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 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 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® Knee System 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 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 and based on the surgical plan, the system mainly assists the surgeon for 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 pre-operative plan using pre-operative imaging), and (3), and precisely positioning the cut guide relative to the planned orthopedic implant location by using a robotic arm.

AI/ML Overview

This document is a 510(k) premarket notification from Orthosoft, Inc. (d/b/a Zimmer CAS) for their ROSA® Knee System. The purpose of this submission is to add an additional compatible FDA-cleared knee implant system (Persona Personalized Knee System) to the device's labeling.

Based on the provided text, the ROSA® Knee System is a stereotaxic instrumentation system used to assist surgeons in Total Knee Arthroplasty (TKA) surgery. It provides software-defined spatial boundaries for orientation and reference information for accurate knee implant component placement.

Here's an analysis of the acceptance criteria and study information, keeping in mind that this document describes an update (to include a new compatible implant) to an already cleared device, not an initial clearance. Therefore, the performance data presented is focused on demonstrating that this change does not negatively impact the existing safety and effectiveness.

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

The document does not provide a table of acceptance criteria with specific numerical performance metrics for the device itself (e.g., accuracy in mm or degrees). This is because the submission is for a modification to an already cleared device (K221928), and the performance testing is framed as demonstrating that the modification (adding a new compatible implant) does not negatively impact the performance previously established.

Instead, the "Summary of Performance Data (Nonclinical and/or Clinical)" section states:

Acceptance Criteria (Implied)	Reported Device Performance
Device continues to meet existing design inputs, user needs, and intended use.	"An analysis of the performance testing was conducted which followed similar test methods and acceptance criteria to those used for the predicate device. The analysis demonstrated that the subject device did not impact the existing design inputs, user needs, or intended use."
Safety and effectiveness are sustained despite the addition of a new implant system.	"The proposed and predicate device have the same intended use, indications of use and the same principles of operation. The technological characteristics of the proposed device and predicate are identical except for the addition of a new implant to the list of compatible implant systems. 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." (This is the conclusion of the "Substantial Equivalence Conclusion" section, based on the non-clinical tests.)

Acceptance Criteria (Implied)

Reported Device Performance

Device continues to meet existing design inputs, user needs, and intended use.

"An analysis of the performance testing was conducted which followed similar test methods and acceptance criteria to those used for the predicate device. The analysis demonstrated that the subject device did not impact the existing design inputs, user needs, or intended use."

Safety and effectiveness are sustained despite the addition of a new implant system.

"The proposed and predicate device have the same intended use, indications of use and the same principles of operation. The technological characteristics of the proposed device and predicate are identical except for the addition of a new implant to the list of compatible implant systems. 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." (This is the conclusion of the "Substantial Equivalence Conclusion" section, based on the non-clinical tests.)

2. Sample size used for the test set and the data provenance

The document does not specify the sample size for any test set in terms of patient data or clinical trials. The "performance testing" mentioned is "non-clinical," meaning it likely involved bench testing, simulations, or phantom studies rather than patient data.

Sample Size: Not specified for non-clinical testing.
Data Provenance: Not specified (e.g., country of origin). The testing is described as "non-clinical," implying laboratory or bench testing rather than patient data collection. The company is based in Canada.
Retrospective/Prospective: Not applicable as it's non-clinical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As the testing was "non-clinical," it would not involve expert human review of medical images or patient outcomes to establish ground truth in the traditional sense of an AI/human reader study. The ground truth would be based on engineering specifications and measurement tolerances.

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

Not applicable. There is no mention of human readers or an adjudication process for a test set, as the performance testing described is non-clinical.

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. An MRMC comparative effectiveness study was not done according to the provided text. The device is a stereotaxic instrumentation system, a robotic assistance system, not an AI imaging diagnostic aid designed to be interpreted by human readers. The purpose of this submission is to add a compatible implant, not to evaluate human reader performance with or without the system.

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

This is implicitly addressed by the "non-clinical performance testing." The device itself (the robotic system) has standalone performance metrics (e.g., accuracy of cuts, placement of guides). The document states that the analysis demonstrated that the subject device did not impact these existing performance characteristics. However, the specific metrics and results of such standalone performance are not detailed in this 510(k) summary, as it refers back to the original predicate device's clearance.

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

For a robotic surgical system, the ground truth for non-clinical testing would typically involve:

Engineering Specifications: Pre-defined accuracy and precision targets (e.g., millimetric deviation for bone resections, rotational accuracy).
Physical Measurements: Using metrology equipment to measure the actual cuts or placements on phantoms or cadaveric models against the planned surgical targets.
Simulations: Computational models to predict performance based on design parameters.

The document does not explicitly state the specific type of ground truth but refers to "similar test methods and acceptance criteria to those used for the predicate device," which for this type of device would primarily be based on objective physical measurements against established engineering tolerances.

8. The sample size for the training set

Not applicable. The ROSA® Knee System is a robotic surgical assistance system, not an AI/Machine Learning diagnostic algorithm that requires a "training set" of data in the typical sense. Its functionality is based on established engineering principles, sensor data processing, and pre-programmed surgical workflows, not pattern recognition learned from a large dataset.

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

Not applicable, as there is no "training set" in the context of an AI/ML algorithm. The "ground truth" for the device's development would be derived from anatomical studies, surgical principles, biomechanical modeling, and expert surgical input to define the desired outcomes and parameters for knee replacement.

Summary

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February 22, 2023

Orthosoft, Inc (d/b/a Zimmer CAS) Kruti Gosalia Regulatory Affairs Specialist 75 Queen St., Suite 3300 Montreal, OC H3C 2N6 Canada

Re: K230180

Trade/Device Name: Rosa Knee System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: January 17, 2023 Received: January 23, 2023

Dear Kruti Gosalia:

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-S

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) K230180

Device Name ROSA® Knee System

Indications for Use (Describe)

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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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 documents, The Special 510k Program, Guidance for Industry and Food and Drug Administration Staff, issued on September 13, 2019.

Sponsor:	Orthosoft, Inc (d/b/a. Zimmer CAS)75 Queen St., Suite 3300Montreal, QC, CANADA H3C 2N6Establishment Registration Number: 9617840
Contact Person:	Kruti GosaliaRegulatory Affairs SpecialistTelephone: (617) 309-0575
Date:	January 19, 2023
Subject Device:	Trade Name: ROSA® Knee SystemCommon Name: ROSA® Knee SystemClassification Name:• OLO - Orthopedic Stereotaxic Instrument (21 CFR 882.4560)
Predicate Device:
	Manufacturer	Device Name	510(k) Number
	Zimmer CAS	ROSA Knee System	K221928
Purpose and Device Description:	The ROSA® Knee System for use with 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.

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The purpose of this submission is to add an additional compatible FDA cleared knee implant system, the Persona Personalized Knee System (K221479). As a result of this change, the labeling has been updated to include this compatibility with this additional knee implant system.

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)

K230180 Page 2 of 4

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surgery. It is to assist the surgeon in providing softwaredefined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components.

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, 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

Contraindications:

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; and
implants that are not compatible with the system ●

K230180 Page 3 of 4

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Summary of Technological Characteristics:

The rationale for substantial equivalence is based on consideration of the following characteristics:

Intended Use: Same as predicate device ●
Indications for Use: The Indications for Use of the ● proposed device and predicate are identical
Technological Characteristics: Same as predicate device except for the addition of the new implant to the list of compatible implant systems
Principle of Operation: Same as predicate device

Summary of Performance Data (Nonclinical and/or Clinical)

Non-Clinical Tests: ●

An analysis of the performance testing was O conducted which followed similar test methods and acceptance criteria to those used for the predicate device. The analysis demonstrated that the subject device did not impact the existing design inputs, user needs, or intended use.

Substantial Equivalence Conclusion

The proposed and predicate device have the same intended use, indications of use and the same principles of operation. The technological characteristics of the proposed device and predicate are identical except for the addition of a new implant to the list of compatible implant systems. 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).