(115 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 femoral and tibial implant components intraoperatively, and preparing the bones during total knee arthroplasty.
The VELYS™ Robotic-Assisted Solution is indicated for use with the ATTUNE Total Knee System and its cleared indications for use.
The VELYS™ Robotic-Assisted Solution is an image-free robotic-assisted surgery system for Total Knee Arthroplasty (TKA). 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.
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 constrains the position and orientation of the saw handpiece and blade inside each plane corresponding to each resection 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 and the way the surgeon uses the saw handpiece in the predicate device. 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 sub-systems, including applications responsible for general operation of the system and a Clinical Application dedicated to the surgery workflow.
The users interact with the Clinical Application 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.
The VELYS™ Robotic-Assisted Solution is an image-free robotic-assisted surgery system intended to aid in total knee arthroplasty (TKA). The acceptance criteria and the study proving the device meets these criteria are described below.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| System Localization Accuracy | Concluded to be the same as the predicate device (TOTAL KNEE SURGETICS Navigation System with iBlock) in an Accuracy and Repeatability study. (Specific numerical values for accuracy are not provided in the document, but the finding of "the same as the predicate" implies it met the predicate's established performance.) |
| Dynamic Compensation Performance | Performance test conducted. (Specific numerical results not provided, but implicitly met requirements to support substantial equivalence.) |
| Saw Blade Position Accuracy | Accuracy test bench study conducted to confirm. (Specific numerical results not provided, but implicitly met requirements to support substantial equivalence.) |
| Boundary Limit Essential Performance | Performance test conducted. (Specific numerical results not provided, but implicitly met requirements to support substantial equivalence.) |
| Resection Accuracy (Cadaveric) | Confirmed compared to conventional instruments in a Cadaveric Accuracy study. (Specific numerical results not provided, but implicitly met requirements to support substantial equivalence.) |
| Compliance to Standards | Demonstrated compliance with AAMI ANSI ISO 11137-1:2006 (R) 2015, ISO 11137-2:2013, ISO 11607-1:2019, ISO 11607-2:2019, ISO 10993-1:2018, ISO 10993-1:2009, IEC 60601-1:2005 + A1:2012, AAMI ES60601-1:2005 and A1:2012, IEC 60601-1-2:2014, IEC 80601-2-77:2019, ASTM F2554-18, ASTM F3107-14. |
| Biocompatibility | Tested against ISO 10993-1 (2018 and 2009). |
| Electrical Safety & EMC | Tested against IEC 60601-1 (2005+A1:2012) and IEC 60601-1-2 (2014). |
| Sterilization | Tested against ISO 11137-1 (2006 (R) 2015) and ISO 11137-2 (2013). |
| Packaging & Transport | Tested against ISO 11607-1 (2019) and ISO 11607-2 (2019). |
| Software | Verification tests conducted. |
| Usability | Users (surgeons and Operating Room staff) successfully used the device on simulated knees and cadavers. |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test set regarding numerical values. However, it mentions:
- Simulated Use Testing: Included testing on simulated knees (sawbones) and cadavers. The number of each is not specified.
- Accuracy and Repeatability Study: Conducted to compare system localization accuracy to the predicate. The number of test instances or samples is not specified.
- Accuracy Test Bench Study: Conducted to confirm saw blade position accuracy. The number of test instances or samples is not specified.
- Cadaveric Accuracy Study: Conducted to confirm resection accuracy compared to conventional instruments. The number of cadavers used is not specified.
The data provenance is from non-clinical testing conducted by the manufacturer, DePuy Ireland UC. No specifics are given about the location where cadaveric studies were performed or if they represent diverse populations. The studies are by nature prospective as they are testing the newly developed device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document states that for usability testing, "Users included surgeons and Operating Room staff, who were able to successfully use the VELYS™ Robotic-Assisted Solution to implant ATTUNE Total Knee System per specification." However, it does not specify the number of experts, their qualifications (e.g., years of experience), or if these experts established a ground truth for the technical accuracy studies. For the technical accuracy tests, ground truth appears to be based on predefined targets or established metrology rather than expert judgment.
4. Adjudication method for the test set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing ground truth or evaluating test results, as most of the performance tests are objective measurements against defined standards or established benchmarks rather than subjective expert interpretations.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The document explicitly states: "No clinical tests were conducted to demonstrate substantial equivalence." The comparison was primarily against the predicate device's technological characteristics and by demonstrating the device's technical performance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The primary performance studies described are focused on the system's technical accuracy and performance, which does involve the robotic-assisted element but in the context of aiding a surgeon for bone preparation. For example, the dynamic-compensation performance, saw blade position accuracy, and boundary limit tests assess the automated and robotic components directly. While a human surgeon provides input and actuates the saw handpiece, these technical accuracy tests evaluate the device's capability to accurately position and maintain the resection plane. Therefore, these can be considered evaluations of the device's standalone technical performance within its intended functional scope.
7. The type of ground truth used
The ground truth for the performance studies appears to be based on:
- Metrology/Engineering standards: For accuracy measurements (e.g., system localization, saw blade position, dynamic compensation, boundary limits), the ground truth would be defined by precise measurement tools and known physical targets.
- Established specifications: For compliance with international standards (e.g., ISO, IEC, ASTM), the ground truth is the requirement set forth by these standards.
- Conventional instruments/techniques: For the cadaveric accuracy study, the ground truth for resection accuracy was "compared to conventional instruments," implying that the accuracy achieved by established manual techniques served as a benchmark (either for equivalence or non-inferiority).
8. The sample size for the training set
The document describes non-clinical and simulated use testing. It does not mention a training set as this is a robotic-assisted surgical device, not an AI/ML diagnostic algorithm that requires training data in the traditional sense. The device's "training" would be its design, calibration, and verification against engineering specifications.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set for an AI/ML algorithm. The device's operational parameters and accuracy are based on engineering design and validation processes.
§ 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).