(30 days)
Fusion Bx 2.0 is intended for use by physicians for enhanced visualization of ultrasound imaging of the prostate in clinic and hospital settings. It provides 2D and 3D image visualization including review, manipulation, and analysis tools. Additional features include patient data management, multiplanar reconstruction, 3D image registration, segmentation, image annotation, and to record the biopsies were acquired during the procedure.
This device will assist clinicians in planning and performing image-quided interventional procedures such as biopsies and placing instruments and markers in the device is intended for adult men with suspected prostate disorders such as cancer or other prostate problems.
The system will integrate into existing workflow by connecting to standard ultrasound equipment. This system will not prevent the clinician from using the standard ultrasound equipment.
Fusion Bx 2.0 is designed to display the 2D live video received from commercially available ultrasound machines and use this 2D video to reconstruct a 3D ultrasound image volume. The system is designed to work with clinicians' existing ultrasound machines, transrectal ultrasound (TRUS) probes, commercially available needles, needle quides/templates and needle qun combination. Additional software features include patient data management, multi-planar reconstruction, segmentation, image measurements and 3D image registration.
Fusion Bx 2.0 offers the physician additional 3D information for assessing prostate abnormalities, planning and implementing biopsy procedures. The additional image processing features are generated with minimal changes to previous TRUS probe-based procedures, and the physician always has access to the live 2D ultrasound image during prostate assessment or biopsy procedure.
The provided text does not contain a study that proves the device meets specific acceptance criteria with detailed performance metrics. Instead, it is a 510(k) summary for a medical device (Fusion Bx 2.0), which primarily focuses on demonstrating substantial equivalence to a predicate device.
The document states that "Verification and validation plans and reports are provided as a part of the submission to demonstrate substantial equivalence to the predicate device," but it does not include the details of these plans, reports, or the specific performance data gathered. It only lists the standards the device complies with.
Therefore, most of the requested information cannot be extracted from this document, specifically items 1, 2, 3, 4, 5, 6, 7, 8, and 9 as they pertain to specific study results and details.
However, based on the provided text, here's what can be inferred or stated:
- Acceptance Criteria and Reported Device Performance: This information is not provided in a table or discussed in detail. The document states that "Testing and Performance Data" and "Verification and validation plans and reports are provided as a part of the submission to demonstrate substantial equivalence to the predicate device," but the specific criteria and performance outcomes are not detailed in this summary.
- Sample Size for Test Set and Data Provenance: Not mentioned.
- Number of Experts and Qualifications: Not mentioned.
- Adjudication Method: Not mentioned.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned. The focus is on substantial equivalence to a predicate device, not on improvement with AI assistance.
- Standalone (algorithm only) performance study: Not mentioned. The device is a "Medical Image Processing Workstation System" intended for use by physicians for enhanced visualization, implying a human-in-the-loop system.
- Type of Ground Truth: Not mentioned.
- Sample Size for Training Set: Not mentioned.
- Ground Truth for Training Set: Not mentioned.
The summary concludes that "The results of comparing the intended use, function, technological characteristics, mode of operation and specifications of Fusion Bx 2.0 with those of the predicate device demonstrate that Fusion Bx 2.0 is substantially equivalent to the predicate device." This implies that the acceptance criteria for regulatory clearance are primarily based on demonstrating equivalence, as opposed to achieving specific performance thresholds in a clinical study.
§ 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).