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The C-cam camera head is designed for general endoscopic procedures in an operating room or a doctor's office. The camera head is suitable for attachment to all standard KARL STORZ Endoscopes and must be used with a C-MAC monitor or C-HUB for observation purposes in general endoscopic procedures.

The KSEA CMOS Camera System is a camera system designed for use in the operating room for general endoscopic procedures. The camera head is suitable for attachment to all standard KARL STORZ Endoscopes and Fiberscopes and must be used with a C-MAC™ monitor or C-HUB for observation purposes in general endoscopic procedures.

The KSEA CMOS Camera System (C-CAM) consists of a camera head, a cable and a monitor. The camera head must be connected to the C-MAC monitor, 8403ZX. The KSEA CMOS Camera System is compatible for use with all standard KARL STORZ Endoscopes and Fiberscopes for endoscopic observation in general endoscopic procedures.

The provided text describes a 510(k) premarket notification for the KARL STORZ Endoscopy America Incorporated KSEA CMOS Camera System (C-cam). This document focuses on demonstrating substantial equivalence to a predicate device (Tricam) rather than proving the device meets acceptance criteria through a specific study with detailed performance metrics.

However, based on the information provided, I can infer the "acceptance criteria" through the comparison to the predicate device and the "study" appears to be internal bench testing.

Here's the breakdown of the requested information based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set" in the context of clinical or performance data from a specific number of samples. The evaluation primarily relies on bench testing and comparison to a predicate device. Therefore, a sample size for a test set and data provenance (country of origin, retrospective/prospective) are not explicitly mentioned for evaluation of the device's performance against defined acceptance criteria, but rather for validation against design specifications and regulatory standards.

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

Not applicable. The document does not describe a study involving expert readers or ground truth establishment in a clinical setting. The evaluation is based on engineering and regulatory standards and a comparison with a predicate device.

4. Adjudication Method for the Test Set

Not applicable. As there is no "test set" with expert assessment described, no adjudication method is mentioned.

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." This indicates that no MRMC comparative effectiveness study was conducted or presented.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a way. The performance evaluation described is for the device operating on its own through bench testing. The results "show that the subject device has met all its specifications" and its performance for resolution, field flatness, and white balance was verified and validated through this testing. This can be considered a standalone assessment of the device's technical performance.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established through its design specifications and compliance with international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18). The device's performance (e.g., resolution, field flatness, white balance) is measured and compared against these predefined technical specifications and functional requirements.

8. The Sample Size for the Training Set

Not applicable. This is a medical device approval, not an AI/machine learning algorithm, so there is no "training set" in the context of data-driven model development.

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

Not applicable. As there's no training set, there's no ground truth established for it.

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