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This application software is an image analysis package that allows for the visualization of the colon using volume datasets that provide 2D, 3D and MPR images. When employed by a qualified physician, this package can be used to observe polyps, masses and other lesions of the colon. Upon observation of the potential lesion the physician can mark and categorize the observed lesion. This package also allows for the generation of reports that can be exported to DICOM based PACS systems for the continued tracking of changes in the colon.

Colon View is a post processing software package that allows for the review, annotation and reporting of 2D, 3D and MPR images, obtained from volume datasets, of colon images. This device is a post processing software package that enhances currently available 3D image review software. The software does not control the CT scanner, thus has no effect on radiation dose, but allows for the processing of image data for the colon.

Here's a summary of the acceptance criteria and study details for the Toshiba America Medical Systems, Inc. Colon View CSCV-001A, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not include explicit acceptance criteria or a detailed study section with performance metrics. The 510(k) summary focuses on describing the device, its intended use, technological characteristics, and its substantial equivalence to predicate devices. It states that the device is "substantially equivalent" to existing devices, implying it meets similar performance standards, but does not quantify those standards or the device's measured performance against them.

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

The provided text does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). This information is typically found in a detailed clinical study report, which is not present in this 510(k) summary.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The provided text does not mention the number of experts used to establish ground truth or their qualifications. The device is described as an aid for "qualified physicians" to observe and categorize lesions, but the process of establishing ground truth for testing purposes is not detailed.

4. Adjudication Method

The provided text does not specify any adjudication method used for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The provided text does not state if a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, nor does it provide an effect size of how much human readers improve with AI vs. without AI assistance. The submission is a 510(k) for a post-processing software package, and at the time of this filing (2009), comprehensive MRMC studies for AI assistance were less common or typically not required for this type of submission focused on substantial equivalence.

6. Standalone (Algorithm Only) Performance Study

The provided text does not explicitly describe a standalone (algorithm only without human-in-the-loop) performance study. The device is presented as a "post processing software package that allows for the review, annotation and reporting," implying it's an aid for a physician rather than a fully autonomous diagnostic tool.

7. Type of Ground Truth Used

The provided text does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data).

8. Sample Size for the Training Set

The provided text does not specify the sample size for any training set.

9. How Ground Truth for the Training Set Was Established

The provided text does not describe how ground truth for a training set was established.

In summary, the provided 510(k) document is a regulatory submission focused on demonstrating substantial equivalence to predicate devices for a CT Colonography post-processing software. It lacks the detailed performance study results and methodology that would typically include specific acceptance criteria, sample sizes, ground truth establishment, and expert involvement. The core argument in this 510(k) is that the device has "similar features" to other legally marketed devices and therefore does not raise new questions of safety or effectiveness.

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