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The ImageChecker CT Software Package with Filling Defect Indicator (FDI) is used during the review of contrast-enhanced computed tomography (CT) images of the chest. This software tool enables the radiologist to view and analyze regions of the image containing low density within vascular structures that may be indicative of filling defects or other intravascular abnormalities.

The software is designed to assist the radiologist in characterization and classification of these suspicious candidate thoracic abnormalities in terms of density, size, dimension, shape and position, thus aiding in the patient management care decision process.

The ImageChecker CT Software Package with Filling Defect Indicator (FDI), the subject of this notification, is a thoracic image visualization and analysis tool. This tool offers an extended functionality of the ImageChecker CT Workstation, utilizing segmentation techniques similar to the two above-mentioned predicates. Based on physician request, the FDI tool automatically segments locations in the vasculature of the chest containing low densities that typically correlate with filling defects. The process is based on simple segmentation methodology applied to contrast-opacified CT images of the chest segmentation methouorogy appels below a certain HU (Hounsfield Unit) threshold. fuentifying region is highlighted by placing a triangle on the region of the vascular structure of interest. This extended software functionality is designed for use with the structure of interesent on the R2 ImageChecker CT Workstation (K023003) and on other CT workstations that utilize the ImageChecker CT Workstation software tools. The FDI tool contains modifications to the Workstation with a special workflow based on automated segmentation for the visual identification of possible lung filling defects.

Here's an analysis of the provided text regarding the ImageChecker CT Software Package with Filling Defect Indicator:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) premarket notification does not contain any specific acceptance criteria or quantitative performance data on the device's ability to detect filling defects. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use and technological similarities.

Instead, the document states: "The Filling Defect Indicator tools package will undergo design verification tests for conformance with specifications." This indicates that the performance data was likely to be generated after this document was submitted or in a separate report, and not included in this summary.

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

No information is provided regarding the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). This information would typically be found in a study report, which is not present in this 510(k) summary.

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

No information is provided regarding the number of experts, their qualifications, or how ground truth was established for a test set.

4. Adjudication Method for the Test Set

No information is provided regarding any adjudication method (e.g., 2+1, 3+1, none) for a test set.

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

No mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is made. The document does not describe any study comparing human readers with AI assistance versus human readers without AI assistance, nor does it provide any effect sizes.

6. Standalone Performance Study

No information is provided regarding a standalone (algorithm only) performance study. The 510(k) states the device is "an adjunctive device that assists the radiologist in the review of CT images of the chest." This implies it's intended for human-in-the-loop use, but no standalone performance data is presented.

7. Type of Ground Truth Used

No information is provided regarding the type of ground truth used (e.g., expert consensus, pathology, outcomes data).

8. Sample Size for the Training Set

No information is provided regarding the sample size for any training set.

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

No information is provided on how ground truth was established for any training set.

Summary of the Information Provided in the 510(k):

The provided 510(k) Premarket Notification is a regulatory document focused on demonstrating substantial equivalence to predicate devices. It describes the device's intended use ("adjunctive device that assists the radiologist in the review of CT images of the chest"), its technical functionality (segmentation based on Hounsfield Unit threshold to identify low-density regions), and its relationship to existing R2 Technology and Siemens products.

Crucially, it does not include the details of any performance studies, acceptance criteria, or clinical validation data that would typically be found in a separate study report or a more comprehensive submission. The statement "The Filling Defect Indicator tools package will undergo design verification tests for conformance with specifications" indicates that performance testing was planned or ongoing, but the results are not present in this document. Therefore, based solely on the provided text, the specific information requested about acceptance criteria and study details cannot be extracted.

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