(51 days)
The Ebit Sanità Org@nizer software is a medical image management software device intended to be used for digital acquiring, viewing, processing, archiving, reporting and communicating ultrasound medical studies by qualified medical professionals, after proper installation on an appropriate hardware platform.
This medical device is intended for the sole use of digital acquiring, viewing, processing, archiving reporting and communicating digital ultrasound studies. It does not have any influence in the way the medical image is produced, nor it is intended to control ionizing emissions or monitor vital physiological processes. The medical device is able to manage stand-alone or distributed medical image archives. It specifically provides the following added-value:
®Connecting diagnostic modalities for the purpose of centralising the image archiving for later image viewing, processing and reporting;
@Establishing distributed points of access on conventional PCs for distributed image and report viewing and access.
The Ebit Sanità Org@nizer software is a medical Image Management software device used for digital acquisition, viewing, processing, archiving, reporting and communicating ultrasound studies.
The provided text is related to a 510(k) submission for the "Ebit Sanità Org@nizer Software." This document describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence. However, it does not contain any information regarding specific acceptance criteria, study data proving performance, sample sizes, expert involvement, adjudication methods, or ground truth establishment.
The document is a regulatory submission for premarket notification, designed to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This type of submission generally relies on comparing specifications and intended use rather than performing new clinical efficacy studies with specific performance metrics.
Therefore, I cannot fulfill your request for the detailed table and study information because the provided text does not contain this information.
Here's what I can extract based on the available text (though it won't address most of your questions):
- Device Name: Ebit Sanità Org@nizer Software
- Intended Use: For digital acquiring, viewing, processing, archiving, reporting, and communicating ultrasound medical studies by qualified medical professionals on an appropriate hardware platform. It connects diagnostic modalities for centralized image archiving and establishes distributed access points for viewing and reporting.
- Predicate Device: Applicare Radworks Medical Imaging Software with Quality Control Module (K982862)
- Regulatory Class: II (under 21 CFR 892.2050, Picture archiving and communications system, Product Code 90-LLZ)
Missing Information (and why it's missing from this type of document):
- Acceptance criteria and reported device performance: This document doesn't define quantitative acceptance criteria for image processing or display accuracy, as it's not a performance study. It establishes functional equivalence.
- Sample size, data provenance: Not applicable in this context; no performance study is detailed.
- Number of experts, qualifications, adjudication method: Not applicable; no ground truth establishment for a performance study.
- MRMC comparative effectiveness study: Not conducted or reported in this submission.
- Standalone performance study: Not conducted or reported in this submission. The "study" mentioned isn't a performance study of the algorithm/software, but rather a comparison for regulatory purposes.
- Type of ground truth used: Not applicable; no performance study is detailed.
- Training set sample size: The device is an image management software, not an AI/ML algorithm that requires a "training set" in the typical sense for medical image analysis.
- Ground truth for training set: Not applicable for the same reason as above.
In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence through a comparison of features and intended use with a predicate device, rather than providing data from a clinical performance study with specific acceptance criteria.
§ 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).