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MedIQ is a post-processing, productivity software package designed to assist radiologists in the analysis of dynamic CT and MR images. The software provides supplemental information and visual enhancement of time/intensity changes extracted from CT and MR temporal datasets. Single or multi-slice datasets, using standard acquisition protocols, are used for input.

The software displays the temporal variation in dynamic data as a surface map that enhances visualization of pixel intensity and time/intensity changes extracted from CT and MR temporal data sets. The results may be displayed as either a grayscale enhancement or a color overlay on the selected image.

MedIQ also may be used to perform post-processing analysis of multimodality, digital images, including MR, CT, X-Ray, PET and Nuclear Medicine images. The software analysis tools may be applied to image subtractions, reformatted images, multiplanar reformats, and maximum intensity projections.

The software package includes tools to allow the radiologist to manipulate and fly-through images for enhanced visualization, and a z-axis kinematic motion feature.

When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis. Patient management decisions should not be made based solely on the results of MedIQ analysis. The MedIQ software is not intended for use for primary interpretation of digital mammography images.

MedIQ Version 1.0 is a software package designed to assist the radiologist in interpretation of multi-modality, digital radiology images, including dynamic CT and MR image data sets. The software applies standard 2D and 3D image processing techniques on a pixel-by-pixel basis to analyze grayscale data and perform visual enhancement of user-selected images. The software may be applied to image subtractions, reformatted images, multiplanar reformats, and maximum intensity projections. Single or multi-slice data sets may be used as input.

The results of the analysis are displayed as a surface map that enhances visualization of pixel intensity data provided by the image. The results may be displayed in grayscale enhancement or as a color overlay. The software includes standard workflow tools that allow the radiologist to manipulate, rotate and fly-though images for enhanced visualization of the digital output.

The software application consists of proprietary software developed by Clario and is a Windows 2000/XP, DICOM-compatible platform. The software is designed to be distributed as an SDK or as an application for installation on DICOM-compatible OEM imaging systems, PACS, workstations, stand-alone PCs, or embedded in software applications cleared for use in medical imaging. The device also may be distributed by Clario as a stand-alone PC product.

The MedIQ user interface is designed to follow typical clinical workflow patterns to process, review, and analyze digital images.

The provided 510(k) summary (K052963 for MedIQ Version 1.0) does not contain information related to specific acceptance criteria or a study that proves the device meets such criteria.

The document primarily focuses on establishing substantial equivalence to predicate devices, describing the device's functionality, and outlining its intended use. There is no mention of performance metrics, clinical studies, or an evaluation of the device's accuracy, sensitivity, or specificity against established benchmarks.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or details about a study demonstrating this.

Based on the provided text, the following information can be extracted:

• 1. A table of acceptance criteria and the reported device performance:

  • Not applicable. The document does not specify quantitative acceptance criteria or provide data on device performance against such criteria. The submission is a 510(k) for an "Image Processing System" (PACS technology) which, at the time, typically demonstrated substantial equivalence through functional comparisons to existing systems rather than clinical performance metrics.

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

  • Not applicable. No test set or data provenance details are mentioned.

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

  • Not applicable. No ground truth establishment is described.

• 4. Adjudication method for the test set:

  • Not applicable. No test set or adjudication method is described.

• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

  • Not applicable. No MRMC study is mentioned. The submission is a comparison of features and functionality to predicate devices.

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

  • Not applicable. No standalone performance study is mentioned. The device is described as a "software package designed to assist the radiologist in interpretation."

• 7. The type of ground truth used:

  • Not applicable. No ground truth is described as being used for evaluation.

• 8. The sample size for the training set:

  • Not applicable. No training set is mentioned. This is a post-processing software, not an AI/machine learning algorithm requiring a training set in the modern sense.

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

  • Not applicable. No training set and therefore no ground truth establishment for a training set is mentioned.

Summary of what the document implies regarding "proving" the device meets criteria:

The primary method of demonstrating that MedIQ Version 1.0 is acceptable (meets regulatory requirements) is through substantial equivalence to already legally marketed predicate devices. The document extensively compares the functionality and features of MedIQ with several existing "Picture Archiving and Communications System" or similar image processing software products (SharpView, Vitrea 2, FuncTool 2000, MIStar, Syngo Colonography Software Package, Realtime 3D Software Package, Fly Through PACS Software).

The "study" in this context is a comparison of features and intended use to predicate devices, rather than a clinical performance study with defined acceptance criteria. The conclusion states: "MedIQ Version 1.0 provides functionality that is substantially equivalent to the cited predicate software devices. The potential hazards have been studied and controlled as part of the product development process, including risk analysis, test and design considerations, and planned verification and validation testing processes." This indicates internal verification and validation of software functionality, but not a public, comparative study against specific clinical performance metrics.

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