(27 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.
The LVivo Seamless is a standalone application that extends the LVivo Platform and runs offline on a server in a healthcare environment. The system accepts echo examinations in DICOM format that are sent from an Ultrasound device and automatically selects the adequate clips for EF evaluation. After the clip selection, the LVivo Seamless activates the FDA cleared LVivo EF module which performs automatic evaluation. The results are sent to the PACS and are evaluated by a healthcare professional.
Here's an analysis of the provided text to extract the requested information about the device's acceptance criteria and the supporting study:
The provided document describes the LVivo Seamless device, a standalone application that extends the LVivo Platform for processing ultrasound images. The key function highlighted is the automatic selection of clips for EF (Ejection Fraction) evaluation and then applying the FDA-cleared LVivo EF module for automatic evaluation.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantitative, pass/fail format for the LVivo Seamless's performance relative to a specific metric. Instead, it relies on demonstrating substantial equivalence to a predicate device (K200232 LVivo Software Application). The performance evaluation is summarized as having "demonstrated conformity to intended use" based on "well-established test methods."
Therefore, I cannot populate a table with specific acceptance criteria and reported numerical performance for the LVivo Seamless itself. The performance is assessed by its similarity to the predicate and the general statement of conformity.
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "Performance Evaluation" based on "well-established test methods."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number or qualifications of experts used to establish the ground truth for the test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not specify any adjudication method used for the test set.
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
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size related to human reader improvement with or without AI assistance. The focus is on the device's standalone performance in relation to the predicate.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a standalone performance assessment was conducted for the LVivo Seamless. The description states: "The system accepts echo examinations in DICOM format that are sent from an Ultrasound device and automatically selects the adequate clips for EF evaluation. After the clip selection, the LVivo Seamless activates the FDA cleared LVivo EF module which performs automatic evaluation." This indicates the algorithm's performance without direct human intervention in the interpretation process. The results are then sent to PACS for evaluation by a healthcare professional, implying the initial automated steps are standalone.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the type of ground truth used. Given the context of "EF evaluation" and "automatic evaluation," it's highly probable that the ground truth for the underlying LVivo EF module (which the LVivo Seamless activates) would have been established through expert consensus by cardiologists or sonographers reviewing and measuring Ejection Fraction on the ultrasound images. However, this is an inference and not explicitly stated for the LVivo Seamless's specific performance evaluation.
8. The sample size for the training set
The document does not specify the sample size for the training set.
9. How the ground truth for the training set was established
The document does not specify how the ground truth for the training set was established.
Summary of what's provided for LVivo Seamless (K202546):
The submission focuses heavily on demonstrating substantial equivalence to its predicate device (K200232 LVivo Software Application) based on technological characteristics and intended use. The performance evaluation is broadly stated as confirming conformity to intended use via "well-established test methods," rather than providing detailed quantitative results against specific acceptance criteria. A standalone performance was evaluated for the automated steps of clip selection and EF calculation. Details regarding sample sizes, data provenance, expert involvement, ground truth establishment methods, or MRMC studies are not provided in this specific FDA clearance 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).