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Telescopes for adults
KARL STORZ HOPKINS Telescopes for Urology when used with sheaths, obturators, accessories, and instruments are intended to provide visualization and operative access during diagnostic and therapeutic urological procedures in adults.

Telescopes for adults and pediatrics
KARL STORZ HOPKINS Telescopes for Urology when used with sheaths, obturators, accessories, and instruments are intended to provide visualization and operative access during diagnostic and therapeutic urological procedures in adults and pediatrics.

The KARL STORZ HOPKINS Telescopes for Urology are rigid cystoscope systems, which provide visualization and operative access during urological procedures in adults and pediatrics. Urological devices consist of sheaths, obturators, accessories, and instruments, which are combined into a cystoscope system for diagnostic or therapeutic procedures in the lower urinary tract such as prostate, bladder, and urethra. The sheath provides a working channel for therapeutic instruments, as well as ports for irrigation and aspiration. The obturator is inserted through the sheath for atraumatic insertion to the surgical site, then removed after placement. The telescope is inserted through the sheath for visualization of the surgical site. All instruments subject to this submission are optical instruments, and compatible with telescopes; the optical instruments are only compatible with adult systems. Compact telescopes are all-in-one cystoscopes with built-in sheaths, obturators, and optics, they do not require device compilation for use.

The provided text is an FDA 510(k) clearance letter and its accompanying summary for the KARL STORZ HOPKINS Telescopes for Urology. This document details the regulatory pathway for a medical device, specifically rigid endoscopes, not an AI software or system. Therefore, most of the questions regarding acceptance criteria and study design for AI performance are not applicable.

Here's an analysis of the provided information:

Analysis of Acceptance Criteria and Study for a Medical Device (Endoscope):

Given that this is a medical device (endoscope), the "acceptance criteria" are typically related to meeting established performance standards for such devices. The "study" refers to non-clinical bench testing to demonstrate compliance with these standards and substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of acceptance criteria with specific numerical performance targets and reported values in the way you might see for an AI algorithm's accuracy or sensitivity/specificity. Instead, the acceptance criteria are implicit in the adherence to international and national standards for medical devices, particularly endoscopes. The reported device performance is that it complies with these standards.

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

• Sample Size: Not applicable in the context of an endoscope's non-clinical bench testing. The "test set" here refers to the actual device prototypes or representative samples tested in a laboratory setting to verify compliance with engineering and safety standards. The number of units tested isn't specified but typically involves a sufficient number to ensure reproducibility and meet statistical requirements for the specific test (e.g., several samples for biocompatibility, multiple cycles for reprocessing).
• Data Provenance: The testing is non-clinical bench testing, meaning it does not involve human subjects or real-world patient data. It is performed in a controlled laboratory environment by the manufacturer (KARL STORZ SE & Co. KG), likely in Germany given their address.

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

• Experts for Ground Truth: Not applicable. For a rigid endoscope, "ground truth" is defined by established engineering specifications and compliance with recognized national and international standards. The "truth" is whether the device performs according to these measurable standards, not a subjective interpretation by experts.
• Qualifications of Experts: Not applicable. The "experts" involved are likely engineers, quality assurance personnel, and regulatory specialists within Karl Storz and external testing laboratories who are qualified to conduct and interpret the specified tests according to the standards.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., in medical image diagnosis). For physical device testing, the results are typically quantitative measurements that either pass or fail against predefined criteria in the standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

• MRMC Study: No. MRMC studies are used to evaluate the impact of a new diagnostic aid (like an AI system) on human reader performance across multiple readers and cases. This is not relevant for a rigid endoscope, which is a physical visualization and access tool.

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

• Standalone Performance: Not applicable. This device is a physical endoscope, not an AI algorithm. Its function is to provide visualization, which inherently involves a human user (the clinician) in the loop.

7. The type of ground truth used:

• Type of Ground Truth: The "ground truth" is adherence to established engineering specifications, safety standards (e.g., thermal safety), optical performance metrics (e.g., field of view, resolution), biocompatibility requirements, and validated reprocessing protocols as defined by the numerous ISO, IEC, AAMI, ASTM, and ANSI standards listed. It is a technical and regulatory compliance "ground truth."

8. The sample size for the training set:

• Training Set Sample Size: Not applicable. This is a physical medical device, not an AI algorithm that undergoes training.

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

• Training Set Ground Truth: Not applicable. As this is not an AI device, there is no "training set" or "ground truth for the training set."

In summary, the provided document is a regulatory submission for a physical medical device (an endoscope) and not for an AI/software device. Therefore, the specific questions related to AI performance metrics, sample sizes for AI training/test sets, expert adjudication, and MRMC studies are not applicable to this submission. The "acceptance criteria" are demonstrated through non-clinical bench testing proving compliance with relevant industry standards and substantial equivalence to a predicate device.

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