Search Results

Optional movable gantry base unit for use with an Aquilion ONE (TSX-305A) system to support longitudinal movement and allow acquisition of images in the z-direction (z-axis).

Note: When installed with the movable gantry base unit, Aquilion ONE can be used with the INFX-8000C system in the same room.

The Infinix 4DCT is composed of the INFX-8000C interventional angiography system and the dynamic volume CT system, Aquilion ONE, TSX-305A/3. This combination enables patient access and efficient workflow for interventional procedures. Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A, is an optional kit intended to be used in conjunction with an Aquilion ONE / INFX-8000C based IVR-CT system. This device is attached to the Aquilion ONE CT gantry to support longitudinal movement and allow image acquisition in the z-direction (Z-axis), both axial and helical. When this option is installed, the standard CT patient couch is replaced with the patient handling system utilized by the interventional x-ray system, INFX-8000C. The Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A, will be used as part of an Aquilion ONE / INFX-8000C based IVR-CT system. Please note, the intended uses and technological characteristics of the Aquilion ONE CT System and the INFX-8000C Interventional X-Ray System remain the same. There have been no modifications made to the imaging chains in these FDA cleared devices and the base system software remains the same. Since both systems will be installed in the same room and to prevent interference during use, system interlocks have been incorporated into the systems.

The provided text does not contain detailed information on the acceptance criteria and a study proving the device meets those criteria in a format suitable for the requested table. The document is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific performance metrics and acceptance thresholds.

However, based on the text, I can infer some aspects and extract relevant information to address your request as much as possible.

Here's an attempt to answer your questions by extracting information from the provided document:

1. A table of acceptance criteria and the reported device performance:

The document describes verification/validation testing conducted through bench testing to demonstrate that requirements for modifications have been met. It lists several functional aspects that were evaluated. While it doesn't provide specific quantitative acceptance criteria or numerical performance results in the provided text, it states that these functions "performed according to specifications."

2. Sample size used for the test set and the data provenance:

The document mentions "bench testing" but does not specify a sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective). Bench testing typically involves testing a device or its components in a laboratory setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

No information is provided regarding experts used to establish ground truth for a test set. Bench testing for this type of device (a movable gantry base unit) would likely involve technical verification against engineering specifications rather than expert interpretation of images or clinical outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

No information is provided regarding an adjudication method. This is typically relevant for studies involving human interpretation or clinical endpoints, which are not detailed here.

5. 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 study was mentioned or performed. This device is a mechanical accessory (movable gantry base unit for a CT scanner), not an AI-powered diagnostic tool, so an MRMC study comparing human reader performance with and without AI assistance is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No standalone algorithm performance was done/mentioned. As noted, this is a hardware accessory, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Given the nature of the device and the "bench testing" described, the "ground truth" would likely be defined by engineering specifications and functional requirements for mechanical movement, positioning accuracy, safety interlocks, and imaging capabilities (e.g., ability to acquire images in the z-direction). It is not based on clinical "truth" such as pathology or expert consensus on disease.

8. The sample size for the training set:

No training set is mentioned or applicable. This device is a mechanical component, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for this type of device.

In summary, the provided document (a 510(k) summary) focuses on regulatory submission for a device modification and substantial equivalence. It highlights that "bench testing" was conducted to confirm the device's functional performance against specifications and to ensure safety and effectiveness. However, it does not detail specific quantitative acceptance criteria or results in a table, nor does it conduct the types of studies (like MRMC or AI performance studies) that would involve human readers, ground truth established by experts, or training sets.

Ask a specific question about this device