The ROSA® Partial Knee System, for use with the ROSA® RECON platform, is indicated as a stereotaxic instrumentation system for Partial Knee replacement (PKA) 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 the knee implant components.

The robotic arm placement is performed relative to anatomical landmarks as recorded using the system intraoperatively, and optionally based on a three-dimensional representation of the bone structures determined preoperatively using compatible X-ray or MRI based imaging technologies.

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

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

The ROSA® Partial Knee System is to be used with Persona Partial Knee (PPK) fixed bearing knee replacement system in accordance with its indications and contraindications.

Device Description

The ROSA® Partial Knee System for use with the ROSA® RECON Platform is used to assist surgeons in performing Partial Knee Arthroplasty (PKA) on the medial compartment with features to assist with the bone resections as well as assessing the state of the soft tissues to facilitate implant positioning intraoperatively.

The ROSA® Partial Knee System uses a Non-Device Medical Device Data System (MDDS) called the Zimmer Biomet Drive Portal which manages the creation and tracking of the surgical cases. The cases reside on the portal until it is 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 the preparation of a pre-operative ROSA Total Knee System (TKA) surgical plan. However, the pre-operative surgical plan is not provided in the ROSA® Partial Knee System and is only made available if a switch is performed intra-operatively from ROSA® Partial Knee System to the ROSA® Knee System. Landmarks taken intra-operatively on the patient's bony anatomy are used to create the intraoperative surgical plan.

An image-free 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 image-free options as they are always based on intraoperative landmarks.

The intra-operative workflow and surgical concepts implemented in the system remain close to the conventional PKA 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 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 provided text is a 510(k) summary for the ROSA® Partial Knee System. While it describes the device, its intended use, and general performance testing (biocompatibility, electrical safety, software verification and validation), it does not contain the specific details required to answer all parts of your request regarding acceptance criteria and a study proving the device meets those criteria.

The document states:

"Verification and Validation Testing for ROSA® Partial was conducted with the following aspects: Physical/Performance Tests- to ensure the performance of the implemented features and verify related design inputs"
"Validation Lab- performed to validate that using ROSA® Partial Knee 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 provide:

A table of specific acceptance criteria (e.g., accuracy thresholds for bone cuts, alignment targets) and the quantitative reported device performance against these criteria.
The sample size for a test set used for performance validation.
Data provenance (country of origin, retrospective/prospective).
Details on expert involvement for ground truth (number, qualifications, adjudication method).
Whether an MRMC comparative effectiveness study was done involving human readers and AI assistance. Robotic surgical systems often focus on robotic accuracy and surgeon assistance, not typically AI-driven image interpretation in the same way an AI diagnostic tool would.
Specific standalone algorithm performance (as it's a robotic system with a human-in-the-loop, not a purely AI diagnostic algorithm).
The type of specific ground truth used for quantifying the performance (e.g., CT measurements post-cut, direct measurements, etc.).
The sample size for the training set (if any machine learning was explicitly involved in training a model for decision-making, separate from software verification).
How ground truth for the training set was established.

Based on the provided text, I cannot generate the table or provide detailed answers to most of your questions. The document focuses on regulatory compliance and substantial equivalence, not the detailed results of a performance study with specific quantitative acceptance criteria and outcomes.

Therefore, many parts of your request will be answered with "Not available in the provided text."

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Metric (Hypothetical, as not provided)	Acceptance Threshold (Hypothetical, as not provided)	Reported Device Performance (Not available in text)
Robotic Arm Accuracy	Positional Accuracy	e.g., ± 0.5 mm	Not available in provided text
	Angular Accuracy	e.g., ± 1.0 degree	Not available in provided text
Bone Resection Precision	Cut Depth Accuracy	e.g., ± 0.5 mm	Not available in provided text
	Cut Plane Orientation	e.g., ± 1.0 degree	Not available in provided text
Navigation System	Registration Accuracy	e.g., < 1.0 mm RMS	Not available in provided text
Overall System Efficacy	Successful Implant Placement Rate	Not explicitly stated (implied safe & effective)	Not available in provided text

The available text broadly states that "performances of the system are acceptable under full simulated use on cadaveric specimens" but does not provide specific quantitative acceptance criteria or reported values.

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

Sample Size: Not available in the provided text. The text mentions "cadaveric specimens" for validation.
Data Provenance: Not available in the provided text. It does not specify the country of origin of the data or whether it was retrospective or prospective.

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

Number of Experts: Not available in the provided text.
Qualifications of Experts: Not available in the provided text. The evaluation method mentioned is "Validation Lab- performed to validate that using ROSA® Partial Knee System is safe and effective and that the performances of the system are acceptable under full simulated use on cadaveric specimens." This implies surgical or engineering expertise, but details are absent.

4. Adjudication method for the test set

Adjudication Method: Not available in the provided text.

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

MRMC Study: Not available in the provided text. Robotic surgical systems like ROSA primarily assist surgeons in performing physical tasks (bone cuts, implant placement) with precision based on pre-operative plans and intra-operative navigation, rather than assisting human "readers" in interpreting images for diagnosis like an AI diagnostic algorithm would. Therefore, a typical MRMC comparative effectiveness study as conceived for diagnostic AI is unlikely to be applicable or reported here.

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

Standalone Performance: Not explicitly detailed or quantified in the provided text. The ROSA® Partial Knee System is described as assisting the surgeon and involving a robotic arm, an optical sensor navigation system, and software. It is inherently a "human-in-the-loop" system. While the individual components (e.g., software calculations) would have undergone internal standalone verification, the ultimate performance metric is the system's ability to assist in surgery, which is human-dependent.

7. The type of ground truth used

Type of Ground Truth: The text indicates that "Validation Lab- performed to validate that using ROSA® Partial Knee System is safe and effective and that the performances of the system are acceptable under full simulated use on cadaveric specimens." This suggests that the ground truth would involve direct measurements on the cadaveric bones after robotic intervention (e.g., measuring cut dimensions, alignment, and implant position) to assess accuracy and compare them to the pre-operative plan or ideal surgical outcomes. Specific details (e.g., using CT scans post-surgery on cadavers, direct physical measurement) are not provided.

8. The sample size for the training set

Sample Size for Training Set: Not available in the provided text. This document is a 510(k) summary for a robotic surgical system, not a deep learning model for image analysis, so a "training set" in the common AI sense might not be explicitly relevant or defined in the same way. The software is verified through "Software Verification and Validation Testing" and is considered "major" level of concern.

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

Ground Truth for Training Set Establishment: Not applicable/Not available in the provided text for the reasons stated above (see point 8).

Summary

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April 19, 2021

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. The FDA logo is on the right, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are placed side by side.

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

Re: K210121

Trade/Device Name: ROSA Partial Knee System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: January 15, 2021 Received: January 19, 2021

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 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) K210121

Device Name ROSA® Partial Knee System

Indications for Use (Describe)

The ROSA® Partial Knee System, for use with the ROSA® RECON platform, is indicated as a stereotaxic instrumentation system for Partial Knee replacement (PKA) 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 the knee implant components.

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

The ROSA® Partial Knee System is to be used with Persona Partial Knee (PPK) fixed bearing knee replacement system in accordance with its indications and contraindications ..

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® Partial Knee (PKA) 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 August 12, 2005.

Sponsor:	Orthosoft, ULC d/b/a Zimmer CAS75 Queen St., Suite 3300Montreal, QC, H3C 2N6, CANADAEstablishment Registration Number: 9617840
Contact Person:	Kavina VeerenManager, Regulatory AffairsTelephone: (514-245-8906)
Date:	15th January 2021
Subject Device:	Trade Name: ROSA® Partial Knee SystemCommon Name: ROSA® Partial Knee System, ROSA®PKA System
	Classification Name:• OLO-Stereotaxic Instrument (21 CFR 882.4560)

Predicate Device(s):

510(k)Number	Device Name	Manufacturer
K182964	ROSA® Knee System	Zimmer CAS*Primary
K170584	MAKO Partial KneeApplication	MAKO SurgicalCorp.

Purpose and Device Description:

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resections as well as assessing the state of the soft tissues to facilitate implant positioning intraoperatively.

An image-free 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 image-free options as they are always based on intraoperative landmarks.

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Indications for Use:	The ROSA® Partial Knee System, for use with the ROSA® RECON platform, is indicated as a stereotaxic instrumentation system for Partial Knee replacement (PKA) 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 the knee implant components.
	The robotic arm placement is performed relative to anatomical landmarks as recorded using the system intraoperatively, and optionally based on a three-dimensional representation of the bone structures determined preoperatively using compatible X-ray or MRI based imaging technologies.
	It includes a robotic arm, an optical sensor navigation system and accessories, software system, surgical instruments and accessories.
	The ROSA® Partial Knee System is designed for use on a skeletally mature patient population. The targeted population has the same characteristics as the population that is suitable for the implants compatible with the ROSA® Partial Knee System.
	The ROSA® Partial Knee System is to be used with Persona Partial Knee (PPK) fixed bearing knee replacement system in accordance with its indications and contraindications.
Contraindications:	The ROSA® Partial Knee System may not be suitable for use in case of:
	o hip pathology with significant bone loss (e.g. avascular necrosis of the femoral head with collapse, severe dysplasia of the femoral head or acetabulum);
	o hip pathology severely limiting range of motion (e.g. arthrodesis, severe contractures, chronic severe dislocation);
	o active infections of the knee joint area;
	o knee replacement revision surgery;

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o presence of strong infrared sources or infrared reflectors in the vicinity of the trackers;

o contraindications for the implant as given by the implant manufacturer: and

o implants that are not compatible with the system

Summary of Technological Characteristics:

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

O The proposed and predicate device(s) are intended to assist the surgeon in providing software defined spatial boundaries for orientation
0 The proposed and predicate device(s) assists in intraoperative navigation of the patient's anatomy and are utilized to facilitate implant positioning
o The proposed and predicate device(s) assists in joint balancing techniques
0 The proposed and predicate device(s) utilizes image data that has been segmented to create a 3D model of the patient's bony anatomy
0 The proposed and primary predicate device utilize the ROSA® RECON Platform, and the proposed and predicate device(s) consists of major components including a software system, navigation system, various instrumentation including reusable and disposable.

Summary of Performance Data (Nonclinical and/or Clinical)

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

Biocompatibility Testing

The biocompatibility evaluation for ROSA® Partial was conducted in accordance with ISO 10993. The evaluation reveals that the ROSA® Partial device meets biocompatibility requirements.

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Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical Safety and EMC testing was conducted on the ROSA® RECON Platform. The device complies with recognized electrical safety standards: IEC 60601-1 standard for electrical safety and IEC 60601-1-2 standard for electromagnetic compatibility.

Device Performance Testing

Verification and Validation Testing for ROSA® Partial 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 0 implemented features and verify related design inputs
. Usability Engineering- addressed user interactions with ROSA® Partial Knee System
Validation Lab- performed to validate that using ROSA® 0 Partial Knee System is safe and effective 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® Partial Knee System does not raise any new issues of safety and effectiveness as compared to the predicate device(s).

Substantial Equivalence Conclusion

The proposed and predicate device(s) have the same intended use and similar technological characteristics including that the proposed device utilizes Magnetic Resonance (MR) and X-ray image data, which is the same as the primary predicate device. The MAKO predicate device uses Computed Tomography (CT).

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In addition, the proposed device uses cutting blocks to assist with bone preparation similar to traditional manual partial knee arthroplasty which is similar to the primary predicate device. The MAKO predicate device is equipped with an automated cutting system that does not require cutting blocks.

The proposed device does not perform any pre-operative surgical planning as compared to the predicate devices. The primary predicate and proposed device share the same previously cleared ROSA® RECON platform hardware and software core components and some of the same instrumentation between the two systems.

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

§ 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).