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The Image1 GI CCU is to be used in conjunction with a light source and endoscope by physician/endoscopist to provide optical visualization via a video monitor for endoscopic observation and image recording during diagnostic and therapeutic procedures of the upper/lower digestive tract.

The Image1 GI CCU consists of two components: the camera control unit and a keyboard. The Image1 GI CCU is used in conjunction of a videoscope and a light source, which transmit the video signals to camera control unit (image processor) to provide optical visualization via a video monitor.

The provided 510(k) summary for the KARL STORZ Endoscopy America, Inc. Image1 GI CCU does not contain the detailed information requested regarding acceptance criteria and study results.

This summary focuses on demonstrating "substantial equivalence" to predicate devices, which is a different regulatory pathway than providing detailed performance data against specific acceptance criteria. Substantial equivalence generally means proving that the new device is as safe and effective as a legally marketed device that does not require premarket approval (PMA).

Here's why the requested information is not present in the provided text:

• Acceptance Criteria and Reported Device Performance: The document states, "Internal safety and performance testing are performed to ensure the safety and efficacy of the device." However, it does not outline specific acceptance criteria (e.g., image resolution, color accuracy, latency thresholds) nor does it report the quantitative results of these tests.
• Sample Size and Data Provenance: No information is provided about the sample sizes of any test sets or the origin of the data (e.g., country, retrospective/prospective).
• Number and Qualifications of Experts for Ground Truth: There is no mention of experts or ground truth establishment for any test data.
• Adjudication Method: Not applicable as no expert review of test data is described.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This type of study is not mentioned. The device is a camera control unit, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance would not be relevant in this context.
• Standalone Performance: The concept of "standalone performance" (algorithm only) is not applicable here as the device is a hardware component (camera control unit) for endoscopy, not a standalone algorithm.
• Type of Ground Truth: Not applicable as no ground truth data is discussed.
• Training Set Sample Size and Ground Truth Establishment for Training Set: Not applicable as this is not an AI/machine learning device that requires a training set.

In summary, the provided document serves as a 510(k) premarket notification emphasizing substantial equivalence, not a detailed technical report demonstrating device performance against quantitative acceptance criteria through clinical or technical studies with data and expert involvement.

To get the type of information requested, one would typically look for a more detailed Technical File, Design History File, or specific performance testing reports, which are usually proprietary and not publicly disclosed in the 510(k) summary.

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