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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.

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.

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:

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.

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The ROSA® Knee System 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 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 sensor navigation system and accessories, software system, surgical instruments and accessories.

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, Vanguard® CR, and Vanguard PS.

The ROSA® Knee System 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 Medical Device Data System (MDDS) called the Zimmer Biomet Drive Portal which manages the creation and tracking of surgical cases. The cases reside on the portal until it is 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 as well as visualization of planned cuts. The pre-operative plan is then matched to the landmarks taken intra-operatively on the patient's bony anatomy. An imageless option is also available where landmarks taken intra-operatively on the patient's bony anatomy are used to create the surgical plan directly in the surgery. 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 intra-operative landmarks.

The intra-operative 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 pre-operative plan using pre-operative imaging),, and (3) precisely positioning the cut guide relative to the planned orthopedic implant location by using a robotic arm.

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

The provided text describes a 510(k) premarket notification for the ROSA® Knee System, a stereotaxic instrumentation system for total knee replacement (TKA) surgery. However, the document primarily focuses on demonstrating substantial equivalence to predicate devices and does NOT contain information regarding:

• Specific acceptance criteria with numerical targets.
• A "study" that directly proves the device meets these acceptance criteria in the format requested (e.g., performance metrics against specific targets). The document mentions "Verification and Validation Testing" and "Software Verification and Validation Testing" but does not detail the results against quantifiable acceptance criteria for device performance.
• Sample size for test sets or data provenance.
• Number of experts or their qualifications for ground truth establishment.
• Adjudication method.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
• Standalone (algorithm-only) performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document does mention:

• Biocompatibility testing: "The biocompatibility evaluation for ROSA Knee was conducted in accordance with ISO 10993. The evaluation reveals that the ROSA Knee device meets biocompatibility requirements." This implies an acceptance criterion of "meets biocompatibility requirements" and a study showing compliance with ISO 10993.
• Electrical Safety and Electromagnetic Compatibility (EMC): "The device complies with recognized electrical safety standards: IEC 60601-1 standard for electrical safety and IEC 60601-1-2 standard for electromagnetic compatibility." This implies an acceptance criterion of "compliance with IEC 60601-1 and IEC 60601-1-2" and a study demonstrating this compliance.
• Device Performance Testing: Mentions "Physical/Performance Tests," "Engineering Analysis," and "Validation Lab" on cadaveric specimens to "validate that using the ROSA Knee is safe and effective and that the performances of the ROSA Knee are acceptable." However, specific acceptance criteria and detailed performance results are not provided.
• Software Verification and Validation Testing: States that testing was conducted to satisfy FDA guidance and IEC 62304 for "major" level of concern software. It concludes that "The testing demonstrates that the ROSA Knee does not raise any new issues of safety and effectiveness as compared to the predicate device(s)." This implies acceptance criteria related to software safety and effectiveness, and the V&V testing serving as the study.

Conclusion:

Based on the provided text, it is not possible to fully complete the requested table and descriptions because the document, being a 510(k) summary, focuses on substantial equivalence and general statements of compliance rather than detailed performance study results against specific, quantifiable acceptance criteria.

Information that can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The remaining sections cannot be answered with the given text.

The document is a 510(k) summary, which generally provides a high-level overview of testing and conclusions for substantial equivalence rather than granular details of specific study designs, methodologies, and raw results for performance criteria.

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