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The nephroscopy accessory set is intended for minimally invasive procedures in nephroscopy. The shaft is a reusable, surgically invasive device for shortterm use. It is designed to bring instruments, telescopes, and fluids to the surgical site. The Dilator is a reusable, surgically invasive device for temporary use. It is designed to widen existing surgically invasive openings.

The TROKAMED GmbH Mini PCNL-System consists of shaft and dilator. The diameter is specified directly on the shaft and dilator. This ensures that the instrument can be assigned easily and only suitable components are used. The instruments cannot be disassembled. The puncture is expanded with the dilator at the beginning of surgery. The procedure, during which kidney stones can be destroyed, is then performed via the shaft. The kidney stones are automatically transported out of the proximal end of the shaft as a result of the cleaning pressure and by the irrigation fluid. The nephroscope may not be fully mounted on the shaft here.

The provided document is a 510(k) Premarket Notification for a medical device called the "Mini PCNL-System" by TROKAMED GmbH. It details a comparison to a predicate device and non-clinical performance testing. The document does not contain information about acceptance criteria and device performance in the context of a clinical study, human-in-the-loop performance, or AI assistance.

Instead, the document focuses on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical testing of the physical characteristics, reprocessing, life expectancy, biocompatibility, and mechanical properties of the device components.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance related to diagnostic accuracy or clinical outcomes.
• Sample size used for a test set (in a clinical context).
• Data provenance (country of origin, retrospective/prospective) for a clinical test set.
• Number of experts used or their qualifications for establishing ground truth in a clinical setting.
• Adjudication method for a clinical test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study or effect size of AI assistance.
• Standalone (algorithm-only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data) for a clinical study.
• Sample size for a training set (as this is not an AI/ML device).
• How ground truth for a training set was established (as this is not an AI/ML device).

The document is about demonstrating the safety and effectiveness of a surgical instrument (an endoscope accessory set) through engineering and biological testing, not a diagnostic or AI-powered device.

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