(150 days)
Ablation Confirmation™ (AC), is a Computed Tomography (CT) image processing software package available as an optional feature for use with the Certus® 140 2.45 GHz Ablation System. AC is controlled by the user via an independent user interface on a second monitor separate from the Certus 140 user interface. AC imports images from CT scanners and facility PACS systems for display and processing during ablation procedures. AC assists physicians in identifying ablation targets, assessing proper ablation probe placement and confirming ablation zones. The software is not intended for diagnosis.
AC is resident on the Certus® 140 system and is accessible to the physicians via a second, dedicated monitor with its own user interface separate from the ablation user interface. AC functions are controlled via a USB connected mouse. AC connects to a facility PACS system and CT scanner and receives and sends CT and MR images via the DICOM protocol.
AC contains a wide range of image processing tools, including:
- 2D image manipulation
- 3D image generation (from 2D images)
- 3D image manipulation
- Region of interest (ROI) identification, segmentation and measurement
- Automatic identification of ablation probes
- . Registration of multiple images into a single view
Prior to an ablation procedure, physicians can use AC to semi-automatically segment and visualize ablation target lesions in soft tissue including liver, lung and kidney. The physician initiates the segmentation with tools provided on the screen. AC then uses segmentation algorithms to construct a 2-D visualization of the target lesion selected. The physician can accept the initial segmentation results or use AC tools to manually adjust the defined target lesion. Once accepted, the identified target is rendered into a 3D image.
Upon the placement of ablation probes, taking and importing the CT scan, AC can process the image and identify up to three ablation probes. AC can then perform a registration of the initial CT scan, containing the identified target with the second scan containing the ablation probe(s) in place. The resulting image allows the physician to visualize the ablation probe(s) in relation to the identified target. This enables physicians to ensure proper probe(s) placement prior to starting the ablation. Following the ablation procedure and a post-procedure CT scan, AC allows the physician to semi-automatically segment and visualize the ablation zone using the same process as in the initial target segmentation. AC can then performs a registration of the initial CT scan, containing the identified target, with the final CECT scan containing the segmented ablation zone. The resulting image set includes the ablation zone overlaid onto the initial target lesion segmentation to help physicians determine the technical success (ablation zone covers target lesion with desired amount of margin) of the ablation procedure.
All AC processing and viewing is accomplished at the Certus® 140 Ablation System without the physician having to leave the procedure area to utilize separate image processing tools.
Additionally, AC allows for the images to be viewed by a remote physician for time-saving clinical consultation on the current procedure.
The acceptance criteria for the Ablation Confirmation™ device were based on the device successfully passing all pre-determined criteria identified in the test plan for its functions, including segmentation and registration accuracy. While the document states that these accuracies were demonstrated through adequate bench testing and clinical experience, it does not explicitly provide numerical acceptance criteria or reported performance metrics in a tabular format.
Here's a breakdown of the available information:
1. Acceptance Criteria and Reported Device Performance:
The document states: "Ablation Confirmation™ was tested in accordance with a test plan that fully evaluated all functions performed by the software. The system passed all pre-determined acceptance criteria identified in the test plan."
However, specific numerical acceptance criteria (e.g., minimum accuracy percentages, maximum error margins) and the corresponding reported device performance values are not explicitly provided in this document. The document generally states that "Segmentation and Registration accuracy were demonstrated through adequate bench testing and also through clinical experience of qualified users."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific numerical criteria are not detailed in this document. The overall criteria were that the device "passed all pre-determined acceptance criteria identified in the test plan" and showed "adequate bench testing and also through clinical experience of qualified users" for segmentation and registration accuracy. | Specific numerical performance metrics are not detailed in this document. The stated performance is that the device "passed" the predetermined criteria and demonstrated "adequate" accuracy. |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated.
- Data Provenance: "Testing was performed using retrospectively obtained CT image series from ablation procedures." The country of origin for the data is not specified.
3. Number of Experts and Qualifications:
- Number of Experts: Not explicitly stated. The document refers to "clinical experience of qualified users" but does not quantify the number of users or their specific roles.
- Qualifications: "Qualified users" are mentioned, but their specific qualifications (e.g., "radiologist with 10 years of experience") are not detailed.
4. Adjudication Method:
- The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for establishing the ground truth or evaluating the device's performance within the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it quantify any effect size of human readers improving with AI vs. without AI assistance. The device is described as assisting physicians, but a comparative study as described is not presented.
6. Standalone Performance:
- Yes, a standalone performance evaluation was conducted. The document states, "Ablation Confirmation™ was tested in accordance with a test plan that fully evaluated all functions performed by the software. The system passed all pre-determined acceptance criteria identified in the test plan." This implies an assessment of the algorithm's performance independent of human input, as its functions are described to "assist physicians" and "perform" certain tasks like segmentation and registration.
7. Type of Ground Truth Used:
- The ground truth appears to be based on expert interpretation and manual adjustments. For target lesions, the "physician initiates the segmentation with tools provided on the screen. AC then uses segmentation algorithms to construct a 2-D visualization of the target lesion selected. The physician can accept the initial segmentation results or use AC tools to manually adjust the defined target lesion." A similar process is described for the ablation zone. This suggests that the "true" segmentation or identification was ultimately confirmed and potentially modified by a qualified user. This combines algorithmic output with expert consensus/manual correction.
8. Sample Size for the Training Set:
- The document does not specify the sample size used for the training set.
9. How the Ground Truth for the Training Set Was Established:
- The document does not explicitly describe how the ground truth for the training set was established. It describes the process for how the device assists in segmentation during an actual procedure, which involves physician initiation and manual adjustment of the algorithmic output. While this provides insight into the intended use and validation approach, it doesn't detail the training data ground truth establishment.
§ 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).