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The CT-Guide is a stereotactic accessory for Computed Tomography ("CT") systems. The CT-Guide displays an interventional instrument on a computer monitor that also displays a CT-based model of the target organ(s).

The CT-Guide is intended to be used in clinical interventions in the lung, where CT is currently used for visualizing such procedures.

The CT-Guide System is comprised of four main components: (1) the ActiSensor, a disposable video camera that is mounted onto a holder, which is clipped to a needle; (2) the ActiSticker, a disposable pad, which provides visual and radio-opaque reference markers; (3) a workstation that contains a dedicated computer; and (4) accompanying computer software.

The provided text describes the ActiViews Ltd.'s CT-Guide Needle Guidance System (K110812). Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample size used for the test set and the data provenance:
   The document states a "prospective, multi-center clinical study was conducted," but it does not specify the sample size for the test set (number of patients or procedures). The data provenance is prospective and multi-center, but the specific countries of origin are not mentioned.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not provided in the given text.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   This information is not provided in the given text.

4. 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:
   An MRMC comparative effectiveness study is not explicitly mentioned. The clinical study aimed to establish safety and effectiveness of the system rather than compare human readers with and without AI assistance. Therefore, no effect size for human reader improvement with AI assistance is provided.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   The device is described as a "Needle Guidance System" and an "accessory for Computed Tomography ("CT") systems" that "displays an interventional instrument on a computer monitor." This implies a human-in-the-loop system, as the human operator (clinician) uses the guidance for the interventional procedure. Therefore, a standalone (algorithm-only) performance study would not be applicable or described for this type of device, and is not mentioned.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the clinical study, the text states, "The results established that the system is safe and effective for its intended use." While "safety and effectiveness" are outcomes, the specific type of ground truth used to measure these outcomes (e.g., successful lesion targeting confirmed by follow-up imaging, biopsy results, lack of complications) is not detailed. For the bench tests, predefined specifications were met, implying a ground truth based on engineering or performance metrics.

7. The sample size for the training set:
   The document does not specify a training set sample size. It mentions "software was validated and tested," but no details on training data.

8. How the ground truth for the training set was established:
   This information is not provided in the given text.

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