UKR), total knee arthroplasty (TKA) and total hip arthroplasty (THA).

For Knee applications, CORI is indicated for use with cemented implants only.

Device Description

CORI is a computer-assisted orthopedic surgical navigation and surgical burring system. CORI uses established technologies of navigation, via a passive infrared tracking camera.

For robotic knee applications, CORI software can control the cutting engagement of the surgical bur based on its proximity to the planned target surface. Alternatively, the surgeon can disable both controls and operate the robotic drill as a standard navigated surgical drill.

For the hip navigation application, CORI incorporates the Brainlab HIP7 software (K193307) which will be market by Smith & Nephew as RI.HIP NAVIGATION. It uses instruments and reference arrays, which are tracked by the IR camera, to determine pelvis and femur anatomical landmarks as well as implant orientation. RI.HIP NAVIGATION assists the orientation of prosthetic hip implants and enables measurement of leg length and offset when used intraoperatively in combination with CORI.

AI/ML Overview

This document does not contain the requested information about acceptance criteria and a study proving device performance as it is a 510(k) summary for a medical device (REAL INTELLIGENCE CORI) seeking clearance for a new indication (Total Hip Arthroplasty - THA).

Here's why the requested information is not present in this document:

510(k) Summaries Focus on Substantial Equivalence: A 510(k) summary aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and similar technological characteristics, or different characteristics that do not raise new questions of safety or effectiveness.
Performance Data is Summarized, Not Detailed: While the document mentions "Design verification and validation tests were performed on CORI to demonstrate that the changes presented in this submission meet all design input requirements and that CORI is as safe and effective as its predicate device," it does not provide the detailed acceptance criteria, specific study designs, sample sizes, expert qualifications, or ground truth methodologies that you've asked for. These details would typically be found in the full 510(k) submission, not in the publicly available summary.
"No human clinical testing was required": The document explicitly states this, which means there wouldn't be studies involving human readers, comparative effectiveness, or certain types of ground truth (like pathology from live patients) that might be expected from a device requiring clinical trials. The focus here is on bench testing and software validation.
Focus on Bench Testing and Software Validation: The section on "Non-Clinical Testing (Bench)" mentions software integration testing (adhering to IEC 62304 and FDA guidance) and usability engineering validation testing (for safe and effective use in a simulated environment). This indicates the type of testing performed, but not the specific quantitative performance metrics you've requested.

Therefore, I cannot extract the table of acceptance criteria, reported device performance, sample sizes, data provenance, expert details, adjudication methods, MRMC study results, standalone performance, type of ground truth, or training set information from the provided text. This document is a high-level summary for regulatory clearance, not a detailed technical report of performance studies.

Summary

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November 3, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.

Blue Belt Technologies, Inc. Sarah Plittman Regulatory Affairs Specialist II 2905 Northwest Blvd., Ste. 40 Plymouth, Minnesota 55441

Re: K212537

Trade/Device Name: REAL INTELLIGENCE CORI (CORI) Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: August 10, 2021 Received: August 12, 2021

Dear Sarah Plittman:

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.

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) K212537

Device Name REAL INTELLIGENCE CORI (CORI)

Indications for Use (Describe)

CORI is indicated for use in surgical procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined.

These procedures include unicondylar knee replacement (UKR), total knee arthroplasty (THA).

For Knee applications, CORI is indicated for use with cemented implants only.

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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Image /page/3/Picture/0 description: The image shows the logo for Blue Belt Technologies. The logo consists of a blue swirl design on the left, followed by the words "BLUE BELT" in large, bold, blue letters. Below "BLUE BELT" is the word "TECHNOLOGIES" in smaller, gray letters. The logo is simple and modern, and the use of blue and gray gives it a professional look.

2905 Northwest Boulevard, Suite 40, Plymouth, Minnesota 55441 USA Tel 763.452.4950 Fax 763.452.4675 www.bluebelttech.com

510(k) Summary (K212537)

510(k) Owner	Blue Belt Technologies, Inc.2905 Northwest Blvd Ste. 40Plymouth, MN 55441 USATel: (763) 452-4950Fax: (763) 452-4675
Contact Person	Sarah PlittmanRegulatory Affairs Specialist IITel: 423-838-4454Email: sarah.plittman@smith-nephew.com
Date of Submission	08/10/2021
Classification Reference	21 CFR 882.4560
Product Code	OLO
Common/Usual Name	Orthopedic Stereotaxic Instrument
Trade/Proprietary Name	REAL INTELLIGENCE® CORI® (CORI)
Primary Predicate Device	REAL INTELLIGENCE® CORI® (CORI) (K201022)
Reference Device	Brainlab AG HIP7 (K193307)
Reason for Submission	New Indication

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Image /page/4/Picture/0 description: The image shows the logo for Blue Belt Technologies. The logo features a stylized blue swirl on the left, followed by the words "BLUE BELT" in large, bold, blue letters. Below "BLUE BELT" is the word "TECHNOLOGIES" in smaller, gray letters.

Intended Use

REAL INTELLIGENCE CORI (CORI) is intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

Indications for Use

CORI is indicated for use in surgical procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined.

These procedures include unicondylar knee replacement (UKR), total knee arthroplasty (TKA) and total hip arthroplasty (THA).

For Knee applications, CORI is indicated for use with cemented implants only.

Device Description

CORI is a computer-assisted orthopedic surgical navigation and surgical burring system. CORI uses established technologies of navigation, via a passive infrared tracking camera.

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Image /page/5/Picture/0 description: The image shows the logo for Blue Belt Technologies. The logo consists of a blue swirl design on the left, followed by the words "BLUE BELT" in large, blue, sans-serif font. Below "BLUE BELT" is the word "TECHNOLOGIES" in a smaller, gray, sans-serif font. The logo is clean and modern, with a focus on the company name.

Discussion of Similarities and Differences

The subject device, CORI, is substantially equivalent to the predicate device CORI (K201022).

For knee applications, functionality of the subject device is the same as the predicate device. Functionality has been added to support the THA application.

Devices	Subject DeviceREAL INTELLIGENCE CORI [K212537]	Predicate DeviceREAL INTELLIGENCE CORI [K201022]
Intended use	Same as Predicate.	REAL INTELLIGENCE CORI (CORI) is intendedto assist the surgeon in providing software-defined spatial boundaries for orientationand reference information to anatomicalstructures during orthopedic procedures.
Indications for Use	CORI is indicated for use in surgical procedures,in which the use of stereotactic surgery may beappropriate, and where reference to rigidanatomical bony structures can be determined.These procedures include unicondylar kneereplacement (UKR), total knee arthroplasty(TKA), and total hip arthroplasty (THA).For knee applications, CORI is indicated for usewith cemented implants only.	CORI is indicated for use in surgical kneeprocedures, in which the use of stereotacticsurgery may be appropriate, and wherereference to rigid anatomical bonystructures can be determined.These procedures include unicondylar kneereplacement (UKR) and total kneearthroplasty (TKA).CORI is indicated for use with cementedimplants only.
Contraindications	Same as Predicate for UKR and TKA.	CORI is not intended to be used onchildren, pregnant women, patients whohave mental or neuromuscular disordersthat do not allow control of the knee joint,morbidly obese patients, or any otherpatients contraindicated for kneereplacement.
Anatomical Site	The subject device is intended for knee and hipjoint replacement surgery.	The CORI system is intended for knee jointreplacement surgery only.

Table 1: Summary of Technological Similarities with Predicate

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Image /page/6/Picture/0 description: The image shows the logo for Blue Belt Technologies. The logo consists of a blue swirl design on the left, followed by the words "BLUE BELT" in large, blue, sans-serif font. Below "BLUE BELT" is the word "TECHNOLOGIES" in a smaller, gray, sans-serif font. The overall design is clean and modern.

2905 Northwest Boulevard, Suite 40, Plymouth, Minnesota 55441 USA Tel 763.452.4950 Fax 763.452.4675 www.bluebelttech.com

Devices	Subject DeviceREAL INTELLIGENCE CORI [K212537]	Predicate DeviceREAL INTELLIGENCE CORI [K201022]
Environment of Use	Same as Predicate.	CORI is intended to be used by trainedmedical professionals in a hospital orclinical setting equivalent to anorthopedic surgery suite.
Energy Used	Same as Predicate.	Rated Supply Voltage:100-240 V ~, 50/60 HzRobotics Console Power Rating: 175VARobotics Cart Power Rating: 230VA
Compatibility withthe Environmentand Other Devices	Same as Predicate.	60601-1-2 Edition 4.0 2014-02 MedicalElectrical Equipment – Part 1-2: GeneralRequirements for Basic Safety and EssentialPerformance – Collateral Standard:Electromagnetic Compatibility -Requirements and Tests.

ReshapingMobility™

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Image /page/7/Picture/0 description: The image shows the logo for Blue Belt Technologies. The logo consists of a blue swirl design on the left, followed by the words "BLUE BELT" in large, blue, sans-serif font. Below "BLUE BELT" is the word "TECHNOLOGIES" in a smaller, gray, sans-serif font. The overall design is clean and modern.

2905 Northwest Boulevard, Suite 40, Plymouth, Minnesota 55441 USA Tel 763.452.4950 Fax 763.452.4675 www.bluebelttech.com

Devices	Subject DeviceREAL INTELLIGENCE CORI [K212537]	Predicate DeviceREAL INTELLIGENCE CORI [K201022]
TechnologicalCharacteristics	Same as Predicate for UKR and TKA with thefollowing additions:The subject device adds a Virtual Machine withhypervisor to enable the Windows-based HIP7software to run on CORI.The subject device adds a new USB 2.0 toEthernet Adapter that will attach to the CORIconsole. The USB 2.0 to Ethernet Adapter willVirtual Machine when using the Hipapplication.	CORI uses established technologies toprepare bone for attachment of UKR andTKA implant components. In the case of atotal knee arthroplasty, the bone surfacemay also be prepared to receive thefemoral and tibial cutting guides.CORI uses intraoperative data collection(image-free or non-CT data generation) tocreate a model of the patient's femurand/or tibia, dependent on the procedurebeing performed, and allows the surgeonto prepare a surgical plan.CORI uses predefined boundariesgenerated during the planning process tocontrol the motion of the surgical bur andlimit the amount of bone removed in orderto shape the condyles or tibial plateau inpreparation for placement of the surgicalimplant.During a TKA procedure, the surgeon maychoose to prepare the bone surface forreceiving the implant using the Bur Allmethod or the bone surface is prepared toreceive the femoral and tibial cuttingguides with final bone surface for receivingthe implant prepared using a standardsurgical saw.Bur cutting is controlled either by retractingthe bur in a guard, or by controlling thespeed of the bur as the target surface isapproached.

Brainlab HIP7 (K193307) is being listed as a reference device because the subject device is incorporating the HIP7 software and instruments cleared in K193307 to support its new THA indication. The Brainlab HIP7 software and instruments are unchanged from those previously cleared in K193307. There is no change to the HIP7 intended use, indications for use, technological characteristics, or instrumentation as a result of including the HIP7 software on the subject device.

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Image /page/8/Picture/0 description: The image shows the logo for Blue Belt Technologies. The logo consists of a blue swirl design on the left, followed by the words "BLUE BELT" in large, blue, sans-serif font. Below "BLUE BELT" is the word "TECHNOLOGIES" in a smaller, gray, sans-serif font. The overall design is clean and modern.

Non-Clinical Testing (Bench)

Design verification and validation tests were performed on CORI to demonstrate that the changes presented in this submission meet all design input requirements and that CORI is as safe and effective as its predicate device. Refer to Section 11: Summary of Design Control Activities for the results of the testing performed.

Additionally, the following testing was conducted:

• Software Integration Testing was completed. Software was developed in accordance with IEC 62304 Medical device software - Software life cycle processes, and this submission contains documentation

per the requirements of FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

• Usability Engineering Validation Testing demonstrating that representative users were able to safely and effectively use CORI with the THA application in a simulated use environment.

No human clinical testing was required to determine the safety and effectiveness of CORI.

Conclusions

The subject device, CORI, described in this submission has the same intended use and the similar technological characteristics as the predicate device, CORI (K201022). The primary difference between the subject device and CORI (K201022) is the addition of the THA indication supported by HIP7 software, the Virtual Machine, and the optional USB 2.0 to Ethernet Connector. The THA application incorporates HIP7 software (reference device K193307) onto CORI via a virtual machine. The indications for use, functionality, and technological characteristics of the HIP7 software are the identical as presented in K193307. The HIP7 software, and the instrumentation necessary to complete a THA navigation procedure, remains unchanged from what was cleared in K193307.

Performance testing of these minor differences has demonstrated that the subject device is substantially equivalent to the predicate device (K201022) and that these differences raise no new questions of safety or effectiveness. The subject device continues to meet design requirements, is as safe and effective as its 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 and as safe and effective as the predicate, CORI (K201022). Blue Belt Technologies believes that FDA can find the subject device to be substantially equivalent to the predicate device.

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).