(137 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® Hip System, Avenir Complete™ Hip System, Taperloc® Complete Hip System, Echo® Hip System.
The ROSA® Hip System (RHS) 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 ROSA® Hip 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 ROSA® Hip System utilizes the robotic arm of the ROSA® RECON platform cleared in K182964, but does not add new stereotaxic or robotic components
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. Fluoroscopic images are then captured with the ROSA® Tablet and transferred onto ROSA®. 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 system provides pre, intra and post-operative measurements relative to patient anatomy and does not provide infrared-based stereotaxic navigation for implant placement. 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 discrepancies measurements.
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 discrepancies measurements based on fluoroscopic image references.
Based on the provided text, the ROSA® Hip System is a fluoroscopic-guided system for total hip arthroplasty (THA) that assists surgeons in component placement. Here's a breakdown of the acceptance criteria and study information:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a formal table of quantitative acceptance criteria with corresponding performance metrics like sensitivity, specificity, accuracy, or specific measurement tolerances. Instead, it describes various tests and analyses performed to ensure the device's acceptable performance and safety. The acceptance essentially comes from demonstrating that the device meets established regulatory standards and design inputs.
| Acceptance Criteria Category | Description of Acceptance | Reported Device Performance (Summary) |
|---|---|---|
| Biocompatibility | Meets biocompatibility requirements according to ISO 10993. | Evaluation reveals that the ROSA Hip device meets biocompatibility requirements. |
| Electrical Safety | Complies with recognized electrical safety standards (IEC 60601-1). | The device complies with IEC 60601-1 standard for electrical safety. |
| Electromagnetic Compatibility (EMC) | Complies with recognized EMC standards (IEC 60601-1-2). | The device complies with IEC 60601-1-2 standard for electromagnetic compatibility. |
| Device Performance | Performance of implemented features verified; design inputs verified; usability addressed; safe and effective under full simulated use. | Physical/Performance Tests, Engineering Analysis, Usability Engineering, and Validation Lab (on cadaveric specimens) were conducted to ensure performance, verify design inputs, address usability, and validate safety and effectiveness. |
| Software Verification & Validation | Satisfies requirements of FDA Guidance for Premarket Submissions for Software Contained in Medical Devices and IEC 62304; does not raise new safety/effectiveness issues. | Software tests were conducted, and the software was considered a "major" level of concern. Testing demonstrates that the ROSA Hip System does not raise any new issues of safety and effectiveness compared to predicate devices. |
2. Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: The document mentions "full simulated use on cadaveric specimens" for Validation Lab testing, but it does not specify the sample size (i.e., number of cadavers or individual surgical simulations).
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the data was retrospective or prospective. Given the nature of a 510(k) submission for a new device, it's highly probable that the testing, particularly the cadaveric studies, was prospective, and likely conducted in Canada (where Zimmer CAS is located) or the US.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not specify the number of experts used or their qualifications for establishing ground truth during the cadaveric testing. The phrase "full simulated use on cadaveric specimens" implies that the performance was likely assessed by experienced surgeons or researchers against predefined anatomical landmarks and implant placement targets, but the details are not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
The document does not describe any specific adjudication method for the test set, such as 2+1 or 3+1.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, the document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on demonstrating the device's technical performance and safety, rather than directly comparing human reader performance with and without AI assistance. The system assists the surgeon, rather than providing an AI-driven interpretation that human readers would then interpret or compare against.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The ROSA® Hip System is described as assisting the surgeon in a fluoroscopic-guided system where images are acquired, processed, and used to guide robotic arm movements for instrument orientation. It is explicitly stated that the "ROSA® Hip System is not for primary image interpretation." Therefore, no standalone (algorithm-only) performance evaluation would be applicable or relevant for this type of assistive surgical navigation device. Its function is inherently human-in-the-loop.
7. The type of ground truth used:
Based on the description of the device's function, the ground truth for performance testing (particularly the cadaveric studies) would likely involve:
- Anatomical landmarks: Verifying that the system accurately identifies and registers anatomical landmarks from fluoroscopic images.
- Surgical planning values: Comparing the intraoperative cup placement and component orientation achieved with the system against predefined preoperative planning values (which would serve as a form of ground truth for optimal placement).
- Measurements: Verifying the accuracy of leg length and offset discrepancies measurements compared to physical or pre-measured values on the cadavers.
- Expert Consensus/Observation: The outcome of the cadaveric studies (e.g., whether the system successfully assisted in accurate placement to a specified degree) would be assessed by surgical experts.
The ground truth is not pathology or clinical outcomes data, but rather adherence to surgical planning, anatomical accuracy, and positional precision in a simulated environment.
8. The sample size for the training set:
The document does not specify a sample size for a training set. Given that this is a surgical assistance system primarily using fluoroscopic image processing and robotic guidance logic, it's not described as a deep learning or AI model in the conventional sense that would require a large, labeled training dataset for image classification or prediction tasks. The "software" aspect refers more to control logic, image registration algorithms, and user interface elements, rather than a trainable AI model for image interpretation.
9. How the ground truth for the training set was established:
Since a training set with explicitly established ground truth (as in machine learning) is not described, this information is not provided. The development and verification of such a system would rely on mathematical models, engineering principles, and rigorous testing against known physical and anatomical parameters.
§ 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).