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LITHOSKOP is a urologic procedures system primarily designed for the fragmentation of urinary tract stones, such as renal calyx stones and renal pelvis stones and for upper, middle and lower ureteral stones by extracorporeal shock wave lithotripsy (ESWL). In addition to ESWL use, the unit is designed for patient placement in positions which facilitate urological and diagnostic procedures.

Siemens LITHOSKOP is a new lithotripter featuring a patient table, a C-arm with X-ray tube assembly attached to one end, an image intensifier to the other end and a shockwave system adjacent to the x-ray tube. The shockwave system can be coupled with a patient in various positions providing a high flexibility. For positioning of the shockwave focus there will be fluoroscopy and ultrasound imaging provided. The system is intended for stationary use.

The presented document is a 510(k) summary for the Siemens LITHOSKOP, an extracorporeal shockwave lithotripter. It provides information about the device's indications for use, contraindications, warnings, precautions, adverse events, and technological characteristics. It also states that a confirmatory clinical study was conducted to demonstrate the device's safety and effectiveness. However, the document does not explicitly define acceptance criteria in a quantifiable manner or present detailed performance data from the clinical study in the format requested.

Therefore, many of the requested fields cannot be directly extracted from the provided text.

Based on the provided text, here's what can be inferred or stated:

1. Table of Acceptance Criteria and Reported Device Performance

The document states, "The confirmatory clinical study suggests that treatment of urinary tract stones with the LITHOSKOP is safe and effective." However, specific numerical acceptance criteria (e.g., stone-free rate, retreatment rate) and detailed performance metrics are not provided in this summary.

2. Sample Size and Data Provenance

• Sample Size (Test Set): Not specified in the provided summary.
• Data Provenance: Not specified in the provided summary (e.g., country of origin, retrospective/prospective). The study is referred to as a "confirmatory clinical study," which generally implies a prospective design.

3. Number and Qualifications of Experts for Ground Truth

Not specified in the provided summary.

4. Adjudication Method

Not specified in the provided summary.

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

Not applicable, as this device is a medical lithotripter, not an imaging analysis AI tool that assists human readers. No mention of an MRMC study or human reader improvement with AI assistance.

6. Standalone Performance Study (Algorithm Only)

Not applicable, as this is a physical medical device (lithotripter), not a standalone algorithm.

7. Type of Ground Truth Used

The "confirmatory clinical study" would likely use clinical outcomes (e.g., stone fragmentation, stone-free status, need for retreatment, adverse events) as ground truth. The summary mentions monitoring for hematuria, pain, urinary obstruction, etc., as adverse events.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI model that requires a training set in the conventional sense. The "confirmatory clinical study" is likely a pivotal trial for regulatory submission.

9. How Ground Truth for the Training Set Was Established

Not applicable (as above).

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