The ROSA® Shoulder System, for use with the ROSA RECON platform, is indicated as a stereotaxic instrumentation system for Total Shoulder Arthroplasty (TSA) surgery. It is used to assist the surgeon in providing software-defined spatial boundaries for orientation and reference to identifiable anatomical structures for the accurate placement of the shoulder implant components.

The robotic arm placement is performed relative to anatomical landmarks and bony anatomy as recorded using the system intraoperatively, and based on a three-dimensional representation of the bone structures determined pre-operatively using compatible CT based imaging technology.

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

The ROSA® Shoulder System is designed for use on a skeletally mature patient population. The target population has the same characteristics as the population targeted by the implants compatible with the ROSA® Shoulder System.

The ROSA® Shoulder System is to be used with the following shoulder replacement systems in accordance with their indications and contraindications:
• Humerus implants: Comprehensive® Total Shoulder System, Comprehensive® Reverse Shoulder System, Identity® Shoulder System and Identity® Reverse Shoulder System.
• Glenoid implants: Alliance™ Glenoid and Comprehensive® Reverse Shoulder System.

Device Description

The ROSA® Shoulder system (RSS) for use with ROSA® RECON Platform (cleared via K230243) is used to assist surgeons in performing Total Shoulder Arthroplasty (TSA) for both anatomic and reverse techniques. It features humeral resection and glenoid reaming capabilities to reproduce the preoperative plan intraoperatively with The RSS uses a Non-Device Medical Device Data System (MDDS) called the Zimmer Biomet Portal, which manages the creation and tracking of surgical cases. The cases with the pre-operative planning based on surgeon preferences reside on the portal until they are uploaded to the ROSA RECON Platform before surgeries.

The intra-operative workflow and surgical concepts implemented in the system remain close to the conventional TSA 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 intra-operatively based on these reference alignment axes and orthopedic implant geometry, and (3) precisely position the humeral cut guide and glenoid reamer relative to the planned orthopedic implant location by using a robotic arm.

AI/ML Overview

The ROSA® Shoulder System, a stereotaxic instrumentation system for Total Shoulder Arthroplasty (TSA) surgery, underwent various performance tests to ensure its safety and effectiveness.

1. Acceptance Criteria and Reported Device Performance

The provided document does not contain a specific table detailing acceptance criteria alongside reported device performance for specific metrics (e.g., accuracy, precision of implant placement). Instead, it broadly states that "Verification and Validation Testing for ROSA Shoulder System was conducted with the following aspects: Performance Tests- to ensure the performance of the implemented features and verify related design inputs."

However, the study overall aimed to demonstrate that the device is "at least as safe and effective as the legally marketed predicate devices." The successful outcome of the performance tests, engineering analysis, usability engineering, and validation lab on cadaveric specimens, coupled with software verification and validation, implies that the device met its internal acceptance criteria for these aspects.

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

The document mentions a "Validation Lab- performed to validate that using ROSA Shoulder System is safe and effective 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) used for this test set nor the country of origin of the cadaveric data. The study appears to be prospective in nature, as it involved performing tests on cadaveric specimens specifically for the validation of the device.

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

The document does not provide details on the number of experts used to establish ground truth for the cadaveric test set, nor their specific qualifications (e.g., "radiologist with 10 years of experience").

4. Adjudication Method for the Test Set

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

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

The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done. The evaluation focuses on the device's performance in assisting surgeons, rather than comparing human reader performance with and without AI assistance.

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

The ROSA® Shoulder System is described as a system "to assist the surgeon" and involves an "intra-operative workflow and surgical concepts implemented in the system remain close to the conventional TSA workflow." It explicitly states the system "mainly assists the surgeon." This indicates that the device is designed to be used with a human in the loop, and therefore, a standalone (algorithm only without human-in-the-loop performance) study was likely not the primary focus or was not explicitly reported as such. The "Validation Lab" involved "full simulated use on cadaveric specimens," which would implicitly involve human interaction with the system.

7. Type of Ground Truth Used

Based on the "Validation Lab- performed to validate that using ROSA Shoulder System is safe and effective and that the performances of the system are acceptable under full simulated use on cadaveric specimens," the ground truth for evaluating the device's performance (e.g., accuracy of implant placement, effectiveness of guidance) would have been established through direct measurement and observation on the cadaveric specimens in comparison to the pre-operative plan. This would fall under a form of empirical or objective ground truth as determined by surgical best practices and the stated goals of the system. It is not specified if this involved pathology or outcomes data in the traditional sense, but rather the physical outcome of the surgical assistance provided by the device.

8. Sample Size for the Training Set

The document does not provide information on the sample size for the training set of the software or any underlying AI components. The ROSA® Shoulder System is described as using "software-defined spatial boundaries" and "a three-dimensional representation of the bone structures determined pre-operatively." While this implies computational components, the nature of their development and training data is not detailed.

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

Since the document does not mention details about a specific training set or the development of a machine learning model, it does not describe how the ground truth for any potential training set was established. The focus of the provided information is on the verification and validation of the final device system.

Summary

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February 21, 2024

Orthosoft Inc (d/b/a Zimmer CAS) Sankalp Dere Regulatory Affairs Project Manager 75 Queen Street Suite 3300 Montreal, QC H3C 2N6 Canada

Re: K233199

Trade/Device Name: ROSA® Shoulder System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO, LLZ Dated: January 18, 2024 Received: January 22, 2024

Dear Sankalp Dere:

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products: and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/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,

Tejen D. Soni -S

For Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair

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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) K233199

Device Name ROSA® Shoulder System

Indications for Use (Describe)

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

The ROSA Shoulder System is designed for use on a skeletally mature patient population. The target population has the same characteristics as the population targeted by the implants compatible with the ROSA Shoulder System.

The ROSA Shoulder System is to be used with the following shoulder replacement systems in accordance with their indications and contraindications:

· Humerus implants: Comprehensive® Total Shoulder System, Comprehensive® Reverse Shoulder System, Identity® Shoulder System and Identity® Reverse Shoulder System.

· Glenoid implants: Alliance™ Glenoid and Comprehensive® Reverse Shoulder System.

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 Shoulder 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 CAS)75 Queen Street, Suite 3300Montreal, QC, Canada H3C 2N6Establishment Registration Number: 9617840
Contact Person:	Sankalp DereRegulatory Affairs Project ManagerSankalpSanjay.Dere@zimmerbiomet.com
Date:	27 SEP 2023
Subject Device:	Trade Name: ROSA® Shoulder SystemCommon Name: ROSA Shoulder System, ROSA Shoulder, ROSA TSA SystemClassification Name:• OLO - Orthopedic Stereotaxic Instrument (21 CFR 882.4560)• LLZ - Medical image management and processing system (21 CFR 892.2050)
Predicate Device:	Device Manufacturer 510(k) Number Predicate or Reference ExactechGPS TotalShoulder Application,Equinoxe PlanningSoftware Blue Ortho K213546 PrimaryPredicate ROSA Knee System Zimmer CAS K230243 SecondaryPredicate
Purpose and Device Description:	The ROSA® Shoulder system (RSS) for use with ROSA® RECON Platform (cleared via K230243) is used to assist surgeons in performing Total Shoulder Arthroplasty (TSA) for both anatomic and reverse techniques. It features humeral resection and glenoid reaming capabilities to reproduce the preoperative plan intraoperatively with

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	The RSS uses a Non-Device Medical Device Data System (MDDS)called the Zimmer Biomet Portal, which manages the creation andtracking of surgical cases. The cases with the pre-operative planningbased on surgeon preferences reside on the portal until they areuploaded to the ROSA RECON Platform before surgeries.The intra-operative workflow and surgical concepts implemented inthe system remain close to the conventional TSA workflow. As such,at the time of the surgery, the system mainly assists the surgeon in (1)determining reference alignment axes in relation to anatomicallandmarks, (2) planning the orthopedic implants location intra-operatively based on these reference alignment axes and orthopedicimplant geometry, and (3) precisely position the humeral cut guide andglenoid reamer relative to the planned orthopedic implant location byusing a robotic arm.
Indications for Use:	The ROSA® Shoulder System, for use with the ROSA® RECONplatform, is indicated as a stereotaxic instrumentation system for TotalShoulder Arthroplasty (TSA) surgery. It is used to assist the surgeonin providing software-defined spatial boundaries for orientation andreference to identifiable anatomical structures for the accurateplacement of the shoulder implant components.The robotic arm placement is performed relative to anatomicallandmarks and bony anatomy as recorded using the systemintraoperatively, and based on a three-dimensional representation ofthe bone structures determined pre-operatively using compatible CTbased imaging technology.It includes a robotic arm, an optical sensor navigation system andaccessories, software system, surgical instruments and accessories.
	The ROSA® Shoulder System is designed for use on a skeletallymature patient population. The target population has the samecharacteristics as the population targeted by the implants compatiblewith the ROSA® Shoulder System.The ROSA® Shoulder System is to be used with the followingshoulder replacement systems in accordance with their indications andcontraindications:• Humerus implants: Comprehensive® Total Shoulder System,Comprehensive® Reverse Shoulder System, Identity® ShoulderSystem and Identity® Reverse Shoulder System.• Glenoid implants: Alliance™ Glenoid and Comprehensive® Reverse Shoulder System.

Contraindications:	The ROSA® Shoulder System may not be suitable for use in case of:• Shoulder pathologies with significant bone loss• Shoulder pathology severely limiting range of motion• Active infections of the shoulder joint area• Shoulder replacement revision surgery• Presence of strong infrared sources or infrared reflectors in thevicinity of the trackers• Contraindications for the implants as given by the implantmanufacturer• Implants that are not compatible with the system• Presence of pre-existing radio-opaque elements that couldinterfere with pre-operative image acquisition or intra-operativeregistration
Summary ofTechnologicalCharacteristics:	The rationale for substantial equivalence is based on consideration ofthe following characteristics:• Indications for Use/Intended Use: The proposed device has thesame intended use and similar indications for use as thepredicates. The devices are intended to assist surgeons byproviding software-defined spatial boundaries for orientation, andreference information to relative anatomical structures foraccurate implant component placement.• The proposed and the predicates allow users for patient boneregistration within the software and use it to guide instrumentsintra-operatively in real time using similar navigation system.• The proposed and ROSA predicate device share the samepreviously cleared ROSA RECON Platform with its major corehardware and software components, tracking system, variousinstrumentation including reusable and disposable. The proposedand ROSA predicate use the robotic arm on the ROSA RECONPlatform to assist the guidance of instruments.• The proposed and primary predicate assist surgeon using similarintra-operative instruments guiding to perform the glenoidreaming based on the surgeon's plan.
Summary ofPerformance Data(Nonclinical and/orClinical):	The following performance data was provided in support of thesubstantial equivalence determination:Biocompatibility TestingThe biocompatibility evaluation for ROSA Shoulder System wasconducted in accordance with ISO 10993. The evaluation shows thatthe ROSA Shoulder devices meets biocompatibility requirements.Electromagnetic Compatibility (EMC) and Electrical Safety
Substantial Equivalence Conclusion:	Both the proposed device and predicate devices have the same intended use and similar indications for use and are used to guide instrumentation to assist with orthopedic surgery. The technological characteristics between the proposed device and the primary predicate are similar with bone registration and intra-operatively instrument guidance with live tracking. The proposed device does not perform any pre-operative surgical planning as is the case with primary predicate. The proposed ROSA Shoulder System and the secondary ROSA predicate utilize the same ROSA RECON Platform with its core hardware and software components. In addition, the proposed device and ROSA predicate use the robotic arm to assist the guidance of instruments. In summary, any differences between the devices do not raise new questions of safety and effectiveness and verification and validation


	Electrical Safety and EMC testing was conducted on the ROSA RECON Platform. The device complies with recognized standards: IEC 60601-1, IEC 60601-1-2 & IEC 60601-1-6 standards.Device Performance TestingVerification and Validation Testing for ROSA Shoulder System was conducted with the following aspects:• Performance Tests- to ensure the performance of the implemented features and verify related design inputs• Engineering Analysis- to ensure the performance of the implemented features and verify related design inputs• Usability Engineering- addressed user interactions with ROSA Shoulder System• Validation Lab- performed to validate that using ROSA Shoulder System is safe and effective and that the performances of the system are acceptable under full simulated use on cadaveric specimensSoftware Verification and Validation TestingSoftware tests were conducted to satisfy requirements of the FDA Guidance for the Content Premarket Submissions for Device Software Functions and IEC 62304 (Medical Device Software - Life Cycle Processes). The software was considered an "Enhanced" Documentation Level, since a failure of the software could result in serious injury or death to the patient. The testing demonstrates that the ROSA Shoulder System does not raise any new issues of safety and effectiveness as compared to the predicate devices.

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activities demonstrate that the proposed device is at least as safe and
effective as the legally marketed predicate devices.

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).