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The CAS-One Liver system is indicated for open liver surgical procedures where image guidance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia.

The CAS-One Liver system is indicated for open liver surgical procedures where image aujdance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia. It visualizes the position and pose of surgical instruments relative to a three-dimensional model of the patients liver in real-time.

The provided text describes the CAS-One Liver system, its indications for use, and a summary of performance data submitted for its 510(k) premarket notification. However, it does not contain specific acceptance criteria for device performance or a detailed study proving the device meets those criteria.

The document states:

• "Bench testing to show the accuracy and reproducibility was conducted and shown to meet the defined acceptance criteria for various functionality of the system (such as calibration, tracking and registration)."

This indicates that acceptance criteria were defined and testing was performed, but the document does not report what those criteria were, nor does it provide the results of the tests against those criteria.

Therefore, I cannot provide the requested information about acceptance criteria, reported device performance, sample sizes, ground truth, or details of a comparative effectiveness study.

Here's what can be extracted, based on the absence of the requested information:

1. Table of acceptance criteria and reported device performance:

   • The document states "Bench testing to show the accuracy and reproducibility was conducted and shown to meet the defined acceptance criteria for various functionality of the system (such as calibration, tracking and registration)."
   • CRITERIA NOT SPECIFIED.
   • REPORTED PERFORMANCE NOT SPECIFIED.

2. Sample size used for the test set and the data provenance:

   • NOT SPECIFIED. The document only mentions "Bench testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • NOT SPECIFIED, as details of the "Bench testing" are not provided.

4. Adjudication method for the test set:

   • NOT SPECIFIED.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:

   • NO, an MRMC comparative effectiveness study is not mentioned. The device is a navigation system for surgical procedures, and the testing described is "Bench testing" for accuracy and reproducibility, not a study of human reader improvement with AI assistance.

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

   • The "Bench testing" for "accuracy and reproducibility" of "calibration, tracking and registration" could be considered standalone performance, as it tests the system's technical function. However, the exact details of how "human-in-the-loop" was excluded or included are NOT SPECIFIED.

7. The type of ground truth used:

   • For "Bench testing" of a navigation system, ground truth would typically be established through precise measurements from calibrated instruments, phantoms, or simulated environments. However, the specific type of ground truth used for the CAS-One Liver system's bench testing is NOT SPECIFIED.

8. The sample size for the training set:

   • The document implies a "virtual surgery planning tool" (MeVis Medical Solutions, Bremen, Germany) that processes CT/MRI scans. This tool likely uses algorithms that would have been "trained," but the details of any training set for the CAS-One Liver system's own components (if applicable for navigation algorithms) are NOT SPECIFIED. The document focuses on the end-use navigation system's performance.

9. How the ground truth for the training set was established:

   • NOT SPECIFIED.

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