CORI is indicated for use in surgical knee 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) and total knee arthroplasty (TKA).

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, to aid the surgeon in establishing a bone surface model for the target surgery and in planning the surgical implant location. Based on intraoperatively-defined bone landmarks and known geometry of the surgical implant, CORI aids the surgeon in establishing a bone surface model for the target surgery and planning the surgical implant location.

CORI 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 drill motor controller 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

The acceptance criteria and study proving device performance are described below, based on the provided text for the Real Intelligence Cori (CORI) device.

1. A table of acceptance criteria and the reported device performance

The document mentions "Comprehensive performance testing demonstrated that the system meets required design inputs" and "The comparative results of the cut-to-plan accuracy data is acceptable and equivalent to the predicate devices." However, specific quantitative acceptance criteria and detailed reported performance metrics are not explicitly stated in the provided text. The submission focuses on substantial equivalence to predicate devices (K193120 and K191223) rather than presenting new, specific acceptance criteria with distinct performance numbers for this iteration of CORI.

It can be inferred that the acceptance criteria for accuracy are implicitly tied to demonstrating equivalence to the predicate devices, which are also navigational systems for orthopedic surgery.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily describes bench testing and states, "No human clinical testing was required to determine the safety and effectiveness of CORI." Therefore, the concept of a "test set" in the context of clinical data provenance (country, retrospective/prospective) does not directly apply here.

The performance data consisted of "physical performance test for all system components and system accuracy testing." The sample size for these non-clinical tests is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Since "No human clinical testing was required" and the testing primarily involved "physical performance test for all system components and system accuracy testing," the concept of "experts" establishing ground truth for a clinical test set is not applicable in the traditional sense. The "ground truth" for accuracy testing would have been established through validated measurement techniques (e.g., precise optical metrology, CMM measurements) under controlled laboratory conditions, not by human expert assessment of medical images or outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Given that clinical data from human subjects was not used for this submission, an adjudication method for a clinical test set is not applicable.

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 MRMC comparative effectiveness study was conducted, as stated: "No human clinical testing was required." The CORI system is an orthopedic stereotaxic instrument for surgical guidance, not an AI-assisted diagnostic imaging tool that would typically involve human readers.

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

The document describes the CORI device as a "computer-assisted orthopedic surgical navigation and surgical burring system" that "assists the surgeon" and provides "software-defined spatial boundaries." It also states, "Alternatively, the surgeon can disable both controls and operate the robotic drill as a standard navigated surgical drill." This indicates that the device is designed to be human-in-the-loop, providing assistance to a surgeon.

However, "Performance data consisted of physical performance test for all system components and system accuracy testing," which implies that the accuracy of the algorithm's guidance and burring control was tested in a standalone, bench setting, separate from a surgeon's subjective usage. The "cut-to-plan accuracy data" would represent the standalone performance of the algorithm and hardware.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical "system accuracy testing" and "cut-to-plan accuracy data," the ground truth would have been established through precise, objective physical measurements (e.g., using metrology equipment) of the planned bone resection versus the actual bone resection created by the device on a test medium. This is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

The document refers to the device as a "computer-assisted orthopedic surgical navigation and surgical burring system" that uses "established technologies." While it mentions "software verification testing" and development in accordance with IEC 62304, there is no specific mention of a "training set" in the context of machine learning. If machine learning models were used, details about their training setup are not provided in this regulatory submission summary. The equivalence is primarily based on the functional and technological similarities to predicate devices and performance in physical accuracy tests.

9. How the ground truth for the training set was established

As no "training set" in the context of machine learning is explicitly mentioned, how its ground truth was established is not provided. If the system is primarily rule-based or model-based on known geometry and intraoperative data rather than a data-driven machine learning model, then a traditional "training set" with established ground truth would not be applicable. The "ground truth" for the system's underlying models would be based on engineering specifications and anatomical models.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.

June 12, 2020

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

Re: K201022

Trade/Device Name: Real Intelligence Cori Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO, HSX, HRY, NPJ Dated: May 14, 2020 Received: May 15, 2020

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.

{1}------------------------------------------------

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 (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 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, MPH 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K201022

Device Name REAL INTELLIGENCE CORI (CORI)

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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 font. Below "BLUE BELT" is the word "TECHNOLOGIES" in a smaller, gray font. The logo is clean and modern, with a focus on the company name.

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 x4128Email: corrine.herlinger@smith-nephew.com
Date Prepared	June 12, 2020
Classification Reference	21 CFR 882.4560
Product Code	OLO
Supported Codes	HSX, HRY, NPJ
Common/Usual Name	Orthopedic Stereotaxic Instrument
Trade/Proprietary Name	REAL INTELLIGENCE® CORI® (CORI)
Predicate Device(s)	REAL INTELLIGENCE® CORI® (CORI) (K193120) (Primary Predicate)NAVIO Surgical System (Navio system) (K191223)
Reason for Submission	New Indication

{4}------------------------------------------------

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

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 with cemented implants only.

Device Description

CORI 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 drill motor controller 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.

{5}------------------------------------------------

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 knee implants are supported on CORI:

Table 1: Currently Supported Knee Implants

Implant Model Name	Manufacturer	510(k) Number
JOURNEY II Unicompartmental Knee System	Smith and Nephew	K191211
JOURNEY UNI	Smith and Nephew	K102069
STRIDE Unicondylar Knee	Smith and Nephew	K123380
ZUK Select Knee System	Smith and Nephew	K160738
JOURNEY II CR	Smith and Nephew	K121443
JOURNEY II BCS	Smith and Nephew	K111711
JOURNEY II XR	Smith and Nephew	K141471, K152726
GENESIS II CR/PS	Smith and Nephew	K951987, K962557
LEGION CR/PS	Smith and Nephew	K951987, K962557, K093746
ANTHEM	Smith and Nephew	K142807

Discussion of Similarities and Differences

The subject device, CORI, is substantially equivalent to the predicate devices: CORI (K193120) and the Navio system (K191223). The intended use and the established technologies used to prepare bone for the attachment of implant components, including implant accuracy, is the same as the predicate devices. The CORI UKR and TKA software applications feature a workflow that is nearly identical to the predicate devices, cleared via K191223 and K193120.

Table 2: Summary of Technological Similarities with Predicates

Devices	Subject DeviceCORI	Primary PredicateCORI[K193120]	Secondary PredicateNAVIO Surgical System[K191223]
Intended Use	REAL INTELLIGENCE CORI(CORI) is intended to assistthe surgeon in providingsoftware-defined spatialboundaries for orientationand reference informationto anatomical structuresduring orthopedicprocedures.	REAL INTELLIGENCE CORI(CORI) is intended to assistthe surgeon in providingsoftware-defined spatialboundaries for orientationand reference informationto anatomical structuresduring orthopedicprocedures.	The NAVIO Surgical System isintended to assist the surgeonin providing software-definedspatial boundaries fororientation and referenceinformation to anatomicalstructures during orthopedicprocedures.
Devices	Subject DeviceCORI	Primary PredicateCORI[K193120]	Secondary PredicateNAVIO Surgical System[K191223]
Indications forUse	CORI is indicated for use insurgical knee proceduresin which the use ofstereotactic surgery maybe appropriate, and wherereference to rigidanatomical bonystructures can bedetermined. Theseprocedures includeunicondylar kneereplacement and totalknee arthroplasty.CORI is indicated for usewith cemented implantsonly.	CORI is indicated for use inunicondylar kneereplacement (UKR) surgicalknee procedures, in whichthe use of stereotacticsurgery may beappropriate, and wherereference to rigidanatomical bony structurescan be determined.CORI is indicated for usewith cemented implantsonly.	The NAVIO system is indicatedfor use in surgical kneeprocedures in which the useof stereotactic surgery may beappropriate, and wherereference to rigid anatomicalbony structures can bedetermined. Theseprocedures includeunicondylar kneereplacement, patellofemoralarthroplasty, and total kneearthroplasty.The NAVIO system is indicatedfor use with cementedimplants only.
ImplantProduct CodesSupported	HSX, HRY, NPJ		HRY, HSX, JWH, KRR, NPJ
Environmentof Use	Same as primarypredicate.	CORI is intended to be usedby trained medicalprofessionals in a hospitalor clinical setting equivalentto an orthopedic surgerysuite.
TechnologicalCharacteristics	CORI uses establishedtechnologies to preparebone for attachment ofUKR and TKA implantcomponents. In the case ofa total knee arthroplasty,the bone surface may alsobe prepared to receive thefemoral and tibial cuttingguides.CORI uses intraoperativedata collection (image-freeor non-CT data generation)to create a model of the		The NAVIO system usesestablished technologies toprepare bone for attachmentof UKR, PFA, or TKA implantcomponents. In the case of atotal knee arthroplasty, thebone surface may also beprepared to receive thefemoral and tibial cuttingguides.NAVIO uses intraoperativedata collection (image-free ornon-CT data generation) tocreate a model of the
Devices	Subject DeviceCORI	Primary PredicateCORI[K193120]	Secondary PredicateNAVIO Surgical System[K191223]
	patient's femur and/ortibia, dependent on theprocedure beingperformed, and allows thesurgeon to prepare asurgical plan.CORI uses predefinedboundaries generatedduring the planningprocess to control themotion of the surgical burand limit the amount ofbone removed in order toshape the condyles ortibial plateau inpreparation for placementof the surgical implant.During a TKA procedure,the surgeon may choose toprepare the bone surfacefor receiving the implantusing the Bur All methodor the bone surface isprepared to receive thefemoral and tibial cuttingguides with final bonesurface for receiving theimplant prepared using astandard surgical saw.Bur cutting is controlledeither by retracting the burin a guard, or bycontrolling the speed ofthe bur as the targetsurface is approached.		patient's femur and/or tibia,dependent on the procedurebeing performed, and allowsthe surgeon to prepare asurgical plan.The NAVIO system usespredefined boundariesgenerated during the planningprocess to control the motionof the surgical bur and limitthe amount of bone removedin order to shape thecondyles, tibial plateau, orpatellofemoral joint inpreparation for placement ofthe surgical implant.During a TKA procedure, thesurgeon may choose toprepare the bone surface forreceiving the implant usingthe Bur All method or thebone surface is prepared toreceive the femoral and tibialcutting guides with final bonesurface for receiving theimplant prepared using astandard surgical saw.Bur cutting is controlled eitherby retracting the bur in aguard, or by controlling thespeed of the bur as the targetsurface is approached.

Page 3 of 6

{6}------------------------------------------------

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

Page 4 of 6

ReshapingMobility™

{7}------------------------------------------------

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

Page 5 of 6

{8}------------------------------------------------

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 testing was performed to demonstrate that CORI meets all design requirements and is as safe and effective as its predicate devices.

Comprehensive performance testing demonstrated that the system meets required design inputs. Performance data consisted of physical performance test for all system components and system accuracy testing. Additionally, the following testing was conducted:

Biocompatibility testing demonstrating that the system satisfies the requirements of BS EN ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a risk management process.
Software verification testing, including software integration and workflow 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 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 same technological characteristics as the predicate devices, CORI (K193120) and the NAVIO system (K191223). The primary difference between the subject device and CORI (K193120) is the update to the system's indications for use to add the TKA application onto the CORI system. The CORI TKA application is based on existing NAVIO TKA software version 7.0. The main functionality of the TKA software is the same as presented in K191223, with modifications to allow for communication with the CORI accessories (robotic drill, tablet, foot pedal, camera, and optional monitor).

The key determining factor in establishing substantial equivalence is whether CORI can accurately accomplish the desired bone cutting in accordance with the surgical plan. The comparative results of the cut-to-plan accuracy data is acceptable and equivalent to the predicate devices. Usability engineering test 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 Special 510(k) premarket notification demonstrates that the updated CORI is as safe and effective as the predicates, CORI (K193120) and the NAVIO system (K191223). Blue Belt Technologies believes that FDA can find CORI to be substantially equivalent to the predicate devices.

Page 6 of 6

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).