(91 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility requirements | The ROSA Knee device meets biocompatibility requirements (evaluation conducted in accordance with ISO 10993). |
| Electrical safety standards | The device complies with IEC 60601-1 standard for electrical safety. |
| Electromagnetic compatibility (EMC) | The device complies with IEC 60601-1-2 standard for electromagnetic compatibility. |
| Software safety and effectiveness | Software testing (satisfying FDA Guidance for Software in Medical Devices and IEC 62304) demonstrates that the ROSA Knee does not raise any new issues of safety and effectiveness as compared to the predicate device(s). The software's level of concern was classified as "major." |
| System performance for TKA | Physical/Performance Tests, Engineering Analysis, and Usability Engineering were carried out to ensure the performance of implemented features and verify related design inputs. Validation Lab testing on cadaveric specimens was performed to validate that using the ROSA Knee is safe and effective and that its performances are acceptable under full simulated use. |
| (Specific quantifiable performance metrics and thresholds are not provided in this document.) | |
| Performance of robotic arm placement accuracy | The robotic arm placement is performed relative to anatomical landmarks as recorded using the system intraoperatively. (Specific accuracy criteria and results are not provided in this document.) |
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.
§ 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).