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The Endoscopic Camera TC804/C4 is intended to attach to standard endoscopes to permit visualization of body cavities, hollow organs and canals during endoscopic procedures. It also may be attached to a microscope. The endoscopic image can be displayed on any standard video monitor.

The Endoscopic Camera TC804/C4 is a 3-CCD camera, which consists of a camera control unit (CCU), a camera head, various connecting objectives, cables and adapters. The Endoscopic Camera TC804/C4 takes the image through standard endoscopes that would be normally seen with the naked eye, and displays it on any standard video monitor. The camera head is supplied with a standard 30 mm endofocus objective but may also be used with a 25 mm or zoom objective. The device is programmable by two head key bottons and is equipped with a ring-focus for both right-handed and left-handed users.

The provided text describes a 510(k) summary for the Endoscopic Camera TC804/C4. It outlines the device's intended use and design but does not contain information regarding specific acceptance criteria, performance data from a study, or details about ground truth establishment or sample sizes as would be expected for an AI/ML device.

The section titled "VIII. Performance Data" states: "The Endoscopic Camera TC804/C4 complies with the International Standard IEC 601-1. IEC 601-1-2. the European Standard EN 55011 and conforms to the Medical Device Directive 93/42 EEC. The device will be tested in accordance with UL2601-1." This indicates compliance with general electrical safety and EMC standards, and a plan for UL testing, but not a study evaluating its "performance" in the context of image quality or diagnostic accuracy, which would be relevant for devices that AI/ML systems typically enhance.

Therefore, I cannot populate the requested table and answer many of the questions because the document does not contain the necessary information about acceptance criteria, specific device performance metrics, study design, ground truth, or expert involvement as outlined in the prompt. The device described appears to be a standard endoscopic camera, not one incorporating AI/ML, and its regulatory submission focuses on substantial equivalence to predicate devices based on design and intended use, rather than detailed performance studies against specific acceptance criteria.

Analysis of Provided Information vs. Requested Details:

1. Table of acceptance criteria and reported device performance: Not available. The document only mentions compliance with general medical device standards (IEC, EN, UL). It does not provide specific performance metrics like resolution, sensitivity, specificity, or image quality against defined acceptance criteria.
2. Sample size for test set and data provenance: Not available. No test set or study validating specific performance claims is described.
3. Number of experts and qualifications for ground truth: Not available. No ground truth establishment is described for a performance study.
4. Adjudication method: Not available.
5. MRMC comparative effectiveness study: Not applicable/not available. The document does not describe an AI-assisted device.
6. Standalone performance study: Not available in the context of AI/ML or image quality metrics.
7. Type of ground truth used: Not available.
8. Sample size for training set: Not applicable/not available. No AI/ML model training is mentioned.
9. How ground truth for training set was established: Not applicable/not available.

In summary, the provided 510(k) summary is for a traditional endoscopic camera, and its "Performance Data" section refers to compliance with safety and electrical standards, not to clinical or image quality performance studies that would typically have acceptance criteria, ground truth, and expert evaluation described.

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