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The compact operating Uretero-Renoscope 8706.402 is used to examine the ureter and kidney. Various diagnostic and therapeutic procedures can be performed by using additional accessories.

• transurethral extraction and lithotripsy of ureteroliths and kidney stones via electrohydraulic, laser, pneumatic, or ultrasonic technology.
• tumor diagnostics and / or biopsy
• removal of foreign bodies .

The insertion sleeve, 8706.042 is used as a guide during insertion of the flexible ureterorenoscope and for evacuation of irrigation solution.

Uretero-rensoscope 8706.402 is a thin endoscope with a rod lens system, a channel for irrigation and for the simultaneous use of an instrument.

The uretero-renoscope may be inserted with the introduction sheath, 8706.042 to view the renal pelvis. The introduction sheath remains stationary while the ureterorenoscope may be removed and replaced by a flexible uretero-renoscope when reaching the upper calyx group.

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Compact Operating Uretero-Renoscope with Insertion Sleeve":

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided document, the device did not have explicit, quantifiable acceptance criteria or associated performance metrics. The submission focuses on demonstrating substantial equivalence to a predicate device rather than meeting specific performance benchmarks.

• Atraumatic tip
• Sharp, brilliant image quality
• Autoclavable/steam sterilizable (134°C / 273°F) | "atraumatic tip for problem free introduction into the uteri ostium."
  "sharp, brilliant quality over the entire image."
  ". autoclavable / steam sterilization 134°C / 273°C" |
  | Substantially equivalent to predicate device (K963855) | "The submitted devices are substantially equivalent to existing devices sold by Richard Wolf." |

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

• Sample Size for Test Set: Not applicable. No clinical or performance tests were conducted on a 'test set' as defined for typical device performance studies (e.g., diagnostic accuracy, efficacy).
• Data Provenance: Not applicable. No data from a test set was generated from specific countries or in a retrospective/prospective manner.

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

• Not applicable. No ground truth was established for a test set, as no clinical performance studies were performed. The submission relies on design and testing to assure safety and effectiveness, and claims substantial equivalence.

4. Adjudication Method for the Test Set:

• Not applicable. No clinical performance studies were performed that would require an adjudication method for a test set.

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

• No MRMC comparative effectiveness study was done. The document explicitly states, "Clinical tests performed were not performed." Therefore, there is no effect size reported for human readers with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study:

• No standalone performance study was done. This device is a physical medical instrument (uretero-renoscope), not an algorithm or AI-powered system, so a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used:

• Not applicable in the context of clinical performance or diagnostic accuracy. The "ground truth" for the device's claims of safety and effectiveness, and substantial equivalence, appears to be based on:
  • Engineering design and testing ("These devices are designed and tested to assure their safety and effectiveness...")
  • Comparison to a predicate device already on the market (K963855).

8. Sample Size for the Training Set:

• Not applicable. This is a physical medical device, not an AI/ML algorithm that would require a training set of data.

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

• Not applicable. As this is not an AI/ML device, there is no training set or ground truth for it.

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