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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 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 the 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® 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 preoperative 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, 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 preoperative 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 tracking system and accessories, software system, surgical instruments and accessories.

This document, K230243, is a 510(k) premarket notification for the ROSA® Knee System. It specifically describes the addition of new disposable instruments (sterile checkpoint screws) to an already cleared device, K221928.

Therefore, the document does not contain the detailed acceptance criteria and study data typical for the initial clearance of a medical device or an AI/ML-driven device. Instead, it justifies substantial equivalence by stating that the existing performance testing for the predicate device (K221928) remains unchanged and applicable, and that the only modification (sterile packaging of checkpoint screws) does not raise new questions of safety or effectiveness.

Based on the provided text, I cannot extract the specific information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria, as this document focuses on a minor modification (sterilization of existing components) rather than the foundational performance of the "ROSA® Knee System" itself.

The document explicitly states:

• "The existing performance testing that was O performed for the predicate device remains unchanged and is still applicable for the proposed device." (Page 6)
• "The technological characteristics between the proposed device and predicate are identical with differences in the instrumentation where the proposed device checkpoint screws are sold in a sterile packaging to end users." (Page 6)
• "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." (Page 6)

To obtain the requested information about the performance and acceptance criteria of the ROSA® Knee System as a whole, one would need to refer to its predicate device's 510(k) submission (K221928) or potentially earlier submissions if K221928 was also a modification.

In summary, the provided text does not contain the study details you are asking for because this specific 510(k) is for a minor modification to an already cleared device, not for its initial performance validation.

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