(131 days)
The PROcedure Rehearsal Studio software is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner to an output file. It is also intended as pre-operative software for simulating/evaluating surgical treatment options.
The Simbionix PROcedure Rehearsal Studio software allows clinicians to create a patient specific 3D anatomical model based on a patient's CT for the purpose of simulating, analyzing and evaluating for preoperative surgical treatment options. Once the 3D segmentation model has been exported to the Simbionix ANGIO Mentor Simulator Practice Environment, the physician can use it to create a library of modules for training and post operative debriefing. The modifications subject to this Special 510(k) submission are: (1) Graphic User Interface changes in various locations; (2) functional change in various locations which include the addition of an EVAR module that allows the software to create 3D models of abdominal scans in addition to the carotid option that was previously cleared.
The provided text is a 510(k) summary for the PROcedure Rehearsal Studio, a software device. The submission focuses on modifications to a previously cleared device (K093269).
Analysis of the Provided Text regarding Acceptance Criteria and Study:
The document explicitly states: "The company has performed extensive verification and validation activities to ensure the device performs according to its specifications." However, it does not provide any specific acceptance criteria or details about the studies performed (e.g., performance metrics, statistical analyses, sample sizes, ground truth establishment, expert qualifications, etc.) that would prove the device meets said criteria.
The 510(k) summary for this device focuses on demonstrating substantial equivalence to a predicate device based on modifications to GUI and the addition of an EVAR module. The "Performance Data" section merely states that "extensive verification and validation activities" were performed, but does not elaborate on what these activities entailed in terms of clinical or technical performance studies, or what their outcomes were.
Therefore, I cannot populate the requested table and answer the specific questions about the study from the provided text. The document is too high-level in its description of performance data.
Missing Information:
- Specific Acceptance Criteria: The document does not list any quantitative or qualitative acceptance criteria for the device's performance (e.g., accuracy, precision, sensitivity, specificity for segmentation, or simulation fidelity).
- Reported Device Performance: No actual performance results are reported against any criteria.
- Sample Size for Test Set and Data Provenance: No information is given about the size or characteristics of any test datasets.
- Number of Experts and Qualifications for Ground Truth: No mention of experts or how ground truth was established for testing.
- Adjudication Method: No adjudication method is described.
- MRMC Comparative Effectiveness Study: No mention of such a study.
- Standalone Performance: While the device is a software tool, no specific standalone performance metrics (e.g., segmentation accuracy) are presented.
- Type of Ground Truth: The method for establishing ground truth for any testing is not specified.
- Sample Size for Training Set: The document does not mention any training sets, which would typically be relevant for machine learning-based devices. This device is described as an "image segmentation system," which could potentially use AI/ML, but no details are provided.
- How Ground Truth for Training Set was Established: Not applicable as training set details are missing.
Conclusion:
Based solely on the provided text, it is not possible to construct the requested table or answer the detailed questions about acceptance criteria and the study that proves the device meets them. The document is a regulatory summary focused on substantial equivalence rather than a detailed performance report.
§ 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).