(127 days)
LVivo platform is intended for non-invasive processing of ultrasound images to detect, measure, and calculate relevant medical parameters of structures and function of patients with suspected disease. In addition, it has the ability to provide Quality Score feedback.
The LVivio IQS is an extension to the LVivio Software Application (K210053), as an additional Algorithm with API that will be able to provide a Quality Score in real time to the Left Ventricle from the 4 chamber apical view of the heart. In addition, the LVivo IQS will be provided as a software component to be integrated by another computer programmer into their legally marketed ultrasound imaging device. Essentially, the Algorithm and API, which is a module, will be a medical device accessory. The QIS Meter concept is similar to the legally marketed Caption Guidance Software Device.
Acceptance Criteria and Device Performance for LVivo IQS
The LVivo IQS device was evaluated through two performance studies. Below is a summary of the acceptance criteria and the reported device performance, along with details of the studies.
1. Table of Acceptance Criteria and Reported Device Performance
| Study | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Retrospective Study (Agreement with Experienced Sonographer) | Overall agreement of 75% between LVivo IQS results and quality tagging by experienced sonographers | Overall agreement between LVivo IQS and quality tagging by experienced sonographers was 81% |
| Prospective Study (POC Interns & Expert Echocardiologist) | a. 80% of saved Exams with image quality 3-5 (visual estimation) receive at least "Medium" image quality by LVivo IQS | a. In 90% of patients with image quality 3-5 (visual estimation), it was possible to obtain at least "Medium" quality score by LVivo IQS |
| b. 90% of these cases are clinically interpretable by expert echocardiologists | b. 93% of the above saved clips were clinically interpretable |
2. Sample Size and Data Provenance
Retrospective Study (Agreement with Experienced Sonographer):
- Sample Size (Test Set): 100 patient examinations (22,663 frames)
- Data Provenance: Data was "already acquired with different ultrasound devices and various cardiac pathologies." The document does not specify the country of origin.
- Retrospective/Prospective: Retrospective.
Prospective Study (POC Interns & Expert Echocardiologist):
- Sample Size (Test Set): 64 patients
- Data Provenance: Data acquired after using the LVivo IQS in real-time by POC interns in a POC environment. The document does not specify the country of origin.
- Retrospective/Prospective: Prospective.
3. Number of Experts and their Qualifications (Ground Truth for Test Set)
Retrospective Study:
- Number of Experts: Not explicitly stated, but refers to "experienced sonographer" (singular or plural not clear from the text, but implies a consensus or single expert for tagging each case).
- Qualifications: "experienced sonographer." No further details on years of experience or certification are provided.
Prospective Study:
- Number of Experts: At least one "expert echocardiologist."
- Qualifications: "expert echocardiologist." No further details on years of experience or certification are provided.
4. Adjudication Method for the Test Set
The document does not explicitly describe a formal adjudication method (like 2+1 or 3+1) for either study.
- Retrospective Study: Implies a direct comparison of LVivo IQS results against "quality tagging by experienced sonographer," suggesting a single "expert" assessment served as the ground truth without further multi-reader adjudication.
- Prospective Study: The "clinical interpretability" was determined by an "expert echocardiologist," again suggesting single expert assessment rather than a multi-reader adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned or performed according to the provided text. The studies focus on the performance of the LVivo IQS directly against expert assessment or clinical interpretability.
6. Standalone (Algorithm Only) Performance
Yes, standalone performance was done. The studies explicitly evaluate the LVivo IQS system's performance.
- The Retrospective Study directly compares the algorithm's output ("LVivo IQS results") with expert quality tagging.
- The Prospective Study assesses the "quality score by LVivo IQS" and the subsequent "clinical interpretability" of clips identified by the system as having sufficient quality.
7. Type of Ground Truth Used
- Retrospective Study: Expert Consensus/Tagging. The ground truth was established by "quality tagging by experienced sonographer(s)."
- Prospective Study: Expert Clinical Interpretability. The ground truth for clinical utility was established by "expert echocardiologist" interpreting the saved clips. Initial quality (3-5) was based on visual estimation, presumably by POC interns.
8. Sample Size for the Training Set
The document does not report the sample size for the training set. It only describes the validation/test sets for performance evaluation.
9. How the Ground Truth for the Training Set was Established
Given that the sample size for the training set is not reported, the method for establishing ground truth for the training set is also not described in the provided text.
§ 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).