(92 days)
ApolloKnee is indicated to aid the surgeon in locating anatomical structures and aligning endoprostheses with these anatomical structures during total knee arthroplasty.
Apollo Robot and BalanceBot are optional accessories and are specifically indicated for use in total knee arthroplasty with the ApolloKnee system.
ApolloKnee is compatible with the following implant systems:
- · Apex Knee™ System.
- · Unity Knee™ System.
ApolloKnee is indicated for use in surgical knee procedures in which the use of stereotactic surgery may be appropriate.
ApolloKnee™ (formerly OMNBotics) is a robotic-assisted stereotaxic surgery system that aids the surgeon in locating anatomical structures and aligning endoprostheses with these anatomical structures during total knee replacement (TKR). ApolloKnee is composed of eight sub-systems that integrate to form the ApolloKnee system. Four of these sub-components (Station, Tracking System, Communication Module and Nonsurgical Application) form the main structure of Corin's core platform for robotic or computer assisted surgeries. This core platform is referred to as "Apollo". Future Corin technologies are intended to be developed on the basis of the Apollo core platform. ApolloKnee is one such technology built upon the Apollo common platform. ApolloKnee includes four system specific sub-components (Apollo Robot, BalanceBot, TKR Instruments and ApolloKnee Software),
ApolloKnee is an evolution of the former OMNIBotics Knee System. ApolloKnee is the first launched under Corin Ltd following acquisition of the OMNIBotics' prior manufacturer OMNIlife Science. ApolloKnee differs from OMNIBotics Knee System (as previously marketed under K200888) in branding (for commercial reasons), as well as redesigns of the station and software, and introduction of additional surgical instrumentation, namely the BalanceBot Pre-Resection Paddles, Tibial Cutting Guide and V-Array.
This document, a 510(k) Summary for the ApolloKnee device, details the premarket notification to the FDA. However, it does not contain the specific information required to answer your prompt about acceptance criteria and a study proving the device meets them.
The sections you've highlighted (Non-Clinical Testing, Conclusion) mention "Accuracy testing per custom protocols and ASTM F2554-22" and "surgeon user validation studies (cadaver evaluations)." While these indicate testing was performed, the document does not provide the acceptance criteria or detailed results of these studies.
Therefore, I cannot provide the requested information from this document. It lacks:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication methods.
- Information on MRMC studies or effect sizes.
- Standalone performance data.
- Specific type of ground truth used.
- Sample size for training sets.
- How ground truth for training was established.
This document primarily focuses on establishing substantial equivalence to a predicate device based on design, intended use, and general non-clinical testing categories, rather than presenting a detailed clinical or performance study report with specific acceptance criteria and detailed outcomes.
§ 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).