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The KARL STORZ Cysto-Urethro-Fiberscope and accessories are indicated for visualization and operative access during diagnostic and therapeutic endoscopic procedures of the urinary tract including the urethra and bladder.

The KARL STORZ Cysto-Urethro-Fiberscope and Accessories consists of a flexible fiber endoscope (Model Number: 11272CU1 / 11272C2) 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 visualization and operative access during diagnostic and therapeutic endoscopic procedures of the urinary tract including the urethra and bladder.

Based on the provided FDA 510(k) clearance letter for the KARL STORZ Cysto-Urethro-Fiberscope, it's clear that no clinical performance data was provided or required for this 510(k) submission. The submission relies entirely on non-clinical (bench) performance data.

Therefore, many of the requested elements pertaining to acceptance criteria and clinical study design (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types for clinical data) are not applicable to this particular device clearance.

The 510(k) summary explicitly states:

Clinical Performance Data Clinical testing was not required to demonstrate substantial equivalence to the predicate device. Non-clinical bench testing was sufficient to assess safety and effectiveness and to support substantial equivalence.

Given this, I will describe the acceptance criteria as implied by the non-clinical tests conducted and the proof that the device met these criteria based on the information provided.

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria for KARL STORZ Cysto-Urethro-Fiberscope

As per the submitted 510(k) summary (K244001), the substantial equivalence of the KARL STORZ Cysto-Urethro-Fiberscope was established through non-clinical performance data only. No clinical studies were conducted or required for this clearance.

Therefore, the "acceptance criteria" are derived from the successful completion of various bench tests and compliance with recognized standards designed to ensure the safety and effectiveness of the device. The "study" proving the device meets these criteria refers to the non-clinical (bench) performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to the successful completion and passing results of the tests conducted in accordance with the listed standards and internal design specifications. The performance is reported as meeting these standards.

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

• Test Set Sample Size: Not applicable. No clinical test set was used. The "test set" in this context refers to the physical units of the device subjected to bench testing. The specific number of units tested for each non-clinical performance test is not detailed in the 510(k) summary, but it would have been sufficient to meet the requirements of the cited standards and internal quality procedures.
• Data Provenance: Not applicable for a clinical study. The non-clinical testing was conducted by KARL STORZ SE & CO. KG, which is based in Tuttlingen, Germany. The data is from laboratory (bench) testing, not patient data.

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

Not applicable. No clinical test set requiring expert ground truth establishment was used. Bench testing relies on objective measurement against predefined specifications and standard requirements, not subjective expert assessment of clinical data.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC study was not conducted as no clinical performance study was performed or required.

6. If a Standalone Performance Study (Algorithm Only) Was Done

Not applicable. This device is a medical instrument (fiberscope), not an AI algorithm. Therefore, a standalone algorithm performance study is irrelevant.

7. The Type of Ground Truth Used

• For Non-Clinical Testing: The "ground truth" for the bench tests is the objective, measurable performance of the device against established engineering specifications, safety standards (e.g., IEC, ISO, ANSI/AAMI), and the functional capabilities of the predicate device. This is determined through physical measurements, chemical analyses, and standardized test protocols.

8. The Sample Size for the Training Set

Not applicable. No clinical training set was used as this is a physical medical device (fiberscope), not an AI/ML algorithm requiring data-driven training.

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

Not applicable. No clinical training set was used.

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