(118 days)
DynaCAD/Prostate Interventional is a computer-based image-guidance accessory for use with commercially available Magnetic Resonance (MR) imaging systems and interventional devices.
The application provides the user with patient data processing, visualization and storage functions. It allows image analysis, display and recording of simulated images of a tracked insertion tool, such as a needle guide or sleeve, on a computer monitor or other display that shows images of the target organs and the current and/or projected path of the interventional instrument.
The device is intended to be used by physicians in a clinical setting for treatment planning and guidance for clinical, interventional and/or diagnostic procedures of the prostate.
DynaCAD/Prostate Interventional (a.k.a. Dynal.OC/Prostate) is medical device software that is intended to be loaded onto a commercially available computer workstation. The DynaLOC/Prostate software application is designed for use with the DynaTRIM positioning device. The software receives DICOM images from a pre-procedure magnetic resonance (MR) study and performs calculations to assist the clinician with adjustments to the DynaTRIM positioning device. The software does not directly control the Dynall'RIM device, the interventional accessories or the MR scanner. The users must manually adjust the DynaTRIM device and confirm proper positioning of the interventional accessories via an MR verification scan. Additionally, the users must manually control the MRI scanner to obtain the correct MR data sets.
The provided text describes the DynaCAD/Prostate Interventional software, but it does not contain the specific details required to complete all sections of your request regarding acceptance criteria and a detailed study proving performance. The document focuses on the substantial equivalence discussion to predicate devices.
However, based on the limited information available, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "The safety and effectiveness of the DynaCAD/Interventional software (a.k.a. DynaLOC/Prostate) for the proposed indications for use is supported by preclinical software verification and validation testing. This includes validation of the software with the DynaTRIM device is a simulated clinical use setting."
This indicates that acceptance criteria and performance were assessed during software verification and validation testing, but the specific metrics (e.g., accuracy, precision, sensitivity, specificity, user task completion rates, time savings) and their corresponding performance values are not provided in the given text. Thus, a detailed table cannot be created.
| Acceptance Criteria (Inferred) | Reported Device Performance (Not Specified) |
|---|---|
| Software functionality meets specifications | Not detailed in the provided text |
| Software runs without critical errors | Not detailed in the provided text |
| Calculations for device adjustments are accurate | Not detailed in the provided text |
| Visualization of tracked insertion tool is accurate | Not detailed in the provided text |
| Meets safety and effectiveness requirements | "Safe and effective when used with the DynaTRIM device for prostate interventional procedures." (No specific metrics) |
| Clinical use in simulated setting is effective | Confirmed in "simulated clinical use setting" (No specific metrics) |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "validation of the software with the DynaTRIM device is a simulated clinical use setting." However, it does not specify the sample size for this test set (e.g., number of cases, number of simulated procedures).
The data provenance is also not specified (e.g., no mention of country of origin, or whether the data was retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth and Their Qualifications:
The document does not mention the use of experts to establish a ground truth for a test set, nor does it specify their number or qualifications. The validation appears to be software-centric and in a simulated environment, suggesting ground truth might have been established through engineering specifications or simulated scenarios rather than expert interpretations of clinical data.
4. Adjudication Method for the Test Set:
Given that expert involvement for ground truth is not mentioned, an adjudication method is not applicable or described in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was performed. There is no mention of human readers improving with or without AI assistance, as the device is an "image-guidance accessory" and not an AI diagnostic tool in the sense of automating interpretation.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop):
The document primarily describes the software as an "image-guidance accessory" that "assists the clinician with adjustments" and provides "patient data processing, visualization and storage functions." The clinicians "must manually adjust the DynaTRIM device and confirm proper positioning." This strongly implies that the device is designed for human-in-the-loop use and does not provide information on a standalone performance study (i.e., algorithm only without human-in-the-loop).
7. Type of Ground Truth Used:
The document states, "The safety and effectiveness... is supported by preclinical software verification and validation testing. This includes validation of the software with the DynaTRIM device is a simulated clinical use setting." This suggests the ground truth was likely based on engineering specifications, simulated accuracy targets, and functional correctness within the simulated environment, rather than expert consensus on clinical findings, pathology, or outcomes data from real patients.
8. Sample Size for the Training Set:
The document does not provide any information regarding a training set sample size. Given that the device performs calculations and visualization for assistance rather than complex pattern recognition or diagnostic assessment typical of machine learning, a "training set" in the conventional AI sense may not be applicable or explicitly used for this type of software.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a training set, there is no information on how its ground truth might have been established.
§ 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).