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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.

Device Description

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.

AI/ML Overview

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:

Acceptance Criteria (Not explicitly stated in text for calcium scoring)	Reported Device Performance (Summary from text for calcium scoring)
No specific quantitative criteria are provided in the document for the calcium scoring feature. For example, it does not specify a target accuracy for calcium score measurement, a minimum detectability of calcifications, or a maximum acceptable motion artifact level.	"the proposed device can obtain clinically acceptable
calcium scoring images."

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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K Number

K181414

Device Name

uCT 530, uCT 550

Manufacturer

Shanghai United Imaging Healthcare Co., Ltd.

Date Cleared

2018-08-14

(76 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K172135

Intended Use

The uCT Computed Tomography X-ray System uCT 530/550 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, vascular).

Device Description

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, Xray 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.

AI/ML Overview

The provided text does not contain acceptance criteria or a detailed study that proves the device meets specific acceptance criteria in the format requested.

Instead, the document is a 510(k) summary for a Computed Tomography X-ray System (uCT 530, uCT 550) seeking FDA clearance based on substantial equivalence to a predicate device (uCT 760, uCT 780).

Here's what can be extracted and inferred from the text regarding performance, though it doesn't meet all your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a comparison table of technological characteristics between the proposed device (uCT 530, uCT 550) and a predicate device (uCT 760, uCT 780). While not explicitly "acceptance criteria" against numerical targets, it implies that comparable performance to the predicate is the acceptance criterion for substantial equivalence.

ITEM	Acceptance Criteria (Implicit: Similar to Predicate)	Reported Device Performance (uCT 530, uCT 550)	Notes/Differences from Predicate
Intended Use	The uCT Computed Tomography X-ray System 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 and vascular).	The uCT Computed Tomography X-ray System uCT530/uCT550 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, vascular).	Note 1: Does not include cardiac, but states this does not affect safety and effectiveness.
Product Code	JAK	JAK	Same
Regulation No.	21 CFR 892.1750	21 CFR 892.1750	Same
Class	II	II	Same
Scan Regime	Continuous Rotation	Continuous Rotation	Same
Scan Modes	Scout, Axial Scan, Helical Scan	Scout, Axial Scan, Helical Scan	Same
Detector Material	Solid-state GOS	Solid-state GOS	Same
Z-plane coverage	40mm	22mm	Note 2: Shorter coverage induces longer scanning time, but does not affect safety and effectiveness.
Size of detector element in Z-plane	0.5mm	0.55mm	Note 3: Bigger minimum element size induces lower spatial resolution, but does not affect safety and effectiveness.
Number of element per row	936	864	Note 4: Smaller number of elements induces less data sampling but provides sufficient data for reconstruction, not affecting safety and effectiveness.
Number of detector row	80	40	Note 5: Determined by Z-plane coverage and element size, not affecting safety and effectiveness.
Maximum slices generated per rotation	128 for uCT 760, 160 for uCT 780	40 for uCT 530, 80 for uCT 550	Note 6: Smaller slice number induces longer scanning time, but does not affect safety and effectiveness.
Minimum slice thickness	0.625mm for uCT 760, 0.5mm for uCT 780	0.55mm	Note 7: Determined by detector element size, not affecting safety and effectiveness.
Maximum sampling rate	Up to 4800 views per 360°	Up to 4800 views per 360°	Same
Tube anode storage capacity	7.5MHU	5.3MHU	Note 8: Lower capacity affects continuous scans' throughput, but not independent scans' effect.
Maximum cooling rate	1386 kHU/min	815 kHU/min	Note 9: Lower rate affects continuous scans' throughput, but not independent scans' effect.
Focal spot size	0.7x0.7mm, 1.0x1.0mm	0.5x1.0mm, 1.0x1.0mm	Note 10: Smaller size helps resolution, but image spatial resolution is "equivalent substantially."
Power	80kW for uCT 760, 100 kW for uCT 780	50kW	Note 11: Smaller power output induces lower ability of x-ray penetration for high BMI, but safety evaluated.
mA Range	6-667mA for uCT 760, 6-833mA for uCT 780	10-420mA	Note 12: Smaller mA output induces lower ability of x-ray penetration for high BMI, but safety evaluated.
kV Settings	70, 80, 100, 120, 140	70, 80, 100, 120, 140	Same
Aperture	700mm	700mm	Same
Rotation speed	Up to 0.35 sec per 360° rotation for uCT 760, Up to 0.3 sec per 360° rotation for uCT 780	Up to 0.5 sec per 360° rotation	Note 13: Slower rotation speed induces longer scan time, but does not affect safety and effectiveness.
Gantry Tilt	± 30° with 0.5 increment	± 30° with 0.5 increment	Same
Scannable range	1700 mm	1700 mm	Same
Horizontal motion range	2180 mm	2180 mm	Same
Table Horizontal Speed	Up to 200mm/sec	Up to 200mm/sec	Same
Vertical motion range	480 mm-950 mm from the floor	480 mm-950 mm from the floor	Same
Vertical speed	Up to 40 mm/sec	Up to 40 mm/sec	Same
Table Horizontal Position accuracy	± 0.25mm	± 0.25mm	Same
Table Maximum table load	205kg	205kg	Same
Image Spatial Resolution	High mode: >20 lp/cm @ MTF 0%, 16.5 ± 1.7 lp/cm @ MTF10%, 11.5 ± 1.2 lp/cm @ MTF50%	High mode: >20 lp/cm @ MTF 0%, 16.5 ± 1.7 lp/cm @ MTF10%, 11.5 ± 1.2 lp/cm @ MTF50%	Same
Image Noise	3.0 ± 0.5 HU at 120 kV, 5 mm slice thickness, CTDIvol 29.1mGy	3.0 ± 0.5 HU at 120 kV, 5 mm slice thickness, CTDIvol 28.9 mGy	Note 14: Noise level is "equivalent substantially" considering slightly different CTDIvol.
CT Number Display Range	-1024 ~+8191 HU	-1024 ~+8191 HU	Same
Scan Field of View	Up to 500 mm, 600mm with extend FOV	Up to 500 mm, 600mm with extend FOV	Same
Reconstruction Field of View	40mm-500mm, 40mm-600mm with extend FOV	40mm-500mm, 40mm-600mm with extend FOV	Same
Maximum scannable length	1700mm	1700mm	Same
Image Matrix	Up to 1024 x 1024	Up to 1024 x 1024	Same
Reconstructed slice thickness	uCT 760: 0.625mm,1.25mm,2.5mm,5mm,10mm (axial), 0.625-10mm(helical); uCT 780: 0.5mm,0.625mm,1.25mm,2.5mm,5mm,10mm (axial), 0.5-10mm (helical)	0.55mm,1.1mm,2.2mm,5.5mm,11mm (axial), 0.55-10mm(helical)	Note 15: More slice thickness options for predicate, but similar capabilities overall, not affecting safety/effectiveness.
Pitch	0.1~2.0	0.1~2.0	Same
Maximum continuous exposure time	Up to 100seconds	Up to 100seconds	Same
Electrical Safety	Comply with ES60601-1	Comply with ES60601-1	Same
EMC	Comply with IEC60601-1-2	Comply with IEC60601-1-2	Same
Biocompatibility	Patient Contact Materials were tested and demonstrated no cytotoxicity (ISO 10993-5), no evidence for irritation and sensitization (ISO 10993-10).	Patient Contact Materials were tested and demonstrated no cytotoxicity (ISO 10993-5), no evidence for irritation and sensitization (ISO 10993-10).	Same
Iterative noise reduction	KARL 3D	KARL 3D	Same
Adaptive Filter	Adaptive Filter	Adaptive Filter	Same
Metal artifact reduction	MAC	MAC	Same

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "Clinical Evaluation for sample clinical images evaluation" and "sample clinical images for proposed devices are provided in Section 36 Clinical Evaluation. Electronic file for each image are provide in MISC Folder." However, it does not specify the sample size of the test set for image evaluation or the data provenance (e.g., country of origin, retrospective/prospective). It only refers to "sample clinical images."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not provide information on the number of experts used, their qualifications, or how ground truth was established for the "sample clinical images."

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention a MRMC comparative effectiveness study or any effect size of AI assistance for human readers. This device is a CT scanner, not an AI-assisted interpretation tool in the context of this submission. The "KARL iterative denoising reconstruction algorithm and MAC Metal artifact correction algorithm" are features of the CT system itself, not necessarily AI for reader improvement.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

As mentioned above, the device is a CT scanner. Its performance verification focuses on technical specifications (e.g., Image Spatial Resolution, Image Noise). The "KARL iterative denoising reconstruction algorithm" and "MAC Metal artifact correction algorithm" are integral parts of the image reconstruction process, not standalone interpretive algorithms. Therefore, a separate "standalone" performance for an interpretive algorithm is not applicable in the context described.

7. Type of Ground Truth Used

For the "sample clinical images evaluation," the type of ground truth is not specified. It refers to "sample clinical images," implying they are real patient images, but how their "truth" was confirmed (e.g., pathology, subsequent expert consensus) is not detailed. For the technical performance parameters (e.g., image noise, spatial resolution), the "ground truth" is typically established through phantom studies and objective measurements according to industry standards.

8. Sample Size for the Training Set

The document does not mention a training set sample size. This submission is for a CT scanner and its image reconstruction algorithms, not a deep learning AI model that typically requires a large training set of labeled data for classification or detection tasks. While iterative reconstruction algorithms have parameters that might be "trained" or optimized, the document does not discuss this in the context of a "training set" of patient images.

9. How the Ground Truth for the Training Set Was Established

Since no training set and its ground truth are mentioned (as per point 8), this information is not provided.

In summary: The provided document is a 510(k) summary focused on demonstrating substantial equivalence of a new CT system to a predicate device based on technical specifications and functional capabilities. It does not contain the detailed clinical study design, acceptance criteria (beyond substantial equivalence to predicate), and performance metrics typically associated with AI-driven diagnostic software, especially concerning human reader performance or defined ground truth for clinical datasets. The "Performance Verification" section lists standards compliance and "Clinical Evaluation for sample clinical images evaluation" but lacks the specifics requested.

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