(167 days)
echoPlaque is a software product intended to be used to review, analyze, and measure intravascular ultrasound (IVUS) images. echoPlaque is intended to help qualified medical professionals examine intravascular ultrasound (IVUS) images and make measurements to quantify vessel and stent dimensions. These features aid in post-procedure analysis regarding the placement of interventional devices.
echoPlaque is a software product intended to be used to visualize, analyze, and save DICOM and IMG/BMG (INDEC proprietary format) Intravascular Ultrasound (IVUS) images. echoPlaque is intended to allow qualified medical professionals to view, measure, and save new IVUS images. Images can be loaded into the echoPlaque software via removable media (CD/DVD) or hard disk or new images can be acquired from an analog or digital video signal. echoPlaque supports linear, area, and volumetric measurements. Measurements can be exported and images can be saved using echoPlaque. Images can be saved in either a compressed or uncompressed format. These features aid in post-procedure analysis regarding the placement of interventional devices.
echoPlaque is a software product that provides capabilities for loading, acquiring, viewing, analyzing and saving vendor-neutral, multi-frame DICOM data from Intravascular Ultrasound (IVUS) studies, INDEC echoPlaque IMG/BMG IVUS files, and medical datasets saved as Microsoft Video 1 codec compressed AVI files. echoPlaque's main functionality includes viewing and playback of medical images and ancillary files, acquiring new images from analog and digital signals, image analysis including 2D and volumetric measurements, and the ability to resave multi-frame images in either a compressed or uncompressed format for future visualization and analysis.
The provided text does not contain detailed information about specific acceptance criteria and the study that proves the device meets these criteria. The document is a 510(k) summary and FDA clearance letter, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a comprehensive study report with performance metrics.
However, based on the general information provided, I can infer some aspects and note what is missing:
Here's a breakdown of the requested information, indicating what is present and what is not:
Acceptance Criteria and Device Performance Study Information
The provided 510(k) summary and FDA letter do not contain explicit acceptance criteria (e.g., specific accuracy or precision thresholds) or a detailed study report that proves the device meets such criteria. The document focuses on demonstrating substantial equivalence to predicate devices, which often involves showing that the new device performs as well as, or comparably to, the predicate, rather than presenting novel performance metrics against pre-defined acceptance criteria.
Therefore, many of the requested fields cannot be populated from the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| *Not specified in | |
| the document.* | *Not specified in |
| the document.* |
Explanation: The document states that "echoPlaque is substantially equivalent in intended use, design, and operation characteristics to the following currently marketed devices: QIVA Intra Vascular Ultrasound Analysis software (K021495) and Medis Medical Imaging Systems B.V. QCU-CMS Analytical Software Package (K011582)." This indicates that the device's performance is implicitly accepted if it is comparable to these predicate devices, but no quantitative performance metrics or specific acceptance thresholds are provided for echoPlaque itself.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the document.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified 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 specified in the document.
- Qualifications of Experts: Not specified in the document.
4. Adjudication method for the test set
- Adjudication Method: Not specified in the document.
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 specified in the document. The device is described as "Intra Vascular Analysis Software" and "intended to help qualified medical professionals examine intravascular ultrasound (IVUS) images and make measurements." This suggests it's a tool for professionals, but there's no mention of a study evaluating reader improvement with or without AI assistance.
- Effect Size of Human Readers' Improvement: Not specified in the document.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
- Standalone Performance Study: Not specified in the document. The device is described as a software product "intended to help qualified medical professionals," implying human-in-the-loop operation. No standalone performance is detailed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not specified in the document.
8. The sample size for the training set
- Sample Size for Training Set: Not specified in the document.
9. How the ground truth for the training set was established
- Method for Establishing Training Set Ground Truth: Not specified in the document.
§ 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).