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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 ablation procedures in the abdomen, performed by physicians trained for CT procedures and performed under general anesthesia with rigid straight instruments such as needles and probes of diameters ranging from 11G to 19G. During the planning phase, the desired instrument and performance is defined relative to the target anatomy. During the guidance phase, the device enables to monitor respiratory 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 proposed Epione v1.0.2 is a modified version of the Epione predicate device as was cleared under 510(k) K211645. Aside from the modifications that are summarized further below, the Epione v1.0.2 is the same as the predicate as follows.

The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device 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) quided percutaneous procedures.

During the planning phase, the desired instrument placement and performance is defined relative to the tarqet anatomy. During the quidance 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 with rigid straight instruments such as needles, and applicators (cryoprobes, electrodes, and antennas), used in CT-guided interventional procedures performed by physicians trained for CT procedures on organs and anatomical structures in the abdomen.

The EPIONE device v1.0.2 consists in the following components: Robot cart, Display cart, Navigation cart, EPIONE software, EPIONE instruments (Needle guide, Patient reference, Short Navigation probe).

The modifications include:

• expanding its ablation procedure indications to organs in the abdomen as compared to ablation procedures only on the liver in the Epione predicate,
• the addition of a new software functionalities to facilitate multi-needle planning that include configurable multiple needle array configurations for simultaneous needle group planning as compared to the planning of one needle at a time in a sequential manner in the Epione predicate,
• the addition of post-procedure imaging software tools to measure the post-procedure ablated zones as compared to only visual assessment in the Epione predicate, and
• the addition of an alternate shortened version of the navigation probe as compared to original longer version in the Epione predicate. This short navigation probe replaces the longer original navigation probe.

Here's a breakdown of the acceptance criteria and the study details for the Epione v1.0.2 device, based on the provided FDA 510(k) summary:

Acceptance Criteria and Reported Device Performance

The provided document primarily focuses on demonstrating substantial equivalence to predicate devices rather than setting explicit numerical acceptance criteria for a new, unique performance claim. However, the non-clinical tests re-performed from the predicate and the clinical study aim to demonstrate that the device performs equivalently to the predicates.

The implied acceptance criterion is that the device should be as safe and effective in achieving its intended use as in the predicates. The reported device performance is that it meets this implied criterion based on the conducted studies.

Study Information:

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size:
  • Non-Clinical (Bench) Testing: The document does not specify a numerical sample size for the "Overall System Accuracy Tests," "Respiratory Monitoring Effectiveness Tests," or "positional accuracy testing." It states these were "re-performed" from the predicate.
  • Usability Testing: Not specified, but re-performed.
  • Clinical Study: 33 patients (interim data).
• Data Provenance:
  • Non-Clinical Tests: In-vitro (bench testing).
  • Usability Testing: Re-performed.
  • Clinical Study: Ongoing clinical study in France (prospective data).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• The document does not specify the number of experts or their qualifications for establishing ground truth in the non-clinical or usability testing. These tests likely rely on standardized measurements and expert evaluation of safety and effectiveness, but specific details are not provided.
• For the clinical study, the ground truth for "in-vivo equivalence in safety and effectiveness" is established through physician-performed procedures and patient outcomes, but the number of adjudicating experts or their detailed qualifications for assessing the clinical data are not explicitly mentioned. The study is non-interventional, investigating device performance in procedures performed by "physicians trained for CT procedures."

4. Adjudication Method for the Test Set

• The document does not specify an explicit adjudication method (e.g., 2+1, 3+1, none) for any of the tests, including the clinical study. It states that the clinical study investigated the performance of the device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• A MRMC comparative effectiveness study is not explicitly mentioned or described in the provided text. The clinical study is a non-interventional study investigating the performance of the device itself, not comparing human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

• The device is described as a "user-controlled, stereotactic accessory" with a robotic arm and software components, indicating a human-in-the-loop system. While software verification and validation were performed, a standalone (algorithm only) performance study in the sense of an independent diagnostic algorithm without human interaction is not described. The software functions assist the physician.

7. Type of Ground Truth Used

• Non-Clinical Tests:
  • Overall System Accuracy & Positional Accuracy: Likely based on objective physical measurements and comparisons to known standards or established predicate device performance.
  • Respiratory Monitoring Effectiveness: Likely based on objective physiological measurements.
• Usability Testing: Based on user interaction, feedback, and demonstration of safe and effective use by intended users.
• Clinical Study: "In-vivo equivalence in safety and effectiveness" is the ground truth assessed. This would involve clinical outcomes, procedure success rates, safety endpoints, and potentially expert assessment of procedural metrics, though details are not provided.

8. Sample Size for the Training Set

• The document does not provide information about a specific training set size. The EPIONE device is a robotic surgical assistance system, and while it has software, it's not primarily an AI/ML image interpretation algorithm that would typically have a distinct image-based training set described in this context. The software development likely involved extensive internal testing and refinement, but a dedicated "training set" in the context of machine learning model development is not detailed here.

9. How the Ground Truth for the Training Set Was Established

• As a training set is not explicitly identified or described in the context of AI/ML model training, the method for establishing its ground truth is also not provided.

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