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3D TIPCAM®1: The Rigid Videoendoscope is intended to be used together with the camera control unit is for use during diagnostic and/or surgical procedures when endoscopic video assistance is required. For use in all endoscopy and endoscopic surgery within the peritoneal and thoracic cavity, including gynecological anatomy.

IMAGE1 SPIES is a camera control unit (CCU) for use with camera heads or videoendoscopes for the visualization and documentation of endoscopic and microscopic procedures.

The SPIES 3D System is intended for use during diagnostic and/or surgical procedures when endoscopic video assistance is required within the peritoneal and thoracic cavity, including gynecological and urological anatomy.

The SPIES 3D System is a medical device system which consists of the camera control unit (CCU) – a combination of the previously 510k cleared device (K131953) – Image1 Connect module (TC200) and the D3-Link module, and 3D Tipcam®1.

The provided text is a 510(k) summary for the Karl Storz Endoscopy-America, Inc. SPIES 3D System. Based on the information provided, here's a detailed breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in a quantitative table format with corresponding reported performance values for each criterion. Instead, it lists the types of performance characteristics that were tested and states that the device "met all its specifications" and "met all its design specification." Since specific numerical criteria and corresponding results are not given, the table below will summarize the areas of performance validated and the general conclusion.

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

The document explicitly states: "No clinical information is required for this submission." The performance data presented are from bench tests and non-clinical performance tests.

• Sample Size for Test Set: Not applicable for a clinical test set, as no clinical studies were performed. For bench tests, the sample size is not specified but would typically involve one or a small number of devices tested under various conditions.
• Data Provenance: The data provenance is from internal non-clinical performance and bench testing conducted by the manufacturer (Karl Storz Endoscopy-America, Inc.). It is retrospective in the sense that the tests were performed on finished devices, but the data itself is from laboratory settings, not patient data. Country of origin of data is not specified but implicitly North America (where the applicant is located) and/or Germany (where Karl Storz is headquartered).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. No clinical test set was used, and thus no expert ground truth panels were involved. The "ground truth" for the non-clinical tests would be the established engineering and performance specifications, and the judgment was made by engineers and quality assurance personnel performing the tests.

4. Adjudication Method for the Test Set

Not applicable. Since no clinical test set requiring human interpretation or judgment was used, there was no adjudication method involving multiple experts.

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

No. The document explicitly states: "No clinical information is required for this submission." Therefore, no MRMC study was performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in essence. The "standalone" performance here refers to the device's technical specifications and functionality independent of human interpretation of its output in a clinical scenario. The document describes various "bench test data" and "non-clinical performance data" that demonstrate the device's capabilities. These include tests for resolution, brightness, white balance, color performance, latency, minimum illumination, auto-exposure response, and zero-degree parallax. These tests evaluate the inherent technical performance of the device itself.

7. The Type of Ground Truth Used

The ground truth for the non-clinical performance tests was the engineering design specifications and recognized international standards (e.g., IEC 60601 series for safety, ISO 10993 series for biocompatibility). The device was tested to verify that it met these predetermined functional and safety requirements.

8. The Sample Size for the Training Set

Not applicable. This device is an imaging system (hardware and associated software), not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "training" for such a device involves its design, manufacturing, and internal testing to ensure it meets its intended specifications.

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

Not applicable. As mentioned, this is not an AI/machine learning algorithm requiring a separate training set. The "ground truth" for the device's development (design and manufacturing of the hardware and embedded software) would effectively be established through engineering principles, established medical device development processes, and adherence to relevant industry standards and regulatory requirements.

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