(30 days)
ADAS 3D is indicated for use in clinical settings to support the visualization and analysis of MR and CT images of the heart for use on individual patients with cardiovascular disease.
ADAS 3D is indicated for patients with myocardial scar produced by ischemic heart disease. ADAS 3D processes MR and CT images. The quality and the resolution of the medical images determines the accuracy of the data produced by ADAS 3D.
ADAS 3D is indicated to be used only by qualified medical professionals (cardiologists, radiologists, radiologists, or trained technicians) for the calculation quantification of cardiac images and intended to be used for pre-planning and during electrophysiology procedures. The data produced by ADAS 3D must not be used as an irrefutable basis or a source of medical advice for clinical diagnosis or patient treatment. The data produced by ADAS 3D is intended to be used to support qualified medical professionals for clinical decision making.
The clinical significance of using ADAS 3D to identify arrhythmia substrates for the treatment of cardiac arrhythmias (e.g., ventricular tachycardia) or risk stratification has not been established.
ADAS 3D is a stand-alone software tool designed for post-processing cardiovascular enhanced Magnetic Resonance (MR) images and Computed Tomography Angiography (CTA) images that are formatted in the Digital Imaging and Communication in Medicine (DICOM) standard. ADAS 3D software aids in the non-invasive calculation, quantification and visualization of cardiac imaging data to support a comprehensive diagnostic decisionmaking process for understanding cardiovascular disease.
ADAS 3D exports information to multiple industry standard file formats suitable for documentation and information sharing purposes. The 3D data is exported into industry standard file formats supported by catheter navigation systems.
ADAS 3D analyses the enhancement of myocardial fibrosis from DICOM MR images to support:
- Visualization of the distribution of the enhancement in a three-dimensional (3D) chamber of the heart.
- Quantification of the total volume of the enhancement within the Left Ventricle (LV) and the visualization of the enhancement area in multiple layers through the cardiac structure.
- Calculation, quantification and visualization of corridors of intermediate, signal intensity enhancement in the LV.
- Quantification and visualization of the total area and distribution of the enhancement within the left Atrium (LA).
Additionally, ADAS 3D imports DICOM CTA images to support:
- Quantification of LV wall thickness.
- Identification and Visualization of other 3D anatomical structures.
- Quantification and visualization of LA wall thickness.
- Quantification and visualization of distances from the LA epicardium to other 3D anatomical structures.
It is designed to be used by qualified medical professionals (cardiologists, radiologists or trained technicians) experienced in examining and evaluating cardiovascular MR and CTA images as part of the comprehensive diagnostic decision-making process.
Here's an analysis of the acceptance criteria and study information for the ADAS 3D device based on the provided text:
Important Note: The provided document is a 510(k) summary for a modified device, ADAS 3D, that adds two new functional features compared to a predicate device (K210850). The summary primarily focuses on demonstrating substantial equivalence of the new features and therefore might not contain all the detailed clinical study information typically found for an initial device clearance.
Description of Acceptance Criteria and Study Proving Device Meets Them
The document describes the modified ADAS 3D device as a software tool for post-processing cardiovascular MR and CTA images to aid in diagnosis and pre-planning for electrophysiology procedures. The two new features are:
- Quantification and visualization of LA wall thickness.
- Quantification and visualization of distances from the LA epicardium to other 3D anatomical structures.
The device's acceptance criteria, for these new features, are centered around the validation of the software's ability to accurately measure and visualize these anatomical parameters.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Software fully satisfies system requirements for new features. | Assessed using synthetic phantoms to validate software. |
| Accurate quantification of Left Atrial (LA) wall thickness. | Successfully validated as per system requirements. |
| Accurate quantification of distances from LA epicardium to other 3D anatomical structures. | Successfully validated as per system requirements. |
| Safety and effectiveness of modified device demonstrated. | Implemented design control activities (design review, risk analyses, design verification/validation testing). |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "The two new features (Left Atrial wall thickness and Left Atrial distances measurements) were assessed using synthetic phantoms to validate that the software fully satisfies system requirements."
- Sample Size: Not explicitly stated, as "synthetic phantoms" usually implies a set of simulated data rather than a specific number of patient cases. The number of phantoms used is not provided.
- Data Provenance: Synthetic/simulated data. No specific country of origin is applicable as these are not real patient cases. This was a prospective simulation/validation study of the software's performance on engineered data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document for the new features' validation. Since synthetic phantoms were used, the "ground truth" would likely be the known, precisely engineered dimensions within the phantoms themselves, rather than requiring expert consensus on clinical images.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method. This aligns with the use of synthetic phantoms where the ground truth is inherently known and does not require expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done for these new features, nor is any such study mentioned in the context of human readers improving with AI vs. without AI assistance for these specific functionalities. The validation focused on the software's technical accuracy using synthetic data.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, implicitly. The validation was conducted using "synthetic phantoms to validate that the software fully satisfies system requirements." This indicates a standalone assessment of the algorithm's performance in measuring the specified parameters without human-in-the-loop interaction for these specific validation steps.
7. The Type of Ground Truth Used
The ground truth for the validation of the new features was based on known, engineered measurements within synthetic phantoms.
8. The Sample Size for the Training Set
The document does not specify the sample size for the training set. This 510(k) summary is for a modification to an already cleared device (K210850) and focuses on the validation of new features, not the creation or re-training of the entire underlying model.
9. How the Ground Truth for the Training Set Was Established
The document does not provide details on how the ground truth for the training set was established. This information would likely have been part of the original K210850 submission for the predicate device. For the validation of the new features, the ground truth was inherent in the design of the synthetic phantoms.
§ 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).