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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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