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Resectoscopes are used for endoscopically controlled ablation of tissue. They are used for examination, diagnosis and/or therapy in conjunction with endoscopic accessories in the various medical disciplines such as Urology and Gynecology.

Resectoscopes are used in transuretheral resection of the prostate (TURP) and in transuretheral resection of bladder tumors (TURB). They consist of:

• · Endoscope
• · Resectoscope sheaths with obturators
• · Working Element
• · Electrodes
  The devices are reusable and provided nonsterile. They must be cleaned and sterilized before use.
  The body contact materials are surgical grade stainless steel which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.

The provided text is a 510(k) summary for the AED Resectoscope, and it does not contain the detailed information typically found in a study proving a device meets acceptance criteria. This document focuses on demonstrating substantial equivalence to predicate devices, rather than independent performance studies with specific acceptance criteria and detailed statistical analysis.

Therefore, many of the requested fields cannot be filled from the given text.

Here's a breakdown of what can and cannot be answered:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided. The document describes a "design analysis and comparison" rather than a clinical or performance test set involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable / Not provided. Ground truth establishment is typically for diagnostic devices or those requiring expert interpretation. This device is a surgical instrument. The evaluation here is against engineering standards and comparison to predicate devices, not against a "ground truth" established by experts in a clinical scenario.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable / Not provided. This relates to clinical studies with expert reviewers, which is not the type of evaluation described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is a resectoscope, a surgical instrument, not an AI-powered diagnostic tool. MRMC studies are not relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a physical surgical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable. For this type of device, the "truth" is typically adherence to engineering specifications, safety standards, and functional equivalence to legally marketed predicate devices, not a clinical "ground truth" derived from patient outcomes or pathology.

8. The sample size for the training set

• Not applicable. This relates to machine learning models, which are not involved here.

9. How the ground truth for the training set was established

• Not applicable. (See point 8).

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