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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.

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.

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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.

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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

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.

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