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510(k) Data Aggregation
(167 days)
The CURA 778 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 CURA 778 scanner is a whole body scanner, with cardiac and vascular X-ray Computed Tomography applications in patients of all ages.
The CURA 778 scanner is a medical imaging device utilizing X-ray computed tomography (CT) to obtain images of the entire body. The CURA 778 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 778 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 778 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 778 system is a stationary full gantry device. The 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 utilized to facilitate the transfer of electrical power and data between the gantry rotor and stator.
The CURA 778 system software implements many of the CURA 778 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
- Dose modulation feature (imA)
- . Integrate a 30 party device for cardiac image processing, CREALIFE Anythink PACS Workstation, K131299 (510(k) number).
The CURA 778 is a Computed Tomography X-Ray system. The provided text details the device's characteristics and compares it to two predicate devices (Philips Ingenuity CT and CURA 16) to establish substantial equivalence. However, the document does not present specific acceptance criteria in the form of a table with numerical thresholds for performance metrics that the device had to meet and then report the device's performance against those criteria. Instead, it argues for substantial equivalence based on comparable design, intended use, technology, and performance, asserting that any differences do not affect safety or efficacy.
The document mentions "Performance Testing" which states: "The CURA 778 system was tested to ensure it functions as intended throughout the design process. The executed test documents were reviewed for accuracy and appropriateness as part of the design of the system. Additionally, evidence of dosimetric testing has been provided within this submission and was performed to ensure the allowable limits set forth by FMI Medical Systems are accurate and achievable by the system. Sample clinical images have been provided within the submission. The image quality has been evaluated by a certified radiologist."
This indicates that:
- Performance Testing was done: The device was tested to ensure it functions as intended, with dosimetric testing and image quality evaluation.
- Ground Truth for Image Quality: A certified radiologist evaluated image quality.
However, the specific "acceptance criteria" and "reported device performance" in a quantitative, side-by-side table are not explicitly provided in the furnished text. The tables provided are primarily for comparative characteristics between the CURA 778 and its predicates, aiming to demonstrate substantial equivalence, rather than a direct presentation of acceptance criteria and measured performance of the CURA 778 against those criteria.
Therefore, I cannot populate the requested table entirely as the specific acceptance criteria and the exact reported device performance against those criteria are not detailed in the provided text. The tables given show comparisons of specifications between the proposed device and predicates, with comments indicating "Compares favorably" or explaining why differences do not affect safety or efficacy, which serves the purpose of demonstrating substantial equivalence rather than fulfilling a predefined set of acceptance criteria.
Also, the document does not contain information on:
- Sample size used for the test set
- Data provenance (e.g. country of origin of the data, retrospective or prospective)
- Number of experts used to establish the ground truth for the test set
- Qualifications of those experts (other than "certified radiologist")
- Adjudication method
- Multi-reader multi-case (MRMC) comparative effectiveness study
- Effect size of human readers improvement with AI assistance
- Standalone (algorithm only without human-in-the-loop performance) study
- Type of ground truth used (other than for image quality evaluation by a radiologist)
- Sample size for the training set
- How the ground truth for the training set was established
Based on the provided text, here’s what can be extracted and what is missing:
Acceptance Criteria and Study for CURA 778
1. Table of Acceptance Criteria and Reported Device Performance
As noted above, the document does not provide a table of explicit acceptance criteria with specific numerical thresholds and the CURA 778's measured performance against them. Instead, it uses comparative tables with predicate devices to demonstrate substantial equivalence in terms of design, specifications, and intended use. The "Comments" column in these tables serves as a narrative for why the CURA 778's specifications are considered acceptable relative to the predicate.
| Feature / Metric | Acceptance Criteria (from Document) | Reported Device Performance (from Document) | Comments in Document (Substantial Equivalence) |
|---|---|---|---|
| Indications for Use | Consistent with predicate | Whole body, cardiac, vascular X-ray CT applications in patients of all ages, with signal analysis and display equipment, patient and equipment supports, components and accessories. | The CURA 778 proposed indications for use are consistent with the predicate. Both systems are capable of imaging in axial and spiral planes, at multiple angles. Indication of potential for signal analysis and display equipment, patient and equipment supports, components and accessories. Whole body scanner, with cardiac and vascular X-ray Computed Tomography applications in patients of all ages. (Note: Philips Ingenuity adds low dose CT lung cancer screening, which CURA 778 does not explicitly state it has, but this difference does not affect safety/efficacy for the stated indications). |
| Application | Full body (includes head) | Full body (includes head) | Compares favorably |
| Scan Regimen | Continuous rotation | Continuous rotation | Compares favorably |
| Scan Modes | Scout, Helical, Axial, Multi-Axial | Scout (Surview), Helical, Axial, Multi-Axial (Step and Shoot) | Compares favorably |
| Gantry Aperture | 70 cm | 70 cm | Compares favorably |
| Gantry Tilt | +/-30 degrees | +/-30 degrees | Compares favorably |
| Focus – Isocenter Distance | Similar to predicate (~570mm) | 558 mm | Isocenter distance for CURA 778 is 12 mm smaller than the predicate. This difference does not affect safety or efficacy. (When compared to Ingenuity CT). Compares favorably (When compared to CURA 16, both 558mm) |
| Focus – Detector Distance | Similar to predicate (~1040mm) | 950.25 mm | Detector distance for the CURA 778 is 89.75 mm smaller than the predicate. This difference does not affect safety or efficacy. (When compared to Ingenuity CT). Detector distance for the CURA 778 is 1.58 mm length than the predicate. This difference does not affect safety or efficacy. (When compared to CURA 16). |
| Rotation Times | Similar to predicate (0.4-2.0s) | 0.39, 0.5, 0.75, 1.0, 1.5, 2.0 seconds | Rotation time capability for CURA 778 (ranges from 0.39 to 2.0 seconds) is similar to the predicate (ranges from 0.4 to 2.0 seconds). For CURA 778, 5 out of 6 specific settings are identical. This does not affect safety or efficacy. (When compared to Ingenuity CT). Rotation time capability for CURA 778, 5 out of 6 specific settings (0.5, 0.75, 1.0, 1.5, and 2.0 seconds) are identical to the predicate. 0.39 second is the enhancement for this 64 row/128 slices machine. This does not affect safety or efficacy. (When compared to CURA 16). |
| Patient Supports | Included | Included | Compares favorably |
| Patient Table Scan Range | Similar to predicate (2000mm or 1700mm) | 1700 mm | The patient table scan range is 300 mm shorter than the predicate. This difference does not affect safety or efficacy. (When compared to Ingenuity CT). Compares favorably (When compared to CURA 16, both 1700mm). |
| Table Z-Position Accuracy | +/- 0.25 mm | +/- 0.25 mm | Compares favorably |
| Table Longitudinal Speed | Similar/Greater than predicate (1-100 mm/s or 1-150mm/s) | Up to 200 mm / second | The maximum speed capability of the CURA 778 is 100 mm/sec greater than the predicate. This difference does not affect safety or efficacy. (When compared to Ingenuity CT). The maximum speed capability of the CURA 778 is 50 mm/sec greater than the predicate. This difference does not affect safety or efficacy. (When compared to CURA 16). |
| Table Maximum Load Capacity | Similar to predicate (204kg or 205kg) | 205 kg | Table load capacities are similar. The table supports 1 additional kilogram compared to the predicate. This difference does not impact safety or efficacy. (When compared to Ingenuity CT). Compares favorably (When compared to CURA 16, both 205kg). |
| Generator Power Rating | Similar to predicate (80kW or 50kW) | 80 kW | Compares favorably (When compared to Ingenuity CT, both 80kW). Compares favorably (When compared to CURA 16, 50kW predicate vs 80kW proposed, still favorable). |
| kVp Settings | Similar to predicate | 80, 100, 120, 140 kV | Compares favorably (When compared to Ingenuity CT). CURA 778 has similar kV setting compared with CURA 16. This difference does not affect safety or efficacy. (When compared to CURA 16, which had 80, 110, 130 kV). |
| mA Range (Step Size) | Similar to predicate | 10 – 660 mA (10 mA steps) | The mA range for the CURA 778 (10 – 660 mA) is similar than the predicate (20 – 665 mA). Also, the step size (10 mA) is greater than that of predicate (1 mA). These differences do not affect safety or efficacy. (When compared to Ingenuity CT). The mA range for the CURA 778 (10 – 660 mA) is bigger than the predicate (10 – 420 mA), while has the same step size (10 mA). Bigger range enables more patient scan capacity and some specific application protocols. These differences do not affect safety or efficacy. (When compared to CURA 16). |
| Focal Spot Size | Similar to predicate | Small: 0.6 mm x 1.2 mm, Large: 1.1 mm x 1.2 mm | The focal spot sizes for the CURA 778 are greater than those of the predicate. This difference does not affect safety or efficacy. (When compared to Ingenuity CT's 0.5x1.0mm and 1.0x1.0mm). The focal spot sizes for the CURA 778 specs are smaller than those of the predicate. This difference does not affect safety or efficacy. (When compared to CURA 16's 0.7x1.2mm and 1.2x1.2mm). |
| Anode Effective Heat Capacity | Similar/Greater than predicate (8.0 MHU or 5.3MHU) | 8.0 MHU | Compares favorably (When compared to Ingenuity CT, both 8.0 MHU). CURA 778 anode effective heat capacity is bigger than the predicate (CURA 16, 5.3MHU). Bigger heat capacity enables more patient scan possibility and some specific application protocols. These differences do not affect safety or efficacy. |
| X-ray Tube Max Applied Power | Similar to predicate (665mA or 420mA) | 660 mA | X-ray tube maximum applied power for the CURA 778 is 5 mA smaller than the predicate. This difference does not affect safety or efficacy. (When compared to Ingenuity CT). X-ray tube maximum applied power for the CURA 778 is 240 mA bigger than the predicate. This difference does not affect safety or efficacy. (When compared to CURA 16). |
| Detectors | Solid-state GOS or similar | Solid-state GOS | Compares favorably (When compared to Ingenuity CT). Compares favorably (When compared to CURA 16, which used "Solid-state ultra-high speed rare earth ceramic scintillator"). |
| Slices | Similar/Greater than predicate (128 slices or 16 slices) | 128 slices | Compares favorably (When compared to Ingenuity CT, both 128 slices). CURA 778 is a 128 slices product, while CURA 16 is a 16 slices one. This difference does not affect safety. 128 slices can have more features, for example cardiac. |
| Coverage | Similar/Greater than predicate (40mm or 18.56mm) | 40 mm | Compares favorably (When compared to Ingenuity CT, both 40mm). Coverage for the CURA 778 is 21.44 mm wider than the predicate. This difference does not affect safety. With bigger coverage detector, product can have more features, for example cardiac. (When compared to CURA 16). |
| Slice Thickness (Axial Reconstruction) | Similar range and options to predicate | 0.5mm, 0.625mm, 1.25mm, 2.5mm, 5mm, 10mm (for axial) | For reconstruction of axial images, the range of and number of options for slice thickness are similar between the CURA 778 and the predicate. Multiple options provide the user with the ability to select parameters that support required image quality and capture the target area of interest. The differences do not affect safety or efficacy. |
| Slice Thickness (Helical Reconstruction) | Similar range and options to predicate | 0.5mm, 0.625mm, 1mm, 1.25mm, 2mm, 2.5mm, 3mm, 4mm, 5mm, 6mm, 7mm, 8mm, 9mm, 10mm (for helical) | For reconstruction of helical images, the range of and number of options for slice thickness are similar between the CURA 778 and the predicate. Multiple options provide the user with the ability to select parameters that support required image quality and capture the target area of interest. The differences do not affect safety or efficacy. |
| Scan Field | Similar to predicate | 250 mm, 500 mm | Compares favorably (When compared to Ingenuity CT). Compares favorably (When compared to CURA 16, starting from 500mm predicate to 250mm, 500mm optional). |
| Image Matrix | Similar options to predicate | 512 x 512, 1,024 x 1,024 (Optional) | The image matrix of the CURA 778 is less than the predicate (Ingenuity CT, which has 512x512, 768x768, 1024x1024). This difference does not affect safety or efficacy. The image matrix of the CURA 778 has more option than the predicate (CURA 16, only 512x512). This difference does not affect safety or efficacy. |
| Image Quality | Implied adequate | Evaluated by a certified radiologist | "Sample clinical images have been provided within the submission. The image quality has been evaluated by a certified radiologist." |
| Dosimetric Performance | Implied within allowable limits | Evidence provided within submission | "Evidence of dosimetric testing has been provided within this submission and was performed to ensure the allowable limits set forth by FMI Medical Systems are accurate and achievable by the system." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text. The text mentions "Sample clinical images have been provided," but no details on their origin or nature (retrospective/prospective) are given.
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: "A certified radiologist" evaluated image quality. No further details (e.g., years of experience, subspecialty) are provided.
4. Adjudication method for the test set:
- Not specified in the provided text.
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 or AI assistance evaluation is mentioned for this device. The CURA 778 is described as a Computed Tomography X-Ray system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not mentioned, as the device is a CT scanner, not an AI algorithm.
7. The type of ground truth used:
- For image quality, "evaluation by a certified radiologist" served as the ground truth.
- For dosimetric performance, "allowable limits set forth by FMI Medical Systems" were used as criteria.
- For other functional and technical specifications, compliance with engineering design and relevant standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-44, IEC 60601-1-3, IEC 60825-1, IEC 61223-3-5, IEC 62366-1) implies conformance to established physical and performance benchmarks, which effectively serve as a form of ground truth for those technical aspects.
8. The sample size for the training set:
- Not applicable/Not mentioned, as this is a hardware device (CT scanner) and not an AI algorithm that typically requires a large training dataset. The software mentioned (e.g., "Image viewing (3d reconstruction, MPR, CPR, MIP), Image analysis (ROI), Dose modulation feature (imA)") are standard CT functionalities, not typically requiring "training sets" in the machine learning sense.
9. How the ground truth for the training set was established:
- Not applicable/Not mentioned for the reasons stated in point 8.
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(370 days)
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.
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.
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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