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 Special 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

The provided text describes a 510(k) submission for the REAL INTELLIGENCE™ CORI™ surgical navigation and burring system. This submission is a "Special 510(k)" which supports an update to the CORI system to allow it to be used with porous Unicondylar Knee Replacement (UKR) implants.

The core of this submission is to demonstrate substantial equivalence to a previously cleared predicate device (also REAL INTELLIGENCE™ CORI™, K221224). Therefore, the provided documentation focuses on showing that the modifications to support porous UKR implants do not impact the system's intended use, indications for use, or fundamental scientific technology, and that the device remains safe and effective.

Crucially, the document does NOT contain a detailed report of a study proving the device meets specific performance acceptance criteria for the AI component, nor does it explicitly mention an AI component as typically understood in medical image analysis (e.g., for diagnosis or prognosis). The device is described as a "robotic-assisted orthopedic surgical navigation and burring system" that uses "intraoperative data collection (image-free or non-CT data generation)" and "predefined boundaries generated during the planning process to control the motion of the surgical bur." This suggests a system for surgical precision and control, not necessarily one that employs machine learning/AI for diagnostic or predictive tasks from imaging data.

Given the information provided, it's not possible to populate all the requested fields as they pertain to a study proving an AI/ML-based device meets acceptance criteria through performance metrics like sensitivity, specificity, or reader improvement. The document focuses on demonstrating that the modified surgical control system still performs as expected and is safe and effective for its intended surgical guidance purpose.

However, I can extract information related to the closest aspects of "acceptance criteria" and "study" described, which in this context refer to verification and validation testing of the updated surgical system.

Here's an attempt to answer based on the provided text, highlighting where information is absent for an AI/ML context:

Device: REAL INTELLIGENCE™ CORI™ (K231963 Special 510(k) update)
Predicate Device: REAL INTELLIGENCE™ CORI™ (K221224)
Purpose of Submission: Update to allow use with porous Unicondylar Knee Replacement (UKR) Implants.

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

The document does not provide a quantitative table of acceptance criteria with specific performance metrics (e.g., accuracy, precision measurements for anatomical structures, or percentages for successful burring). Instead, it makes a general statement about meeting design inputs.

Acceptance Criterion (Implicit)	Reported Device Performance
All design inputs (for the updated system) are met.	"Blue Belt Technologies has concluded that all design inputs have been met."
Safety and efficacy of CORI for porous UKR implants demonstrated.	"Verification and validation testing demonstrated the safety and efficacy of CORI when the system is used to place porous UKR implants..."
Usability for surgeons to safely and effectively use the device.	"Summative usability testing (including labeling validation) demonstrated that participating surgeons were able use the subject device safely and effectively in a simulated use environment."
No new questions of safety or effectiveness raised by testing.	"...the verification and validation testing performed did not raise any new questions of safety or effectiveness."
Substantial equivalence to predicate device maintained.	"The information presented in this 510(k) premarket notification demonstrates that CORI may be used for the placement of porous UKR implants, and that CORI is as safe and effective as the predicate CORI system (K221224)."

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

Sample Size for Test Set: Not specified. The document mentions "verification and validation testing" and "summative usability testing," but does not provide details on the number of cadaveric specimens, phantom models, or simulated cases used.
Data Provenance: Not specified. The studies appear to be bench and simulated use tests, not clinical data from patients.

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)

Number of Experts: Not specified. For "summative usability testing," the document states "participating surgeons," but provides no number or qualifications beyond "surgeons."
Qualifications of Experts: Assumed to be surgeons, but no specific professional experience or certification details are given.

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

Adjudication Method: Not specified.

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

MRMC Study: Not applicable/not mentioned. This device is a surgical navigation and burring system, not an AI for diagnostic image interpretation that would typically involve an MRMC study comparing human readers with and without AI assistance. The "AI" in "REAL INTELLIGENCE" appears to refer more broadly to advanced computational control/guidance rather than a diagnostic AI algorithm.

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

Standalone Performance: Not explicitly detailed as a separate "algorithm only" study. The system provides "software-defined spatial boundaries" and "controls the motion of the surgical bur." The testing mentioned is for the integrated system's performance (human-in-the-loop operation, or mechanical performance of the robotic arm/burring based on software control), not a standalone AI algorithm validating its own output without physical action.

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

Type of Ground Truth: Not explicitly stated but implied to be based on:
- Design Inputs: The system's performance is verified against its predefined engineering design specifications for spatial accuracy and burring control.
- Simulated Surgical Environment: For usability testing, the "ground truth" would be the successful and safe completion of the simulated surgical task according to established surgical principles and desired outcomes for UKR implant placement. This would likely involve measuring accuracy of bone cuts against a planned target.

8. The sample size for the training set

Sample Size for Training Set: Not applicable/not mentioned. This document describes an update to a surgical system, not the development of a new machine learning model. The system uses "intraoperative data collection (image-free or non-CT data generation) to create a model of the patient's femur and/or tibia" and "predefined boundaries." This implies real-time data capture and processing based on established anatomical models and surgical plans, rather than a system trained on a large dataset of patient images to learn patterns.

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

Ground Truth for Training Set: Not applicable/not mentioned. As per point 8, there's no indication of a machine learning training set in the conventional sense. The "ground truth" for the system's operational principles would be based on anatomical science, biomechanics, engineering specifications, and surgical planning principles.

Summary

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

August 1, 2023

Blue Belt Technologies, Inc. Corrine Herlinger Senior Principal Regulatory Affairs Specialist 2875 Railroad Street Pittsburgh, Pennsylvania 15222

Re: K231963

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, 2023 Received: July 3, 2023

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,

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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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

K231292

Device Name

REAL INTELLIGENCE™ 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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:

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"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."

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510(k) Summary

510(k) Owner	Blue Belt Technologies, Inc.2875 Railroad StreetPittsburgh, PA 15222 USATel: (412) 683-3844Fax: (412) 683-6447
Contact Person	Corrine HerlingerSenior Principal Regulatory Affairs SpecialistTel: 412.552.6428Email: corrine.herlinger@smith-nephew.com
Date of Submission	30-June-2023
Classification Reference	21 CFR 882.4560
Classification Name	Stereotaxic instrument
Product Code	OLO
Supported Codes	HSX, JWH, MBH, NJD
Common/Usual Name	Orthopedic Stereotaxic Instrument
Trade/Proprietary Name	REAL INTELLIGENCE™ CORI™ (CORI)
Predicate Device(s)	REAL INTELLIGENCE™ CORI™ (K221224)
Reason for Submission	This Special 510(k) submission supports an updateto CORI to allow the system to be used with porousUnicondylar Knee Replacement (UKR) Implants

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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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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
ENGAGE Partial Knee System	K190439	NJD, HSX
JOURNEY II UK™ and ENGAGE™ Cementless PartialKnee System	K222653	NJD, HSX

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Discussion of Similarities and Differences

This Special 510(k) submission supports an update to allow for porous UKR implants on Real Intelligence CORI for the following implant combinations:

ENGAGE™ Partial Knee System consisting of the ENGAGE Femur and Tibia, intended for cemented or cementless implantation cleared per K190439
JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System consisting of the Journey II Unicompartmental Cemented Femur and Engage Cemented or Cementless Tibia cleared per K222653

The modifications made to support the change do not impact the system's intended use, indications for 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 (K221224).

Table 1: Predicate Device

Manufacturer	Description	Submission Number	Clearance Date
Blue Belt Technologies, Inc.	REAL INTELLIGENCE CORI	K221224	August 19, 2022

Table 2: Summary of Technological Similarities with Predicate

Devices	Subject DeviceCORI	Primary PredicateCORI - K221224
Intended use	Same as predicate.	REAL INTELLIGENCE CORI (CORI) is intended toassist the surgeon in providing software-definedspatial boundaries for orientation and referenceinformation to anatomical structures duringorthopedic procedures.
Indications forUse	Same as predicate.	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 knee replacement (UKR),• total knee arthroplasty (TKA),• revision knee arthroplasty, and• total hip arthroplasty (THA).

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Devices	Subject DeviceCORI	Primary PredicateCORI - K221224
Knee ImplantProduct CodesSupported	HSX, JWH, MBH, NJD	HSX, JWH, MBH
Environmentof Use	Same as predicate.	CORI is intended to be used by trained medicalprofessionals in a hospital or clinical settingequivalent to an orthopedic surgery suite.
TechnologicalCharacteristics	Same as predicate.	For knee applications, CORI uses establishedtechnologies to prepare bone for attachment ofUKR and TKA implant components. In the caseof a total knee arthroplasty, the bone surfacemay also be prepared to receive the femoraland tibial cutting guides.CORI uses intraoperative data collection (image-free or non-CT data generation) to create amodel of the patient's femur and/or tibia,dependent on the procedure being performed,and allows the surgeon to prepare a surgicalplan.The system uses predefined boundariesgenerated during the planning process tocontrol the motion of the surgical bur and limitthe amount of bone removed in order to shapethe condyles or tibial plateau in preparation forplacement of the surgical implant. Bur cutting iscontrolled either by retracting the bur in aguard, or by controlling the speed of the bur asthe target surface is approached.To support the hip application, CORI uses aVirtual Machine with hypervisor to enable theWindows-based HIP7 software to run on CORI.

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Non-Clinical Testing (Bench)

Verification and validation testing demonstrated the safety and efficacy of CORI when the system is used to place porous UKR implants intended for use with or without bone cement. Summative usability testing (including labeling validation) demonstrated that participating surgeons were able use the subject device safely and effectively in a simulated use environment.

Blue Belt Technologies has concluded that all design inputs have been met and that the verification and validation testing performed did not raise any new questions of safety or effectiveness.

Conclusions

The subject device, CORI, described in this submission has the same intended use, indications for use, and the same technological characteristics as the predicate device, CORI (K221224). The difference between the two systems is an update to the CORI User Manual and an update to the Implant Database to include the ENGAGE™ Partial Knee System and the JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System.

Comprehensive verification testing demonstrated that the system meets required design inputs. Summative usability testing results demonstrate that representative users can 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 UKR implants, and that CORI is as safe and effective as the predicate CORI system (K221224). 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).