(61 days)
The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
The RIO is indicated for use in surgical knee and hip procedures in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include:
Unicondylar knee replacement and/or patellofemoral knee replacement
Total hip arthroplasty (THA)
MAKOplasty Total Hip Application is an upgrade to RIO-THA (K093425). The features of this application are to improve overall performance of the system in supporting total hip arthroplasty. MAKOplasty Total Hip Application is used with RIO which includes an optical detector, robotic arm, and guidance module. In addition, the application is designed to be used with a pre-operative planning laptop, as well as both reusable and disposable instrumentation.
The main RIO platform includes an optical detector, computer, dedicated instrumentation, operating software, tools and accessories, drill system, and a robotic arm. The system's architecture is designed to support two main surgical applications: hip procedures and knee procedures (per K112507). With application specific hardware and software, it provides stereotactic guidance during minimally invasive orthopedic surgical procedures by using patient CT data to assist a surgeon with presurgical planning and interpretive/intraoperative navigation.
RIO's robotic arm, once configured for a specific application, can serve as surgeon's "intelligent" tool holder or tool guide by passively constraining the preparation of an anatomical site for an orthopedic implant with software-defined spatial boundaries.
This document describes the MAKOplasty Total Hip Application, an upgrade to the RIO-THA (Total Hip Arthroplasty) system. This device is intended to assist surgeons by providing software-defined spatial boundaries and real-time guidance during orthopedic procedures, specifically total hip arthroplasty, unicondylar knee replacement, and patellofemoral knee replacement. It uses patient CT data for pre-surgical planning and intraoperative navigation.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it states that "All testing Passed" for the verification activities and "Passed" for validation testing. The main performance characteristic is the device's ability to "support total hip arthroplasty procedures, and unicondylar and/or patellofemoral knee replacement" and a "System Accuracy" test. No specific quantitative metrics for accuracy (e.g., target deviation in mm) or other performance parameters are provided in the excerpt.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Total Hip Application Full Cadaver Validation Lab" for validation testing. However, it does not specify the sample size (number of cadavers or cases) used for this test set, nor does it provide details on the data provenance (e.g., country of origin, retrospective or prospective). Cadaver labs are typically prospective and aim to simulate real-world surgical conditions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The nature of the "Full Cadaver Validation Lab" suggests surgical experts would be involved in assessing the outcomes, but their number and qualifications are not detailed.
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 in the validation lab.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document does not mention an MRMC comparative effectiveness study involving human readers or an AI assistance component. The device itself is an assistive robotic system for surgical procedures, not an AI diagnostic tool primarily for human reader interpretation. No effect size for human reader improvement is provided.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The document describes the device as a "Robotic Arm Interactive Orthopedic System (RIO)" intended to "assist the surgeon" and serve as a "surgeon's 'intelligent' tool holder or tool guide." This indicates a human-in-the-loop system, not a standalone algorithm without human involvement. Therefore, a standalone performance study as typically understood for diagnostic AI was likely not performed or relevant in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "Total Hip Application Full Cadaver Validation Lab," the ground truth would likely be based on objective measurements of implant placement, alignment, and other surgical parameters post-procedure, measured against pre-operative plans. This would involve expert assessment and direct measurement within the cadaveric setting, rather than pathology or long-term outcomes data. The document does not explicitly state the specific methods used to establish this ground truth.
8. The sample size for the training set
The document does not provide information about a "training set" or its sample size. This device is an upgrade to an existing robotic surgical system, and the information presented focuses on the verification and validation of the application itself, not on the training of an AI model in the conventional sense.
9. How the ground truth for the training set was established
As no training set is mentioned for an AI model, this information is not applicable. The device's functionality is based on pre-programmed designs and real-time navigation guided by CT data, rather than machine learning trained on large datasets.
§ 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).