Search Results

The IQQA-Guide System is a stereotactic accessory for Computed Tomography (CT). It displays simulated image of interventional instruments (such as biopsy needle, ablation needle, probe) on a computer monitor that also shows an imaging-based 3D model of the patient anatomy, and the current and the projected future path of the interventional instruments.

The system supports the imaging-based model derived from physician's confirmed segmentation results of patient's image scans, including intra-operative CT, pre-procedural CT, and CT or MR previously acquired before surgical procedures. Additionally, overlaying ultrasound images (when available) may be displayed with the model of patient anatomy.

The system supports a workflow based on automated image registrations of spatial mapping from one image space to another image space, or from image space to physical space. Physician may interactively adjust and confirm registration results, and evaluate 3D visualization and quantitative information in terms of distance, size, and spatial location associated with patient anatomy and instruments.

The system is intended for intra-operative guidance for surgical procedures. It is intended for use by trained physicians in clinical intervention and for structures where imaging is currently used for visualizing such procedures.

The IQQA-Guide System is a stereotactic accessory for Computed Tomography (CT). It utilizes electromagnetic tracking technology to locate and navigate instruments relative to an imaging-based model of the patient anatomy. IOOA-Guide displays the simulated image of interventional instruments (such as biopsy needle, ablation needle, probe) on a computer monitor that also shows the imaging-based 3D model of the patient anatomy, and the current and the projected future path of the interventional instruments.

IQQA-Guide supports the imaging-based 3D model derived from physician's confirmed segmentation results of patient's image scans, including intra-operative CT, pre-procedural CT, and CT or MR previously acquired before surgical procedures. The model of segmentation results may also be loaded from saved reports of the IQOA-BodyImaging software (K141745). Additionally, overlaying ultrasound images (when available) may be displayed with the model of patient anatomy. The system supports a workflow based on automated image registrations of spatial mapping from one image space to another image space, or from image space to physical space. Physician may interactively adjust and confirm registration results, and evaluate 3D visualization and quantitative information in terms of distance, size, and spatial location associated with patient anatomy and instruments.

The IQQA-Guide system consists of an EM tracking system, software, and a computer system. The system is intended for intra-operative guidance for surgical procedures. It is intended for use by trained physicians in clinical intervention and for structures where imaging is currently used for visualizing such procedures.

The acceptance criteria and study proving the device meets them are described below:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

The provided text only mentions "experiments involving intervention on phantoms" and "experiments involving patient studies." It does not specify the exact sample size (number of phantoms or patients) used for the test set.

• Data Provenance: The testing was conducted at "two hospital sites". This suggests retrospective or prospective clinical data, though details are not provided. The country of origin is not specified.

3. Number of Experts and Qualifications for Ground Truth

The document mentions that "physicians use the IQQA-Guide during clinical interventional procedures" and "provide feedback along the line of the intended use of the system." It also states "Test results were reviewed by designated technical professionals." However, it does not specify the number of experts or their detailed qualifications (e.g., years of experience, subspecialty) used to establish the ground truth for the test set.

4. Adjudication Method for Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1). It only states that "physicians use the IQQA-Guide" and "provide feedback," and "Test results were reviewed by designated technical professionals."

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

No multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance is mentioned in the provided text. The device is a "stereotactic accessory" for guidance, not an AI for image interpretation or diagnosis.

6. Standalone (Algorithm Only) Performance

The device, IQQA-Guide, is described as a "stereotactic accessory" that displays simulated images of interventional instruments and anatomical models. It relies on physician input for confirmed segmentation results and interactive adjustments. Therefore, it is not a standalone algorithm in the sense of making independent diagnostic or interventional decisions without human-in-the-loop. Its performance is evaluated in the context of aiding a physician.

7. Type of Ground Truth Used

The ground truth for the registration accuracy in phantom studies would likely be based on precisely known physical measurements of the phantom and instrument positions. For patient studies, the ground truth for accuracy would be based on "physician's confirmed segmentation results of patient's image scans" and potentially real-time imaging modalities, but the document does not explicitly state the definitive ground truth method for patient accuracy.

8. Sample Size for the Training Set

The document does not mention the sample size used for any training set. The device is described as an upgrade from already cleared software (IQQA-BodyImaging K141745), but information about its original development or training data is not provided in this 510(k) summary.

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 available in the provided text.

Ask a specific question about this device