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

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 provided text is a 510(k) Summary for the "REAL INTELLIGENCE CORI (CORI)" device. It details the device's intended use, indications for use, technological characteristics, and comparison to a predicate device (NAVIO Surgical System).

However, the document does not contain the specific information required to answer the prompt regarding acceptance criteria and the study proving the device meets these criteria. The text mentions "Design verification and validation testing was performed to demonstrate that CORI meets all design requirements" and "Comprehensive performance testing demonstrated that the system meets required design inputs," but it does not provide details of:

A table of specific acceptance criteria values (e.g., accuracy thresholds, precision targets).
Reported device performance values for these criteria.
Sample sizes used for the test set.
Data provenance (country, retrospective/prospective).
Number/qualifications of experts for ground truth.
Adjudication method.
MRMC comparative effectiveness study details (effect size, human improvement).
Standalone performance details.
Type of ground truth used (expert consensus, pathology, outcomes).
Training set sample size and ground truth establishment for training set.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through shared intended use, indications, and technological characteristics, along with various general performance tests (biocompatibility, EMC, software verification, usability). It states, "No human clinical testing was required to determine the safety and effectiveness of CORI."

The closest the document comes to specific performance data is: "The comparative results of the cut-to-plan accuracy indicate that CORI implant placement accuracy data is acceptable and equivalent to the UKR implant placement accuracy data for the NAVIO system." However, it does not provide the numerical accuracy data itself or the acceptance criteria for "acceptable."

Therefore, based solely on the provided text, I cannot fulfill the request for detailed information about acceptance criteria and the study proving the device meets them. The document indicates that such testing was done ("Design verification and validation testing was performed to demonstrate that CORI meets all design requirements"), but it does not disclose the specific criteria or the quantitative results.

Summary

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February 14, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

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

Re: K193120

Trade/Device Name: Real Intelligence Cori Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: November 8, 2019 Received: November 12, 2019

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.

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

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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

Enclosure

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Indications for Use

510(k) Number (if known) K193120

Device Name REAL INTELLIGENCE CORI (CORI)

Indications for Use (Describe)

Indications for use:

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/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.

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	Corrine HerlingerPrincipal Regulatory Affairs SpecialistTel: (412) 683-3844 x 4128Email: corrine.herlinger@smith-nephew.com
Date of Submission	November 8, 2019
Classification Reference	21 CFR 882.4560
Product Code	OLO
Supported Codes	HSX
Common/Usual Name	Orthopedic Stereotaxic Instrument
Trade/Proprietary Name	REAL INTELLIGENCE® CORI® (CORI)
Predicate Device(s)	NAVIO Surgical System (NAVIO System) (K191223)
Reason for Submission	New Device

Section 6 – Page 1

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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, 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 softwaredefined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

Indications for Use

CORI is indicated for use in unicondylar knee replacement (UKR) surqical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined.

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.

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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, bold letters. Below the words "BLUE BELT" is the word "TECHNOLOGIES" in smaller, gray letters.

Currently Supported Unicondylar Knee Implants

The following unicondylar knee implants are supported on CORI:

Table 1: Currently Supported UKR 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

Discussion of Similarities and Differences

CORI is substantially equivalent to the predicate device, 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 device. The CORI UKR software application features a workflow that is nearly identical to the predicate device, cleared via K191223.

	Subject DeviceCORI [Subject]	Predicate DeviceNAVIO [K191223]
Intended use	REAL INTELLIGENCE CORI (CORI) isintended to assist the surgeon inproviding software-defined spatialboundaries for orientation andreference information to anatomicalstructures during orthopedicprocedures.	The NAVIO surgical system is intended toassist 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 inunicondylar knee replacement (UKR)surgical knee procedures, in whichthe use of stereotactic surgery maybe appropriate, and where referenceto rigid anatomical bony structurescan be determined.CORI is indicated for use withcemented implants only.	The NAVIO system is indicated for use insurgical knee procedures in which the useof stereotactic surgery may beappropriate, and where reference to rigidanatomical bony structures can bedetermined. These procedures includeunicondylar knee replacement,patellofemoral arthroplasty, and total kneearthroplasty.The NAVIO system is indicated for use withcemented implants only.
Supported ProductCode(s)	HSX	HRY, HSX, JWH, KRR, NPJ
Environment of Use	CORI is intended to be used bytrained medical professionals in ahospital or clinical setting equivalentto an orthopedic surgery suite.	The NAVIO system is intended for use bytrained orthopedic surgeons in anorthopedic surgical suite.
TechnologicalCharacteristics	CORI uses established technologiesto prepare bone for attachment ofUKR implant components.CORI uses intraoperative datacollection (image-free or non-CT datageneration) to create a model of thepatient's femur and tibia and allowsthe surgeon to prepare a surgicalplan.CORI uses predefined boundariesgenerated during the planningprocess to control the motion of thesurgical bur and limit the amount ofbone removed in order to shape thecondyles or tibial plateau inpreparation for placement of thesurgical implant.Bur cutting is controlled either byretracting the bur in a guard, or bycontrolling the speed of the bur asthe target surface is approached.	The NAVIO system uses establishedtechnologies to prepare bone forattachment of UKR, PFA, or TKA implantcomponents. In the case of a total kneearthroplasty, the bone surface may also beprepared to receive the femoral and tibialcutting guides.NAVIO 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.The NAVIO system uses predefinedboundaries generated during the planningprocess to control the motion of thesurgical bur and limit the amount of boneremoved in order to shape the condyles,tibial plateau, or patellofemoral joint 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 byretracting the bur in a guard, or bycontrolling the speed of the bur as thetarget surface is approached.

Table 2: Summary of Technological Similarities with Predicate

Section 6 - Page 3

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Image /page/6/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.

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

Section 6 – Page 4

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Image /page/7/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.

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

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 device.

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 test data was provided:

. 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.
. Safety and Electromagnetic Compatibility (EMC) testing demonstrating that the device complies with IEC 60601-1 Medical Electric Equipment – Part 1: General Requirements for Basic Safety and Essential Performance and IEC 60601-1-2 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances -Requirements and Tests.
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 device, the NAVIO system (K191223). The primary difference between the two systems is that CORI is a nextgeneration system designed to improve overall system usability and ergonomics, offer increased system performance, and reduce the dependency on outside vendor components. The differences in the system hardware and accessories do not raise any new questions of safety or effectiveness.

Section 6 - Page 5

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Image /page/8/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.

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

The key determining factor in establishing substantial equivalence is whether CORI hardware and accessories can accurately accomplish the desired bone cutting in accordance with the surgical plan. The comparative results of the cut-to-plan accuracy indicate that CORI implant placement accuracy data is acceptable and equivalent to the UKR implant placement accuracy data for the NAVIO system. 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 510(k) premarket notification demonstrates that the redesigned system is substantially equivalent to the NAVIO system (K191223) and that CORI is as safe and effective as the predicate.

Section 6 - Page 6

ReshapingMobility™

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).