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The Gemini XXP-HP is indicated for the fragmentation of urinary tract stones, i.e. renal calyceal stones, renal pelvic stones, and upper ureteral stones.

The Gemini XXP-HP is a modular urological work station designed for extracorporeal shock wave lithotripsy ("ESWL") and for diagnostic and therapeutic procedures usual in Urology. The Gemini XXP-HP is composed of the following modules: Basic Unit with integrated X-ray C-arm and Therapy Arm for Shockwave Treatment, Patient Table, Control Desk User Interface. The basic unit contains the power supplies, control unit, power electronics for motor drives, components for shockwave generation, and an integrated Therapy C-arm and an X-Ray C-arm. The therapy and X-Ray C-arm house the shock wave source ("EMSE") and the complete X-ray unit. The X-ray unit consists of the X-ray generator, the X-ray tube, an image receptor system, and a high resolution imaging chain. This provides the imaging to perform the procedures. The C-arms allow for a wide range of movement to facilitate performing urological procedures. The shock wave circuit supplies the shock wave energy needed for the treatment of kidney stones. The Gemini XXP-HP's urological patient table provides longitudinal, lateral and vertical travel range to allow easy positioning of the stone in the shock wave focus for lithotripsy and urological procedures. The image processing system with DICOM 3 capability supports PACS connection and offers complete X-ray control and image handling. The Gemini XXP-HP also includes a camera to view in real time the integrity of the patient to bellows coupling interface.

The provided text describes the 510(k) summary for the Dornier Gemini XXP-HP lithotripter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study against specific acceptance criteria for a new device type, especially one leveraging AI. Therefore, much of the requested information cannot be directly extracted as it pertains to a different type of device assessment (e.g., AI/ML device performance).

However, I can extract information related to the device's performance based on the clinical study mentioned, even if it's not framed as "acceptance criteria."

Here's the breakdown of what can be inferred and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state formal acceptance criteria in a quantitative table format that would typically be seen for a new AI/ML device being evaluated for specific metrics (e.g., sensitivity, specificity, accuracy). Instead, the clinical study aimed to confirm usability, safety, and effectiveness of the modified lithotripter.

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

• Sample Size: Not explicitly stated in the provided text. The phrase "a confirmatory clinical study was performed" implies a patient cohort was involved, but the number of patients is not given.
• Data Provenance: Not explicitly stated. Clinical studies for such devices are typically multi-site and can involve different countries, but this information is absent. It's likely prospective since it's a "confirmatory clinical study."

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

This information is not applicable as the study described is a clinical study on a medical device, not a study evaluating an AI algorithm where ground truth for imaging or diagnostic tasks would be established by experts.

4. Adjudication Method for the Test Set:

This information is not applicable for the reasons stated above. Adjudication methods like 2+1 or 3+1 are typical for expert review of AI outputs, not for the direct outcome of a lithotripsy procedure.

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

• Was it done? No, an MRMC comparative effectiveness study was not done. This type of study assesses how AI assistance impacts human reader performance, which doesn't apply to a lithotripter device that directly performs a physical intervention.
• Effect size: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Was it done? No, a standalone algorithm performance study was not done. This device is a physical medical device, not an AI algorithm.

7. Type of Ground Truth Used:

The "ground truth" in this context refers to the clinical outcomes and safety observations from the patients treated with the device. This would typically include:

• Stone fragmentation (assessed via follow-up imaging)
• Stone-free status
• Adverse events (e.g., hematoma, pain, other complications)

This is effectively a form of outcomes data.

8. Sample Size for the Training Set:

This information is not applicable. This device is a physical medical device. It does not involve an AI algorithm with a training set.

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

This information is not applicable for the reasons stated in point 8.

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The Lite-Med LM-9200ELMA Lithotripter is indicated for fragmentation of kidney stones such as renal calyx stones and renal pelvic stones and for upper, middle, and lower ureteral stones.

The Lite-Med LM-9200 ELMA is an Electromagnetic Extracorporeal Shock Wave Lithotripter that effectively treats urinary calculi. It is routinely used for the fragmentation of kidney and ureteral stones and offers a good combination of clinical performance, flexibility and affordability. The standard LM-9200 ELMA device consists of a Shockwave Generator, an operator interface/touch panel, and a water circulation subsystem. Shock waves are generated on the basis of a principle similar to that used in loudspeakers. An electrical impulse is sent through an inductance coil, generating a magnetic ficld which repulses a metallic membrane. The acoustic impulse created by this repulsion is focused by an acoustic lens to form a shock wave. A water circulation subsystem is used to provide transmission of shockwaves and cooling of the generator.

For the ESWL operation to be fully functional, two or three optional subsystems are needed. The first is a special treatment table. The second and third are a C-arm X-ray fluoroscope and an ultrasound imaging unit. The treatment table is a motorized floating table which can be moved electrically in all three axes.

The provided document describes the Lite-Med LM-9200 ELMA Lithotripter, an Extracorporeal Shock Wave Lithotripter (ESWL) for fragmenting kidney and ureteral stones.

1. Table of Acceptance Criteria and Reported Device Performance

The direct acceptance criteria for clinical performance are not explicitly stated as numerical targets in the provided text. Instead, the study reports an "overall success rate" against which its performance is implicitly measured, and also highlights safety and compliance with standards.

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

• Sample Size for Test Set: 40 patients (30 male, 10 female)
• Data Provenance: Not explicitly stated, but the company is based in Taipei City, Taiwan. The clinical investigations were performed at 2 sites, implying prospective data collection for the purpose of this application.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

The document refers to "experiences of physicians" but does not specify the number of experts used to establish a formal "ground truth" for the test set, nor their specific qualifications (e.g., years of experience). The assessment of device function and safety, as well as the success rate, would presumably be based on clinical evaluations by the treating physicians at the two sites.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing the success rate or safety outcomes. Clinical outcomes were reported, implying a direct assessment by the treating physicians without an explicit external adjudication panel.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The study focused on the performance of the LM-9200 ELMA Lithotripter alone.

6. Standalone Performance Study

Yes, a standalone study was performed. The clinical investigation directly assessed the performance of the LM-9200 ELMA Lithotripter without human-in-the-loop assistance for the primary function of stone fragmentation. The clinical success rate of 85% for stone fragmentation and the safety profile were assessed based on the device's use.

7. Type of Ground Truth Used

The ground truth appears to be based on clinical outcomes as assessed by treating physicians. The "overall success rate" would be defined by the clinical fragmentation of kidney and ureteral stones, likely confirmed through imaging or other medical follow-ups. Safety was also assessed based on clinical observations and patient evaluations.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of an algorithm or AI. The device is an Extracorporeal Shock Wave Lithotripter, a physical medical device, not an AI/software as a medical device (SaMD). Therefore, the concept of a training set as typically applied to machine learning models is not relevant here.

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

As noted above, the device is a physical lithotripter, not an AI/ML algorithm. Thus, there is no "training set" or ground truth establishment method for a training set in this context. The physical and technological characteristics of the device were established through measurements based on standards like IEC 61846.

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