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The CURA CT16/ScintCare CT16 is a Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data collected at different angles and planes. The system may include signal analysis and display equipment supports, components and accessories. The system is suitable for all patients.

Device Description

The CURA CT16/ScintCare CT16 computed tomography (CT) scanner is a medical imaging device utilizing X-ray computed tomography to obtain images of the entire body. The CURA CT16/ScintCare CT16 is a high performance imaging system that uses retina Solid State Detector technology to ensure high image quality. It uses ultrafast scintillator technology and application optimized algorithm to enhance image details and integrated anti-scatter grid (ASG) and A/D technology (ASIC) to maximize SNR. It produces better image quality by innovative calibration algorithms. Efficient design of the gantry helps achieve structural stability under high G-Load and optimize the air flow to guarantee long thermal stability for wide range of ambient temperature and pleasant user experience.

The primary components of this system include the gantry, patient table, operator console and power distribution unit. Patient images are acquired, through the use of both hardware and software, via a rotating X-ray tube and detector array on the opposite side. The collected data is transmitted to the operator console for reconstruction into cross-sectional images.

The CURA CT16/ScintCare CT16 is designed for use in a controlled clinical setting, to collect X-ray images that aid in the diagnosis and treatment of various medical conditions by a physician or similarly licensed medical professional. The CURA CT16/ScintCare CT16 is intended for use by an appropriately trained or licensed professional, such as a physician, CT X-ray technician, or field service engineer. This device is restricted to sale by or on the order of a physician or similarly licensed medical professional (i.e. by prescription only).

The CURA CT16/ScintCare CT16 system is a stationary full gantry is comprised of several subsystems, including the X-ray tube, pre-patient collimator, detector array, cooling fans, power distribution unit, high voltage inverter, high voltage generator, data collection board (DCB) electronics and support electronics. The gantry is organized into two distinct sections, the stator (stationary elements) and the rotor (rotating elements). Slip rings are utilitate the transfer of electrical power and data between the gantry rotor and stator.

The CURA CT16/ScintCare CT16 system software implements many of the CURA CT16/ScintCare CT16 Whole Body system scanner. Among the functions performed by the software are:

Entering and editing protocol, patient, and scan parameter data
Initiating scans, executing scan protocols, monitoring status, and responding to faults
Collecting image data and generating image views
Image viewing (3d reconstruction, MPR, CPR, MIP)
Image analysis (ROI)
Reporting and image filming
Exporting data for external viewing or printing
Performing calibrations
Performing diagnostics
Metal artifact reduction is a capability of the system software, but is currently a future option.
Iterative reconstruction is a capability of the system software, but is currently a future option.
Dose modulation feature (imA) is a capability of the system software, but is currently a future option.

AI/ML Overview

The provided text describes a Computed Tomography (CT) X-Ray System (CURA CT16/ScintCare CT16) and its substantial equivalence to a predicate device (Siemens SOMATOM Emotion 16). The document does not detail specific acceptance criteria or a dedicated study explicitly designed to "prove" the device meets acceptance criteria in the manner of a clinical efficacy study for an AI algorithm. Instead, it focuses on demonstrating substantial equivalence to a legally marketed predicate device through technical comparisons and compliance with relevant safety and performance standards.

However, based on the information provided, we can infer performance aspects and an evaluation approach.

Key takeaway: The document emphasizes substantial equivalence to a predicate device and compliance with safety and performance standards for CT systems, rather than presenting a performance study with acceptance criteria for a novel AI component.

Here's an attempt to extract and interpret the requested information based on the provided text, recognizing that some points might not be directly available for this type of submission:

1. Table of acceptance criteria and reported device performance:

The document doesn't present explicit "acceptance criteria" in the format of specific quantitative thresholds unique to the CURA CT16/ScintCare CT16 for a particular clinical application. Instead, it relies on demonstrating that its technical specifications are comparable to or exceed those of the predicate device, which is already deemed safe and effective. The "performance" described is largely the inherent function of a CT system and its technical specifications compared to the predicate.

Characteristic / Performance Aspect	Acceptance Criteria (Inferred from Predicate Equivalence)	Reported Device Performance (CURA CT16/ScintCare CT16)
Indications for Use	Consistent with the predicate (produce cross-sectional images of the body by computer reconstruction of X-ray transmission data from different angles and planes).	Produce cross-sectional images of the body by computer reconstruction of X-ray transmission data collected at different angles and planes. Suitable for all patients. Includes potential for signal analysis, display equipment, patient/equipment supports, components, and accessories.
Scan Modes	Equivalent to predicate (Surview/Scout, Helical, Axial).	Scout (surview), Helical, Axial, Multi-Axial. (Compares favorably)
Gantry Aperture (bore) size	70 cm (consistent with predicate).	70 cm. (Compares favorably)
Gantry Tilt	+/- 30 degrees (consistent with predicate).	+/- 30 degrees. (Compares favorably)
Patient Supports	Included (consistent with predicate).	Included. (Compares favorably)
Patient Table Scan Range	At least 160 cm (1600 mm) (predicate's typical range).	1700 mm (170 cm). (Slightly greater, but deemed not to affect safety or efficacy).
Generator Power Rating	50 kW (consistent with predicate).	50 kW. (Compares favorably)
kVp Settings	Similar range to predicate (80, 110, 130 kV).	80, 100, 120, 140 kV. (Similar range, with 80 kVp identical, difference deemed not to affect safety or efficacy).
mA Range (step size)	Similar to predicate (20-345 mA, 1 mA steps).	10 – 420 mA (10 mA steps). (Greater range and larger step size, deemed not to affect safety or efficacy).
Focal Spot Size	Comparable to predicate (0.8 x 0.5 mm, 0.8 x 0.7 mm).	0.7 mm x 1.2 mm (small), 1.2 mm x 1.2 mm (large). (Greater, deemed not to affect safety or efficacy).
Anode Effective Heat Capacity	5 MHU (consistent with predicate).	5.3 MHU. (Slightly greater, deemed not to affect safety or efficacy).
X-ray Tube, Max Applied Power	345 mA (consistent with predicate).	420 mA. (Greater, deemed not to affect safety or efficacy).
Detectors	Solid state array, ultra-fast ceramic (UFC) (consistent with predicate).	Solid-state ultra-high speed rare earth ceramic scintillator. (Compares favorably)
Slices	16 slices (consistent with predicate).	16 slices. (Compares favorably)
Coverage	Maximum 1500 mm (consistent with predicate).	Maximum 1700 mm. (Greater, deemed not to affect safety or efficacy).
Image Quality Evaluation	Satisfactory image quality for diagnostic purposes as determined by a certified radiologist for sample images.	"Sample clinical images have been provided within the submission. The image quality has been evaluated by a certified radiologist." (Implicitly, the image quality was found acceptable.)
Safety and Effectiveness	Demonstrated by successful completion of verification and validation testing, risk management, and conformance to international standards (e.g., IEC 60601-1, IEC 61223-3-5).	"Successful completion of verification and validation testing, risk management activities and conformance to international standards." Specific standards listed include IEC 60601-1, -1-2, -2-44, -1-3, IEC 60825-1, IEC 61223-3-5, IEC 62366-1, ISO 14971, ISO 13485, and relevant CFRs.

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

Test Set Sample Size: The document mentions that "Sample clinical images have been provided within the submission" for image quality evaluation. However, it does not specify the number of sample images (cases) used in this evaluation.
Data Provenance: Not explicitly stated. The document indicates that FMI Medical Systems Inc. is based in Solon, Ohio, USA, but does not provide information on the country of origin for the clinical images. It also does not specify if the data was retrospective or prospective.

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

Number of Experts: "The image quality has been evaluated by a certified radiologist." This phrasing suggests one certified radiologist performed the evaluation.
Qualifications of Experts: The expert was a "certified radiologist." No further details on years of experience or specific subspecialty are provided.

4. Adjudication method for the test set:

Not applicable or not specified. With likely only one radiologist reviewer mentioned for "sample clinical images," there would be no need for an adjudication method in the traditional sense (e.g., 2+1, 3+1). The radiologist's assessment would be the sole evaluation of the sample images 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:

MRMC Study: No, an MRMC comparative effectiveness study was not conducted or reported for this submission. The device is a CT scanner, not an AI-powered diagnostic aid designed to assist human readers.
Effect Size of AI Improvement: Not applicable, as this is not an AI-based diagnostic assistance device.

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

Standalone Study: No, a standalone performance study in the context of an AI algorithm was not conducted or reported. The CURA CT16/ScintCare CT16 is a medical imaging device (CT scanner). While it has an application-optimized algorithm for image details and innovative calibration algorithms, and mentions future options for Metal Artifact Reduction and Iterative Reconstruction (which are algorithmic in nature), the submission does not present a standalone performance evaluation of these algorithms as a separate performance claim. The "device performance" refers to the entire CT system.

7. The type of ground truth used:

For the evaluation of "sample clinical images" by the certified radiologist, the "ground truth" would implicitly be the diagnostic interpretation and assessment of image quality by a human expert (the certified radiologist). There is no mention of pathology, outcomes data, or other independent forms of ground truth for these specific samples in the context of this submission. The overall ground truth for the device's safety and effectiveness relies on its performance against established engineering and medical device standards, and substantial equivalence to a predicate device.

8. The sample size for the training set:

Not applicable. This submission is for a Computed Tomography X-Ray System, not an AI/Machine Learning algorithm that requires a training set in the typical sense for image interpretation. The algorithms mentioned (application optimized, innovative calibration, future options for MAR/Iterative Reconstruction) are part of the CT system's processing, but their development (if they involved ML) is not detailed here.

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

Not applicable, as this is not an AI/Machine Learning algorithm submission with a defined "training set" in the context of image interpretation.

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