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The uCT Computed Tomography X-ray System uCT530/550 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 planes and indicated for the whole body, including head, neck, cardiac (calcium scoring) and vascular.

The uCT 530/uCT 550 is a multi-slice X-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system provides the filter back-projection (FBP) algorithm to reconstruct images in DICOM format, which can be used by post-processing applications. The system consists of the Gantry, X-ray System, Data Management System, Patient Table, Console, Power Supply Cabinet, Image Processing Computer, and Software. The system software is a program used for patient management, data management, X-ray scan control, image reconstruction, and image archive. A motorized patient table moves the patient through a circular opening in the Gantry. As the patient passes through the Gantry, a source of x rays rotates around the inside of the circular opening. Detectors on the exit side of the patient record the X rays exiting the section of the patient's body being irradiated as an X-ray "snapshot". Many different "snapshots" (angles) are collected during one complete rotation. The data are sent to a computer to reconstruct all of the individual "snapshots" into a cross-sectional image (slice) of the internal organs and tissues for each complete rotation of the source of x rays. There are two features for denoising and reduce metal artifact, which are KARL iterative denoising reconstruction algorithm and MAC Metal artifact correction algorithm.

The provided text does not contain the detailed acceptance criteria or a study proving the device meets specific performance criteria, especially for the newly added "cardiac (calcium scoring)" indication. The document is a 510(k) summary for a Computed Tomography X-ray System (uCT 530, uCT 550) seeking clearance for a modification that adds cardiac calcium scoring functionality.

Here's a breakdown of what is stated regarding performance and what is missing for the specific request:

What is provided:

• Device Name: uCT 530, uCT 550
• New Indication for Use: Cardiac (calcium scoring)
• Justification for new indication: ECG gating tests and sample clinical images evaluation of calcium scoring scan showed the proposed device can obtain clinically acceptable calcium scoring images.
• Performance Verification Tests conducted (general):
  • Clinical Evaluation for sample clinical images evaluation
  • AEC Test Report for AEC performance study
  • MAC Performance Evaluation Report (Metal Artifact Correction)
  • ECG R-Wave Detection Algorithm Performance Evaluation Report
• Standards Conformance: A wide range of electrical safety, EMC, product, software, and biocompatibility standards were conformed to.
• General assertion of equivalence: "The features described in this premarket submission are supported with the results of the testing mentioned above, the uCT 530/uCT 550 was found to have a safety and effectiveness profile that is similar to the predicate device."
• No Clinical Study: The document explicitly states "No Clinical Study is included in this submission."

What is missing from the document to answer your specific questions:

The document does not provide any specific quantitative acceptance criteria or detailed results of the studies for the new cardiac (calcium scoring) feature. It merely states that "ECG gating tests and sample clinical images evaluation of calcium scoring scan showed the proposed device can obtain clinically acceptable calcium scoring images." This is a general statement of positive outcome, not a detailed report of criteria or performance.

Therefore, for almost all your specific questions (1-7, and details for 8 and 9), the information is not present in the provided text.

Based on the provided text, I can only provide the following:

Acceptance Criteria and Study for uCT 530/550 (Cardiac Calcium Scoring)

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified. The document mentions "sample clinical images evaluation" but does not give a number of images or patients.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Adjudication Method: Not specified. The phrase "clinical images evaluation" implies assessment by experts, but the method (e.g., consensus, independent reads) is not detailed.

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:

• MRMC Study: No. The document explicitly states "No Clinical Study is included in this submission." The evaluation appears to be a review of image quality rather than a human-in-the-loop study with human readers.
• Effect Size: Not applicable, as no such study was conducted or reported.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• The document implies the system's ability to produce "clinically acceptable calcium scoring images" based on "ECG gating tests and sample clinical images evaluation." This suggests an assessment of the system's output, which can be considered a form of standalone performance evaluation for the imaging capability.
• The ECG R-Wave Detection Algorithm Performance Evaluation Report would be a standalone evaluation of a component algorithm. However, the details of its performance or acceptance criteria are not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Type of Ground Truth: The ground truth for "clinically acceptable" images would implicitly be based on expert subjective evaluation of the images. No objective ground truth (e.g., quantitative calcium scores from a reference standard, pathology confirmed calcifications, or patient outcomes) is mentioned.

8. The sample size for the training set:

• The document does not describe the training set for any algorithms, as it focuses on the device's substantial equivalence to predicates and its modified features. The mention of "KARL iterative denoising reconstruction algorithm" and "MAC Metal artifact correction algorithm" implies underlying algorithms, but their training data specifics are not provided.

9. How the ground truth for the training set was established:

• Not applicable, as details on training sets for any algorithms are not provided.

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