(21 days)
DynaCAD is a MR image analysis software medical device used during clinical diagnosis, reporting, and interventional pre-planning and is intended to assist the physician through a series of sequential tasks. DynaCAD consists of: • MR Analysis Server post-processing software application facilitates the analysis of dynamic MR datasets to provide study review, lesion characterization, and additional mathematical and/or statistical analysis. · Viewer application facilitates the analysis and presentation of datasets generated by the MR Analysis Server. · Interventional Planning image-guidance application for diagnostic and interventional procedure planning for biopsy and/ or soft tissue ablation. DynaCAD is indicated for medical conditions that require interventional and/or diagnostic procedures of the prostate gland or breast tissue.
DynaCAD is a MR image analysis software only medical device used during clinical diagnosis, reporting, and interventional pre-planning and is intended to assist the physician through a series of sequential tasks. DynaCAD consists of: - . MR Analysis Server post-processing software application, which facilitates the analysis of dynamic and non-dynamic MR datasets to provide study review, lesion characterization, and additional mathematical and/or statistical analysis. It includes the following software modules: DynaCAD Breast, DynaCAD Prostate, DynaLOC Breast, DynaLOC Prostate, and PK MRI Analysis. - . Viewer application, which facilitates the analysis and presentation of datasets generated by the MR Analysis Server. It includes the following functions: Region of Interest (ROI) curve, Pixel of Interest (POI) curve, Report Card, Volume Calculation, Statistical Analysis, 3-D visualization of image series, and DICOM reporting, among other capabilities. - Interventional Planning image-guidance application, i.e. Ablation Planning, which facilitates diagnostic and interventional procedure planning for biopsy and/or soft tissue ablation. It helps the user to prepare for ablation procedures by presenting the target regions along with critical structures identified in MR, and previously acquired biopsy data. It provides information about the ablation devices and applicators for automatic ablation plan computation, which the user can adjust as necessary. DynaCAD is used in both the radiology, i.e. DynaCAD Radiology, and urology domain, i.e. DynaCAD Urology.
The provided text does not contain information about the acceptance criteria or a study that proves the device meets specific performance criteria. It is a 510(k) summary for DynaCAD, a medical image analysis software, asserting its substantial equivalence to a predicate device.
The document focuses on:
- Description of the Device: DynaCAD, its components (MR Analysis Server, Viewer application, Interventional Planning application), and its use in radiology and urology for breast and prostate tissue.
- Intended Use/Indications for Use: Confirms similarity to the predicate device, emphasizing assistance to physicians for diagnosis, reporting, and interventional pre-planning.
- Technological Characteristics: Details the similarities and minor differences (e.g., urology workflow, ablation planning) between the subject and predicate devices, stating that these differences do not raise new safety or effectiveness questions.
- Non-Clinical Performance Data: Mentions compliance with international and FDA-recognized consensus standards (IEC 62304, IEC 62366-1, ISO 14971, ISO 15223-1, NEMA PS 3.1-3.20 DICOM). It states that software verification and validation testing (including usability and in-house simulated use) were performed, and all tests "passed." These tests demonstrated that DynaCAD meets "acceptance criteria of the device requirements" and is adequate for its intended use.
- Clinical Performance Data: Explicitly states, "The subject DynaCAD did not require clinical performance data to demonstrate safe and effective use."
Therefore, I cannot provide the requested information regarding acceptance criteria and performance study details because they are not present in the provided text. The text asserts that non-clinical tests were performed and that "all executed verification test passed" and "all executed validation protocols were passed," indicating the device "Meets the acceptance criteria of the device requirements," but it does not list what those specific acceptance criteria are or the quantitative results of those tests.
The document makes a claim of substantial equivalence based on the device's technological characteristics and non-clinical performance (software verification and validation), rather than a comparative effectiveness study with human readers or a standalone performance study with specific metrics.
§ 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).