(77 days)
The VELYS™ Robotic-Assisted Solution is intended for stereotaxic surgery to help the surgeon to identify the relative position and orientation of anatomical structures, plan the position of the femoral and tibial implant components intraoperatively and prepare 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 VELYST™ 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 of anatomical structures and landmarks, planning the position of the femoral and tibial implant components intraoperatively, and preparing total knee arthroplasty.
The image-free system uses a dedicated optical tracking device to acquire anatomical 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 plane corresponding to each resection on the patient's femur and tibia. The surgeon actuates the saw handpiece, within the planned resection plane, to execute the bone resection. This is analogous to using manual instruments in TKA. 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 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. Cases Reports including PHI are only available to the surgeon who performed the procedure.
The provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria, as typically found in clinical study reports. The document is an FDA 510(k) clearance letter and an accompanying summary.
The summary states: "No clinical tests were conducted to demonstrate substantial equivalence." This means the 510(k) submission relied on non-clinical tests (functional system integration, software verification, cybersecurity) to demonstrate substantial equivalence to a predicate device, rather than a clinical study with human subjects.
Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types derived from clinical data, are not available or not applicable based on the provided document.
However, I can extract the information that is present:
1. A table of acceptance criteria and the reported device performance:
The document does not provide a table of explicit acceptance criteria with quantitative performance metrics. It lists the types of non-clinical tests performed:
- Functional System Integration Test
- Full software verification test campaign, including unit, integration, and software system-level testing
- Cybersecurity testing, including penetration testing
The reported "performance" is implicitly that the device passed these tests sufficiently to demonstrate substantial equivalence for FDA clearance. No specific numerical results are provided in this summary.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified for any of the non-clinical tests.
- Data Provenance: Not applicable in the context of a clinical test set. The tests were likely conducted internally by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable, as no clinical ground truth establishment involving human experts for a clinical test set is described.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable, as no human reader performance assessment or clinical ground truth adjudication is described.
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:
- MRMC Study: No, the document explicitly states: "No clinical tests were conducted to demonstrate substantial equivalence." Therefore, no MRMC comparative effectiveness study was done.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: The listed "Functional System Integration Test" and "Full software verification test campaign" would assess the algorithm's performance in a simulated or controlled environment, but no specific quantitative standalone performance metrics (e.g., accuracy, precision) for a defined task are provided beyond the statement that these tests were conducted to demonstrate substantial equivalence.
7. The type of ground truth used:
- Type of Ground Truth: For the functional and software tests, the "ground truth" would be the expected functional behavior and software output based on design specifications. For cybersecurity, it would be the absence of exploitable vulnerabilities. No clinical ground truth (e.g., pathology, outcomes data, expert consensus on medical images) was used as no clinical study was performed.
8. The sample size for the training set:
- Training Set Sample Size: Not applicable. As this device is a robotic-assisted surgical system and not described as an AI/ML algorithm that learns from training data (beyond potentially internal software development and testing data), the concept of a "training set" in the context of machine learning does not apply to the information provided. The document highlights software verification, implying traditional software engineering and testing.
9. How the ground truth for the training set was established:
- Ground Truth Establishment for Training Set: Not applicable, as there is no mention of a training set in the context of an AI/ML model for which ground truth would be established.
§ 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).