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).

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

I am sorry, but the provided text does not contain the specific information required to answer your request.

Here's why:

Acceptance Criteria and Reported Device Performance: The document states that "Verification and validation testing demonstrated the safety and efficacy of CORI when the system is used to place porous total knee implants intended for use without bone cement." and "Comprehensive verification testing demonstrated that the system meets required design inputs." However, it does not list the specific acceptance criteria (e.g., target accuracy, precision thresholds) or report the numerical performance results against these criteria.
Sample Size and Data Provenance for Test Set: The document mentions "Verification and validation testing" and "Summative usability testing" but does not provide details on the sample size used for these tests (e.g., number of procedures, number of patients, number of simulated cases) or the provenance of the data (e.g., country of origin, retrospective/prospective).
Experts for Ground Truth: There is no mention of experts used to establish a ground truth for a test set, nor their qualifications or number.
Adjudication Method: No information regarding an adjudication method is provided.
MRMC Comparative Effectiveness Study: The document does not describe any multi-reader multi-case (MRMC) comparative effectiveness study, nor does it mention any effect size for human reader improvement with AI assistance.
Standalone Performance: While the document describes the device's functionality, it does not explicitly state or provide data for a standalone (algorithm only without human-in-the-loop) performance evaluation. The description focuses on its function as an assistant to the surgeon.
Type of Ground Truth: The document does not specify the type of ground truth used (e.g., expert consensus, pathology, outcomes data) for any of its testing.
Sample Size for Training Set & Ground Truth for Training Set: The document is a 510(k) summary for a premarket notification, which focuses on device modifications and substantial equivalence. It does not provide details about the training set used for the underlying AI/software components, including its size or how its ground truth was established.

The document primarily focuses on establishing substantial equivalence to a predicate device (K212537) by highlighting that the subject device (CORI) has the same intended use and technological characteristics, with the main difference being an updated indication for use to support porous total knee implants. It confirms that non-clinical testing and usability testing were performed but does not delve into the detailed results or methodologies that would be needed to answer your specific questions about acceptance criteria and study particulars.

Summary

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Blue Belt Technologies, Inc. Corrine Herlinger Principal Regulatory Affairs Specialist 2905 Northwest Blvd., Ste. 40 Plymouth, Minnesota 55441

Re: K220255

Trade/Device Name: REAL INTELLEGENCE CORI Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO, HSX, JWH, MBH Dated: January 28, 2022 Received: January 31, 2022

Dear Corrine Herlinger:

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) K220255

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 (TKA), and total hip arthroplasty (THA).

Type of Use (Select one or both, as applicable)
X 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/1 description: The image is the logo for Blue Belt Technologies. The logo has a blue swirl design on the left, followed by the words "BLUE BELT" in large blue font. Below that, the word "TECHNOLOGIES" is written in a smaller gray font.

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	Corrine HerlingerPrincipal Regulatory Affairs SpecialistTel: (412) 683-3844 x 4128Email: corrine.herlinger@smith-nephew.com
Date of Submission	January 28, 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® (K212537)
Reason for Submission	Updated Indications for Use

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Image /page/4/Picture/1 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.

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

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/1 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.

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

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 the placement of porous total knee implants intended for use without bone cement. The modifications made to CORI to support the updated indications for use include:

updates to the CORI labeling, and
updates to the Implant Database (IDB) to include Smith+Nephew LEGION Porous TKS.

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 (K212537).

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Image /page/6/Picture/1 description: The image shows the logo for Blue Belt Technologies. The logo features 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.

Table 2: Predicate Device

Manufacturer	Description	SubmissionNumber	Clearance Date
Blue Belt Technologies, Inc.	REAL INTELLIGENCE CORI	K212537	11/03/2021

Table 3: Summary of Technological Similarities with Predicate

Devices	Subject DeviceCORI	Primary PredicateCORI
		K212537
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 procedures includeunicondylar knee replacement (UKR), totalknee arthroplasty (TKA), and total hiparthroplasty (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), totalknee arthroplasty (TKA), and total hiparthroplasty (THA).For Knee applications, CORI is indicated foruse with cemented implants only.
Knee ImplantProduct CodesSupported	HSX, JWH, MBH	HSX, JWH
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/1 description: The image is a 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.

Devices	Subject DeviceCORI	Primary PredicateCORIK212537
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 testing demonstrated the safety and efficacy of CORI when the system is used to place porous total knee implants intended for use without bone cement. Summative usability testing demonstrated that participating surgeons were able use the subject device safely and effectively in a simulated use environment.

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Image /page/8/Picture/1 description: The image is a 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 clean and modern, and the blue color gives it a sense of trustworthiness and reliability.

Conclusions

The subject device, CORI, described in this submission, has the same intended use and the same technological characteristics as the predicate device, CORI (K212537). The primary difference between the two systems is the Indications for Use, which has been updated to allow the system to be used for the placement of porous total knee implants intended for use without bone cement.

Comprehensive 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 the placement of porous total knee implants, and that CORI is as safe and effective as the predicate CORI system (K212537). Blue Belt Technologies believes that FDA can find CORI 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).