(252 days)
The BIT-Motion is a stand-alone image post processing software. The Bit-Motion is intended for use as a PACS device, which is interfaced to the clinics' LAN. It receives clinical studies from hospital modalities, processes functional volumetric data and generates parametric maps that display changes intensity. It also includes manual display manipulation, annotation and control tools, which assist professional users to evaluate the displayed maps and to transfer the results to the PACS, in DICOM format.
The BIT-Motion indications for use are receiving breast studies from MRI scanners and processing them to generate DTI (Diffusion Tensor Imaging) 2D and 3D parametric maps that display changes in the values of water diffusion coefficients and directions, as well as in indices defining diffusion anisotropy. The device-displayed DTI parametric maps are evaluated by the users. The device is indicated for use by trained radiologists and may provide information on breast water diffusion features. The BIT-Motion should not be used in isolation breast tissue features or for making patient management decisions.
The BIT-Motion is a software package that is aimed to process MRI images. The software runs on a PC server, which is connected to the Local Area Network (LAN). The device receives MRI datasets from MRI scanner over the network in DICOM format, processes the images and transfers the outcome images in DICOM format, to selected PCAS stations.
While the provided text describes the regulatory filing and general device information for BIT-Motion, it does not contain a detailed performance study section with specific acceptance criteria, study design, or results in the format requested. The "Performance Tests" section is very high-level and only states that software verification and validation occurred. There's no mention of a clinical study with human subjects, ground truth establishment, or specific metrics of device performance (like sensitivity, specificity, etc.) that would typically be associated with acceptance criteria and a study proving those criteria are met.
Therefore, I cannot fulfill the request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test set, data provenance, ground truth establishment details, adjudication methods, MRMC study details, standalone performance, or training set details.
The document indicates:
- Non-Clinical tests: Software verification and validation were performed according to 21CFR820.30(f) and (g) using a "predefined software test plan" and an "MRI dedicated phantom." The results "demonstrate that the device output meet the design input and the intended use." This is not a clinical study on human data, nor does it provide specific, quantifiable performance metrics.
- Risk Management: Device risks were managed and controlled following ISO 14971.
The core of the submission relies on the "Substantial Equivalence" argument to a predicate device (CADstream Version 4.0), emphasizing that differences in technological characteristics "do not raise new questions of safety or effectiveness." This implies that extensive comparative clinical performance data might not have been required if the new device's technology and intended use were deemed sufficiently similar to the predicate.
In summary, the provided document does not contain the information necessary to describe acceptance criteria and a study proving the device meets them as outlined in your request.
§ 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).