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The TELE PACK X LED 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 X LED is a portable and compact all-in-one imaging system that includes a 15 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 videonendoscope) for the purpose of visualization and documentation of endoscopic and microscopic procedures as well as stroboscopy.

The Telepack X LED includes a LED illumination light source to illuminate the intended area and a 15 inch monitor for display. It also allows the users to redefine the functions that take place when a button is pressed. The Telepack X LED is a non-patient contacting and require only wipe down as needed.

The provided document describes a 510(k) submission for the KARL STORZ Endoscopy-America, Inc. Telepack X LED, an all-in-one imaging system for endoscopic and microscopic procedures. It is a traditional 510(k) submission, demonstrating substantial equivalence to a predicate device.

The study presented focuses primarily on non-clinical performance and bench testing to demonstrate substantial equivalence, rather than a clinical study involving human readers or AI. Therefore, many of the requested elements for an AI study (e.g., acceptance criteria for AI performance, MRMC study, expert ground truth for test sets) are not applicable to this submission.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with numerical targets against which performance of an AI algorithm is measured. Instead, it relies on comparison to a predicate device and adherence to recognized consensus standards for its non-AI related functions.

However, it lists various performance testing conducted to ensure the device met its design specifications and is substantially equivalent to its predicate. These can be considered the "acceptance criteria" for the device's fundamental image capture and display capabilities in a non-AI context.

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

• Test Set Sample Size: Not applicable. The submission primarily relies on bench testing and comparison to a predicate device's technical specifications and previously cleared performance, rather than a "test set" of clinical cases for an AI algorithm.
• Data Provenance: Not applicable for an AI test set. Bench testing data is typically generated internally by the manufacturer. If any clinical "data" were used for comparison (e.g., images), the provenance is not specified. The document mentions "Clinical published literatures were provided to support the effectiveness of NIR imaging," but this is for reference, not a direct clinical test of this specific device's AI capabilities.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable as this is not an AI device validation requiring ground truth established by clinical experts on a test set. This device is an imaging system, not an AI diagnostic algorithm.

4. Adjudication Method for the Test Set

Not applicable.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC study is typically performed to evaluate the diagnostic performance of an AI system, often in comparison to or in assistance of human readers. This submission is for an imaging system hardware, not an AI diagnostic algorithm.

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

Not applicable. There is no AI algorithm being evaluated for standalone performance.

7. The Type of Ground Truth Used

Not applicable for an AI algorithm. The "ground truth" for this device's performance is its ability to meet engineering specifications and produce images comparable to the predicate device, as verified through bench testing.

8. The Sample Size for the Training Set

Not applicable. This document pertains to the submission of an imaging system, not the training of an AI algorithm.

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

Not applicable.

Summary of the study that proves the device meets acceptance criteria (as per this 510(k) submission):

The KARL STORZ Telepack X LED demonstrated that it meets acceptance criteria, primarily through non-clinical bench testing and comparison to its predicate device (Image 1 Video Imaging System K070716).

The studies performed included:

• Electrical Safety and EMC Testing: Conformance to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, and IEC 62471. The device was certified for various classes of electrical shock protection and drip-water protection (IPX1).
• Software Verification and Validation (V&V) Testing: Conducted in accordance with FDA guidance for software in medical devices, with a "Moderate" level of concern.
• Performance Testing: Bench tests were conducted to verify parameters such as minimum illumination, spatial resolution, color performance, latency, white balance, AE step response, and head button functionality. These tests aimed to ensure the device met its design specifications and performed comparably to the predicate device in terms of image quality characteristics.

The conclusion drawn was that the Telepack X LED's intended use, operating principles, technological characteristics, and features are similar, if not identical, to the predicate device. Differences identified (e.g., integrated light source, storage methods, absence of interoperability/split screen enhancement) were determined not to raise new or different questions of safety and effectiveness, as the underlying principles, functions, and compliance to standards were maintained. Clinical performance data was not required or provided to establish substantial equivalence for this type of device, as non-clinical bench testing was deemed sufficient.

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