Search Results

The KARL STORZ Pediatric Cysto-Urethro-Fiberscope and accessories are intended for use by a physician in the visual examination and treatment of a variety of urological endoscopic procedures for pediatric patients.

The KARL STORZ Pediatric Cysto-Urethro-Fiberscope and Accessories consists of a flexible fiber endoscope (Model Number: 11274BCU1) which can be used standalone or connected to compatible FDA-cleared camera heads which transfer images to compatible FDA-cleared Computer Control Units (CCUs) for the purposes of visual examination and treatment of a variety of urological endoscopic procedures for pediatric patients.

The provided text is a 510(k) Summary for the KARL STORZ Pediatric Cysto-Urethro-Fiberscope. It outlines the characteristics of the device and establishes its substantial equivalence to a predicate device. However, it does not contain acceptance criteria or a study that proves the device meets specific performance criteria in the context of AI/ML or diagnostic accuracy.

The document details non-clinical performance data, primarily focusing on compliance with various international standards for biocompatibility, reprocessing validation, and bench performance testing for mechanical, optical, and thermal/photobiological safety.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance related to diagnostic accuracy or AI/ML.
2. Sample size and data provenance for a test set (as no such test set for diagnostic performance is described).
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone (algorithm only) performance.
7. Type of ground truth (as no ground truth for diagnostic performance is mentioned).
8. Sample size for the training set.
9. Ground truth establishment for the training set.

The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate device." This confirms that there was no study conducted to assess the device's diagnostic performance against specific acceptance criteria using patient data, which is what your questions are geared towards.

The "Non-Clinical Performance Data" section lists various standards the device complies with, but these are related to the physical and functional safety of the endoscope itself, for example:

• Biocompatibility Testing: ISO 10993 series for biological evaluation of medical devices.
• Reprocessing Validation: Standards like ISO 14937, ISO 17665-1, AAMI ST98 for cleaning and sterilization.
• Bench Performance Testing: IEC 60601-2-18, IEC 62471, ISO 8600-3, ISO 8600-5 for mechanical, optical, and thermal/photobiological performance.

These are not acceptance criteria or performance metrics related to diagnostic accuracy or the performance of an AI/ML component. The device is a flexible fiber endoscope, and the regulatory filing focuses on its substantial equivalence to another endoscope based on engineering specifications and safety standards, rather than any AI-driven diagnostic capabilities.

Ask a specific question about this device