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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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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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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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