(59 days)
FlightPlan for Embolization is a post processing software package that helps the analysis of 3D X-ray angiography images. Its output is intended to be used by physicians as an adjunct means to help visualize vasculature during the planning phase of embolization procedures. FlightPlan for Embolization is not intended to be used during therapy delivery.
The output includes segmented vasculature, and selective display of proximal vessel and distal vessels from a reference point determined by the user. User-defined data from the 3D X-ray angiography images may be exported for use during the guidance phase of the procedure. The injection points should be confirmed independently of FlightPlan for Embolization prior to therapy delivery.
FlightPlan for Embolization is a post processing software application which operates on the Advantage Workstation (AW) [K110834] platform and AW Server [K081985] platform. It is an extension to the Volume Viewer application [K041521] modified from FlightPlan for Liver (K121200) and is designed for processing 3D X-ray angiography images to help visualize vasculature
The primary features of the software are: semi-automatic segmentation of vascular tree from a starting point determined by the user; selective display (Live Tracking) of proximal vessel and distal vessels from a point determined by the user's cursor; ability to segment part of the vasculature; ability to mark points of interest (POI) to store cursor position; save results and export to other applications such as Vision Applications [K092639] for 3D road-mapping.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for FlightPlan for Embolization:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list quantitative acceptance criteria in a dedicated section for "acceptance criteria." However, it describes validation activities that implicitly define the performance considered acceptable. Based on the "Summary of Non-Clinical Tests" and "Summary of Clinical Tests," the following can be inferred:
| Acceptance Criteria (Inferred from Validation Activities) | Reported Device Performance |
|---|---|
| Non-Clinical: | |
| Capability to automatically segment and selectively display vascular structures from a single user-defined point. | "FlightPlan for Embolization algorithms' capability to automatically segment and selectively display vascular structures from a single user defined point using a database of XACT exams... established satisfactory quality for FlightPlan for Embolization usage." |
| Compliance with NEMA PS 3.1 - 3.20 (2016) Digital Imaging and Communications in Medicine (DICOM) Set (Radiology) standard. | "The FlightPlan for Embolization complies with NEMA PS 3.1 - 3.20 (2016) Digital Imaging and Communications in Medicine (DICOM) Set (Radiology) standard." |
| Adherence to design control testing per GE's quality system (21 CFR 820 and ISO 13485). | "FlightPlan for Embolization has successfully completed the required design control testing per GE's quality system. FlightPlan for Embolization was designed and will be manufactured under the Quality System Regulations of 21CFR 820 and ISO 13485. |
| • Risk Analysis | |
| • Requirements Reviews | |
| • Design Reviews | |
| • Performance testing (Verification, Validation) | |
| • Safety testing (Verification)" | |
| Clinical: | |
| Ability of the device to help physicians in the analysis of 3D X-ray angiography images and in the planning of embolization procedures, including the selection of embolization injection points. | "The assessment demonstrated that the proposed device (FlightPlan for Embolization) helps physicians in the analysis of 3D X-ray angiography images and in the planning of embolization procedures, including the selection of embolization injection points." |
2. Sample Size Used for the Test Set and Data Provenance
-
Non-Clinical Test Set:
- Sample Size: A "database of XACT exams." The specific number of cases is not provided.
- Data Provenance: Not explicitly stated, but clinical scenarios are considered "representative" and include "consideration of acquisition parameters, image quality and anatomy." It can be inferred that these are existing clinical data, likely retrospective.
-
Clinical Test Set:
- Sample Size: "A sample of 3D X-ray angiography images representative of clinical practice." The specific number of cases is not provided.
- Data Provenance: Not explicitly stated, but described as "representative of clinical practice" and "most common anatomic regions where embolization procedures are performed." It can be inferred that these are retrospective clinical cases.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Clinical Test Set:
- Number of Experts: Four
- Qualifications: "board certified interventional radiologists." No information on years of experience is provided.
4. Adjudication Method for the Test Set
- Clinical Test Set: The document states that the assessment was done "using a 5-point Likert scale." This implies an individual scoring system by each radiologist, but it does not specify an adjudication method (e.g., 2+1, 3+1 consensus). It sounds like individual assessments were performed and then aggregated or analyzed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size
- No, an MRMC comparative effectiveness study was not explicitly stated to have been done in the traditional sense of comparing human readers with AI vs. without AI assistance.
- The clinical study described is an assessment of the device's helpfulness by radiologists, rather than a comparative study measuring improvement in diagnostic accuracy or efficiency for humans using the AI vs. not using it. The statement "demonstrated that the proposed device (FlightPlan for Embolization) helps physicians" is an outcome of an assessment, not a quantitative effect size from an MRMC study comparing assisted vs. unassisted performance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done
- Yes, a form of standalone performance was assessed in the "Summary of Non-Clinical Tests." The "Engineering...validated FlightPlan for Embolization algorithms' capability to automatically segment and selectively display vascular structures..." using a database of XACT exams. This implies an evaluation of the algorithm's output against some reference (likely manual segmentations or ground truth established by experts) without direct human interaction at the time of assessment.
7. The Type of Ground Truth Used
- Non-Clinical Test Set: The ground truth for the non-clinical validation of segmentation and display capabilities is implicitly based on expert-defined correct segmentations or "satisfactory quality" as determined by engineering validation. The document does not explicitly state "expert consensus" or "pathology" for this.
- Clinical Test Set: The ground truth for the clinical assessment relies on the judgment of "four board certified interventional radiologists" using a 5-point Likert scale to determine if the device "helps physicians." This is a form of expert assessment/opinion as ground truth regarding the device's utility/helpfulness.
8. The Sample Size for the Training Set
- Not provided. The document does not disclose information about the training data used for the FlightPlan for Embolization algorithms.
9. How the Ground Truth for the Training Set was Established
- Not provided. Since the training set details are not mentioned, how its ground truth was established is also not available in this document.
§ 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).