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uCT 760/780 is a computed tomography x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and indicated for the whole body (including head, neck, cardiac and vascular).

uCT 760/780 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 programs / 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.

uWS-CT-Dual Energy Analysis is a post-processing software package that accepts 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 uCT Computed Tomography X-ray system is intended to produce crosssectional images of the patient by computer reconstruction of X-ray transmission data taken at different angles and planes. These images may be obtained either with or without contrast.

This proposed device includes two models: uCT 760 and uCT 780. The differences between the two models are as follows:

| Spec.
Model | HV Power | Rotation speed | Minimum
slice thickness | Maximum
slices generated
per rotation |
|----------------|----------|-------------------------------------|----------------------------|---------------------------------------------|
| uCT 760 | 80kW | Up to 0.35 sec per
360° rotation | 0.625mm | 128 |
| uCT 780 | 100kW | Up to 0.3 sec per
360° rotation | 0.5mm | 160 |

The uWS-CT-Dual Energy Analysis is a post-processing software package that accepts 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 modification performed on the uCT 760 & 780 in this submission is mainly due to the following new features:

• Low Dose CT Lung Cancer Screening Protocol .
• . uAI Vision
• . Auto ALARA kVp
• Organ-Based Auto ALARA mA
• CT-Guided Intervention
• Injector Linkage
• . Dual Energy Analysis

CT-Guided Intervention is a medical tool for assisting a minimally invasive procedure. CT-Guided Intervention in uCT 760/780 is to provide CT-imaging guidance for interventional procedures. During the CT-Guided Intervention procedure, CT images can help the user guide the needle entry path before operating a minimally invasive procedure and display the placement of the needle during a minimally invasive procedure based on the four scan modes: Single Axial, Continuous, Fluoro and Single helical. In this case, cells or tissue can be taken for biopsy, or minimally invasive surgeries such as drainage and ablation can be performed.

The provided text describes the 510(k) submission for the Shanghai United Imaging Healthcare Co., Ltd.'s uCT 760/780 computed tomography x-ray systems with uWS-CT-Dual Energy Analysis. It focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing of dosimetry and image performance.

However, the document does not contain specific details regarding:

• Acceptance criteria values for device performance (e.g., specific thresholds for accuracy, sensitivity, specificity, or image quality metrics).
• A study proving the device meets the acceptance criteria (other than general statements about non-clinical testing).
• Sample sizes used for a test set (only mentions overall non-clinical testing).
• Data provenance (country of origin, retrospective/prospective).
• Number of experts and their qualifications.
• Adjudication method.
• Whether a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done or its effect size.
• If standalone (algorithm only) performance was evaluated.
• The type of ground truth used (explicitly).
• Sample size for the training set.
• How ground truth for the training set was established.

The document primarily focuses on:

• Indications for Use.
• Comparison of technological characteristics to predicate devices.
• Conformity to various electrical safety, EMC, biocompatibility, and software standards.

Therefore, based only on the provided text, I cannot fulfill most of the request's specific points. The text indicates that non-clinical testing, including dosimetry and image performance tests, were conducted to verify that the proposed device met all design specifications and was substantially equivalent to the predicate device. However, it does not provide the details of these tests as requested.

If this were a submission for a software-as-a-medical-device (SaMD) or an AI/ML device, such details would typically be required and present. Given this is a CT scanner with an added "Dual Energy Analysis" software package and "uAI Vision" (which is not detailed), the submission focuses more on the hardware's safety and performance equivalence, and general conformance to standards for the software components rather than a detailed clinical validation study of AI performance.

Therefore, as per the instructions, I will explain why I cannot fulfill the request specifically due to the lack of information in the provided document.

Explanation of Missing Information:

The provided 510(k) summary for the uCT 760/780 with uWS-CT-Dual Energy Analysis does not contain the detailed information required to describe the acceptance criteria and the study proving the device meets these criteria in the manner requested. Specifically:

1. Table of acceptance criteria and reported device performance: The document states that "non-clinical testing including dosimetry and image performance tests were conducted... to verify that the proposed device met all design specifications," but it does not list the specific acceptance criteria (e.g., quantitative metrics for image quality, accuracy of dual-energy analysis outputs) or the reported numerical performance results against these criteria.
2. Sample size for the test set and data provenance: No information is provided regarding the sample size of any test set used or the provenance (country of origin, retrospective/prospective nature) of the data. The testing mentioned is "non-clinical," implying laboratory or phantom-based tests rather than clinical study data.
3. Number and qualifications of experts for ground truth: Since no specific clinical performance or AI diagnostic study is detailed, there is no mention of experts, their number, or qualifications for establishing ground truth.
4. Adjudication method: Not applicable/not mentioned, as no multi-reader or diagnostic performance study is described.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: The document does not describe an MRMC study or any human-in-the-loop performance evaluation. The "uAI Vision" feature is mentioned but without any performance data or clinical study details.
6. Standalone (algorithm only) performance: While the "uWS-CT-Dual Energy Analysis" and "uAI Vision" are software features, the document does not present a standalone performance evaluation of these algorithms with specific metrics (e.g., accuracy, sensitivity, specificity) against a defined ground truth.
7. Type of ground truth used: No specific type of ground truth (e.g., pathology, expert consensus) is mentioned, as no clinical performance study is detailed. The "ground truth" for the non-clinical tests would likely be derived from physical measurements or simulations rather than clinical outcomes.
8. Sample size for the training set: The document does not discuss the training of any AI/ML models or the size of a training dataset.
9. How ground truth for the training set was established: Not applicable, as AI training details are not provided.

In summary, the provided document focuses on demonstrating substantial equivalence to existing predicate CT devices through conformity to general safety and performance standards for CT systems and basic non-clinical testing, rather than detailed clinical validation or AI performance studies which would typically include the requested information.

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