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RapidiaColon ™ is a software application for the display and 3D visualization of medical data derived from digital modalities (CT and MRI scanners). It is intended for use by radiologists, clinicians and referring physicians to acquire, process, render, review, store, print, and distribute DICOM compliant image studies using standard PC hardware.

RapidiaColon™ is a software device for 3D (three dimensional) and 2D (two dimensional) viewing and manipulation of digital DICOM compliant images using graphics rendering technology. The software device provides 3D volume rendering (VR), multi-planar reconstruction (MPR), virtual endoscopy, and issues reports.

Here's an analysis of the provided text regarding the RapidiaColon™ device, focusing on the acceptance criteria and study information:

Unfortunately, the provided 510(k) summary for the INFINITT RapidiaColon™ System does not contain the detailed information necessary to fully answer all aspects of your request. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study with acceptance criteria and results.

Specifically, it lacks information on:

• Specific acceptance criteria.
• A dedicated study proving the device meets these criteria.
• Sample sizes for test or training sets.
• Data provenance.
• Details on expert consensus for ground truth.
• Adjudication methods.
• MRMC study results.
• Standalone performance.
• The type of ground truth used for performance evaluation.
• How ground truth was established for "training" data (though the device appears to be a viewing/processing tool, not one that uses machine learning in the modern sense of training data).

Based on the provided text, here's what can be extracted and what remains unknown:

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

Explanation: The 510(k) summary for RapidiaColon™ System does not provide explicit acceptance criteria or measured performance metrics for the device. The document's primary purpose is to establish substantial equivalence to a predicate device (Voxar Limited's plug 'n view 3d, version 1.0) based on technological characteristics and intended use, rather than presenting a detailed performance study with defined criteria and results. It primarily states that "Validation testing was provided that confirms that RapidiaColon performs all input functions, output functions, and all required actions according to the functional requirements specified in the Software Requirements Specification (SRS)." However, the specifics of these functional requirements, the tests performed, and the quantitative results are not included in this summary.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified (country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
• Role of Experts: Given the nature of the device (viewing and processing), "ground truth" as typically understood in AI/CAD performance studies (e.g., presence/absence of a lesion) is not directly applicable in the same way. The validation would likely involve functional testing to ensure accurate display and manipulation of images, not diagnostic accuracy against a ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not specified.

5. 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

• MRMC Study: Not mentioned or implied. The device is described as a "Picture Archiving Communications System" and a "software application for the display and 3D visualization of medical data." It does not appear to incorporate AI for diagnostic assistance, so an MRMC study comparing human readers with and without "AI assistance" would not be relevant in this context. It's a tool for visualization and manipulation, not an interpretation aid.

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

• Standalone Performance: The concept of "standalone performance" as it relates to AI algorithms is not applicable here. RapidiaColon™ is a software tool for image viewing and manipulation, not an independent algorithm making diagnostic determinations. Its "performance" would be related to its functionality (e.g., speed of rendering, accuracy of MPR reconstruction, stability) rather than a diagnostic output. The validation would have focused on its ability to perform its specified functions: acquiring, processing, rendering, reviewing, storing, printing, and distributing DICOM-compliant image studies.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Type of Ground Truth: Not specified in the context of diagnostic accuracy. For a viewing and processing system, "ground truth" would more likely refer to the correctness of the displayed medical data against the original DICOM data or the accuracy of its reconstruction algorithms, verifiable through technical specifications and controlled test cases rather than clinical outcomes or pathology.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable/Not specified. This device is described as a viewing and manipulation tool, not a machine learning model that requires a "training set" in the conventional sense.

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

• How Ground Truth for Training Set was Established: Not applicable. As noted above, the device does not appear to be an AI/ML model requiring a training set. Its functionality is based on established rendering and image processing algorithms.

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Rapidia® is a software package intended for viewing and manipulating DICOM-compliant medical images from CT (computerized tomography) and MR (magnetic resonance) scanners. Rapidia can be used for real-time viewing, image manipulation, segmentation, 3D volume and surface rendering, virtual endoscopy, and reporting.

Rapidia® is a fast, practical and accurate tool for 3D (three dimensional) and 2D (two dimensional) viewing and manipulation of CT and MRI images using the most advanced graphics rendering technology. The proposed software provides volume rendering (VR), maximum/minimum intensity projection 3D (MIP/MinIP), surface shaded display (SSD), multi-planar reconstruction (MPR), virtual endoscopy, 2D image editing and segmentation (2D), and issues reports.

Here's an analysis of the provided text regarding the Rapidia® device, focusing on acceptance criteria and study details.

Executive Summary:

The provided 510(k) summary for the Rapidia® device offers very limited information regarding explicit acceptance criteria and a detailed study proving its performance. The primary focus of the document is on establishing substantial equivalence to a predicate device (Plug'n View 3D K993654) and demonstrating conformance to DICOM standards and internal functional requirements.

Acceptance Criteria and Device Performance:

Study Details:

The document describes a "Validation testing" but provides very few specifics about its methodology or results in terms of concrete performance metrics.

1. Sample size used for the test set and the data provenance: Not specified. The document only mentions "Validation testing was provided." We don't know the number of images, patient cases, or the origin (country, retrospective/prospective) of the data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. The document does not mention any expert involvement in establishing ground truth for testing.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not specified.
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: No, an MRMC comparative effectiveness study is not mentioned. The device is purely an image processing and visualization tool, not an AI-assisted diagnostic aid in the context of this 2001 submission.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes, the "Validation testing" appears to be a standalone performance evaluation against the Software Requirements Specification (SRS), focusing on the software's functionality. It's an algorithm-only performance in the sense that it tests the software's ability to execute its programmed functions.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's validation appears to be its internal "Software Requirements Specification (SRS)." The testing confirmed the software performed "according to the functional requirements specified in the Software Requirements Specification (SRS)." This is essentially a black-box functional testing approach, not clinical ground truth.
7. The sample size for the training set: Not applicable/specified. This device, submitted in 2001, is described as an "Image processing and 3D visualization system." It does not appear to employ machine learning or AI that would require a "training set" in the modern sense. Its functionality is based on explicit programming for rendering and manipulation.
8. How the ground truth for the training set was established: Not applicable, as there's no mention of a training set or machine learning.

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