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The Low Dose CT Lung Cancer Screening Option for Canon/Toshiba CT systems is indicated for using low dose CT for lung cancer screening. The screening must be conducted with the established program criteria and protocols that have been approved and published by a governmental body, a professional medical society and/or Canon.

Information from professional societies related to lung cancer screening can be found, but is not limited to: American College of Radiology® (ACR)-resources and technical specification; accreditation American Association of Physicists in Medicine (AAPM) - Lung Cancer Screening Protocols; radiation management.

The low dose lung cancer screening option is an indication being added to the following existing, previously FDA-cleared scanners: [List of Aquilion and Lightning CT scanner models and their corresponding 510(k) numbers]. No functional, performance, feature, or design changes are being made to the devices that will be indicated for low dose lung cancer screening. The devices already include low dose lung screening protocols, intended for use in the review of thoracic CT images within the established inclusion criteria of programs/protocols that have been approved and published by either a governmental body or professional medical society.

The provided text describes a 510(k) premarket notification for a "Low Dose CT Lung Cancer Screening Option" from Canon Medical Systems Corporation. The submission seeks to add this indication to existing, previously FDA-cleared CT scanners. The key claim is substantial equivalence to a predicate device (Aquilion RXL, K121553, which is a successor to the Aquilion 16 used in the National Lung Screening Trial - NLST). The device's performance is demonstrated through bench testing only, not a clinical study involving human subjects or AI-assisted readings.

Therefore, the following information can be extracted/inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that performance was "substantially equivalent" to the predicate. Specific numerical values for the reported performance are not provided in this regulatory summary.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not applicable in the traditional sense of a clinical test set with patient data. The "test set" consists of bench testing data from representative scanners from different CT system families. One device from each of the three identified families (Aquilion 16/32/64/RXL, PRIME/PRIME SP, ONE/ViSION/Genesis, and Lightning) was used for bench testing.
• Data Provenance: The data is from bench testing performed by Canon Medical Systems Corporation. The document does not specify the country of origin for this bench testing data, but the manufacturer is Canon Medical Systems Corporation (Japan) with a U.S. agent. The original NLST data (which the predicate is compared against) was from a large-scale, prospective clinical trial conducted in the United States.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This submission relies on bench testing for substantial equivalence, not a clinical study requiring expert ground truth for image interpretation.

4. Adjudication Method for the Test Set

Not applicable, as no human readers or clinical image interpretation were part of the presented performance data.

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. This submission is for a CT scanner's indication for low-dose lung cancer screening, not an AI-powered diagnostic assist device. The performance demonstration is based on the physical imaging characteristics of the CT system.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Not applicable. This is for a CT imaging device, not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this substantial equivalence argument is the performance of the predicate device (Aquilion RXL), which is stated to have similar technological characteristics and performance equivalent to the Aquilion 16 used in the NLST. The "ground truth" for the benefit of low-dose CT lung cancer screening itself comes from clinical literature, specifically referencing the National Lung Screening Trial (NLST) results, which demonstrated reduced mortality from lung cancer with low-dose CT screening. However, the device's performance itself is measured against established phantom-based image quality metrics.

8. The Sample Size for the Training Set

Not applicable. This is a CT imaging device, not an AI/ML algorithm that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

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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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