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a. Endoscopes: The Henke-Sass, Wolf Cystoscopes are indicated to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples for the devices include the visualization and manipulation of the anatomy, as the surgeon deems appropriate. The Henke-Sass, Wolf Cystoscopes are intended to be used in general urological surgery through a minimally invasive approach by utilizing natural orifices to access the surgical site.

b. Urology Instruments: The Henke-Sass, Wolf Urology Instruments in combination with endoscopes are intended to provide the user with the means for endoscopic visualization during examination, diagnosis and therapy of the lower urinary tract in conjunction with endoscopic accessories, or as the surgeon deems appropriate. The intended for use in urological procedures through the minimally invasive approach, by utilizing natural orifices to access the surgical site.

The Henke-Sass, Wolf Cystoscopes, Hysteroscopes and Accessories are composed of cystoscopes, hysteroscopes and cystoscopic accessories, which provide the user with the means for endoscopic diagnostic and therapeutic procedures. Examples of use of the product include the visualization and manipulation of anatomy, biopsy, and as the surgeon deems appropriate.

The provided text is a 510(k) Summary for the Henke-Sass, Wolf Cystoscopes, Hysteroscopes, and Accessories. It describes the device, its indications for use, and a comparison to a predicate device to establish substantial equivalence. The document is a regulatory submission to the FDA, not a study report that details acceptance criteria and the results of a specific clinical or technical study proving the device meets those criteria.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC effectiveness studies cannot be fully extracted from this document because it does not contain such a study report.

However, based on the Non-Clinical Performance Data section, we can infer some aspects related to acceptance criteria and the nature of the "study" conducted.

Here's an attempt to answer based only on the provided text, with many fields explicitly stated as "Not applicable" or "Not provided" as the document does not present a detailed scientific evaluation report.

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

• Optical Performance: (Implicit: Clear visualization, light transmission suitable for endoscopic procedures.)
• Illumination Performance: (Implicit: Adequate light output for visualization, comparability to predicate's light source types like Xenon, LED.)
• Sterilization Efficacy: (Achieve Sterility Assurance Level (SAL) of 10^-6 after steam sterilization.) | - Working length: 269mm - 302mm (Meets or is comparable to predicate)
• Outer diameter: 2.7mm - 4.0mm (Meets or is comparable to predicate)
• Deflection: 0° - 70° (Meets or is comparable to predicate)
• Light Source: Xenon, LED (Comparable to predicate)
• Validated for manual and automated cleaning.
• Validated for steam sterilization to provide a sterility assurance of 10^-6. |
  | Safety & Risk Management | - Risk Analysis: (Implicit: Risks identified and mitigated in accordance with ISO 14971.) | - Risk analysis carried out in accordance with established in-house acceptance criteria based on ISO 14971. |
  | Regulatory Conformance | - Conformance to Recognized Standards and Guidances: (e.g., 510(k) submission guidance for Hysteroscopes and Gynecology Laparoscopes; IEC 60601-2-18, Sec. 201.11.1.2.2; ISO 8600-1, -3, -4, -5, -6.)
• Substantial Equivalence: (Implicit: Demonstrate equivalence in indications for use, technological characteristics, safety, and effectiveness to the identified predicate device K040390.) | - Demonstrates conformance with listed recognized standards and guidances.
• Concluded to be substantially equivalent to the predicate device (K040390) based on intended uses, technological characteristics, and non-clinical performance.
• Results show that the subject device has met pre-defined design and performance acceptance criteria. Results of all non-clinical testing support the safety and effectiveness of the subject devices. |
  | Cleaning Validation | (Implicit: Cleaning instructions must be effective in preparing the device for sterilization or reuse.) | - The cleaning instructions were validated. |

Explanation of the "Study":
The document refers to "Bench testing" and "Design verification testing" for evaluating mechanical, optical, and illumination performance, and validation for cleaning and sterilization procedures. This is a non-clinical performance study.

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

• Sample Size: Not provided. The document states "Bench testing was conducted" but doesn't specify the number of devices or components tested.
• Data Provenance: Not provided, but implicitly generated as part of the device development and validation by Henke-Sass, Wolf GmbH in Germany (company address provided). The testing is proprietary non-clinical data. It is prospective testing designed to validate the new device.

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. This was non-clinical bench testing, not an evaluation requiring expert clinical ground truth assessment for diagnosis. Performance was measured against engineering specifications and validated processes.

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

• Not applicable. This was non-clinical bench testing, not an evaluation requiring adjudication of human readings or interpretations.

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 document describes traditional medical devices (endoscopes and accessories), not AI software. Therefore, no MRMC study for AI assistance was performed or reported.

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

• Not applicable. This device is not an algorithm or AI.

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

• For functional performance (mechanical, optical, illumination): Ground truth was established by engineering specifications, recognized industry standards (e.g., ISO, IEC), and comparison to the characteristics of the legally marketed predicate device.
• For cleaning and sterilization: Ground truth was established by microbiological testing methods to demonstrate a Sterility Assurance Level (SAL) of 10^-6, adhering to relevant standards for reprocessing medical devices.

8. The sample size for the training set

• Not applicable. This is a traditional medical device, not an AI or machine learning model that requires a training set.

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

• Not applicable. As above, this is not an AI/ML device.

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