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The KARL STORZ Holders are manually operated surgical devices intended to hold endoscopes (such as arthroscopes, etc) and accessories during general and neurologic diagnostic and therapeutic procedures.

The KARL STORZ Holder is a manually operated surgical instrument intended to hold scopes (such as endoscopes, arthroscopes, etc) in a desired position during diagnostic, therapeutic, and surgical procedures (including neurologic procedures). The holder is manufactured from Stainless Steel and functions by the user manually tightening or loosening a knob, which opens and closes around a surgical scope. The device is intended to attach to the several KARL STORZ holding systems, which are a Class 1, table-mounted, mechanical and electromechanical holding arms that have many general surgical functions in addition to scope holding; it can also be used for instrument holding, retraction, and positioning.

The provided text is a 510(k) summary for the KARL STORZ Holders, which are manually operated surgical devices intended to hold endoscopes and accessories. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive details about a clinical study with acceptance criteria for an AI/CAD-like device.

Therefore, the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, ground truth establishment, and MRMC studies for an AI/CAD device is not available in the provided text. The document describes a traditional medical device (a mechanical holder) and its non-clinical performance testing.

However, based on the information that is available in the document, here's a summary of the non-clinical performance data and the demonstration of substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not detail specific quantitative acceptance criteria or reported values in a table format for a clinical outcome beyond demonstrating functional equivalence. The performance data is described qualitatively as meeting the needs for substantial equivalence.

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

• The document describes non-clinical performance testing rather than a clinical test set involving human subjects or AI algorithm evaluation.
• The exact sample size for the "Holding Performance testing" and "Direction of view/Image stability testing" is not specified.
• Data Provenance: The testing was performed on the "subject device" (KARL STORZ Holders). The country of origin of the data is not explicitly stated beyond the submitter being KARL STORZ SE & Co. KG in Tuttlingen, Germany. The data would be considered prospective as it's testing of the new device for regulatory submission.

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

• This information is not applicable as the document describes non-clinical performance testing of a mechanical device, not the evaluation of an AI algorithm requiring expert ground truth for image interpretation.

4. Adjudication Method for the Test Set:

• This is not applicable for the same reason as point 3.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not the subject of this 510(k) submission for a mechanical endoscope holder.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

• No, a standalone algorithm performance study was not done. This device is a mechanical surgical instrument, not an AI algorithm.

7. The Type of Ground Truth Used:

• The concept of "ground truth" as typically used for AI/CAD devices (e.g., expert consensus, pathology, outcome data) is not applicable. For this mechanical device, performance is evaluated against engineering specifications and functional requirements (e.g., ability to hold weight, maintain stability).

8. The Sample Size for the Training Set:

• This is not applicable. The device is a mechanical instrument, not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established:

• This is not applicable for the same reason as point 8.

In summary, the provided FDA 510(k) summary (K240506) pertains to a mechanical endoscope holder, not an AI/CAD-enabled medical device. Therefore, the detailed requirements for acceptance criteria and study designs related to AI performance are not present in this document. The purpose of this 510(k) is to demonstrate substantial equivalence to a predicate mechanical device through non-clinical performance testing.

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