(30 days)
The ig4™ Image Guided System is a stereotactic accessory for Computed Tomography (CT) or 3D fluoroscopic x-ray systems. The ig4 System is indicated for displaying an interventional instrument such as a biopsy needle, an aspiration needle, or ablation needle, on a computer monitor that also displays a CT-based or 3D fluoroscopic x-ray-based model of the target organ(s). The ig4™ System is additionally indicated for overlaying Ultrasound images onto the model of the target organ(s). The ig4™ System compensates for the patient's respiratory phases.
The ig4™ System is intended for use in clinical interventions and for anatomical structures where computed tomography, 3D fluoroscopic x-ray, or ultrasound are currently used for visualizing such procedures.
The ig4™ Image Guided System is an accessory for a CT or 3D fluoroscopic x-ray System that utilizes electromagnetic tracking technology to locate and navigate instruments relative to a CTbased or 3D fluoroscopic x-ray-based model of the patient anatomy. The system software allows additional data overlay of real-time Ultrasound images onto the model of the patient anatomy. Due to system use to locate structures in soft tissue, the system incorporates a method of gating the location information on soft tissue to the patient's respiration. The ig4™ System consists of an EM tracking accessory for rigid needles/Ultrasound probes or tip-tracked coaxial needle, a patient referencing system, an EM field generator and tracking system, software and a computer system.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Navigation Accuracy with Ultrasound Overlay (on a static phantom) | Demonstrated safety and effectiveness of the device. (Specific quantitative accuracy metrics are not provided in the summary.) |
Study Details
The provided document describes a 510(k) submission for the Veran Medical Technologies ig4™ Image Guided System with Ultrasound Overlay. The "study" mentioned refers to performance testing conducted to support the substantial equivalence claim.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document mentions "Bench accuracy testing... on a static phantom." This suggests a controlled laboratory environment rather than a large clinical test set.
- Data Provenance: Not explicitly stated, but based on "Bench accuracy testing on a static phantom," the data would be considered prospective in a controlled lab setting, likely conducted internally by Veran Medical Technologies. No country of origin for the data is mentioned, but the company is based in St. Louis, MO, USA.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "bench accuracy testing" likely refers to engineering or technical measurements against a known standard (the phantom itself) rather than expert opinion.
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Adjudication method for the test set:
- Not applicable. As noted above, the testing appears to be a technical measurement against a known standard.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study was done. The document explicitly states: "Clinical tests were not required to demonstrate the safety and effectiveness of the device." This device is an image-guided navigation system, not an AI for image interpretation or diagnosis.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in a sense. The "Bench accuracy testing" would represent the standalone performance of the system (algorithm and hardware) in navigating instruments relative to an ultrasound overlay on a static phantom. The results "demonstrated the safety and effectiveness of the device" in this context. However, specific quantitative metrics for standalone performance (e.g., mean accuracy, standard deviation) are not provided in this summary.
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The type of ground truth used:
- For the bench accuracy testing, the ground truth would be the known geometry and characteristics of the static phantom used for the test, likely established through precise manufacturing or measurement.
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The sample size for the training set:
- Not applicable. The document does not describe the use of machine learning models requiring a distinct "training set" in the context of this 510(k) submission. The ig4™ system is described as utilizing electromagnetic tracking technology and software for image overlay and instrument navigation.
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How the ground truth for the training set was established:
- Not applicable, as no training set for machine learning is described.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.