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The Sonolith® i-move is intended to fragment stones in the kidney (renal pelvis and renal calyces) and the ureter (upper, middle and lower ureter).

The ESWL L8 table is intended for extracorporeal shock wave lithotripsy (ESWL) procedures in conjunction with the diagnostic and therapeutic module of the platform.

The TEU table is intended for urological diagnostics, endourological procedures and extracorporeal shock wave lithotripsy (ESWL) procedures in conjunction with the diagnostic and therapeutic module of the platform.

The SONOLITH® i-move medical device is a lithotripter of ESWL type (Extracorporeal Shock Wave Lithotripsy). The physical principle consists in delivering pulsed pressure waves which are focalized on the stone to be treated, at fixed frequency or patient synchronized frequency.

The SONOLITH® i-move ESWL generator Diatron V uses a patented electrode including a reservoir with a highly conductive solution. This electrode type is the same for the previous generator Diatron IV and III used in clinics and hospitals for several years.

A membrane mounted on the top of the generator ensures the acoustical coupling between the generator and the patient's skin. Moreover, the generator benefits from a real time pressure servo control device.

The shock wave generation consists of emitting an electrical discharge at the first focus (F1) of the truncated ellipsoid. The shock wave generated is bent back by the ellipsoid's inner wall to be precisely concentrated at the second focus (F2). The highly conductive liquid incorporated into the electrode guarantees a very high stability of the electrical arc at F1 ensuring very low dispersion at F2.

The SONOLITH® i-move has to be coupled with, at least, one table dedicated at minimum, ESWL application, and one imaging system (Ultrasound scanner and/or X-ray C-arm). The two tables (TEU and ESWL_L8) are presented in the part hereafter (e: Intended Use).

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them:

Acceptance Criteria and Device Performance Study for SONOLITH® i-move Module

The SONOLITH® i-move module is an Extracorporeal Shock Wave Lithotripter (ESWL) intended to fragment kidney and ureteral stones. The following information details the acceptance criteria and the studies conducted to demonstrate the device's performance.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally inferred from the "Relevant standards or Guidance" column, and the reported performance is from the "Conclusions" column in the provided summary.

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

For the Confirmatory Clinical Testing:

• Sample Size: 24 patients
• Data Provenance: Not explicitly stated, but the study was conducted at "2 clinical sites." The country of origin is not specified, but the sponsor/manufacturer is EDAP TMS France. The study appears to be prospective given the nature of "confirmatory clinical testing."

The other performance tests (Electrical safety, EMC, Shock Wave characterization, Localization accuracy, Road testing) do not typically involve patient data and were conducted in certified laboratories or under controlled engineering environments.

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

For the Confirmatory Clinical Testing:
The document does not explicitly state the number of experts or their qualifications for establishing ground truth in the clinical study. It refers to a "confirmatory clinical study" but does not detail the methodology for determining ground truth (e.g., stone fragmentation success, safety events).

4. Adjudication Method for the Test Set

The document does not specify an adjudication method for any of the tests, particularly the clinical study.

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

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor any effect size information regarding human readers improving with AI assistance. This device is an ESWL lithotripter, which is a therapeutic device, not an AI-assisted diagnostic tool for human readers.

6. Standalone (Algorithm Only) Performance

The concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable in the context of this device. The SONOLITH® i-move is a physical medical device designed to fragment stones, not a software algorithm with a diagnostic output. Its operation inherently involves a human urologist.

7. Type of Ground Truth Used

For the Confirmatory Clinical Testing:
The ground truth would have been based on clinical outcomes data related to stone fragmentation, device functioning (as observed by clinicians), system ergonomics, and patient safety (e.g., adverse events, complications). While not explicitly detailed, it would likely involve imaging follow-ups to confirm stone fragmentation and clinical assessments for safety and effectiveness.

For the Localization Accuracy Testing:
The ground truth would have been established using physical measurements or phantoms with known target locations, against which the device's targeting accuracy was measured.

8. Sample Size for the Training Set

The document does not mention a training set as this device is not an AI/machine learning algorithm that requires a training phase. It's a physical medical device.

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

As there is no training set, this question is not applicable.

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