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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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The SOMATOM Definition AS/ ASt is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles. (*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)

The Siemens SOMATOM Definition AS/ AST is a Computed Tomography X- ray Systems, which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation. The SOMATOM Definition AS/AS+ system produces CT images in DICOM format, which can be used by postprocessing applications commercially distributed by Siemens and other vendors. The computer system delivered with the CT scanner is able to run such post processing applications optionally.

This 510(k) summary for the SIEMENS SOMATOM Definition AS/AS+ Computed Tomography X-ray System does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily focuses on establishing "substantial equivalence" of the new device to existing predicate devices already on the market. It covers:

• Contact Information: Details of the submitting company and regulatory contact.
• Device Name and Classification: Product name, proprietary trade name, classification name, panel, CFR section, device class, and product code.
• Substantial Equivalence: Identification of predicate devices (Siemens SOMATOM Sensation 64 and Toshiba Aquilion 64) with their FDA clearance numbers and dates.
• Device Description: A general description of the SOMATOM Definition AS/AS+ as a CT X-ray system, its function, software, and output format (DICOM).
• Indications for Use: The intended purpose of the device to produce cross-sectional images of the body.
• General Safety and Effectiveness Concerns: A statement that labeling provides instructions, cautions, and warnings, and that risk management (hazard analysis) is performed to minimize hazards.
• FDA Clearance Letter: Official correspondence from the FDA confirming the substantial equivalence determination.

Therefore, I cannot provide the requested information regarding acceptance criteria or the study that proves the device meets those criteria, as it is not present in the provided text.

If this information were available, it would typically be found in a separate section detailing performance testing, clinical validation, or engineering specifications. For a device like a CT scanner, acceptance criteria would likely relate to image quality parameters (e.g., spatial resolution, contrast resolution, noise, dose efficiency), dose limits, system reliability, and electrical/mechanical safety standards. The study proving these criteria would involve specific tests and measurements.

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