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The Smart View 3D option is used as part of a head or whole body CT interventional procedure when the physician desires to obtain a visualization, 3D orientation, and localization of the needle in patients of all ages. SmartView 3D can automatically detect various sized needles during CT interventional procedures. SmartView 3D reconstructs and displays the traditional 2D images, and immediately thereafter additionally displays Multiple Planar Reconstruction images from a reconstruction in an orthogonal reference frame aligned with the needle 's orientation where the needle tip is at the origin. This additional information may aid in guidance and/or monitoring during interventional procedures.

The GE SmartView 3D Option is for use with a GE CT system. SmartView 3D is an enhanced software option to the current SmartView Option application (predicate device: K973168). The SmartView 3D Option is designed to be used during CT-guided interventional procedures with the ability to detect needles and produce, in a needlebased geometry, orthogonal 3D reformats. SmartView 3D displays the oblique Multiple Planar Reconstruction (MPR) images of the needle and provides 3D information of the needle orientation. The SmartView Option is intended to be used during CT interventional procedures with either a continuous fluoro acquisition mode or a step-andshoot, single segment rotation acquisition mode, both of which create 2D axial images using the CT scanner's reference frame. When applied, the SmartView 3D option allows the user to acquire image data from a step-and-shoot, single segment rotation acquisition, which it then uses for the three MPR reconstructions (Needle-sagittal plane, Needle-axial plane, Needle-tip plane) that are able to be displayed simultaneously. SmartView 3D also displays 2D axial images reconstructed from the same acquisition. The 3D interventional viewports automatically update each time an acquisition is initiated with the foot pedal. SmartView 3D provides both the 2D axial reconstructions as well as the three MPR reconstructions which provide the physician with additional information for needle position visualization and localization for CT intervention procedures.

The provided document, a 510(k) Premarket Notification Submission for the SmartView 3D Option, describes the device and its testing in relation to its substantial equivalence to a predicate device. However, it does not explicitly state quantitative acceptance criteria or a detailed study proving the device meets those criteria in the way typically expected for a detailed performance study with metrics like sensitivity, specificity, or AUC based on ground truth.

Instead, the submission focuses on substantial equivalence to an existing predicate device (SmartView Option K973168) and verification/validation testing to ensure design requirements are met and new safety/effectiveness concerns are not introduced.

Here's an analysis based on the available information regarding the SmartView 3D Option's performance:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table with specific, quantifiable acceptance criteria (e.g., minimum accuracy, sensitivity, or geometric precision for needle detection) and corresponding reported performance metrics.

Instead, the "acceptance criteria" are implied by the statements that:

• "SmartView 3D is of clinical quality for its intended use and indications for use."
• "SmartView 3D Option provides equivalent or better performance compared to SmartView Option."
• "SmartView 3D... performs as well as devices currently on the market."
• "System and subsystem verification have been successfully executed... which demonstrated the SmartView 3D option met design requirements."
• "Engineering testing also included testing to substantiate the updated product claims and acceptance testing."
• "No adverse effects or new questions of safety or effectiveness have been introduced."

2. Sample Size for Test Set and Data Provenance:

• Test Set (Clinical Simulation Bench Testing): The document states that "Clinical simulation bench testing was performed by an experienced interventional radiologist using the current production Discovery CT590 RT (K132410) CT system with the current production SmartView option (K973168) and the new SmartView 3D option."
  The test set consisted of "a variety of phantoms that are either used for training physicians on these types of procedures or, with the concurrence of the interventional radiologist, determined to be representative surrogates for evaluation of device performance."
  • Sample Size: The exact number of phantoms or number of needle insertions/scans performed during this clinical simulation is not specified.
  • Data Provenance: The "data" (phantom scans) were generated prospectively during the bench testing. The origin of the phantoms themselves is not stated (e.g., specific manufacturer, country).
• Other Testing: "System and subsystem verification" and "Engineering testing" were also conducted, but details on sample sizes for these are not provided. These are generally internal tests.

3. Number of Experts and Qualifications for Ground Truth (Test Set):

• Number of Experts: One "experienced interventional radiologist" was used for the clinical simulation bench testing.
• Qualifications: "experienced interventional radiologist." No specific number of years of experience is given.
• Role: This radiologist performed the needle biopsies on phantoms and concurred that the phantoms were "representative surrogates for evaluation of device performance." They also assessed that "SmartView 3D is of clinical quality for its intended use." This suggests the radiologist served as a primary evaluator of the device's performance in a simulated clinical setting.

4. Adjudication Method for the Test Set:

• Based on the information, there was no formal adjudication method (e.g., 2+1, 3+1) described. Ground truth or performance evaluation appears to have been based on the assessment and concurrence of a single experienced interventional radiologist during the clinical simulation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, a MRMC comparative effectiveness study was not explicitly conducted or reported. The testing involved a single experienced interventional radiologist, and the comparison was primarily between the new SmartView 3D option and the predicate device's capabilities (SmartView Option K973168) in terms of enhanced functionality, rather than a quantifiable improvement in human reader performance with and without AI assistance. The document states "External clinical evaluation was not needed to establish safety and effectiveness. All changes were able to be fully evaluated on the bench..."

6. Standalone (Algorithm Only) Performance Study:

• Yes, a form of standalone testing was done implicitly. The "design of SmartView 3D adds a needle-specific detection algorithm to identify the needle, needle tip, and its 3D orientation." This algorithm's performance would have been evaluated during "System and subsystem verification" and "Engineering testing" to ensure it "met design requirements" and "substantiate the updated product claims." The clinical simulation tested the integrated system, including the algorithm's functional output, without directly involving human interpretation of images from the algorithm only vs. without the algorithm. The focus was on the system's ability to produce the new orthogonal 3D reformats based on the detected needle.

7. Type of Ground Truth Used (Test Set):

• The ground truth for the clinical simulation bench testing on phantoms would have been the known physical location and orientation of the needles within the phantoms. This is established by the design of the phantoms and the controlled insertion of needles by the interventional radiologist. The radiologist's assessment of the device's ability to accurately visualize and localize these known needle positions acted as the validation of this ground truth.

8. Sample Size for the Training Set:

• The document does not explicitly state the sample size for the training set used for the "needle-specific detection algorithm." As this is a 510(k) submission focused on substantial equivalence and verification testing, detailed information about algorithm training data (which usually includes its own set of ground truth) is often not included unless it's critical to demonstrate safety and effectiveness for a novel algorithm.

9. How Ground Truth for Training Set was Established:

• This information is not provided in the document.

In summary, the submission emphasizes substantial equivalence, bench testing, and a clinical simulation with one expert on phantoms to demonstrate the device's functionality and safety, rather than a detailed performance study against specific, quantifiable acceptance criteria using a large, independently adjudicated test set.

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