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The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The systems with 160 mm detector coverage have the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, liver, kidney, pancreas, etc. The system may acquire data using Axial, Cardiac, and Gated CT scan techniques from patients of all ages. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. Further, the images can be post processed to produce additional imaging planes or analysis results.

The system is indicated for head, whole body, cardiac, and vascular X-ray Computed Tomography applications.

The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.

If the spectral imaging option is included on the system can acquire CT images using different kV levels of the same anatomical region of a patient in a single source. The differences in the energy dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials. This approach enables images to be generated at energies selected from the available spectrum to visualize and analyze information about anatomical and pathological structures.

GSI provides information of the chemical composition of renal calculi by calculation and graphical display of the spectrum of effective atomic number. GSI Kidney stone characterization provides additional information to aid in the characterization of uric acid versus nonuric acid stones. It is intended to be used as an adjunct to current standard methods for evaluating stone etiology and composition.

The Revolution CT family of products, including Revolution CT, Revolution CT ES, Revolution CT with Apex edition, Revolution CT ES with Apex edition Apex, Revolution Apex Elite, Revolution Apex Plus, and Revolution Apex Select, Revolution CT Power, Revolution Apex Pro are multi-slice CT scanners consisting of a gantry, patient table, scanner desktop (operator console), system cabinet, power distribution unit (PDU), and interconnecting cables. The system includes image acquisition hardware, image acquisition and reconstruction software, and associated accessories.

GE has modified the cleared Revolution CT (K19177) within our design controls to include the 0.23 s/rot option. The 0.23s/rot option can be used with axial scan acquisitions and is especially beneficial during certain cardiac scan acquisitions. The scan workflow and user interface remain identical to the of the predicate device, with the exception that the user now has the option to select 0.23 s/rot in addition to other gantry rotation speeds.

The addition of a new maximum gantry rotation speed leads to updates to system performance claims about maximum temporal resolution when combined with the optional Snapshot Freeze 2 (K183161) feature.

The provided text does not contain detailed acceptance criteria for the device or a study explicitly proving the device meets said criteria. The document is a 510(k) premarket notification for a Computed Tomography (CT) system (Revolution CT family) that includes the addition of a 0.23 s/rot option. The focus of the submission is to demonstrate substantial equivalence to a predicate device (Revolution CT, K191777), not to present an independent study with explicit acceptance criteria for a novel device performance claim.

However, based on the information provided, we can infer some aspects related to evaluating the new 0.23 s/rot option:

Inferred Acceptance Criteria and Reported Device Performance (Focusing on the 0.23 s/rot option)

Detailed Breakdown of Study Information (Focusing on the 0.23 s/rot option):

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

   • Test Set Sample Size: Not explicitly stated by number of cases or patients. The non-clinical testing involved "a cardiac phantom" and "mathematical modeling." This implies a phantom-based study for physical performance and computational analysis.
   • Data Provenance: The study was non-clinical and conducted by the manufacturer, GE Medical Systems, LLC. It's an internal validation of the new feature.

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

   • This information is not provided in a way that aligns with "ground truth" for a clinical test set, as no clinical study was performed. The evaluation relied on technical performance metrics validated against engineering standards and a cardiac phantom, rather than expert interpretation of medical images.

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

   • Not applicable as there was no clinical test set requiring expert adjudication. The substantiation was based on physical measurements from a phantom and mathematical modeling.

4. 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 comparative effectiveness study was done. This submission is for a hardware/software update to a CT scanner, not an AI-assisted diagnostic tool.

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

   • The evaluation focused on the standalone performance of the CT system with the new gantry rotation speed. The "algorithm" here refers to the system's operational parameters and image reconstruction, rather than a diagnostic AI algorithm. The performance items were verified and substantiated through phantom studies and mathematical analysis.

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

   • For the non-clinical testing, the "ground truth" was likely established by:
     • Physical measurements/known properties of the cardiac phantom: For evaluating temporal resolution and other imaging characteristics.
     • Engineering specifications and mathematical models: To predict and verify performance parameters.

7. The sample size for the training set:

   • Not applicable in the context of this submission. The device is a CT scanner with a hardware and software update, not a machine learning algorithm that requires a specific "training set" of patient data in the typical sense. The development involved general engineering design, development, and verification processes.

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

   • Not applicable as there was no distinct "training set" for a machine learning model. The system's design and engineering would be based on established physics, engineering principles, and prior knowledge from existing CT technology, rather than a labeled training dataset.

Summary of the Study:

The study was a non-clinical performance evaluation conducted by GE Medical Systems, LLC. It involved:

• Engineering testing: To ensure compliance with electrical, mechanical, and safety standards (IEC 60601-1 Ed. 3.1, 21CFR Subchapter J, NEMA XR-25, XR-26, and XR-28).
• Performance evaluation testing: Utilized a cardiac phantom and mathematical modeling to technically substantiate claims related to the 0.23 s/rot option, particularly in conjunction with the Snapshot Freeze 2 feature for temporal resolution.
• Quality System Compliance: The development followed the Quality System Regulations of 21CFR 820 and ISO 13485, including risk analysis, technical reviews, design reviews, code inspections, and various levels of testing (unit, integration, performance, safety, simulated use).

The conclusion was that the device, with the new 0.23 s/rot option, is "as safe and effective, and performs in a substantially equivalent manner to the predicate device Revolution CT (K191777)." No clinical testing was deemed necessary because the modifications were fully testable on an engineering bench.

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The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system has the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, liver, kidney, pancreas, etc. The system may acquire data using Axial, Cine, Helical, Cardiac, and Gated CT scan techniques from patients of all ages may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. Further, the images can be post processed to produce additional imaging planes or analysis results.

The system is indicated for head, whole body, cardiac, and vascular X-ray Computed Tomography applications.

The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.

If the spectral imaging option is included on the system can acquire CT images using different kV levels of the same anatomical region of a patient in a single source. The differences in the energy dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials. This approach enables images to be generated at energies selected from the available spectrum to visualize and analyze information about anatomical and pathological structures.

GSI provides information of the chemical composition of renal calculi by calculation and graphical display of the spectrum of effective atomic number. GSI Kidney stone characterization provides additional information to aid in the characterization of uric acid versus nonuric acid stones. It is intended to be used as an adjunct to current standard methods for evaluating stone etiology and composition.

The Revolution CT family of products including Revolution CT. Revolution CT ES and Revolution Apex are multi-slice CT scanner consisting of a gantry, patient table, scanner desktop (operator console), system cabinet, power distribution unit (PDU), and interconnecting cables. The system includes image acquisition hardware, image acquisition and reconstruction software, and associated accessories. The Revolution CT ES has 128 detector rows with 80mm coverage while the Revolution CT and Revolution Apex have 256 detector rows with 160mm detector coverage.

GE has modified the cleared Revolution CT (K163213) within our design controls to include the SmartScout Option to offer optimized thermal management and improved workflow. The SmartScout mode, if selected by the user, allows for performance of tube warmups during patient scout scanning, eliminating user intervention and wait times for tube warmup. It quides the user to the optimal scout scanning parameters, in order to optimize image quality and dose during patient scanning. The user will still have access to the Regular Scout mode where all traditional routine scout technique settings can be accessed and manually prescribed, such as kV, mA, and cradle speed. SmartScout is an added capability and does not remove access to Regular scout mode.

The provided document is a 510(k) summary for the GE Revolution CT Family with the SmartScout option. It details the device's technical specifications, intended use, and a comparison to its predicate device. However, it explicitly states that no additional clinical testing was required for this submission.

Therefore, the document does not contain the information requested regarding acceptance criteria, performance data from a clinical study, sample sizes, expert ground truth establishment, or multi-reader multi-case studies, as these types of studies were not conducted for the justification of this specific modification (SmartScout).

The document notes: "The Revolution CT family with SmartScout can be fully tested on the engineering bench thus no additional clinical testing was required."

It emphasizes that "Qualitative and quantitative phantom studies demonstrate that the SmartScout delivers the similar CT Scout image quality at the similar size-appropriate dose levels (CTDIvol) compared to regular Scout scan." This indicates that the substantiation of performance was based on non-clinical phantom studies and engineering testing.

In summary, none of the requested information regarding clinical acceptance criteria or studies can be extracted from this document, as no such clinical studies were performed or reported for this 510(k) submission.

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The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different ans the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, liver, kidney, pancreas, etc. The system may acquire data using Axial, Cine, Helical, Cardiac, and Gated CT scan techniques from patients of all ages. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment supports, components and accessories.

This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. Further, the images can be post processed to produce additional imaging planes or analysis results

The system is indicated for head, whole body, cardiac, and vascular X-ray Computed Tomography applications.

The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.

If the spectral imaging option is included on the system can acquire CT images using different kV levels of the same anatomical region of a patient in a single rotation from a single source. The differences in the energy dependence of the attenuation coefficient of the different materials provide information of body materials. This approach enables images to be generated at energies selected from the visualize and analyze information about anatomical and pathological structures.

GSI provides information of the chemical composition of renal calculation and graphical display of the spectrum of effective atomic number. GSI Kidney stone characterization orovides addin the characterization of uric acid versus nonuric acid stones. It is intended to be used as an adjunct to current standard methods for evaluating stone etiology and composition.

The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table, scanner desktop (operator console), system cabinet, power distribution unit (PDU), and interconnecting cables. The system includes image acquisition hardware, image acquisition and reconstruction software, and associated accessories.

GE has modified the cleared Revolution CT (K133705) within our design controls to include the Gemstone™ Spectral Imaging (GSI) Option. GSI is the state-of-the-art single source, projection-based, spectral CT application. It is GE's unique dual energy design and implementation which offers clear advantage over traditional dual source Dual Energy implementation. This feature has been previously cleared on Discovery CT750 HD (K081105, K120833) and it is fundamentally the same technology on Revolution CT. Revolution CT however offers a few technology improvements to enable Volume GSI with up to 80mm GSI zcollimation, 245mm/s GSI volumetric scan speed, dose neutrality and more improved workflow to support GSI in routine scanning.

The provided text is a 510(k) summary for the GE Revolution CT with GSI option. The document describes the device, its intended use, and indicates that it is substantially equivalent to predicate devices. However, it does not explicitly detail acceptance criteria in a quantitative table or a specific study proving the device meets acceptance criteria in the way often associated with performance claims for AI/ML devices.

Instead, the document focuses on demonstrating substantial equivalence by outlining:

• Technological similarities and differences with predicate devices.
• Compliance with various industry standards (IEC, 21CFR Subchapter J, NEMA XR-25, XR-26, XR-28, XR-29).
• Adherence to quality system regulations (21CFR 820 and ISO 13485).
• Results from non-clinical (phantom) testing and clinical testing.

The clinical testing aimed to evaluate "image quality related to diagnostic use, reduction of metal artifacts using the MAR algorithm, and suppression of iodine in contrast enhanced acquisitions using VUE algorithm." The evaluation was based on a 5-point Likert scale by radiologists, indicating a subjective assessment of image quality and clinical acceptance rather than predefined quantitative performance metrics or acceptance criteria for a specific diagnostic task.

Therefore, many of the requested items cannot be fully extracted as they are not explicitly or quantitatively provided in the document.

Here's an attempt to answer based on the available information:

1. A table of acceptance criteria and the reported device performance

The document does not provide a quantitative table of acceptance criteria for diagnostic performance metrics (e.g., sensitivity, specificity, AUC) and therefore no numerical performance results against such criteria. The clinical assessment focused on "acceptable diagnostic imaging performance" and "image quality," which are qualitative statements derived from expert review.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size (Test Set): 51 subjects.
• Data Provenance: The clinical data was collected from two sites: one in the US and one in Canada. The study was prospective in the sense that it involved recruitment of patients and collection of clinical images for the specific evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of experts: 6 board-certified and qualified radiologists.
• Qualifications: "board certified and qualified radiologists at different institutions in the United States of America." (Specific years of experience are not mentioned).
• Ground Truth establishment for Test Set: This refers to the radiologists evaluating the images for "clinical acceptance and image quality using a 5 point Likert scale." This implies a subjective expert assessment of image quality for diagnostic use, reduction of metal artifacts, and suppression of iodine, rather than a definitive "ground truth" for a specific disease outcome or pathology.

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

• "Each data set was read by three different radiologists depending on their area of expertise." This implies a consensus or individual review approach, but the specific adjudication method (e.g., how disagreements between the three radiologists were resolved or combined into a single outcome) is not specified. It's unclear if a formal adjudication process like 2+1 or 3+1 was used, or if individual reads were separately analyzed.

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

The document describes an evaluation of the device’s image quality and diagnostic performance by multiple radiologists ("multi-reader"). However, it is not an MRMC comparative effectiveness study comparing human readers with AI assistance vs. without AI assistance. The study evaluated the images produced by the device (which includes the GSI option, a form of advanced image processing, but not explicitly framed as an 'AI assistance' to human interpretation in the common sense of AI CAD/X systems) directly for their diagnostic quality. Therefore, there's no reported effect size of human improvement with vs. without AI assistance.

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

The GSI functionality itself could be considered a form of "algorithm only" processing that produces specific images/data (e.g., material density maps, monochromatic images, virtual unenhanced images, information for kidney stone characterization). The document states GSI "provides information of the chemical composition of renal calculi by calculation and graphical display of the spectrum of effective atomic number" and "provides additional information to aid in the characterization of uric acid versus non-uric acid stones." This output is interpreted by humans. The testing described focuses on the quality of these generated images/information as assessed by radiologists, not on an automated diagnostic output from the algorithm itself without human interpretation. So, while GSI involves algorithms, it's not presented as a standalone diagnostic algorithm in the typical sense of AI/CAD systems providing a diagnosis.

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

• The "ground truth" for the clinical evaluation of the test set was essentially expert assessment/consensus based on image quality and clinical acceptance using a Likert scale. It was not based on definitive pathology, histology, or long-term outcomes data for establishing true disease presence or absence for a diagnostic accuracy study. For kidney stone characterization, it 'provides additional information' and is 'intended to be used as an adjunct to current standard methods for evaluating stone etiology and composition,' implying that the ultimate ground truth for stone composition would come from other established methods.

8. The sample size for the training set

The document does not explicitly mention a "training set" with a specified sample size. This device is an imaging system (CT scanner) with advanced image processing (GSI), not a machine learning model that would typically have a distinct training set for diagnostic classification in the same way. The technologies are based on physics and signal processing, using proprietary algorithms.

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

Since a "training set" for a machine learning model is not explicitly described, neither is the method for establishing its ground truth. The development of the GSI algorithms would have involved engineering and possibly empirical data to refine the material decomposition and image generation, but this is not characterized as a "training set" in the context of supervised learning.

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The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system has the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, liver , kidney, pancreas, etc.. The system may acquire data using Axial, Cine, Helical, Cardiac , and Gated CT scan techniques from patients of all ages. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

This device may include data and image processing to produce images in a variety of transaxial and reformatted planes. Further, the images can be post processed to produce additional imaging planes or analysis results

The system is indicated for head, whole body, cardiac, and vascular X-ray Computed Tomography applications.

The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.

The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table, scanner desktop (operator console), system cabinet, power distribution unit (PDU), and interconnecting cables. The system includes image acquisition hardware, image acquisition and reconstruction software, and associated accessories.

The system generates images through the computer reconstruction of data acquired at different angles and planes of the rotating gantry. The gantry rotates at up to 0.28 seconds per rotation, and can acquire up to 512 slices of image data per rotation with a maximum total coverage of 160 mm in the z direction. The gantry however is designed to be able to rotate at 0.20 second per rotation. The system can be operated in Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisition modes.

The Revolution CT system is a powerful Volume High Definition CT scanner that is designed to provide best-in-class technologies for whole organ coverage, high image quality and responsible dose performance with the following characteristics:

• 160 mm detector coverage
• 140ms temporal resolution (0.28s rot. Speed) combined with intelligent motion correction with SnapShot Freeze for excellent cardiac imaging at any heart rate.
• 0.23 mm spatial resolution
• A wide bore (80-cm bore size) to image all patients allowing better patient positioning & access.
• The next-generation of iterative reconstruction technology, ASiR-V, designed to deliver ultra-low noise levels, improved low contrast detectability and may enable a reduction in dose for all clinical applications

Built upon the existing technologies the Revolution system is designed to use less radiation dose than the previous generation product while maintaining the same diagnostic level of image quality. Further, the fast speed of the scan could potentially reduce contrast volumes. The hardware platform is also capable of supporting Gemstone spectral imaging and 0.2s rotation speed.

Here's a breakdown of the acceptance criteria and study information for the GE Healthcare Revolution CT, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text for the GE Healthcare Revolution CT does not explicitly define quantitative acceptance criteria for specific performance metrics in a readily tabular format. Instead, it states that "The results of this clinical assessment demonstrate the acceptable diagnostic imaging performance of the GE Healthcare Revolution CT scanner." and that the device is "as safe and effective, and performs in a substantially equivalent manner to the predicate device Discovery CT750 HD".

However, the document does list key performance characteristics and areas of evaluation for both non-clinical and clinical testing, which implicitly serve as the basis for "acceptable performance."

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

• Sample Size: 49 subjects.
• Data Provenance:
  • Country of Origin: United States.
  • Retrospective or Prospective: Prospective. The text states, "Sample clinical data was collected from 49 subjects at one site in the US... Patients were selected for potential recruitment to meet these needs. Any patient who met these criteria stated in the Protocol and who voluntarily signed the Informed Consent Form was recruited."

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

The document does not explicitly state that "ground truth" was established by experts in a specific, annotated sense. Instead, it describes a clinical assessment of image quality and diagnostic performance.

• Number of Experts: "multiple readers." A specific number is not provided.
• Qualifications of Experts: "qualified radiologists at different institutions in the United States of America." Further details on their years of experience or subspecialty are not provided.

4. Adjudication Method for the Test Set

The document describes the evaluation being done by "multiple readers" who are "qualified radiologists" using a "5 point Likert scale." It does not specify if there was a formal adjudication method (e.g., 2+1, 3+1 consensus process) for disagreeing interpretations among these readers or how their individual Likert scale ratings were combined or adjudicated to reach the overall conclusion of "acceptable diagnostic imaging performance." It simply states "The results of this clinical assessment demonstrate the acceptable diagnostic imaging performance."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

While "multiple readers" were involved in the clinical assessment, it was not a comparative effectiveness study pitting human readers with AI assistance versus without AI assistance. The study evaluated the Revolution CT scanner's performance (which incorporates advanced algorithms like ASiR-V and SnapShot Freeze as integral parts of its image reconstruction), but there is no mention of comparing human readers' performance with and without these specific AI-driven features as a standalone intervention. Therefore, no effect size of human readers improving with AI vs. without AI assistance is reported.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in a sense. The document describes extensive Non-Clinical Testing where various mathematical, physics, and statistical analyses were performed using phantoms and clinical datasets to verify and substantiate performance specifications. This includes evaluation of temporal resolution, dose performance, and image quality metrics like artifacts, scatter, spatial resolution, and low contrast detectability (using a model observer study with the MITA LCD phantom). These evaluations assess the device's technical performance, including its algorithms, without direct human interpretation of clinical images for diagnosis.

7. The Type of Ground Truth Used

The concept of "ground truth" for the clinical study is implicitly the radiologists' assessment of the diagnostic quality and clinical acceptance of the images. It's a form of expert consensus/assessment of image quality and diagnostic utility, rather than comparison to a definitive, independent "ground truth" like pathology for specific disease detection. The radiologists evaluated images using a 5-point Likert scale for "clinical acceptance and image quality."

8. The Sample Size for the Training Set

The document does not provide a specific sample size for a "training set" for the Revolution CT's algorithms (like ASiR-V or VHD). It describes the algorithms as new technologies (e.g., "ASiR-V, the next generation of GE's ASiR iterative recon technology") and states they were "designed" to address specific challenges (e.g., "Volumetric High Definition (VHD) has been designed specifically to reduce cone-beam artifacts"). This suggests they are developed and refined through engineering, physics, and potentially extensive internal datasets, but the specific training set size is not disclosed in this 510(k) summary.

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

Since a specific training set or its "ground truth" establishment isn't detailed in this summary, it can only be inferred:

• For reconstruction algorithms like ASiR-V and VHD, ground truth would typically involve physics-based simulations, phantom data (with known properties), and potentially large datasets of clinical images used for iterative refinement and validation of noise reduction, artifact suppression, and image quality metrics. This process would rely on engineering specifications, known physics of CT image formation, and expert review of image characteristics.
• The document states, "The software user interface has been redesigned to provide more simplified workflow and user experience," implying a focus on usability, which would involve user feedback and design principles rather than a traditional "ground truth" for a diagnostic algorithm.

In summary, the 510(k) focuses on demonstrating "substantial equivalence" to a predicate device through engineering verification, adherence to standards, and a clinical assessment of image quality and diagnostic acceptability by qualified radiologists, rather than a detailed breakdown of acceptance criteria and ground truth for individual AI/algorithmic components.

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