(231 days)
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).
The uCT 760/780 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, Vital Signal Module 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 crosssectional 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.
This proposed device includes two models: uCT 760, 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 provided text describes a 510(k) summary for the uCT 760 and uCT 780 Computed Tomography X-ray systems, comparing them to a predicate device (Philips Plus CT scanner, models Brilliance 40 & 64). However, the document does not contain specific acceptance criteria and detailed study results for device performance.
Instead, it focuses on demonstrating substantial equivalence to the predicate device through comparisons of:
- Technological Characteristics: Listed in Table 1, detailing various specifications like detector material, slice thickness, power, mA range, kV settings, and image resolution.
- Application Features: Listed in Table 2, highlighting iterative noise reduction (KARL 3D vs. iDOSE) and metal artifact reduction (MAC vs. MAR).
The document states:
- "No Clinical Study is included in this submission." (Page 13)
- Performance data were provided through "Non-Clinical Testing including dosimetry and image performance tests" (Page 11). These tests were conducted during product development, but specific acceptance criteria and the results are not detailed in this provided summary.
- It mentions "Clinical Evaluation for sample clinical images evaluation," "Artifact Evaluation Report for MAC performance study," and "Iterative Denoising Test Report for KARL performance study" as part of performance verification, but the actual data, methodologies, and acceptance criteria for these evaluations are not presented.
Therefore, based solely on the provided text, I cannot extract a table of acceptance criteria with reported device performance or details about the studies that prove the device meets these criteria as requested in your prompt. The document asserts that these tests were performed and the results supported the claim of substantial equivalence, but it does not provide the specifics.
However, I can extract the information that is present about the studies and evaluations:
1. A table of acceptance criteria and the reported device performance:
- Not explicitly provided in the document. The document lists technological specifications for the proposed device and compares them to the predicate, with remarks indicating when the proposed device's performance is "better" (e.g., higher spatial resolution, lower image noise with specific CTDIvol) or "equivalent substantially." These are not framed as "acceptance criteria" but rather as comparative technical specifications that support substantial equivalence.
2. Sample size used for the test set and the data provenance:
- Not provided. The document mentions "sample clinical images evaluation" but does not specify the number of images or their origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not provided. The document refers to "Clinical Evaluation for sample clinical images evaluation" but gives no details about the experts involved or how ground truth was established.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not provided.
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 MRMC study was done. The device itself is a CT scanner, not an AI-assisted diagnostic tool for human readers in the context of comparative effectiveness for improved diagnostic accuracy. Its features, KARL iterative denoising and MAC metal artifact correction, are integrated reconstruction algorithms. The document states "No Clinical Study is included in this submission."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, for certain aspects. The "Artifact Evaluation Report for MAC performance study" and "Iterative Denoising Test Report for KARL performance study" indicate standalone evaluations of these algorithms. However, explicit criteria and results are not provided. The main "device" (uCT 760/780) is a standalone system for image acquisition and reconstruction.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified. For the "Clinical Evaluation for sample clinical images," the method for establishing ground truth is not detailed. For the technical performance tests (e.g., image noise, spatial resolution), generally, these are measured against established phantoms and physical standards rather than clinical ground truth alone.
8. The sample size for the training set:
- Not applicable/Not provided. This device is a CT scanner with integrated reconstruction algorithms, not a machine learning model that would typically have a separate "training set" in the conventional sense of supervised learning. The algorithms (KARL, MAC) are developed through engineering and physics principles, likely refined using various datasets, but these are not specified as "training sets" in this context.
9. How the ground truth for the training set was established:
- Not applicable/Not provided. (See point 8)
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.