(84 days)
ShowCase is diagnostic quality radiological viewing software. ShowCase can be used to receive, store, display and manipulate medical images and associated clinical data. This device is not intended for diagnosis of lossy compressed images.
ShowCase is diagnostic quality radiological viewing software. ShowCase can be used to receive, store, display and manipulate medical images and associated clinical data. This device is not intended for diagnosis of lossy compressed images.
The provided text is a 510(k) summary for the Trillium Technology, Inc. ShowCase soft-copy reading system. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study against specific acceptance criteria for a novel algorithm.
Therefore, many of the requested sections (acceptance criteria, reported performance, sample sizes, ground truth establishment, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) are not applicable or not explicitly detailed in this type of submission.
The 510(k) summary for the ShowCase device emphasizes its functional equivalence to existing PACS and ultrasound workstations. The validation described is primarily related to software development and general safety, rather than a clinical performance study with statistical endpoints.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly defined in terms of quantitative performance metrics for a specific algorithm. The substantial equivalence claim is based on the device's ability to perform functions similar to predicate devices (eFilm Workstation, syngo Ultrasound Workplace, and Volcano s5i for a specific feature) and its adherence to software development and safety protocols.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence: | |
| - Receive, store, display, and manipulate medical images and associated clinical data. | ShowCase performs these functions, similar to predicate devices. |
| - DICOM compliance. | ShowCase is DICOM compliant. |
| - Image and structured report viewing. | ShowCase includes these functions. |
| - Imaging measurements and manipulation tools. | ShowCase includes these tools. |
| - Stress echo displays (for ultrasound). | ShowCase includes stress echo displays. |
| - Doppler measurement tools (for ultrasound). | ShowCase includes Doppler measurement tools. |
| - In-line Digital Display (ILD) for intravascular ultrasound pullback. | ShowCase provides ILD image playback. |
| Safety and Effectiveness: | |
| - Labeling with instructions, cautions, and warnings. | ShowCase labeling contains these. |
| - Use of "off the shelf" computer components. | Hardware components are "off the shelf". |
| - No direct patient contact or control of life-sustaining devices. | Confirmed, leading to a "minor" Level of Concern. |
| - Software designed, developed, tested, and validated according to written procedures. | Certification provided. |
| - Diagnostic quality images and associated information. | Claimed by the manufacturer. |
2. Sample size used for the test set and the data provenance
Not applicable in the context of a clinical performance study for an AI algorithm.
The "testing" mentioned refers to software verification and validation, not a clinical test set with specific image data.
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 by experts for a test set is described.
4. Adjudication method for the test set
Not applicable. No clinical test set requiring adjudication is described.
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
Not applicable. ShowCase is a viewing system, not an AI-assisted diagnostic tool as understood in the context of MRMC studies for AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. ShowCase is a software system for human interpretation, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The validation described is for software functionality and safety, not for diagnostic accuracy against a clinical ground truth.
8. The sample size for the training set
Not applicable. There is no mention of a machine learning or AI algorithm being "trained" in this submission. The "training set" concept is irrelevant to a soft-copy reading system.
9. How the ground truth for the training set was established
Not applicable. As above, no training set or associated ground truth establishment is mentioned.
Summary of Device and Evidence:
The Trillium Technology ShowCase is a diagnostic quality radiological viewing software (PACS). Its 510(k) submission demonstrates substantial equivalence to predicate devices (eFilm Workstation, syngo Ultrasound Workplace, and the Volcano s5i for its ILD feature) primarily through functional comparison and adherence to software development and quality control processes. The "validation and effectiveness" section describes internal testing by programmers, non-programmers, and potential customers to ensure the software functions as intended and provides diagnostic quality images. This is a typical approach for software-only medical devices that are tools for clinicians, rather than algorithms performing independent diagnoses. The submission does not include a clinical performance study against specific diagnostic acceptance criteria, as it is not presenting a new diagnostic algorithm but rather a viewing system.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).