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The Karl Storz Imaging (KSI) Direct Coupled (DCC) Camera Head is a color, television camera head designed for attachment to a Karl Storz Tuttlingen (KST) DCC endoscopic visioning system. The KSI DCC camera head is compatible with the currently marketed KSI Telecam SL (Super Luxury) video processor and the KSI Telecam SL with IPM (Image Processing Module) video processor.

The camera head is suitable for attachment to any KST DCC rigid or flexible endoscope, including, but not limited to sinoscopes, colonoscopes, sigmoidoscopes, bronchoscopes, gastroscopes, laparoscopes, choledoscopes, ureteroscopes, hysteroscopes and arthroscopes. The camera head is coupled to the endoscope by directly pressing the endoscope onto the front of the DCC camera head until it locks into place. An optional adapter allows DCC camera head attachment to non-DCC rigid and flexible endoscopes. The endoscopic image can be displayed on any standard operating room video monitor.

The KSI DCC incorporates two programmable function buttons (to select an accessory port(s) and to control the port output) and two focus buttons. The light cable is connected directly to the back of the camera head. The camera is designed to allow the user to directionally rotate the camera head to maintain proper image orientation on the monitor.

The provided document is a 510(k) summary for the Karl Storz Imaging Direct Coupled Camera Head, submitted in 1997. It describes the device, its intended use, and claims substantial equivalence to previously marketed devices. However, it does not contain any information regarding acceptance criteria, study details, performance data, or ground truth establishment.

Therefore, I cannot populate the requested table or answer the specific questions about studies, sample sizes, experts, or ground truth based on this document. The document essentially states that the new device is substantially equivalent to existing ones because it integrates features already present in their earlier models, implying that extensive new performance studies were not deemed necessary for this submission.

Summary of what cannot be provided from the document:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample sized used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
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 mentioned. This device is a camera head, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable as this is a camera, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not mentioned.
8. The sample size for the training set: Not applicable as this is a physical device, not a machine learning model.
9. How the ground truth for the training set was established: Not applicable.

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