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Optional movable gantry base unit for use with an Aquilion ONE (TSX-301C) 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 Aquilion ONE Vision Self-Propelled Scan Base Kit for IVR-CT, CGBA-033A is an optional kit intended to be used in conjunction with an Aquilion ONE Vision / INFX-8000C based IVR-CT system. The subject device is attached to the CT gantry to support longitudinal movement and allow image acquisition in the z-direction (Z-axis), both axial and helical. When this option is selected, the standard CT patient couch is replaced with the patient handling system utilized by the interventional x-ray system, Toshiba INFX-8000C. The intended uses and technological characteristics of the Aquilion ONE Vision CT System and INFX-8000C Interventional X-Ray System with which this device is used, remain the same.

I am sorry, but the provided text does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them in the format you requested.

The document is a 510(k) premarket notification for an accessory to a Computed Tomography (CT) system (an optional movable gantry base unit). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study with acceptance criteria for device performance in detecting or diagnosing conditions, which is typically what your request implies.

Here's a breakdown of why I cannot fulfill your request based on the provided text:

• Acceptance Criteria Table and Device Performance: The document describes the device's function (supporting longitudinal movement and allowing image acquisition in the z-direction) and notes modifications from a predicate device. It does not provide specific performance metrics (e.g., sensitivity, specificity, accuracy, resolution) with numerical targets that would constitute acceptance criteria, nor does it present "reported device performance" in that context.
• Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance: These items are relevant for studies evaluating diagnostic or prognostic accuracy, often involving image interpretation by human readers or an algorithm. This document describes a hardware accessory for a CT system, and the "testing" mentioned is primarily engineering verification and validation (bench testing) to ensure that the modifications function as intended and meet safety standards. There's no indication of a clinical study involving patients, image interpretation, or ground truth establishment in the manner your questions suggest.
• Type of Ground Truth: Since there's no clinical study described, there's no ground truth (pathology, expert consensus, outcomes data) discussed.
• Training Set Sample Size and Ground Truth Establishment (for training set): These questions are relevant for AI/ML-based devices. The device described here is a hardware accessory for a CT system, not an AI/ML algorithm.

What the document does provide regarding "testing" (which is more about engineering validation than clinical performance):

• Non-Clinical Tests: "This submission includes summary tables detailing the risk analysis and verification/validation testing conducted through bench testing which demonstrates that the requirements for the modifications made to the system have been met. Evaluation of the modified device included, but was not limited to, confirmation that base movement speed, scanogram and axial/helical scan functions, and interlocks including contact detection, performed according to specifications."
• Software Documentation: "Software Documentation for a Moderate Level of Concern, per the FDA guidance document, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document' issued on May 11, 2005, is also included as part of this submission."
• Standards Compliance: "Additionally, testing of the modified system was conducted in accordance with the applicable standards published by the International Clectrotechnical Commission (IEC) for Medical Devices and CT Systems."

In summary, the provided text describes a regulatory submission for a hardware component where the "evidence" is primarily engineering verification and validation against design specifications and international safety standards, not a clinical study assessing diagnostic performance against specific acceptance criteria.

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