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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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Acquisition and display of axial x-ray images of the whole body to include the head.

The Aquilion CXL is a whole body multi-slice helical CT System, consisting of a gantry, patient couch and console. The system generates up to 128 slices per rotation using a selectable slice-thickness multi-row detector. Additionally, the Aquilion CXL will utilize the new dose-reduction technologies adopted from Aquilion ONE (currently under FDA review), the system substantially reduces patient exposure dose and improves image quality.

1. Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state numerical acceptance criteria in a formal table or a direct comparison of the device's performance against such criteria. Instead, it relies on a statement of "substantial equivalence" to a predicate device and notes that "Testing was conducted utilizing phantoms and accepted image quality metrics. The results of this testing is contained in the user information for the device." This implies that the device's performance was deemed acceptable based on meeting standard image quality metrics in phantom studies, but the specific metrics and their target values are not detailed in this summary.

Therefore, a table cannot be constructed with specific numerical acceptance criteria and reported performance values based solely on the provided text.

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

The document mentions that "Testing was conducted utilizing phantoms." This indicates that the "test set" consisted of phantoms, which are artificial objects used to simulate human tissue for imaging purposes. Consequently, there is no human patient data test set.

• Sample Size for Test Set: Not applicable as real patient data was not used. Instead, phantoms were used for testing. The number or type of phantoms used is not specified.
• Data Provenance: Not applicable as no human patient data was used.

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

Not applicable, as phantoms were used for testing, and image quality metrics from these phantoms would be objectively measured rather than requiring expert ground truth establishment in the traditional sense of clinical diagnosis.

4. Adjudication Method for the Test Set:

Not applicable, as expert adjudication is not relevant for phantom-based image quality testing.

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

No, an MRMC comparative effectiveness study was not done. The document states that "Testing was conducted utilizing phantoms and accepted image quality metrics." This type of testing is focused on the device's technical image quality, not its impact on human reader performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, a standalone performance assessment was conducted through "Testing... utilizing phantoms and accepted image quality metrics." This evaluated the device's inherent image quality capabilities (such as resolution, contrast, noise reduction) without human intervention in the diagnostic process.

7. Type of Ground Truth Used:

For the phantom-based testing, the "ground truth" would be the known physical properties and internal structures of the phantoms, against which the reconstructed images' accuracy and quality metrics (e.g., spatial resolution, contrast-to-noise ratio, signal-to-noise ratio) were measured.

8. Sample Size for the Training Set:

The document does not mention the use of a "training set" in the context of device performance evaluation. This device is a CT scanner, and typical performance evaluation for such devices involves physical and technical testing against established standards and metrics using phantoms, rather than AI model training on a dataset. The "Application of AIDR algorithm" is mentioned as a new feature, suggesting the use of an algorithm, but the document does not provide details about its development or training data.

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

Not applicable, as a training set for an algorithm is not described or detailed in the provided information.

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This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head.

The Aquilion PRIME has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.

The TSX-302A is an 80-row CT System that is intended to produce axial scans of the whole body to include the head. The TSX-302A is based upon the technology and materials of previously marketed Toshiba CT systems.

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, or any studies conducted to prove the device meets said criteria. The document is a 510(k) summary for the TSX-302A, Aquilion Prime CT System, detailing its intended use, substantial equivalence to a predicate device, and regulatory information from the FDA. It does not include any performance data or study details.

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