Search Results

The FACT Medical Imaging System is a medical software application that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. The FACT Medical Imaging System is not meant for primary image interpretation in mammography. In addition, the FACT Medical Imaging System has the following indications:

(1) Pulmonary Review and Analysis Application

Pulmonary Review and Analysis application is an option that is intended for supporting physicians in the diagnosis and documentation of pulmonary tissue images (e.g., abnormalities) from pulmonary CT images. Three-Dimensional segmentation and isolation of sub-compartments, volumetric analysis, density evaluations, and reporting tools are combined with a dedicated workflow.

The automated image registration facilitates the synchronous display and navigation of multiple datasets for viewing data and easy follow-up comparison. The summary report of findings helps the user to track findings and note changes, such as shape, size, or overtime.

(2) Vessel Review and Analysis Application

Vessel Review and Analysis application is an option intended for viewing the anatomy and pathology of a patient's coronary arteries.

Physicians can select any artery to view the following anatomical references: the highlighted vessel in 3D, curved MPR vessel view, and straightened MPR view with cross sections of the vessel. Physicians can semi-automatically stenosis measurements, and maximum and minimum lumen diameters. In addition, physicians can also measure vessel dimensions along the centerline in curved MPR view and examine Hounsfield unit or signal intensity statistics.

The FACT Medical Imaging System is self-contained, non-invasive medical image processing software. It can be marketed as software only, as well as packaged with standard off-the-shelf PC hardware. It can operate as a stand-alone workstation or in a distributed server-client configuration across a computer network.

The FACT Medical Imaging System allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. This device addresses physicians' needs through various application options for pulmonary and vessel applications.

The provided document is a 510(k) summary for the FACT Medical Imaging System. It focuses on establishing substantial equivalence to predicate devices rather than deeply detailing the device's acceptance criteria and the comprehensive study results. While it mentions having performed non-clinical tests and that those tests "successfully passed," it does not provide the specific quantitative acceptance criteria or detailed results of those studies.

Therefore, for aspects like specific performance metrics, sample sizes, ground truth establishment methods for test data, and detailed information about expert involvement, the document states "Not provided" or "Not applicable" because this information is not present in the given text.

Here's the information that can be extracted or inferred from the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "Pass/Fail criteria were based on the requirements and intended use of the proposed device. Test results showed that all tests successfully passed." However, specific numerical acceptance criteria and reported device performance are not explicitly provided in the given text. The tests performed include:

• Functional test
• Functional regression test
• Performance test
• Portability test
• Graphical user interface test
• Usability test
• Interoperability test
• Measurement accuracy evaluation and validation:
  • Accuracy of pulmonary segmentation and measurements
  • Accuracy of fissure segmentation and measurements
  • Accuracy of airway segmentation and measurements
  • Accuracy of vessel segmentation and measurements

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

• Sample size for the test set: Not provided in the document.
• Data provenance (country of origin, retrospective/prospective): Not provided in the document.

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

• Number of experts: Not provided in the document.
• Qualifications of experts: Not provided in the document.

4. Adjudication method for the test set

• Adjudication method: Not provided in the document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

• MRMC study: No. The document states "Discussion of Clinical Tests Performed: None." This indicates that no clinical studies, including MRMC studies comparing human readers with and without AI assistance, were performed or submitted.

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

• The document implies that accuracy evaluations were performed for segmentation and measurements, which would typically be standalone algorithm performance. However, specific standalone performance metrics are not given. The document focuses on demonstrating that the software functions as intended and is comparable to predicate devices in its capabilities.

7. The type of ground truth used

• For the "Measurement accuracy evaluation and validation" tests (pulmonary, fissure, airway, and vessel segmentation and measurements), the ground truth type is not explicitly stated. It's common for such evaluations to use expert-annotated data, but this is not confirmed in the text.

8. The sample size for the training set

• The document does not mention a "training set" or "training data" as it describes a medical image processing software (PACS) rather than an AI/ML device that requires a distinct training phase. If any internal parameters of the segmentation or measurement algorithms were optimized, the datasets used for such optimization are not specified.

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

• Not applicable, as no training set is discussed for this type of device and submission.

Ask a specific question about this device