(41 days)
Quantib Prostate is image post-processing software that provides the user with processing, visualization, and editing of prostate MRI images. The software facilitates the analysis and study review of MR data sets and provides additional mathematical and/or statistical analysis can be displayed in a variety of formats, including images overlaid onto source MRI images.
Quantib Prostate functionality includes registered multiparametric-MRI viewing, with the option to view images combined into a single image to support visualization. The software can be used for semi-automatic segmentation of anatomical structures and provides volume computations, together with tools for manual editing. PI-RADS scoring is possible using a structured workflow.
Quantib Prostate is intended to be used by trained medical provides information that, in a clinical setting, may assist in the interpretation of prostate MR studies. Diagnosis should not be made solely based on the analysis performed using Quantib Prostate.
Quantib Prostate is an extension to the Quantib Al Node software platform and enables analysis of prostate MRI scans. Quantib Prostate makes use of Quantib Al Node functionality, and includes the following specific Quantib Prostate modules:
- An automatic processing module that performs prostate segmentation and multiparametric MRI image registration.
- A user-interaction module in which the user can edit and approve the computed prostate segmentation and determine PSA density.
- . A user-interaction module in which the user can view multi-parametric MRI images, and segment and analyze potential lesions. This extension will also apply a mathematical operation on the input images to combine information from the MRI sequences into a single combination image.
- . An automatic processing module that collects all results for exporting and transferring back to the user.
The provided text describes the Quantib Prostate device and its substantial equivalence to a predicate device (DynaCAD). However, it does not contain the specific details required to fully address all points of your request regarding acceptance criteria and the study that proves the device meets those criteria.
Here's an analysis of what is available and what is missing:
1. A table of acceptance criteria and the reported device performance
The document states: "The testing results support that all the system requirements have met their pre-defined acceptance criteria." and "Bench testing did not reveal any issues with the system, demonstrating that the performance of Quantib Prostate is as safe and effective as its predicate devices."
And for clinical performance: "It was concluded that a trained medical professional using Quantib Prostate performs better or equal in prostate segmentation than without use of Quantib Prostate."
However, the document does NOT provide a table detailing specific numerical acceptance criteria (e.g., minimum accuracy, sensitivity, specificity, or volumetric error thresholds) or the reported numerical performance metrics from either the non-clinical or clinical studies.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test set sample size: Not specified.
- Data provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not specified. The document mentions "correction by trained clinicians" for the prostate segmentation algorithm in a clinical use context for non-clinical testing, and "trained medical professional" for clinical testing, but no details on their number or qualifications for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not specified.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document mentions: "comparing the performance of a clinician using Quantib Prostate to segment a prostate with a clinician not using Quantib Prostate is a reasonable way to prove safety and effectiveness of the semi-automatic segmentation algorithm." And later: "It was concluded that a trained medical professional using Quantib Prostate performs better or equal in prostate segmentation than without use of Quantib Prostate."
This strongly suggests a comparative study was performed. However:
- The exact design (MRMC vs. other comparative study) is not explicitly stated.
- The effect size of improvement (e.g., specific metrics like Dice coefficient improvement, time saved, or diagnostic accuracy change) is NOT provided. The statement "better or equal" is qualitative.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, for non-clinical performance, it states: "This included characterization of the stand-alone performance of the prostate segmentation algorithm."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not explicitly stated. It refers to "correction by trained clinicians" when discussing the non-clinical performance of the prostate segmentation algorithm, which implies expert consensus or expert-corrected segmentations were used as ground truth for evaluating the algorithm's standalone performance within a clinical context.
8. The sample size for the training set
Not specified.
9. How the ground truth for the training set was established
Not specified. (Likely similar to the test set ground truth, but not confirmed).
Summary of Available vs. Missing Information:
| Information Requested | Available in Document? | Details |
|---|---|---|
| 1. Acceptance Criteria & Reported Performance Table | No | The document states acceptance criteria were met and performance is "better or equal" to unassisted, but no specific numerical criteria or reported metrics are provided. |
| 2. Test Set Sample Size & Data Provenance | No | Not specified. |
| 3. Number & Qualifications of Experts for Test Set Ground Truth | No | Mentions "trained clinicians" and "trained medical professional" but no specifics on number or qualifications for ground truth creation. |
| 4. Adjudication Method for Test Set | No | Not specified. |
| 5. MRMC Comparative Effectiveness Study & Effect Size | Partially - Study hinted, but no effect size | A comparative study was likely done ("clinician using Quantib Prostate... with a clinician not using"), but the specific study design (MRMC) is not confirmed, and no effect size quantification is provided beyond "better or equal." |
| 6. Standalone (Algorithm Only) Performance Study | Yes | "characterization of the stand-alone performance of the prostate segmentation algorithm." |
| 7. Type of Ground Truth (Test Set) | Implicit (Expert-corrected/Consensus) | For the prostate segmentation algorithm, "correction by trained clinicians" is mentioned for non-clinical testing, implying expert-edited or expert consensus segmentations served as ground truth. |
| 8. Training Set Sample Size | No | Not specified. |
| 9. Ground Truth Establishment for Training Set | No | Not specified. |
§ 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).