(132 days)
The VELYS Robotic-Assisted Solution is intended for stereotaxic surgery to aid the surgeon in identifying the relative position and orientation of anatomical structures, planning the position of the femoral and tibial implant components intraoperatively, and preparing the bones during unicompartmental knee arthroplasty.
When indicated for unicompartmental knee arthroplasty, the VELYS Robotic-Assisted Solution is indicated for use with the SIGMA HP Partial Knee Implants and INTUITION Instruments for SIGMA HP Partial Knee and their cleared indications for use.
The VELYS™ Robotic-Assisted Solution is an image-free robotic-assisted surgery system. It is intended for stereotaxic surgery to aid the surgeon in identifying the relative position and orientation of anatomical structures and landmarks, planning the position of the femoral and tibial implant components intraoperatively, and preparing the bones during total knee arthroplasty (TKA) and unicompartmental knee arthroplasty (UKA).
The image-free system uses a dedicated optical tracking device to acquire anatomical landmarks intra-operatively. These landmarks are then used to plan the femoral and tibial implant locations based on the surgeon's preferred surgical technique and placement preferences. Following the planning step, the VELYS™ Robotic-Assisted Solution helps the surgeon to execute the bone preparation according to the plan.
The system includes a Robotic-Assisted Device that constrion and orientation of the saw handpiece and blade inside each resection plane on the patient's femur and tibia. The surgeon actuates and manipulates the saw handpiece, within the planned resection plane, to execute the bone resection. This is analogous to using manual instruments in TKA or UKA. If the patient's leg moves during the resection, the Robotic-Assisted Device compensates for such movement in real-time.
The Robotic-Assisted Device is assembled with a Robotic-Assisted Device arm, mounted on the Operating Room (OR) bed rail, for a minimal footprint
The VELYS® Robotic-Assisted Solution incorporates several software subsystems, including applications responsible for general operation of the system and clinical applications dedicated to the surgery workflow.
The users interact with the clinical applications via a touchscreen and footswitch to navigate through the surgery steps. Case Reports including key surgical procedure information are stored on the system and can be retrieved by the surgeon for future use. Cases Reports including PHI are only available to the surgeon who performed the procedure.
The provided text describes a 510(k) submission for the VELYS Robotic-Assisted Solution, primarily focusing on its expanded indication for unicompartmental knee arthroplasty (UKA). The document outlines the device's intended use, technological characteristics, and the non-clinical testing performed to demonstrate substantial equivalence to a predicate device.
Based on the provided document, here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document mentions "Performance testing activity included," followed by a list. However, it does not explicitly state specific quantifiable acceptance criteria or the numerical results for these tests. It only lists the types of tests performed.
| Test Category | Acceptance Criteria (Not explicitly stated in the document) | Reported Device Performance (Not explicitly stated in the document) |
|---|---|---|
| Sagittal Border Guard Evaluation | (e.g., maintain specified distance from bone) | (e.g., Met 99% accuracy within X mm) |
| Dynamic Compensation Performance Test | (e.g., maintain alignment during specified movement) | (e.g., Successfully compensated for Y mm of movement) |
| Cadaveric Resection Accuracy and Soft Tissue Study | (e.g., resection within X mm/degree of plan) | (e.g., Achieved an average resection accuracy of Z mm) |
| Summative Usability Evaluation | (e.g., completion of tasks within time, low error rate) | (e.g., Usability metrics within acceptable range) |
| Design Validation | (e.g., meeting all design requirements) | (e.g., All design requirements validated) |
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 states:
- "Bench testing was performed on the subject device, VELYS™ Robotic-Assisted Solution for Unicompartmental Knee Arthroplasty (UKA)..."
- "Cadaveric Resection Accuracy and Soft Tissue Study" was performed.
The sample sizes for the test sets (e.g., number of cadavers, number of test runs) are not specified in the provided text.
The data provenance is generally "Bench testing" and "Cadaveric Study," implying a controlled laboratory environment. The country of origin of the data and whether it was retrospective or prospective is not specified.
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)
The document does not provide information on the number of experts used or their qualifications to establish ground truth for any of the performance tests. The focus is on technical performance rather than clinical interpretability requiring expert adjudication.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Given that the performance tests are largely technical (e.g., robotic alignment, resection accuracy), rather than diagnostic interpretations, adjudication methods like 2+1 or 3+1 are not applicable and are not mentioned in the document.
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 explicitly states: "No clinical data was necessary to support the determination of substantial equivalence."
Therefore, an MRMC comparative effectiveness study was not performed for this submission. The device is a robotic-assisted surgical tool, not an AI-powered diagnostic imaging tool that would typically involve human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is described as a "Robotic-Assisted Device" where "The surgeon actuates and manipulates the saw handpiece, within the planned resection plane, to execute the bone resection." While the system has "Robotic-Assisted Device" that "compensates for such movement in real-time," it is fundamentally a human-in-the-loop system. The tests mentioned (e.g., resection accuracy, dynamic compensation) assess the integrated human-robot system's performance, rather than a standalone AI algorithm without human interaction.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "Cadaveric Resection Accuracy and Soft Tissue Study," the ground truth for resection accuracy would likely be precise measurements of the actual bone cuts compared to the planned cuts post-resection using highly accurate metrology (e.g., CMM, 3D scanning). For other tests like "Sagittal Border Guard Evaluation" and "Dynamic Compensation Performance Test," the ground truth would be engineering specifications and measurements of the robot's or system's physical behavior against those specifications. The document doesn't specify the exact methods for ground truth establishment, but it is implied to be based on physical measurements against design specifications.
8. The sample size for the training set
This device is not an AI/ML device in the sense that it performs a diagnostic or predictive function learned from a large dataset. It is a robotic-assisted surgical system with software that aids in planning and execution. Therefore, the concept of a "training set" in the context of machine learning model development is not applicable to the information provided. The system's "training" would be its engineering design, calibration, and validation rather than statistical learning from a dataset.
9. How the ground truth for the training set was established
As the concept of a "training set" in the AI/ML context is not applicable here, the method for establishing its ground truth is also not relevant/described. The "ground truth" for the device's functionality would be its design specifications and physical principles.
§ 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).