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The Karl Storz Image 1® Video Imaging System with optional insufflators control allows remote control of Karl Storz insufflators by Image 1® camera head control buttons. The Karl Storz Image 1® Video Imaging System is a color video camera system which can be used as an endoscopic accessory with rigid or flexible endoscopes. The camera head is directly coupled to the endoscope. Any compatible Image 1® camera head may be used with the Image 1® Karl Storz Camera Control units (CCU). The endoscopic image can be displayed on any standard operating room video monitor and all standard endoscopic light sources may be used with the Image 1® camera head.

The Image 1® Video Imaging System with modification for insufflators control is a digital video imaging system used by qualified personnel in the operating room to view endoscopic images and to interface with Karl Storz devices such as selected insufflators through the Karl Storz Communication Bus (SCB). Karl Storz SCB technology, based on a modular design concept, provides centralized remote control over compatible medical equipment and peripheral system via touch screen or camera head buttons in the sterile environment. The modification for insufflators control is a software change only to the Image 1® Video Imaging System to allow the camera to exert control over Karl Storz insufflators functions through Karl Storz SCB

This document is a 510(k) summary for the Karl Storz Image 1® Video Imaging System with optional insufflators controls. It focuses on establishing substantial equivalence to a predicate device, rather than presenting a study that defines and proves acceptance criteria for a new AI/CADe device. Therefore, a direct response to your detailed request about acceptance criteria and study design for an AI/CADe system is not possible based on the provided text.

The document discusses a software change only to allow the camera to control insufflators, focusing on general safety and effectiveness in comparison to a predicate device. It does not provide information about performance metrics such as sensitivity, specificity, or any clinical trial data that would be relevant for an AI/CADe system’s acceptance criteria.

Based on the provided text, the following information cannot be extracted:

1. A table of acceptance criteria and the reported device performance: No specific performance metrics or acceptance criteria are listed.
2. Sample size used for the test set and the data provenance: Not applicable, as no performance study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary of available information related to the device and its submission:

• Trade/Device Name: Image 1® Video Imaging System with Optional Insufflators Controls
• Regulation Number: 21 CFR 876.1500
• Regulation Name: Endoscope and accessories
• Regulatory Class: II
• Product Code: FET
• Indications for Use: The system allows remote control of Karl Storz insufflators by Image 1® camera head control buttons. It is a color video camera system that can be used as an endoscopic accessory with rigid or flexible endoscopes. The camera head couples to the endoscope, and the image can be displayed on standard operating room video monitors, using standard endoscopic light sources.
• Device Description: A digital video imaging system for qualified personnel to view endoscopic images and interface with Karl Storz devices (like selected insufflators) via the Karl Storz Communication Bus (SCB). The modification for insufflator control is "a software change only" to allow the camera to control insufflator functions via SCB.
• Substantial Equivalence Claim: The device is substantially equivalent to legally marketed predicate devices, with similar basic technology, design, and intended usage. The differences are minor and do not raise new issues of safety and effectiveness.

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