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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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The Sonolith I sys is intended to fragment stones in the kidney (renal pelvis and renal calyces) and the ureter (upper, middle and lower ureter)

The Endourology table I-sys table is intended for urological diagnostics, endourological interventions (e.g. TURP) extracorporeal lithotripsy in conjunction with the diagnostic and therapeutic module of the platform.

The SONOLITH® I-SYS medical device is a lithotripter of ESWL type (Extracorporeal Shock Wave Lithotipsy). 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-SYS ESWL generator Diatron IV uses a patented electrode including a reservoir with a highly conductive solution. This electrode type is the same for the previous generator Diatron III used in clinics and hospitals for several years.

A silicone 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) Jocated at 264.62 mm above F1. 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.

An X-ray subsystem is fully integrated as standard in the whole versions of the main treatment module (MIS) of the Sonolities i-Sys system. Each X-ray subsystem is manufactured and controlled before integration in the lithotripsy platform. Two size of image intensifier are available,one with a 23cm (9") Image Intensifier and the other one with a 31cm (12") Image Intensifier.

On the Sonolith® I-Sys range, the only authorized X-ray modes of operation are:

• o Continuous Fluoroscopy.
• o Pulsed Fluoroscopy.
• o Snapshot

The Ultrasound sub-system can be used with the Sonolith® I-sys in two versions. The first one is an external U/S scanner mounted on a trolley (including electronic rack, screen, operator interfaces). The second one, using the same electronic system, is integrated in the main treatment module of the Sonolith® I-sys. The U/S imaging allows the operator to follow in real time and non stop the localization of the calculus, because the ultrasound diagnosis is considered harmless for the patient.

The patient's support Table (TiS) is designed to allow 4 different working modes:

• Used during a Lithotripsy procedure with a treatment module like the Sonolith® I-SYS MIS,
• Used during a Lithotripsy procedure with a treatment module like the Sonolith® Prakts. .
• 2 modes for endo-urology uses with the patient right or left oriented. .

In any configuration, the local user interfaces can be a remote control keypad (hand button box) or a footswitch pedal. Both are controlling all the movements of the table.

This document is a 510(k) summary for the SONOLITH® I-SYS Treatment Module and SONOLITH® I-SYS Table, an Extracorporeal Shock Wave Lithotripter. It focuses on the substantial equivalence to predicate devices and describes the technological characteristics, but does not contain information about a specific study designed to prove the device meets acceptance criteria.

The document details the device's technical specifications, especially its acoustic parameters. However, it does not provide:

• A table of acceptance criteria and reported device performance based on a study.
• Information on sample sizes, data provenance, number or qualifications of experts, or adjudication methods for a test set.
• Details about a multi-reader, multi-case comparative effectiveness study or a standalone algorithm-only performance study.
• The type of ground truth used in such studies.
• Sample size or ground truth establishment for a training set.

The document primarily serves to demonstrate that the SONOLITH® I-SYS is substantially equivalent to existing predicate devices (EDAP TMS France S.A. SONOLITH® Praktis and Dornier Medical Systems, Inc. DoLi S) for its intended use, which is to fragment stones in the kidney and ureter, and for urological diagnostics and endourological interventions. The acoustic measurements provided in the "Technological Characteristics" section are physical measurements of the device's output, not performance metrics against clinical acceptance criteria.

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The UroView 2800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical applications may include but are not limited to urologic and endoscopic procedures. The system may be used for other imaging applications at the physician's discretion.

The UroView 2800 is a fluoroscopic x-ray system including a tilting patient-support table with overhead x-ray tube assembly, high-voltage x-ray generator, image intensifier, and video image display. A separate mobile workstation provides digital image processing, image storage capability, and additional video display.

The provided document K993687, concerning the UroView 2800, is a 510(k) summary and not a comprehensive study report. Therefore, it primarily focuses on establishing substantial equivalence to predicate devices and adherence to relevant standards rather than presenting detailed experimental data on acceptance criteria and device performance as one might find in a clinical trial or performance study.

Based on the provided text, a detailed table of acceptance criteria and reported device performance, information on sample sizes, expert qualifications, and adjudication methods for a test set, and specific details about MRMC studies, standalone algorithm performance, or training set ground truth cannot be fully extracted.

The document mainly highlights the device's adherence to various safety and performance standards without explicitly stating "acceptance criteria" through a defined study with quantifiable outcomes against a benchmark. The "performance" described is in the context of meeting general functional requirements and safety standards.

Here's a breakdown of what can be inferred or is missing based on your request:

1. A table of acceptance criteria and the reported device performance

The document does not present a table of specific, quantifiable acceptance criteria alongside reported device performance derived from a dedicated study. Instead, the device's "performance" is implicitly deemed acceptable by its compliance with various recognized industry standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Missing. The document does not describe a "test set" in the context of an AI/algorithm evaluation. This is a medical device (fluoroscopic x-ray system), not an AI algorithm. Its performance is assessed through compliance with engineering and safety standards, not typically by analyzing a dataset of medical images.
• Data Provenance: Not applicable as it's not an AI/data-driven device.

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)

• Missing/Not Applicable. The concept of "ground truth" established by experts for a test set is not relevant for this type of device submission. Its safety and effectiveness are established through adherence to engineering and performance standards, and comparisons to predicate devices, rather than through diagnosis or interpretation of clinical images by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Missing/Not Applicable. Adjudication methods are typically used in clinical studies involving interpretation tasks and expert consensus, which is not the nature of this 510(k) submission.

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

• Not Applicable. The UroView 2800 is a physical medical imaging system, not an AI or computer-aided detection/diagnosis (CAD) system. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not have been performed or reported in this context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable in the traditional sense. The "ground truth" for this device's acceptance is its compliance with established regulatory and industry standards for X-ray systems (e.g., radiation output limits, electrical safety, image quality specifications as defined by the standards).

8. The sample size for the training set

• Not Applicable. The UroView 2800 is a conventional medical device; there is no "training set" as it does not employ machine learning or AI algorithms that require data for training.

9. How the ground truth for the training set was established

• Not Applicable. See point 8.

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