(272 days)
The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures.
During the planning phase, the desired instrument placement and performance is defined relative to the target anatomy. During the guidance phase, the device enables to monitor respiratory levels and verify patient position prior to instrument advancement. During the assessment phase, the achieved instrument placement and performance are displayed relative to the previously defined plan through an overlay of the pre- and post-treatment image data.
The device is indicated for use in liver ablation procedures under general anesthesia with rigid straight instruments such as needles and probes of diameters ranging from 11G to 19G by physicians trained for CT procedures.
The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures.
During the planning phase, the desired instrument placement and performance is defined relative to the target anatomy. During the guidance phase, the device enables to monitor respiratory levels and verify patient position prior to instrument. During the assessment phase, the achieved instrument placement and performance are displayed relative to the previously defined plan through an overlay of the pre- and post-treatment image data.
The device is indicated for use in liver ablation procedures under general anesthesia with rigid straight instruments such as needles and probes of diameters ranging from 11G to 19G by physicians trained for CT procedures.
The EPIONE device consists in the following components:
Robot cart: This mobile equipment can be moved in and out of the intervention room and is positioned next to the patient. The cart carries a robotic arm including a force sensor assembly allowing handguiding of the robotic arm by the user. The robotic arm movements are enabled by the user using a footswitch. The robot cart also embeds the electronic systems required to power and operate the robot arm.
Display cart: This mobile equipment can be moved in and out of the intervention room and is positioned next to the operator. The cart carries a touchscreen to operate the system.
Navigation cart: This mobile equipment can be moved in and out of the intervention room and is positioned next to the table. The cart carries a navigation camera.
EPIONET software: A software provides the step-by-step workflow assistance for intervention planning and intraoperative positioning of the robotic arm for instruments placement and post-operative assessment.
EPIONE instruments: Needle guide, Patient reference, Navigation probe
The provided document describes the Quantum Surgical EPIONE device and its FDA 510(k) summary, which includes non-clinical and clinical performance data to demonstrate substantial equivalence to a predicate device. This information will be used to answer your questions about acceptance criteria and the study proving the device meets them.
1. Table of acceptance criteria and the reported device performance
Based on the "Summary of Non-Clinical Performance Data" and "Clinical study" sections, the primary acceptance criteria revolve around the device's accuracy, safety, and effectiveness. A specific quantitative acceptance criterion for accuracy is hinted at by the mention of "average accuracy" being demonstrated as safe and effective, but the numerical value of this criterion is not explicitly stated. The performance is reported as meeting these general standards.
| Acceptance Criterion (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Accuracy | "The average accuracy of the system demonstrates that the EPIONE device is safe and effective for CT-guided needle placement in the liver." |
| Safety | "The study evaluated the accuracy, safety, and feasibility...The results of this study show that the EPIONE™ device is safe and effective... with no adverse events reported for any of the subjects." |
| Effectiveness | "The study evaluated the accuracy, safety, and feasibility...The results of this study show that the EPIONE™ device is safe and effective..." |
2. Sample size used for the test set and the data provenance
- Test set sample size:
- Non-clinical (Animal Study): 36 needle placements were performed in a preclinical animal study (porcine models).
- Clinical Study: 21 patients were enrolled in a multi-center, prospective, and interventional clinical study.
- Data Provenance:
- Animal Study: The document states "preclinical animal study on the liver was conducted on porcine models". It does not specify the country of origin.
- Clinical Study: The document mentions a "multi-center, prospective and interventional clinical study." It does not specify the country of origin, but given the sponsor (Quantum Surgical SAS) is based in France, it is likely the study involved sites in France or other European countries. The study is described as "prospective," indicating data was collected specifically for this study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number of experts used to establish ground truth or their qualifications for either the animal or clinical studies. The clinical study design focuses on the device's safety and effectiveness in guiding procedures performed by trained physicians, but it does not detail an independent ground truth establishment process by experts for, e.g., diagnostic accuracy or outcome evaluation separate from the performing physicians.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not describe an adjudication method for the test set. Given that the clinical study focuses on the device's use in procedures and observed outcomes (safety and effectiveness of the procedure itself), rather than an image-based diagnostic evaluation requiring consensus reads, an adjudication process as typically understood for diagnostic AI might not have been applied in the same way.
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
A multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not reported. The studies described are focused on the device's performance in assisting physicians with CT-guided percutaneous procedures, rather than on improving human reader performance in image interpretation. The EPIONE is a surgical assistance system, not primarily an image interpretation AI.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The EPIONE device is explicitly described as a "user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures." It involves a robotic arm, software, and instruments that are operated by a human. Therefore, a standalone (algorithm only without human-in-the-loop) performance study was not applicable or performed, as the device's function inherently requires human interaction.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Animal Study: The "accuracy" and "feasibility" were evaluated by observing the results of the 36 needle placements in porcine livers. The ground truth for accuracy would likely be the actual vs. planned needle tip position, measured perhaps by post-procedure imaging or dissection, though the specific measurement method is not detailed.
- Clinical Study: The ground truth for the clinical study was primarily outcomes data regarding the safety and performance of the liver ablation procedures. Safety was assessed by the absence of adverse events, and effectiveness (performance) was confirmed by the successful execution of the CT-guided percutaneous procedures for liver ablations using the device.
8. The sample size for the training set
The document does not mention the sample size used for the training set for the EPIONE software or system. This information is typically found in details about the AI/algorithm development, which may not be fully disclosed in a 510(k) summary focused on substantial equivalence.
9. How the ground truth for the training set was established
The document does not provide details on how the ground truth for the training set (if any specific training data was used for AI/ML components within the software) was established. The software development and validation were conducted in compliance with FDA guidance and IEC standards, which would cover verification and validation methods, but not necessarily the detailed ground truth establishment for a training dataset.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.