The ROSA® Knee System, for use with the ROSA® RECON Platform, is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components.

The robotic arm placement is performed relative to anatomical landmarks as recorded using the system intraoperatively, and based on a surgical plan optionally determined pre-operatively using compatible X-ray or MRI based surgical planning tools.

It includes a robotic arm, an optical tracking system and accessories, software system, surgical instruments and accessories.

The ROSA Knee System is designed for use on skeletally mature patient population. The targeted population has the same characteristics as the population that is suitable for the implants compatible with the ROSA Knee System.

The ROSA Knee System is to be used with the following fixed bearing knee replacement systems in accordance with their indications and contraindications: NexGen® CR, NexGen CR-Flex Gender, NexGen LPS, NexGen LPS-Flex, NexGen LPS-Flex Gender, Persona® CR, Persona Ti-Nidium® CR, Persona Ti-Nidium PS, Persona IQ®, Vanguard® CR, and Vanguard PS.

Device Description

The ROSA® Knee System for use with the ROSA RECON Platform is used to assist surgeons in performing Total Knee Arthroplasty (TKA) with features to assist with the bone resections as well as assessing the state of the soft tissues to facilitate implant positioning intra-operatively.

The ROSA® Knee System uses a Non-Device Medical Device Data System (Non-Device MDDS) called the Zimmer Biomet Drive Portal, which manages the creation and tracking of surgical cases. The cases reside on the portal until they are uploaded to the ROSA® RECON Platform before surgeries.

If the case is image-based, a 3D virtual bone model is generated pre-operatively by the PSI systems (X-PSI Knee System or CAS PSI Knee System) to create a 3D model of the patient's femur/tibia and allows for the preparation of a pre-operative surgical plan. An imageless option is also available where landmarks taken intra-operatively on the patient's bony anatomy are used to create the surgical plan. Accuracy of resections, knee state evaluation, and soft tissue assessment are the same between image-based and imageless options as they are always based on intraoperative landmarks.

The intraoperative workflow and surgical concepts implemented in the system remain close to the conventional TKA workflow. As such, at the time of the surgery, the system mainly assists the surgeon in (1) determining reference alignment axes in relation to anatomical landmarks, (2) planning the orthopedic implants location based on these reference alignment axes and orthopedic implant geometry (planning optionally based on a preoperative plan using pre-operative imaging), and (3) precisely positioning the cut guide relative to the planned orthopedic implant location by using a robotic arm.

AI/ML Overview

The ROSA® Knee System is a stereotaxic instrumentation system designed to assist surgeons in Total Knee Arthroplasty (TKA) surgery.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric/Aspect	Acceptance Criteria (Implicit)	Reported Device Performance
Functional Equivalence	The device should assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for accurate knee implant components.	The ROSA® Knee System assists the surgeon in (1) determining reference alignment axes in relation to anatomical landmarks, (2) planning orthopedic implant location based on these reference alignment axes and implant geometry, and (3) precisely positioning the cut guide relative to the planned implant location using a robotic arm.
Accuracy of Resections	Not explicitly stated, but implied to be sufficient for TKA procedures and equivalent to the predicate.	Accuracy of resections is stated to be the same between image-based and imageless options, as they are always based on intraoperative landmarks. The system is designed to facilitate accurate placement of knee implant components.
Knee State Evaluation	Not explicitly stated, but implied to be sufficient for TKA procedures and equivalent to the predicate.	Knee state evaluation is stated to be the same between image-based and imageless options.
Soft Tissue Assessment	Not explicitly stated, but implied to be sufficient for TKA procedures and equivalent to the predicate.	Soft tissue assessment is stated to be the same between image-based and imageless options. The system also assists in joint balancing techniques.
Software Safety	The software contained in the device should not raise new issues of safety and effectiveness and should comply with FDA Guidance for the Content Premarket Submissions for Software Contained in Medical Devices and IEC 62304.	Software tests were conducted to satisfy requirements of the FDA Guidance and IEC 62304. The software was considered a "major" level of concern. The testing demonstrates that the ROSA Knee System does not raise any new issues of safety and effectiveness as compared to the predicate device(s).
Substantial Equivalence	The device should be at least as safe and effective as the legally marketed predicate device, with any differences not raising new questions of safety and effectiveness.	The proposed device and predicate device have the same intended use and similar indications for use, utilize the same platform components, and share similar technological characteristics. Differences in the software application and new instrumentation do not raise new questions of safety and effectiveness, and the proposed device is at least as safe and effective.
Physical/Performance	Not explicitly stated, but implied as ensuring the performance of implemented features and verifying related design inputs.	Physical/Performance Tests were conducted to ensure the performance of the implemented features and verify related design inputs.
Usability	Not explicitly stated, but implied as ensuring user interactions with the system are acceptable.	Usability Engineering addressed user interactions with the ROSA Knee System.
Performance in Simulated Use	The performance of the system should be acceptable under full simulated use on cadaveric specimens and equivalent to the predicate.	A Validation Lab-performed study validated that using the ROSA Knee System is equivalent to the predicate and that the performances of the system are acceptable under full simulated use on cadaveric specimens.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "Validation Lab-performed to validate that using ROSA Knee System is equivalent to the predicate and that the performances of the system are acceptable under full simulated use on cadaveric specimens." However, it does not specify the sample size (number of cadaveric specimens or any other "test set").

The data provenance is described as being generated from "cadaveric specimens," suggesting a controlled laboratory setting. The country of origin of the data is not specified. It is a prospective study as testing was performed on the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

The document does not specify the number of experts used or their qualifications for establishing ground truth in the "Validation Lab" studies or any other testing. Surgical planning can optionally be determined pre-operatively using compatible X-ray or MRI based surgical planning tools, but how this planning forms a "ground truth" and who defines it is not detailed.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set.

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

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it quantify any effect size of human readers improving with AI vs. without AI assistance. The focus is on the device's performance in assisting the surgeon, not on human-reader performance with or without the device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The document does not explicitly state if a standalone algorithm-only performance study was conducted. The description of the device's function and the "Validation Lab" studies imply the device is used "with the ROSA® RECON Platform" and "assists the surgeon," indicating a human-in-the-loop context. However, the software verification and validation testing would assess the algorithm's performance in isolation to some extent.

7. Type of Ground Truth Used

The ground truth for the "Validation Lab" studies appears to be based on:

Intraoperative Landmarks: Accuracy of resections, knee state evaluation, and soft-tissue assessment are "always based on intraoperative landmarks."
Surgical Plan: The system assists in precise positioning "relative to the planned orthopedic implant location." This plan can be optionally determined pre-operatively using X-ray or MRI-based surgical planning tools.
Equivalence to Predicate: The validation also aimed to prove that the system is "equivalent to the predicate," implying the predicate's established performance as a benchmark for ground truth.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set for the software or any AI/machine learning components.

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

The document does not describe how the ground truth for any potential training set was established. Given the nature of the device (stereotaxic instrument for TKA), if machine learning is involved, ground truth for training would likely come from well-annotated anatomical landmarks, surgical plans, and intraoperative measurements from historical TKA cases. However, this is not mentioned in the provided text.

Summary

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October 4, 2022

Image /page/0/Picture/1 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 & 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' in blue, with 'ADMINISTRATION' written below in a smaller font.

Orthosoft d/b/a Zimmer CAS Kavina Veeren Regulatory Affairs Manager 75 Queen Street, Suite 3300 Montreal, QC H3C 2N6 Canada

Re: K221928

Trade/Device Name: ROSA® Knee System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: June 30, 2022 Received: July 1, 2022

Dear Kavina Veeren:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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) f or 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 mediation-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/cdrl-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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221928

Device Name ROSA® Knee System

Indications for Use (Describe)

The ROSA Knee System, for use with the ROSA® RECON Platform, is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate of knee implant components.

It includes a robotic arm, an optical tracking system and accessories, software system, surgical instruments and accessories.

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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K221928 510(k) Summary

In accordance with 21 CFR $807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the ROSA® Knee System 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on September 13, 2019.

Sponsor:	Orthosoft, Inc. d/b/a Zimmer CAS75 Queen St., Suite 3300Montreal, QC, CANADA H3C 2N6Establishment Registration Number: 9617840
Contact Person:	Kavina VeerenRegulatory Affairs ManagerTelephone: 574-245-8906
Date:	June 30, 2022
Subject Device:	Trade Name: ROSA ® Knee SystemCommon Name: ROSA ® Knee System
	Classification Name:
	• OLO- Orthopedic Stereotaxic Instrument (21 CFR 882.4560)
Predicate Device:

Manufacturer	Device Name	510(k) Number
Zimmer CAS	ROSA® KneeSystem	K182964

Purpose and Device Description:

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The purpose of this submission is to (1) add additional compatible FDA cleared knee implant systems, Ti-Nidium® CR, Persona Ti-Nidium. As a result of this change, the labeling and Indications for Use has been updated to include this compatibility with these implant systems. (2) New instrumentation is being added to the subject device as well as the improvement of existing features and the addition of new features within the ROSA Knee Software Application.

Indications for Use:

The ROSA® Knee System, for use with the ROSA RECON Platform is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to

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assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components.

The robotic arm placement is performed relative to anatomical landmarks as recorded using the system intraoperatively, and based on a surgical plan, optionally determined pre-operatively using compatible X-ray or MRI based surgical planning tools.

It includes a robotic arm, an optical tracking system and accessories, software system, surgical instruments and accessories.

The ROSA Knee System is to be used with the following fixed bearing knee replacement systems in accordance with their indications and contraindications: NexGen® CR, NexGen CR-Flex, NexGen CR-Flex Gender, NexGen LPS, NexGen LPS-Flex, NexGen LPS-Flex Gender, Persona® CR. Persona PS. Persona Ti-Nidium® CR. Persona Ti-Nidium PS, Persona IQ®, Vanguard® CR, and Vanguard PS.

The ROSA® Knee System may not be suitable for use in case of:

hip pathology with significant bone loss (e.g. avascular . necrosis of the femoral head with collapse, severe dysplasia of the femoral head or the acetabulum);
hip pathology severely limiting range of motion (e.g. . arthrodesis, severe contractures, chronic severe dislocation);
active infections of the knee joint area: ●
knee replacement revision surgery; ●
presence of strong infrared sources or infrared reflectors ● in the vicinity of the trackers;
. contraindications for the implant as given by the implant manufacturer;
implants that are not compatible with the system

Contraindications:

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Summary of TechnologicalCharacteristics:	The rationale for substantial equivalence is based onconsideration of the following characteristics:
	• The proposed and predicate device are intended to assistthe surgeon in providing software defined spatialboundaries for orientation
	• The proposed and predicate device assist inintraoperative navigation of the patient's anatomy and areutilized to facilitate implant positioning
	• The proposed and predicate device assist in jointbalancing techniques
	• The proposed and predicate device utilize image data thathas been segmented to create a 3D model of the patient'sbony anatomy
	• The proposed and predicate device share the samepreviously cleared ROSA RECON Platform, and theproposed and predicate device consists of majorcomponents including a software system, navigationsystem, various instrumentation including reusable anddisposable.
Summary of Performance Data(Nonclinical and/or Clinical)	The following performance data was provided insupport of the substantial equivalence determination:
Biocompatibility Testing	No new testing was deemed necessary.
	Electrical Safety and Electromagnetic Compatibility (EMC)
	No new testing was deemed necessary on the ROSARECON Platform.
Device Performance Testing
	Verification and Validation Testing for ROSA Knee wasconducted with the following aspects:
	• Physical/Performance Tests- to ensure the performance othe implemented features and verify related design inputs

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Engineering Analysis- to ensure the performance of the ● implemented features and verify related design inputs
Usability Engineering- addressed user interactions with ROSA Knee System
Validation Lab- performed to validate that using ROSA ● Knee System is equivalent to the predicate and that the performances of the system are acceptable under full simulated use on cadaveric specimens

Software Verification and Validation Testing

Software tests were conducted to satisfy requirements of the FDA Guidance for the Content Premarket Submissions for Software Contained in Medical Devices and IEC 62304 (Medical Device Software- Life Cycle Process). The software was considered a "major" level of concern, since a failure of the software could result in serious injury or death to the patient. The testing demonstrates that the ROSA Knee System does not raise any new issues of safety and effectiveness as compared to the predicate device(s).

Substantial Equivalence Conclusion

Both the proposed device and predicate device have the same intended use and similar indications for use. The proposed device and predicate utilize the same platform components. The technological characteristics between the proposed device and predicate are similar with differences in the software application and the addition of new instrumentation with the proposed device. In sum, any differences between the devices do not raise new questions of safety and effectiveness and the proposed device is at least as safe and effective as the legally marketed 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).