The OMNIBotics Knee System is indicated for stereotaxic surgery to aid the surgeon in locating and aligning endoprostheses with these anatomical structures during Total Knee Arthroplasty. The BalanceBot™ is indicated as a tool for adjustment of soft tissue and the femoral implant to reduce instability from flexion gap asymmetry. The OMNIBotics Knee System supports OMNI Apex Knee™ implants and CORIN Unity Knee™ implants.

Device Description

The OMNIBotics® Knee system is a computer-assisted navigation system with a motorized bone cutting quide that is used by surqeons and operating room (OR) staff to assist in performing stereotaxic total knee arthroplasty (TKA). The OMNIBotics® Knee System consists of the OMNIBotics® Station, ART Knee Application software, the OMNIBot cutting quide for quiding femoral bone resections, the BalanceBot defined as an active (motorized) knee spacer and ligament tensioning device, and the OMNIBotics™ Tracker Kit which is comprised of single-use reflective markers that are fixed onto the associated instruments that provide a frame of reference for tracking by the 3D optical optoelectronic localizer.

The OMNIBotics® Station includes the 3D optoelectronic localizer mounted on an articulated arm, a laptop hosting the ART Knee Software and equipped with a touchscreen, an external LCD monitor and a three-button footswitch as a means for the user to interact with the system. The power supply and communication hardware required for the camera, the laptop, the OMNIBot, and BalanceBot are contained within a single enclosure, the control box, located at the base of the OMNIBotics® Station.

The OMNIBotics® Knee System was originally cleared for use with OMNI Apex Knee™ System implants in K163338. This 510(k) notification demonstrates substantial equivalence of the OMNIBotics® Knee System for use with Corin Unity™ Total Knee System implants.

AI/ML Overview

Acceptance Criteria and Study for OMNIBotics® Knee System

The OMNIBotics® Knee System, when used with Corin Unity knee implants, underwent performance testing and process validations to demonstrate substantial equivalence to its predicate device (OMNIBotics® Knee System, K163338).

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
User Requirements & Usability	Device meets established user requirements and is usable.	"The results of the cadaver evaluation demonstrated that the subject device met the established criteria for user requirements, usability..."
Accuracy of Bone Resections	Bone resections performed using the device are accurate.	"...accuracy of bone resections..." (Met established criteria)
Accuracy of Implant Position	Implant positioning achieved with the device is accurate.	"...accuracy of implant position..." (Met established criteria)
Magnitude of Gaps	Achieves appropriate magnitudes of gaps.	"...magnitude of gaps..." (Met established criteria)
Joint Stability	Contributes to stable joint outcomes.	"...and joint stability." (Met established criteria)
Precision, Accuracy, Usability of Reflective Markers	Reflective markers/marker arrays demonstrate acceptable precision, accuracy, and usability.	Demonstrated through "Simulated use and validation testing".
Sterility	OMNIBotics® Tracker Kit is sterile.	Validated for a sterilization dose of 25 kGy of gamma radiation according to the VD max method NF EN ISO 11137-2: 2015.
Endotoxin Levels	Endotoxin levels of single-use reflective markers are within accepted limits.	"The endotoxin levels for the markers were determined to be well within the minimum acceptance criteria" (Tested per ANSI/AAMI ST72. 5.2).
Biocompatibility	Single-use reflective markers are non-cytotoxic.	"The single use markers were determined to be non-cytotoxic per ISO 10993-5."

2. Sample Size for Test Set and Data Provenance

Sample Size: Ten (10) cadaver surgeries.
Data Provenance: Retrospective, using cadaveric subjects. The specific country of origin is not mentioned, but the manufacturer is based in the USA (Corin Ltd., Raynham, MA) and the submitter in Canada (BioVera, Inc., Quebec).

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Four (4) surgeons.
Qualifications: The document describes them as "Surgeon-user," implying they are practicing surgeons experienced in Total Knee Arthroplasty. No further specific details (e.g., years of experience, sub-specialty) are provided.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). It reports that the evaluation "demonstrated that the subject device met the established criteria for user requirements, usability, accuracy...". This suggests a consensus or direct assessment against pre-defined criteria by the performing surgeons, rather than a separate adjudication process involving independent reviewers to resolve discrepancies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned where human readers' performance with and without AI assistance was evaluated. The study focused on validating the device's technical performance and usability, rather than comparing human reader performance.

6. Standalone Performance Study (Algorithm Only)

The study described is not a standalone (algorithm only) performance study. The evaluation involved "surgeon-user verification studies," meaning human surgeons interacted with and utilized the device during the cadaver surgeries. The OMNIBotics® Knee System is a computer-assisted navigation system and cutting guide designed to aid surgeons; therefore, its performance is inherently linked to human interaction.

7. Type of Ground Truth Used

The ground truth was established through direct measurement and assessment by the participating surgeons during the cadaver surgeries. This includes:

Expert Assessment: Surgeons directly evaluated user requirements, usability, joint stability.
Measurement-Based Assessment: Accuracy of bone resections, implant position, and magnitudes of gaps would have been determined through intraoperative measurements and post-resection/implantation evaluation, likely against predetermined surgical plans or anatomical landmarks.
Laboratory Testing: For sterility, endotoxin levels, and biocompatibility of the reflective markers, specific laboratory tests (e.g., gamma radiation validation, ANSI/AAMI ST72. 5.2, ISO 10993-5) were used to establish ground truth.

8. Sample Size for the Training Set

The document does not mention a separate "training set" for the OMNIBotics® Knee System. This device is a navigation and cutting guide system (hardware and software), not an AI model that learns from data in the traditional sense of machine learning. The "ART Knee Application software" is part of the system, but the document does not describe it as having undergone an iterative training process with a dedicated training dataset in the context of this 510(k) submission. The validation primarily focused on the system's performance with the new implant system and revised components.

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

As no dedicated training set is explicitly mentioned or seems applicable in the context of this device's validation described in the 510(k) summary, this question is not directly addressed by the provided text. The device's underlying algorithms and functionalities would have been developed and verified internally during its engineering and design phases, likely using various forms of testing and pre-clinical data, but these are not delineated as a "training set" in this regulatory submission.

Summary

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

Image /page/0/Picture/0 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".

June 27, 2020

Corin Ltd. % Robert A. Poggie President Bio Vera Inc. 65 Promenade Saint Louis Notre Dame de LIle Perrot, Quebec J7v7p2 Canada

Re: K200888

Trade/Device Name: OMNIBotics Knee System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: March 31, 2020 Received: April 3, 2020

Dear Robert Poggie:

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 (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

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

Indications for Use

510(k) Number (if known) K200888

Device Name

OMNIBotics Knee System

Indications for Use (Describe)

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}------------------------------------------------

510(k) SUMMARY

The OMNIBotics® Knee System

In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following information is a summary of safety and effectiveness of the OMNIBotics® Knee System.

A. SUBMITTERS INFORMATION

Submitter Name:	BioVera, Inc.
Submitter Address:	65 Promenade Saint-Louis, Notre-Dame-De-L'Ile-Perrot, Quebec,J7V 7P2, CANADA
Contact Person:	Robert A Poggie, PhD
Phone Number:	(514) 901-0796
Fax Number:	(514) 901-0796
Date of Submission:	March 31, 2020

B. DEVICE IDENTIFICATION & MANUFACTURER

Manufacturer Name:	Corin Ltd.
Manufacturer Address:	480 Paramount Drive, Raynham, MA, 02767, USA
Registration Number:	1226188
Contact Name:	Christina Rovaldi
Title:	Regulatory Affairs Specialist
Device Trade Name:	OMNIBotics® Knee System
Device Common Name:	Stereotaxic instrument
Classification Name:	Stereotaxic instrument
Classification Code:	OLO - Class II
Classification Panel:	Orthopedic
Regulation Number:	21 CFR 882.4560

C1. PRIMARY PREDICATE DEVICE

K163338 OMNIIife Science Inc., OMNIBotics® Knee System

C2. REFERENCE DEVICE

K113060, K173884 K170808, K183533	Corin Ltd. Unity™ Total Knee System
--------------------------------------	-------------------------------------	--

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

D. DEVICE DESCRIPTION

E. INTENDED USE

The OMNIBotics® Knee System is indicated for stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning endoprostheses with these anatomical structures during Total Knee Arthroplasty. The BalanceBot™ is indicated as a tool for adjustment of soft tissue and the femoral implant to reduce instability from flexion gap asymmetry. The OMNIBotics® Knee System supports OMNI Apex Knee™ implants and CORIN Unity Knee™ implants.

F. TECHNOLOGICAL CHARACTERISTICS

The technology of the subject device OMNIBotics Knee System is the same as the predicate device OMNIBotics Knee System, K163338. The basis for this 510(k) notification are three-fold:

(1) New and modified instruments and software for the OMNIBotics Knee System to function with the Corin Unity Knee system,
(2) Change in manufacturer for the single-use reflective markers and associated validations of functionality and manufacturing processes, and
(3) Updated labeling, software, and hardware validations regarding the above changes.

Validation and verification testing for the subject device OMNIBotics Knee System included precision and accuracy of the single-use reflective markers (and arrays), sterility, shelf life, and biocompatibility of the reflective markers (The OMNIBotics® Tracker Kit), and surgeon-user evaluation of Corin Unity knee implants in cadaver knees. The results of these tests showed the subject OMNIBotics® Knee System to perform substantially equivalently to the predicate device.

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

G. PERFORMANCE DATA

The following tests and studies were performed to validate and verify the subject OMNIBotics Knee System to perform substantially equivalently to the predicate device.

. Surgeon-user verification studies of performance measures and accuracy performed by four (4) surgeons in ten (10) cadaver surgeries. The results of the cadaver evaluation demonstrated that the subject device met the established criteria for user requirements. usability, accuracy of bone resections, accuracy of implant position, magnitude of gaps, and joint stability.
Simulated use and validation testing of precision, accuracy, and usability of the reflective markers / marker arrays.
. Sterility of the OMNIBotics® Tracker Kit was validated for a sterilization dose of 25 kGy of gamma radiation according to the VD max method NF EN ISO 11137-2: 2015.
. Endotoxin testing of the single-use reflective markers was performed according to ANSI/AAMI ST72. 5.2. The endotoxin levels for the markers were determined to be well within the minimum acceptance criteria. The single use markers were determined to be non-cytotoxic per ISO 10993-5.

The results of performance testing and process validations demonstrated substantial equivalence of the subject, predicate, and reference devices.

H. CONCLUSION

The OMNIBotics® Knee System used with Corin Unity knee implants was determined to be substantially equivalent to the predicate device OMNIBotics® Knee System (K163338).

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).