(146 days)
The ROSA® Shoulder System, for use with the ROSA RECON platform, is indicated as a stereotaxic instrumentation system for Total Shoulder Arthroplasty (TSA) surgery. It is used to assist the surgeon in providing software-defined spatial boundaries for orientation and reference to identifiable anatomical structures for the accurate placement of the shoulder implant components.
The robotic arm placement is performed relative to anatomical landmarks and bony anatomy as recorded using the system intraoperatively, and based on a three-dimensional representation of the bone structures determined pre-operatively using compatible CT based imaging technology.
It includes a robotic arm, an optical sensor navigation system and accessories, software system, surgical instruments and accessories.
The ROSA® Shoulder System is designed for use on a skeletally mature patient population. The target population has the same characteristics as the population targeted by the implants compatible with the ROSA® Shoulder System.
The ROSA® Shoulder System is to be used with the following shoulder replacement systems in accordance with their indications and contraindications:
• Humerus implants: Comprehensive® Total Shoulder System, Comprehensive® Reverse Shoulder System, Identity® Shoulder System and Identity® Reverse Shoulder System.
• Glenoid implants: Alliance™ Glenoid and Comprehensive® Reverse Shoulder System.
The ROSA® Shoulder system (RSS) for use with ROSA® RECON Platform (cleared via K230243) is used to assist surgeons in performing Total Shoulder Arthroplasty (TSA) for both anatomic and reverse techniques. It features humeral resection and glenoid reaming capabilities to reproduce the preoperative plan intraoperatively with The RSS uses a Non-Device Medical Device Data System (MDDS) called the Zimmer Biomet Portal, which manages the creation and tracking of surgical cases. The cases with the pre-operative planning based on surgeon preferences reside on the portal until they are uploaded to the ROSA RECON Platform before surgeries.
The intra-operative workflow and surgical concepts implemented in the system remain close to the conventional TSA 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 intra-operatively based on these reference alignment axes and orthopedic implant geometry, and (3) precisely position the humeral cut guide and glenoid reamer relative to the planned orthopedic implant location by using a robotic arm.
The ROSA® Shoulder System, a stereotaxic instrumentation system for Total Shoulder Arthroplasty (TSA) surgery, underwent various performance tests to ensure its safety and effectiveness.
1. Acceptance Criteria and Reported Device Performance
The provided document does not contain a specific table detailing acceptance criteria alongside reported device performance for specific metrics (e.g., accuracy, precision of implant placement). Instead, it broadly states that "Verification and Validation Testing for ROSA Shoulder System was conducted with the following aspects: Performance Tests- to ensure the performance of the implemented features and verify related design inputs."
However, the study overall aimed to demonstrate that the device is "at least as safe and effective as the legally marketed predicate devices." The successful outcome of the performance tests, engineering analysis, usability engineering, and validation lab on cadaveric specimens, coupled with software verification and validation, implies that the device met its internal acceptance criteria for these aspects.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions a "Validation Lab- performed to validate that using ROSA Shoulder System is safe and effective and that the performances of the system are acceptable under full simulated use on cadaveric specimens." However, it does not specify the sample size (number of cadaveric specimens) used for this test set nor the country of origin of the cadaveric data. The study appears to be prospective in nature, as it involved performing tests on cadaveric specimens specifically for the validation of the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide details on the number of experts used to establish ground truth for the cadaveric test set, nor their specific qualifications (e.g., "radiologist with 10 years of experience").
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for determining ground truth in the cadaveric test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done. The evaluation focuses on the device's performance in assisting surgeons, rather than comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The ROSA® Shoulder System is described as a system "to assist the surgeon" and involves an "intra-operative workflow and surgical concepts implemented in the system remain close to the conventional TSA workflow." It explicitly states the system "mainly assists the surgeon." This indicates that the device is designed to be used with a human in the loop, and therefore, a standalone (algorithm only without human-in-the-loop performance) study was likely not the primary focus or was not explicitly reported as such. The "Validation Lab" involved "full simulated use on cadaveric specimens," which would implicitly involve human interaction with the system.
7. Type of Ground Truth Used
Based on the "Validation Lab- performed to validate that using ROSA Shoulder System is safe and effective and that the performances of the system are acceptable under full simulated use on cadaveric specimens," the ground truth for evaluating the device's performance (e.g., accuracy of implant placement, effectiveness of guidance) would have been established through direct measurement and observation on the cadaveric specimens in comparison to the pre-operative plan. This would fall under a form of empirical or objective ground truth as determined by surgical best practices and the stated goals of the system. It is not specified if this involved pathology or outcomes data in the traditional sense, but rather the physical outcome of the surgical assistance provided by the device.
8. Sample Size for the Training Set
The document does not provide information on the sample size for the training set of the software or any underlying AI components. The ROSA® Shoulder System is described as using "software-defined spatial boundaries" and "a three-dimensional representation of the bone structures determined pre-operatively." While this implies computational components, the nature of their development and training data is not detailed.
9. How the Ground Truth for the Training Set Was Established
Since the document does not mention details about a specific training set or the development of a machine learning model, it does not describe how the ground truth for any potential training set was established. The focus of the provided information is on the verification and validation of the final device system.
§ 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).