(51 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 then performs a registration of the initial CT scan, containing the identified target, with the final CECT scan containing the segmented ablation zone. The physician also has the option to evaluate the effect of potential tissue contraction to help 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 provided text describes the NeuWave Medical, Inc. Ablation Confirmation™ system and its 510(k) submission (K161285). However, it contains very limited direct information on acceptance criteria and the detailed study that proves the device meets specific acceptance criteria. The document states that "The system passed all pre-determined acceptance criteria identified in the test plan" and "Verification and validation testing were completed in accordance with the company's Design Control process in compliance with 21 CFR Part 820.30, which included testing that fulfills the requirements of FDA "Guidance on Software Contained in Medical Devices"". It does not provide the specifics of these acceptance criteria or the study details.
Below is a summary of the information that is available in the provided text, and explicit statements about what information is not available.
1. Table of Acceptance Criteria and Reported Device Performance
Not available directly in the provided text. The document states that "The system passed all pre-determined acceptance criteria identified in the test plan," but it does not list these criteria or report specific performance metrics against them.
2. Sample Size Used for the Test Set and Data Provenance
Not available in the provided text. The document does not specify the sample size for the test set or the provenance of the data (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not available in the provided text. The document does not mention the number of experts or their qualifications used to establish ground truth for any test set.
4. Adjudication Method for the Test Set
Not available in the provided text. The document does not describe any adjudication method used for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not available in the provided text. The document does not mention an MRMC comparative effectiveness study or any effect size of human readers improving with AI vs. without AI assistance. The device assists physicians, but no comparative study is described.
6. Standalone (Algorithm Only) Performance
Partially available, but not with specific performance metrics. The document implies that the software performs several functions (segmentation, identification of probes, registration) semi-automatically or automatically. However, it does not provide standalone performance metrics (e.g., accuracy, sensitivity, specificity) for these functions. It states that "AC uses segmentation algorithms to construct a 2-D visualization" and "AC can process the image and identify up to three ablation probes."
7. Type of Ground Truth Used
Not explicitly stated for performance evaluation. For segmentation purposes, the text states that "The physician can accept the initial segmentation results or use AC tools to manually adjust the defined target lesion," implying that physician judgment (expert input) forms the ultimate "ground truth" for the intended use of identifying and adjusting target/ablation zones. However, for formal performance evaluation against acceptance criteria, the specific type of ground truth (e.g., pathology, outcomes data, consensus) is not detailed.
8. Sample Size for the Training Set
Not available in the provided text. The document does not mention any training set or its size.
9. How the Ground Truth for the Training Set Was Established
Not available in the provided text. Given that the document does not mention a training set, the method for establishing its ground truth is also not provided.
Summary of what can be gleaned from the text regarding performance and validation:
The document indicates that:
- Ablation Confirmation™ "passed all pre-determined acceptance criteria identified in the test plan."
- "Verification and validation testing were completed in accordance with the company's Design Control process in compliance with 21 CFR Part 820.30, which included testing that fulfills the requirements of FDA "Guidance on Software Contained in Medical Devices"."
- "Potential risks arising from the addition of the Tissue Contraction feature were analyzed and satisfactorily mitigated in the device design and labeling."
However, the specific details of these acceptance criteria, the performance metrics achieved, and the methodologies for the underlying studies (e.g., test set size, expert involvement, ground truth establishment) are not included in the provided 510(k) summary letter.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.