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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 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-only application using 3D X-ray angiography images (CBCT) as input. It helps clinicians visualize vasculature to aid in the planning of endovascular embolization procedures throughout the body.

A new option, called AI Segmentation, was developed from the modifications to the predicate device, GE HealthCare's FlightPlan for Embolization [K193261]. It includes two new algorithms. This Al Segmentation option is what triggered this 510(k) submission.

The software process 3D X-ray angiography images (CBCT) acquired from GE HealthCare's interventional X-ray system [K181403], operates on GEHC's Advantage Workstation (AW) [K110834] platform and AW Server (AWS) [K081985] platform, and is an extension to the GE HealthCare's Volume Viewer application [K041521].

FlightPlan for Embolization is intended to be used during the planning phase of embolization procedures.

The primary features/functions of the proposed software are:

• Semi-automatic segmentation of vasculature from a starting point determined by the user, when AI Segmentation option is not activated;
• Automatic segmentation of vasculature powered by a deep-learning algorithm, when Al Segmentation option is activated;
• Automatic definition of the root point powered by a deep-learning algorithm, when AI Segmentation option is activated;
• Selective display (Live Tracking) of proximal vessels from a point determined by the user's cursor;
• Ability to segment part of the selected vasculature;
• Ability to mark points of interest (POI) to store cursor position(s);
• Save results and optionally export them to other applications such as GEHC's Vision Applications ● [K092639] for 3D road-mapping.

Here's a breakdown of the acceptance criteria and the study details for the GE Medical Systems SCS's FlightPlan for Embolization device, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: 207 contrast-injected CBCT scans, each from a unique patient.
• Data Provenance: The scans were acquired during the planning of embolization procedures from GE HealthCare's interventional X-ray system. The text indicates that these were from "clinical sites" and were "representative of the intended population" but does not specify countries of origin. The study appears to be retrospective, using existing scans.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

• Vessel Extraction: 3 board-certified radiologists.
• Root Definition: 1 GEHC advanced application specialist.

3. Adjudication Method for the Test Set:

• Vessel Extraction: Consensus of 3 board-certified radiologists. (Implies a qualitative agreement, not a specific quantitative method like 2+1).
• Root Definition: The acceptable area was manually defined by the annotator (the GEHC advanced application specialist).

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, an MRMC comparative effectiveness study was not explicitly described in terms of human readers improving with AI vs. without AI assistance. The non-clinical testing focused on the algorithms' performance against ground truth and the clinical assessment used a Likert scale to evaluate the proposed device with the AI option, rather than a direct comparison of human reader performance with and without AI.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Yes, a standalone performance evaluation was conducted for both the vessel extraction and root definition algorithms. The reported success rates of 93.7% and 95.2% are measures of the algorithms' performance against established ground truth without a human in the loop for the primary performance metrics.

6. The Type of Ground Truth Used:

• Vessel Extraction: Expert consensus (3 board-certified radiologists).
• Root Definition: Manual definition by an expert (GEHC advanced application specialist), defining an "acceptable area."

7. The Sample Size for the Training Set:

• The document states that "contrast injected CBCT scans acquired from GE HealthCare's interventional X-ray system [K181403] were used for designing and qualifying the algorithms." However, it does not specify the sample size for the training set. It only mentions that a test set of 207 scans was "reserved, segregated, and used to evaluate both algorithms."

8. How the Ground Truth for the Training Set Was Established:

• The document does not explicitly state how the ground truth for the training set was established. It only details the ground truth establishment for the test set.

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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:

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.

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