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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 KARL STORZ TELEPACK+ is an all-in-one imaging system for endoscopic and microscopic procedures. This submission (K221174) is a modification of a previously cleared device (K193235). The key modifications include:

• Swapping of two camera types (X-link and Office Link) via touchscreen.
• Addition of capacitors to the Office Link front end.
• Mechanical changes: added isolation to the microphone, an additional cover for the power supply, and a mechanical metal part as a protective earth.
• Addition of video playback and image review functionality.
• Additional cybersecurity features.
• Additional camera and videoscope compatibility.

The device's non-clinical performance data and bench testing were deemed sufficient to demonstrate substantial equivalence to its predicate device. This implies that the device meets its design specifications and is as safe and effective as the legally marketed predicate devices.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not specify a separate "test set" and its sample size in the context of a clinical study, as no clinical performance data was required. The "test set" for demonstrating substantial equivalence primarily involved bench testing and electrical, EMC, and software validation tests. The data provenance is internal to KARL STORZ Endoscopy America, Inc., as these were laboratory and engineering tests conducted on the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. For this type of device (an imaging system, not an AI diagnostic tool), "ground truth" established by medical experts for a test set is typically not germane to the substantial equivalence pathway, especially when no clinical data is required. The ground truth for engineering and performance measurements is established by standard measurement techniques and reference equipment.

4. Adjudication method for the test set

Not applicable. Since no clinical study or expert review for diagnostic accuracy was performed or required, an adjudication method for a test set is not relevant.

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. The TELEPACK+ is an imaging system and not an AI-assisted diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance was not conducted.

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

Not applicable. The TELEPACK+ is a medical imaging system, not a standalone algorithm. Its performance is evaluated on its ability to produce high-quality images and manage endoscopic/microscopic procedures, not on an algorithm's diagnostic capabilities.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the performance testing (e.g., minimum illumination, spatial resolution, color performance) was established through objective engineering measurements using calibrated equipment and standard test methods against the device's design specifications. For electrical safety and EMC, the "ground truth" is compliance with recognized international standards (e.g., IEC 60601 series).

8. The sample size for the training set

Not applicable. The TELEPACK+ relies on traditional imaging processing and control technologies, not machine learning or artificial intelligence that would require a "training set" in the context of algorithm development.

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

Not applicable. As no training set for an AI algorithm was used, this question is not relevant.

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