(29 days)
The ROSA® Hip System for use with the ROSA® RECON platform, is indicated as a fluoroscopic-guided system for total hip arthroplasty (THA). It is used to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of hip implant components provided that the points of interest can be identified from radiology images.
The intraoperative cup placement is performed relative to anatomical landmarks as recorded using the system intraoperatively, and based on preoperative planning values optionally determined using compatible X-Ray based surgical planning tools.
The ROSA® Hip 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® Hip System. The ROSA® Hip System is not for primary image interpretation and is applicable for the direct anterior approach.
The ROSA® Hip System is to be used with the following hip replacement systems in accordance with their indications and contraindications: G7® Acetabular System, Avenir Complete™ Hip System, Taperloc® Complete Hip System, Echo® Hip System.
The ROSA® Hip System (RHS) (cleared via K210998) for use with the ROSA® RECON Platform is used to assist surgeons in performing Total Hip Arthroplasty (THA) with features to assist in acetabular shell impaction for the direct anterior approach, as well as assessing the leg length discrepancy and the femoral offset.
The system uses a Non-Device 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 they are uploaded to the ROSA® RECON Platform before surgeries.
The system uses fluoroscopic images to determine the instruments' orientation in relation to the patient anatomy and as a guide for acetabular component orientation. The system allows the surgeon to input the case's surgical preoperative planning values and preview the acetabular component orientation intra-operatively. Throughout the surgical workflow, fluoroscopic images are acquired with a C-arm device. Fluoroscopic images are then captured with the ROSA® Tablet digital camera and transferred onto the ROSA® RECON platform via a wireless connection. The current instruments' orientation is computed from the image capture and is adjusted to match the surgeon's planning values using the ROSA® RECON robotic arm. The robotic arm is maintained stationary to keep the instruments in a fixed orientation during acetabular component impaction. The system also provides component selection options based on leg length and offset changes measurements.
The proposed device provides additional compatibility that allows the ROSA® Hip System Software to display images from flat panel C-arm devices onto the Optical Unit monitor throughout the surgical workflow. Images are captured with the ROSA® Tablet digital camera and landmarks are selected to display the outline of either the Lesser or Greater Trochanter.
The intra-operative workflow and surgical concepts implemented in the system remain close to the conventional THA direct anterior approach workflow. As such, at the time of the surgery, the system mainly assists the surgeon in (1) determining reference alignment axes and cup orientation using image-to-image and robotic registration, (2) precisely orienting the cup inserter relative to the desired orthopedic implant angle by using a robotic arm, and (3) providing leg length and offset changes measurements based on fluoroscopic image references.
I'm sorry, but this document does not contain the detailed information necessary to fully answer your request regarding the acceptance criteria and the study that proves the device meets those criteria.
Specifically, the document is a 510(k) summary for the ROSA Hip System. While it states that "The performance testing conducted on the predicate is still applicable to the proposed device and remains unchanged" and that "Verification and validation activities including integration testing for the newly compatible Flat Panel C-arm, were performed using the same methods as the predicate device," it does not provide the acceptance criteria or detailed results of specific performance studies for either the predicate or the proposed device.
The document focuses on demonstrating substantial equivalence to a predicate device (K210998) primarily based on identical intended use, indications for use, and similar technological characteristics and principle of operation. It implies that the necessary performance data was presented to the FDA, but the specifics are not included in this publicly available summary.
Therefore, I cannot provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for the test set or data provenance.
- Number of experts, their qualifications, or ground truth establishment for the test set.
- Adjudication method for the test set.
- If an MRMC study was done or its effect size.
- If standalone performance was done.
- The type of ground truth used.
- The sample size for the training set.
- How ground truth for the training set was established.
This information would typically be found in the full 510(k) submission, which is not publicly available in this detail, or in separate clinical/performance study reports.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).