OptiVu™ ROSA® MxR is indicated for displaying surgical workflow images from the ROSA® RECON platform in Mixed Reality. It includes functions for viewing the same surgical workflow steps and 2D visualizations as presented on the existing ROSA RECON platform user interface. When accessing ROSA® MxR from a stereoscopic head mounted display (HMD), images viewed are for informational purposes only and are not intended for diagnostic use.

Device Description

OptiVu™ ROSA® Mixed Reality (ROSA® MxR) is indicated for displaying surgical workflow images from the ROSA® RECON Platform and the corresponding ROSA® clinical applications intra-operatively during orthopedic surgeries. It is intended to provide an additional means of display where the ROSA® RECON Platform user interface is duplicated into a Mixed Reality see-through environment. OptiVu™ ROSA® MxR allows the ROSA® RECON Platform user interface and corresponding ROSA® clinical applications (e.g. ROSA® Knee, ROSA® Partial, or ROSA® Hip) to be streamed through a compatible head-mounted display (HMD) (e.g. HoloLens 2).

The subject device's main purpose is to place the duplicated virtual ROSA® user interface at a convenient location to provide the following functionalities:

Mixed Reality visualization solution
Register hand gestures as inputs such as to touch, move and resize views
Wireless connectivity between a HMD (e.g. HoloLens 2) and the ROSA® RECON Platform

AI/ML Overview

The OptiVu™ ROSA® MxR device is designed to display surgical workflow images from the ROSA® RECON platform in Mixed Reality. It includes functions for viewing the same surgical workflow steps and 2D visualizations as presented on the existing ROSA RECON platform user interface via a head-mounted display (HMD) like the HoloLens 2. It's important to note that images viewed through the HMD are for informational purposes only and are not intended for diagnostic use.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list quantitative acceptance criteria in a typical tabular format. Instead, it describes general performance goals and verification activities. The overall acceptance criterion is demonstrating substantial equivalence to predicate devices without raising new questions of safety and effectiveness.

Acceptance Criterion (Inferred from Document)	Reported Device Performance (Summary)
Display surgical workflow images from ROSA® RECON platform in Mixed Reality	Successfully streams a duplicate of the ROSA® RECON Platform user interface in Mixed Reality in real-time.
View same surgical workflow steps as existing ROSA RECON platform UI	Includes functions for viewing the same surgical workflow steps.
View same 2D visualizations as existing ROSA RECON platform UI	Includes functions for viewing the same 2D visualizations.
Register hand gestures as inputs (touch, move, resize views)	Device is designed to register hand gestures as inputs.
Wireless connectivity between HMD and ROSA® RECON Platform	Provides wireless connectivity between the HMD (e.g., HoloLens 2) and the ROSA® RECON Platform.
Performance of implemented features	Physical/Performance Tests were conducted to ensure performance of implemented features and verify related design inputs.
Software safety and effectiveness	Software Verification and Validation Testing was conducted, meeting FDA Guidance and IEC 62304 standards for a "major" level of concern. Testing demonstrates no new issues of safety and effectiveness.
No new questions of safety and effectiveness compared to predicates	Differences between the device and predicates do not raise new questions of safety and effectiveness; device is at least as safe and effective.

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

The document does not specify a separate "test set" in the context of a clinical study with patient data. The performance evaluations described are primarily non-clinical device performance testing, engineering analysis, software verification and validation, and usability engineering. Therefore, the concept of sample size for patient data or data provenance (country of origin, retrospective/prospective) is not directly applicable in the information provided.

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

As there is no mention of a clinical test set requiring expert-established ground truth related to patient data or diagnostic interpretations, this information is not provided. The device explicitly states that images viewed through the HMD are "for informational purposes only and are not intended for diagnostic use."

4. Adjudication Method for the Test Set

Given the absence of a clinical test set requiring expert interpretation of patient data, there is no mention of an adjudication method (e.g., 2+1, 3+1). The performance testing described focuses on the device's technical functionality and software integrity.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not mentioned in the provided document. The device's indications for use emphasize displaying surgical workflow information rather than diagnostic interpretation or AI-driven decision support for human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The document describes "Software Verification and Validation Testing" and "Device Performance Testing." While these are standalone tests of the algorithm's functional performance, they are not presented as a standalone clinical performance study in the sense of an algorithm making diagnostic or treatment decisions without human oversight. The device is an accessory for surgical workflow information display, not an autonomous diagnostic or therapeutic algorithm.

7. The Type of Ground Truth Used

For the software and device performance testing:

Engineering specifications and design inputs served as the "ground truth" or reference for verification and validation activities. The tests aimed to ensure the device met these predefined requirements.
Regulatory standards and guidance documents (e.g., FDA Guidance for Content Premarket Submissions for Software, IEC 62304) provided the "ground truth" for software quality and safety.

No "ground truth" in terms of expert consensus, pathology, or outcomes data for clinical decision-making is mentioned, consistent with its informational purpose.

8. The Sample Size for the Training Set

The document does not provide information on a "training set" in the context of machine learning. The device appears to be primarily an interface and display tool, integrating with existing ROSA® RECON Platform software, rather than a system that learns from a large dataset.

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

As no training set (for machine learning) is discussed, the method for establishing its ground truth is not applicable or provided.

Summary

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July 29, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Orthosoft, Inc. (d/b/a Zimmer CAS) Paul Hardy Associate Director 75 Queen St., Suite 3300 Montreal, QC H3C 2N6 Canada

Re: K220733

Trade/Device Name: OptiVu ROSA MxR Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO, LLZ Dated: April 27, 2022 Received: May 2, 2022

Dear Paul Hardy:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 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,

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

510(k) Number (if known) K220733

Device Name OptiVu™ ROSA® MxR

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)

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K220733 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 OptiVu™ ROSA® MxR 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, H3C 2N6, CANADAEstablishment Registration Number: 9617840
Contact Person:	Paul HardyRegulatory Affairs DirectorTelephone: 574-453-6739Paul.Hardy@zimmerbiomet.com
Date:	July 29th, 2022
Subject Device:	Trade Name: OptiVu™ ROSA® MxRCommon Name: OptiVu™ ROSA® MxR, OptiVu™ ROSA®Mixed RealityClassification Name:• OLO-Stereotaxic Instrument (21 CFR 882.4560)• LLZ- Medical Image Management and Processing System

Predicate Device(s):

510(k) Number	Device Name	Manufacturer	Predicate
K182964	ROSA® Knee System	Zimmer CAS	Primary
K200384	HipXpert System	Surgical Planning Associates, Inc.	Reference

(21 CFR 892.2050)

Purpose and Device Description:

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ROSA® Partial, or ROSA® Hip) to be streamed through a compatible head-mounted display (HMD) (e.g. HoloLens 2).

The subject device's main purpose is to place the duplicated virtual ROSA® user interface at a convenient location to provide the following functionalities:

Mixed Reality visualization solution
Register hand gestures as inputs such as to touch, move ● and resize views
. Wireless connectivity between a HMD (e.g. HoloLens 2) and the ROSA® RECON Platform

Summary of Technological Characteristics:

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

. The proposed device and the primary predicate share the same previously cleared ROSA® RECON Platform hardware (robotic and optical unit) and the same previously cleared ROSA® RECON Platform software (OS, SDK Software, and Case Management software).
The proposed device has similar principles of operation . as the predicate devices. OptiVu™ ROSA® MxR and the secondary predicate both utilize an off-the-shelf HMD (e.g. HoloLens 2) to stream images pertaining to surgical procedures for intra-operative use. The encrypted images streamed through the HMD (e.g HoloLens 2) allows the surgeon to view the display in a Mixed Reality environment. OptiVuTM ROSA® MxR and the secondary predicate device both display surgical workflow images. The ROSA® Knee System displays the workflow through its hardware component, the ROSA® RECON Platform whereas OptiVuTM ROSA® MxR connects through wifi to the ROSA®

Indications for Use:

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RECON Platform to stream a duplicate of the ROSA® RECON Platform user interface in Mixed Reality in real-time. The proposed device does not perform any pre-operative surgical planning as compared to the primary predicate device. The proposed device does not provide the viewing of images in 3D as compared to the secondary predicate.

Summary of Performance Data (Nonclinical and/or Clinical)

The following performance data was provided in support of the substantial equivalence determination:

Device Performance Testing

Verification and Validation Testing for OptiVu™ ROSA® MxR was conducted with the following aspects:

Physical/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 OptiVu™ ROSA® MxR

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 OptiVu™ ROSA® MxR is an accessory to a medical device that has a major level of concern. The testing demonstrates that OptiVuTM ROSA® MxR does not raise any new issues of safety and effectiveness as compared to the predicate device(s).

Substantial Equivalence Conclusion

The proposed device and the primary predicate device share the same previously cleared ROSA® RECON Platform hardware (robotic and optical unit) and the same previously cleared ROSA® RECON Platform software (OS, SDK Software, and Case Management software).

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In addition, the proposed device has similar principles of operation as the predicate devices. The proposed device utilizes an off-the-shelf HMD (e.g. HoloLens 2) to stream images pertaining to surgical procedures for intra-operative use which is the same as the secondary predicate device. The proposed device does not perform any pre-operative surgical planning as compared to the primary predicate. The proposed device does not provide the viewing of images in 3D as compared to the secondary predicate.

In summary, 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(s).

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).