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Endoscopic Camera System is a camera control unit (CCU) for use with camera heads and video endoscopes for visualization, image recording and documentation during general endoscopic and microscopic procedures.

The device consists of a camera control unit (CCU) and a camera head.

The device is intended to be used to connect with an optical endoscope during the endoscopic diagnosis and/or treatment/surgery, and to capture, process and transmit images in the human body cavity under the field of view observed by the endoscope to the monitor.

There are 4 models of the device. The hardware configuration of the device of 4 models are same, and difference is different functions which opened up through software.

The provided FDA 510(k) clearance letter describes an Endoscopic Camera System (K250204) and its substantial equivalence to a predicate device (Image1 SPIES System, K160044). However, it does not provide detailed acceptance criteria or the specific results of a study (e.g., clinical study) that quantitatively proves the device meets strict performance thresholds.

The letter primarily focuses on the device's technical specifications and compliance with non-clinical performance tests relevant to the safety and fundamental function of an endoscopic camera system. It highlights that the device "met all its specifications" and that bench tests demonstrated the device's characteristics have been met, but it does not specify what those specifications or characteristics are in measurable terms related to clinical performance.

Based on the provided text, here's an attempt to answer your questions, highlighting what is available and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "The bench test data for the Endoscopic Camera System demonstrates that the design characteristics used as the basis for the comparison have been met. The results show that the subject device has met all its specifications." and "The bench testing performed verified and validated that the Endoscopic Camera System has met all its design specification and is substantially equivalent to the predicate device, Image1 SPIES System."

However, the specific acceptance criteria (measurable thresholds) and the quantitative reported device performance for these specifications are NOT detailed in this public FDA 510(k) clearance letter.

The letter mentions "minor technology differences" in:

• Horizontal resolution
• Spatial frequency response
• Field of view
• Focal length
• Dimensions
• Weight of camera head
• Image delay
• Video output
• USB port of CCU

For these parameters, the letter ambiguously states that these differences "does not raise new issues of safety and effectiveness." It implies that the new device's performance for these characteristics is either equivalent or acceptably different without introducing new risks compared to the predicate, but specific numbers are not provided.

Crucially, the document explicitly states: "The performance validation test report can be provided upon request." This means the detailed quantitative data is part of the full 510(k) submission but not typically released in the public clearance letter.

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

• Sample Size: Not specified in the clearance letter. The testing mentioned (bench testing, software verification) would imply testing of the device units and their software, but the "sample size" in terms of patient data or clinical cases (which is what your question typically refers to for AI/diagnostic devices) is not applicable or not disclosed for this type of device and submission pathway based on the provided text. This device is a general endoscopic camera system, not an AI-powered diagnostic device trained on patient data itself, but rather a visualization tool. Its performance is typically assessed through technical specifications and bench testing for image quality, safety, and functionality.
• Data Provenance: Not applicable in the context of patient data for a clinical test set. The data would originate from the bench tests conducted by the manufacturer.

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

• Not applicable / Not disclosed. For an endoscopic camera system, the "ground truth" for its performance is typically based on objective physical measurements (e.g., resolution charts, light intensity, color accuracy) and engineering test standards, rather than expert human interpretation of medical images for diagnostic accuracy.

4. Adjudication Method for the Test Set

• Not applicable / Not disclosed. Adjudication is relevant for studies involving human interpretation or multi-expert review, which is not described for this device's performance validation.

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. This device is an "Endoscopic Camera System" for visualization and documentation. The provided information does not indicate that it includes AI or that an MRMC study was performed. The evaluation focuses on the camera system's fundamental performance characteristics, not its impact on human diagnostic accuracy with or without AI assistance.

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

• Not applicable. This device is a hardware camera system, not an algorithm, and the provided text does not indicate any standalone algorithm performance testing.

7. The Type of Ground Truth Used

• Objective Technical Measurements and Engineering Standards. The "ground truth" for an endoscopic camera system's performance would be established through:
  • Metrological standards: Measuring resolution, contrast, brightness, color accuracy, distortion, etc., using calibrated test targets and equipment.
  • Compliance with industry standards: Such as IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), and AAMI TIR 12:2020 (reprocessing).
  • Design specifications: The device is tested against its predefined engineering design specifications to ensure it meets them.

8. The Sample Size for the Training Set

• Not applicable. This device is a hardware camera system, not an AI model, so there is no "training set" in the context of machine learning.

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

• Not applicable. As above, there is no "training set" for this device.

In summary, the provided 510(k) clearance letter details a regulatory approval for an endoscopic camera system based on substantial equivalence to a predicate device and compliance with applicable non-clinical safety, EMC, reprocessing, and software verification standards. It emphasizes that the device met its design specifications and passed bench tests, but it does NOT provide the granular quantitative details of "acceptance criteria" or a "study proving it meets those criteria" in the way one would expect for a diagnostic AI device requiring clinical performance validation. The specific numerical performance data would be part of the full 510(k) submission, not typically included in the public clearance letter.

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