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The TELE PACK + is an all-in-one Imaging System, which comprises a light source for illumination, Camera Control Unit (CCU) for use with compatible camera heads or video endoscopes for image processing, as well as a monitor for image display, intended for the visualization of endoscopic and microscopic procedures.

The Telepack + is a portable and compact all-in-one imaging system that includes a 18.5 inch screen display, a camera control unit and internal LED light source, that is intended to be connected to a compatible device (camera head or videoendoscope) for the purpose of visualization and documentation of endoscopic and microscopic procedures as well as stroboscopy. The Telepack + includes a LED illumination light source to illuminate the intended area and a 18.5 inch monitor for display. It also allows the users to redefine the functions that take place when a button is pressed. The Telepack + is a non-patient contacting and require only wipe down as needed.

The provided text is a 510(k) Summary for the Telepack + imaging system. It describes the device, its intended use, and the non-clinical performance data used to demonstrate substantial equivalence to a predicate device. However, it does not contain information about:

• Acceptance criteria in the context of an AI/algorithm-driven device's performance metrics (e.g., sensitivity, specificity, AUC).
• A study proving the device meets these acceptance criteria through a comparison of algorithm performance against a ground truth dataset, or human reader performance.
• Sample sizes for test sets where ground truth is established by experts.
• The number or qualifications of experts used for establishing ground truth.
• Adjudication methods for ground truth.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Effect sizes of human reader improvement with AI assistance.
• Standalone algorithm performance studies.
• Specific types of ground truth (e.g., pathology, outcomes data for a disease).
• Sample size for training sets.
• How ground truth for training sets was established.

The "Performance Testing" section within the "Non-Clinical Performance Data" discusses basic image quality characteristics like "Minimum Illumination," "Spatial Resolution," "Color Performance," "Latency," "White Balance," and "AE Step Response," along with "Head Button Functionality." These are engineering performance metrics for an imaging system, not performance metrics for an AI/algorithm diagnosing or assisting in diagnosis.

The document explicitly states: "Clinical performance is not required to demonstrate substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish substantial equivalence." This indicates that the Telepack + is a hardware imaging system, and its approval was based on demonstrating that its image quality and functionality are comparable to its predicate, rather than on the diagnostic performance of an embedded AI algorithm.

Therefore, I cannot provide the requested information based on the given text.

In summary, the provided document does not contain the information required to answer your prompt because the device is an imaging system, not an AI/algorithm-driven diagnostic aid.

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