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),
· revision knee arthroplasty, and
· total hip arthroplasty (THA).

Device Description

The subject of this Traditional 510(k) is REAL INTELLIGENCE CORI (CORI), a robotic-assisted orthopedic surgical navigation and burring system. CORI uses established technologies of navigation via a passive infrared tracking camera. Based on intraoperatively-defined bone landmarks and known geometry of the surgical implant, the system aids the surgeon in establishing a bone surface model for the target surgery and planning the surgical implant location. For knee applications, CORI then aids the surgeon in executing the surgical plan by controlling the cutting engagement of the surgical bur.

CORI knee application software controls the cutting engagement of the surgical bur based on its proximity to the planned target surface. The cutting control is achieved with two modes:

. Exposure control adjusts the bur's exposure with respect to a guard. If the surgeon encroaches on a portion of bone that is not to be cut, the robotic system retracts the bur inside the guard, disabling cutting.
. Speed control regulates the signal going to the tool control unit itself and limits the speed of the drill if the target surface is approached.

Alternatively, the surgeon can disable both controls and operate the robotic drill as a standard navigated surgical drill.

AI/ML Overview

This document describes the Real Intelligence CORI surgical navigation and burring system. The current submission (K220958) is an update to a previously cleared device (K220255), specifically updating the Indications for Use to include revision knee arthroplasty procedures.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific numerical acceptance criteria for performance metrics like accuracy or precision. Instead, it relies on demonstrating that the device's performance is not negatively impacted by the expanded indications and is "as safe and effective" as the predicate device.

The reported device performance primarily focuses on the successful completion of a simulated revision knee arthroplasty procedure and confirmation that existing accuracy is maintained.

Acceptance Criteria (Implied/General)	Reported Device Performance
Safe and effective use for revision knee arthroplasty procedures.	Summative usability testing demonstrated that participating surgeons were able to use the subject device safely and effectively to complete a revision knee arthroplasty procedure in a simulated use environment. The usability testing also validated the instructions for use.
Maintenance of implant and cut guide position accuracy.	Analysis confirmed implant position and cut guide position accuracy is not impacted by the addition of revision knee arthroplasty to the CORI indications for use statement since no modifications have been made to the CORI system, reusable or disposable components, software, implant/cut guide database, functional or performance requirements, or bone preparation methods.
Compliance with design input requirements.	Verification testing demonstrated that the system meets required design inputs.
Substantial equivalence to predicate device (K220255).	The submission concludes that CORI is as safe and effective as the predicate CORI system (K220255) and is substantially equivalent.

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

Sample Size for Usability Testing: Not explicitly stated as a number. The document mentions "participating surgeons" and "representative users."
Sample Size for Accuracy Analysis: Not explicitly stated. The analysis focused on confirming non-impact rather than new testing on a specific sample size.
Data Provenance: The usability testing was performed in a "simulated use environment," implying a lab or controlled setting. The document does not specify a country of origin, but Blue Belt Technologies, Inc. is based in Plymouth, Minnesota, USA. The testing appears to be prospective as it was conducted for this submission.

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

Usability Testing: The document mentions "participating surgeons" and "representative users." The specific number is not provided, nor are their detailed qualifications (e.g., years of experience, specific orthopedic specialties). However, it implies they were qualified surgeons capable of performing revision knee arthroplasty procedures.
Accuracy Analysis: For the accuracy analysis, no experts are explicitly mentioned as establishing ground truth in the context of a test set, as the analysis primarily confirmed that no changes were made that would impact the existing accuracy parameters, which would have been established during the predicate device's clearance.

4. Adjudication Method for the Test Set

Not applicable/not specified. The studies described are usability testing and an analysis of impact on accuracy. There is no mention of an adjudication process typically associated with diagnostic performance studies involving multiple readers.

5. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a surgical navigation and burring system, not an AI-assisted diagnostic imaging device for "human readers." The evaluation focused on usability and maintenance of surgical accuracy.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The device itself is inherently "human-in-the-loop" as it assists a surgeon. The system controls bur engagement based on proximity to a planned target surface, but the surgeon operates the bur and plans the surgical implant location. No "standalone" algorithm-only performance is described, as it's an intraoperative assistance system.

7. The Type of Ground Truth Used

Usability Testing: The "ground truth" for usability was the ability of surgeons to "safely and effectively" complete a revision knee arthroplasty procedure in the simulated environment, and validation of the instructions for use. This can be considered a form of expert observation and task completion verification against defined procedural steps and safety metrics.
Accuracy Analysis: For accuracy, the ground truth would be the established accuracy parameters of the predicate device. The analysis confirmed that the updated indications did not alter the physical system or software in a way that would modify these established accuracy limits.

8. The Sample Size for the Training Set

Not applicable. This document describes a surgical navigation system, not a machine learning model that requires a training set in the conventional sense. The "training" of the system would imply its design, development, and validation based on engineering principles and previous surgical data, but not a distinct "training set" of patient data for an AI algorithm. The device uses "intraoperatively-defined bone landmarks and known geometry of the surgical implant" but this is real-time operation, not a pre-trained model on a dataset.

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

Not applicable, as there is no traditional "training set" for a machine learning algorithm described in this submission. The system's functionality is based on established engineering principles, navigation technologies, and predefined anatomical and implant geometries.

Summary

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July 27, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" surrounding a graphic. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the text "U.S. FOOD & DRUG ADMINISTRATION" is written in blue.

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

Re: K220958/S001

Trade/Device Name: Real Intelligence Cori Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: June 30, 2022 Received: July 1, 2022

Dear Unnati Bhuptani:

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.

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

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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 (OS) 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 mediation-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

Enclosure

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Indications for Use

510(k) Number (if known) K220958

Device Name REAL INTELLIGENCE CORI (CORI)

Indications for Use (Describe)

· unicondylar knee replacement (UKR),
· total knee arthroplasty (TKA),
· revision knee arthroplasty, and
· total hip arthroplasty (THA).

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, 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

510(k) Summary

510(k) Owner	Blue Belt Technologies, Inc.2905 Northwest Blvd Ste. 40Plymouth, MN 55441 USATel: (763) 452-4950Fax: (763) 452-4675
Contact Person	Unnati BhuptaniRegulatory Affairs Specialist IITel: (412) 853-6682Email: unnati.bhuptani@smith-nephew.com
Date of Submission	March 31, 2022
Classification Reference	21 CFR 882.4560
Product Code	OLO
Supported Codes	HSX, JWH, MBH
Common/Usual Name	Orthopedic Stereotaxic Instrument
Trade/Proprietary Name	REAL INTELLIGENCE ® CORI® (CORI)
Predicate Device(s)	REAL INTELLIGENCE® CORI® (K220255)
Reason for Submission	Updated Indications for Use

K220958

Page 1

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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

unicondylar knee replacement (UKR), ●
total knee arthroplasty (TKA),
. revision knee arthroplasty, and
total hip arthroplasty (THA).

Device Description

CORI knee application software controls the cutting engagement of the surgical bur based on its proximity to the planned target surface. The cutting control is achieved with two modes:

. Exposure control adjusts the bur's exposure with respect to a guard. If the surgeon encroaches on a portion of bone that is not to be cut, the robotic system retracts the bur inside the guard, disabling cutting.
. Speed control regulates the signal going to the tool control unit itself and limits the speed of the drill if the target surface is approached.

Alternatively, the surgeon can disable both controls and operate the robotic drill as a standard navigated surgical drill.

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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 overall design is clean and modern.

Currently Supported Knee Implants

The following Smith+Nephew knee implants are supported on CORI:

Table 1: Currently Supported Smith+ Nephew Knee Implants

Implant Model Name	510(k) Number	ClassificationProduct Code
STRIDE Unicondylar Knee	K123380	HSX
ZUK Select Knee System	K160738	HSX
JOURNEY II Unicompartmental Knee System	K191211	HSX
JOURNEY UNI	K102069	HSX
JOURNEY II CR	K121443	JWH
JOURNEY II BCS	K111711	JWH
JOURNEY II XR	K141471, K152726	JWH
LEGION CR/PS	K951987, K962557, K093746	JWH
LEGION Porous CR Femoral Components	K073325, K091543	MBH
LEGION Porous CR Narrow Femoral Components	K210566	MBH
LEGION Porous Tibia	K100897	MBH
Porous Tibia Baseplate	K211221	MBH
GENESIS II CR/PS	K951987, K962557	JWH
ANTHEM	K142807	JWH
SMITH & NEPHEW, INC. REVISION KNEE SYSTEM	K043440	JWH
REVISION KNEE SYSTEM	K041106	JWH
LEGION RK TIBIAL WEDGES (Hemi-Step & Full-Step)	K953274	JWH
LEGION COBALT CHROME REVISION KNEE SYSTEM	K060742	JWH
LEGION Knee System	K180334	JWH, MBH

Discussion of Similarities and Differences

This Traditional 510(k) submission supports an update to the CORI Indications for Use to allow the system to be used for revision knee arthroplasty procedures. The modifications made to CORI to support the updated indications for use include:

updates to the CORI labeling
The modifications made to support the updated indications for use do not impact the system's intended use or fundamental scientific technology.

Blue Belt Technologies believes that CORI is subject to premarket notification requirements under Section 510(k) of the Federal Food, Drug and Cosmetic Act ("FFDCA" or "the Act") and is substantially equivalent to the previously cleared REAL INTELLIGENCE CORI (K220255).

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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 that, the word "TECHNOLOGIES" is written in a smaller, gray, sans-serif font. The overall design is clean and modern.

Table 2: Predicate Device

Manufacturer	Description	SubmissionNumber	Clearance Date
Blue Belt Technologies, Inc.	REAL INTELLIGENCE CORI	K220255	03/29/2022

Table 3: Summary of Technological Similarities with Predicate

Devices	Subject DeviceCORI	Primary PredicateCORIK220255
Intended use	REAL INTELLIGENCE CORI (CORI) is intendedto assist the surgeon in providing software-defined spatial boundaries for orientationand reference information to anatomicalstructures during orthopedic procedures.	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 forUse	CORI is indicated for use in surgicalprocedures, in which the use of stereotacticsurgery may be appropriate, and wherereference to rigid anatomical bony structurescan be determined. These proceduresinclude:unicondylar knee replacement (UKR), total knee arthroplasty (TKA), revision knee arthroplasty, and total hip arthroplasty (THA).	CORI is indicated for use in surgicalprocedures in which the use of stereotacticsurgery may be appropriate, and wherereference to rigid anatomical bony structurescan be determined. These procedures includeunicondylar knee replacement (UKR), total knee arthroplasty (TKA), total hip arthroplasty (THA).
Knee ImplantProduct CodesSupported	HSX, JWH, MBH	HSX, JWH, MBH
Environmentof Use	Same as predicate.	CORI is intended to be used by trainedmedical professionals in a hospital or clinicalsetting equivalent to an orthopedic surgerysuite.

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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 logo is clean and modern, with a focus on the company name.

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

Devices	Subject DeviceCORI	Primary PredicateCORIK220255
TechnologicalCharacteristics	Same as predicate.	For knee applications, CORI uses establishedtechnologies to prepare bone for attachmentof UKR and TKA implant components. In thecase of a total knee arthroplasty, the bonesurface may 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 femur and/ortibia, dependent on the procedure beingperformed, and allows the surgeon toprepare a surgical plan.The system uses predefined boundariesgenerated during the planning process tocontrol the motion of the surgical bur andlimit the amount of bone removed in order toshape the condyles or tibial plateau inpreparation for placement of the surgicalimplant. Bur cutting is controlled either byretracting the bur in a guard, or by controllingthe speed of the bur as the target surface isapproached.To support the hip application, CORI uses aVirtual Machine with hypervisor to enablethe Windows-based HIP7 software to run onCORI.

Non-Clinical Testing (Bench)

Verification and validation activities were performed on CORI to demonstrate that changes presented in this submission meet all design input requirements and that CORI is as safe and effective as its predicate device.

Additionally, the following testing was conducted:

Usability Engineering Validation Testing: Summative usability testing demonstrated that participating surgeons were able use the subject device safely and effectively to complete a revision knee arthroplasty procedure in a simulated use environment. The summative usability testing also validated the instructions for the user to complete a revision knee arthroplasty procedure using CORI.

K220958

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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.

Implant and Cut Guide Position Accuracy Analysis: Analysis confirmed implant position and cut guide position accuracy is not impacted by the addition of revision knee arthroplasty to the CORI indications for use statement since no modifications have been made to CORI system, reusable or disposable components, software, implant/cut guide database, functional or performance requirements, or bone preparation methods.

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 same technological characteristics as the predicate device, CORI (K220255). The primary difference between the two systems is the Indications for Use, which has been updated to allow the system to be used for revision knee arthroplasty procedures.

Verification testing demonstrated that the system meets required design inputs. Summative usability testing results demonstrate that representative users are able to use the subject device safely and effectively in a simulated use environment. The information presented in this 510(k) premarket notification demonstrates that CORI may be used for revision knee arthroplasty procedures, and that CORI is as safe and effective as the predicate CORI system (K220255). Blue Belt Technologies believes that FDA can find CORI to be substantially equivalent to the predicate device.

K220958

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).