(174 days)
The NaviSuite SSI Edition is used to support a clinical ultra-sound session and follow percutaneous procedure by means of providing additional real-time image information from a 2nd modality like CT or MR or US or its combination with the possibility to plan the ideal treatment procedure. The second modality or their combinations are acquired and 3D is generated inside the software permitting the anatomical correlation with the patient position.
"The second modality image is not intended to be used as a standalone diagnostic image since it represents information of a patient that could not be congruent with the current (actual) patient position and shall therefore always been seen as an additional source of information."
"The 2nd modality image only should not be used for diagnostic purposes."
NaviSuite SSI Edition 0.9.10 is a medical product to support a clinical ultrasound session and follow percutaneous procedure by means of providing additional realtime image information from a 2nd modality like CT or MR or US or its combination with the possibility to plan the ideal treatment procedure. The second modality or their combinations are acquired and a 3D is generated inside the software permitting the anatomical correlation with the patient position.
By using the 2nd modality image the user gains security in assessing the morphology of the ultrasound image and obtains a virtual feed-back on the procedure provided by the virtual percutaneous tool position enabled by a dedicated receiver, its treatment region delineated by custom tables and a dedicated computation in 3D of the target region.
The 2nd modality image is not intended to be used as a standalone diagnostic image since it represents information of a patient probably not congruent with the current (real) patient situation and shall therefore always been seen as an additional source of information.
NaviSuite SSI Edition is a software designed for use together with an ultrasound device: AIXPLORER (K142100).
Here's a breakdown of the acceptance criteria and study information for the NaviSuite SSI Edition, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| System Accuracy (2nd Modality Image Display) | An "overlapping" accuracy of at least 5mm can be achieved between the ultrasound image and the 2nd modality image, under the presumption that the registration has been done with an overall error better than 5mm. This accuracy is highly dependent on the registration process and the patient's condition (e.g., breathing) compared to when the 2nd modality scan (e.g., CT) was acquired. |
| Needle Navigation Accuracy | The software projects the virtual needle position over the real-time US image. The system passed tests to confirm this function using a phantom. The software itself "cannot determine the accuracy of the treatment procedure," as the therapist/physician is responsible for verification. |
| Tracking Quality Detection | The system can detect low sensor tracking quality and indicate if tracking is distorted (e.g., by metallic objects). Tests for verifying tracking accuracy and "sensor in range status" were carried out. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for a test set in terms of patient data or specific image sets.
- Needle Navigation Test: A CIRS Abdominal Phantom was used for testing. This is a non-human, simulated anatomical model.
- Tracking Quality Test: No specific sample size or type of data (beyond stating "tests... have been carried out") is mentioned for this.
The data provenance for any testing mentioned (phantom-based) is not from human patients, and therefore the concepts of "country of origin" or "retrospective/prospective" do not apply in the context of clinical data for the reported tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
The document does not mention using experts to establish ground truth for any of the reported tests. The tests performed were primarily technical verifications (phantom-based needle navigation, tracking quality) rather than diagnostic performance evaluations requiring expert adjudication.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
No adjudication method is mentioned, as the tests performed do not involve human diagnostic interpretation that would require such a process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No MRMC comparative effectiveness study is mentioned. The device is intended to support a clinical ultrasound session by providing additional real-time image information from a 2nd modality; it is explicitly stated that the 2nd modality image is not intended to be used as a standalone diagnostic image and should not be used for diagnostic purposes. This phrasing suggests the device is an assistive tool rather than a standalone diagnostic AI that would be subject to MRMC studies comparing human performance with and without its assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
The NaviSuite SSI Edition, as described, is not a standalone diagnostic algorithm. It is a software designed to be used "together with an ultrasound device" and provides "additional real-time image information." The provided texts highlight that the "2nd modality image is not intended to be used as a standalone diagnostic image" and "The 2nd modality image only should not be used for diagnostic purposes." Therefore, a standalone performance study in the context of diagnostic accuracy would not be applicable or appropriate for this device's intended use. The technical tests performed (system accuracy, tracking quality) are standalone in the sense that they evaluate the software's functional performance, but not its diagnostic capability.
7. The Type of Ground Truth Used
- System Accuracy (2nd Modality Image Display): The ground truth for the 5mm accuracy claim relies on the "presumption that the registration has been done with an overall error better than 5mm." This implies a technical measurement or calculation of registration error.
- Needle Navigation Testing: The ground truth for this appears to be the physical location of the needle within the CIRS Abdominal Phantom compared to the software's projected virtual needle position. This would be a physical phantom-based ground truth.
- Tracking Quality Test: The ground truth would be the known presence or absence of factors causing "low sensor tracking quality" or "distorted tracking" (e.g., metallic objects) and the software's ability to correctly detect and report these. This is also a technical ground truth.
8. The Sample Size for the Training Set
The document does not mention any training set size. This device appears to be primarily an image registration and visualization tool rather than a machine learning model that would require a dedicated training set of images with established ground truths for learning.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned, information on how its ground truth was established is not provided.
§ 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).