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uCT ATLAS is a computed tomography x-ray system, which is intended to produce cross-sectional images of the whole body by computer reconstruction of x-ray transmission data taken at different angles and planes. uCT ATLAS is applicable to head, whole body, cardiac, and vascular x-ray Computed Tomography.

uCT ATLAS has the capability to image a whole organ in a single rotation. Organs include, but not limited to head, heart, liver, kidney, pancreas, joints, etc.

uCT ATLAS is intended to be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer. The screening must be performed within the established inclusion criteria of protocols that have been approved and published by either a governmental body or professional medical society. * Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

u WS-CT-Dual Energy Analysis software uses UIH CT images acquired using different tube voltages and/or tube currents of the same anatomical location. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials and enable images to be generated at multiple energies within the available spectrum. uWS-CT-Dual Energy Analysis software combines images acquired with low and high energy spectra to visualize this information.

The proposed device uCT ATLAS with uWS-CT-Dual Energy Analysis includes image acquisition hardware, image acquisition, reconstruction and dual energy analysis software, and associated accessories.

The uCT ATLAS is a multi-slice computed tomography scanner that features the following specification and technologies.

• 160 mm z-coverage in a single axial exposure with a 320-row 0.5 mm-slice Z-• Detector
• . 0.25 s rotation speed for high temporal resolution, and maximum 440 mm/s fast volumetric scanning capability
• . 82 cm bore size, 318 kg (700 lbs) maximum table load capacity allows flexible positioning and access for all patients
• . The new generation reconstruction method. Deep IR (also named AIIR), which combines the model-based iterative reconstruction and deep learning technology together, in order to reduce image noise and artifacts, while at the same time improving low contrast detectability and spatial resolution
• . The uAI Vision patient positioning assistance
  Built upon these technologies, the uCT ATLAS is designed to use less radiation dose than the previous generation product while maintaining the same diagnostic level of image quality. Further, the whole organ coverage and fast scanning capability benefits the clinical applications, especially for cardiac imaging, dynamic whole organ imaging and fast body and vascular imaging.

The uWS-CT-Dual Energy Analysis is a software package that uses UIH CT images acquired using different tube voltages and/or tube currents of the same anatomical location. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials. CT dual energy analysis application combines images acquired with low and high energy spectra to visualize this information.

The provided text does not contain information about specific acceptance criteria or a detailed study proving that a device meets those criteria. The document is a 510(k) premarket notification summary for the uCT ATLAS with uWS-CT-Dual Energy Analysis system. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study against predefined acceptance criteria.

While the document mentions "Performance Verification" and "Clinical Image Evaluation of applications," and states that "The testing results show that all the software specifications have met the acceptance criteria," it does not provide:

• A table of acceptance criteria and reported device performance.
• Details on sample sizes, data provenance, number or qualifications of experts, or adjudication methods for test sets.
• Information on multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Specifics about the type of ground truth used or how ground truth for training sets was established.

The document states that "No Clinical Study is included in this submission," which further indicates that the detailed information you're requesting regarding clinical performance studies isn't present in this specific FDA submission summary.

The closest information available is:

• Non-Clinical Testing: Includes dosimetry and image performance tests, and conformance to various electrical safety, EMC, and product particular standards (e.g., NEMA XR 25-2019, IEC 61223-3-5). The acceptance criteria for these would be compliance with the specified standards, but the specific performance values are not detailed.
• Software Verification and Validation: Mentions that "all the software specifications have met the acceptance criteria," but does not list those criteria or performance results.

In summary, the provided document focuses on regulatory clearance through substantial equivalence, indicating that the device has similar performance and safety as legally marketed predicate devices. It does not contain the detailed performance study information you are seeking.

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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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