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The SpotLight CT Computed Tomography X-ray is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles. The system has the capability to image whole organs, including the heart, in a single rotation. The system may acquire data using Axial, Cine and Cardiac 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.

The system is indicated for X-ray Computed Tomography imaging of organs that fit in a 25cm field of view, including cardiac and vascular CT imaging. The device output is useful for diagnosis of disease or abnormality and for planning of therapy procedures.

The SpotLight CT is a third generation rotate-rotate CT scanner, designed and built based on technologies and principles of operation of the predicate device and other legally marketed CT scanners. The SpotLight CT is a multi-slice (192 detector rows), dual tube CT scanner consisting of a gantry, patient table, operator console, power distribution unit (PDU) and interconnecting cables. The system includes image acquisition hardware, image acquisition and reconstruction software for operator interface and image handling.

The provided document describes the Arineta Ltd. SpotLight CT device and its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a tabular format with corresponding "reported device performance." Instead, it describes various performance specifications and how the device performed against them. I've re-framed the reported performance metrics as if they were acceptance criteria.

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

• Test Set (Clinical Testing): 38 subjects
• Data Provenance: Not explicitly stated, but the study was conducted at "one site," and the readers were "US certified." This suggests the data was collected in the US.
• Retrospective or Prospective: The clinical testing describes "data were collected," which could mean either. However, the phrase "The study protocol was designed to test the scanner across different patient populations, clinical scenarios and scan techniques" implies a prospective study design for collecting new data specifically for this evaluation.

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

• Number of Experts: Four (4)
• Qualifications: "US certified readers who are qualified radiologists or cardiologists." Specific years of experience are not mentioned.

4. Adjudication Method for the Test Set

The document states, "The images were evaluated and rated by four US certified readers." It does not specify an adjudication method like 2+1 or 3+1 for resolving discrepancies. It implies independent evaluation by each reader.

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

• Was an MRMC study done? No, a multi-reader multi-case (MRMC) comparative effectiveness study (comparing human readers with and without AI assistance) was not done. The clinical testing focused on evaluating the device's diagnostic image quality for standalone performance.
• Effect size of human readers with AI vs without AI assistance: Not applicable, as no such study was conducted or reported.

6. Standalone (Algorithm Only) Performance

• Was a standalone study done? Yes, the described "Non-clinical Performance Testing" and "Clinical Testing" primarily focus on the standalone performance of the SpotLight CT system. The image quality, temporal resolution, dose performance, and diagnostic quality evaluations are all measures of the device's inherent capabilities without human intervention during the image generation or initial analysis phase. The "clinical diagnostic value and image quality" evaluated by the readers are also assessing the output of the device itself.

7. Type of Ground Truth Used

• Non-clinical/Phantom Testing: The ground truth for these tests would be objective physical measurements and known parameters of the phantoms used to evaluate image quality metrics (e.g., spatial resolution targets, known low contrast objects, CT number uniformity).
• Animal Testing: The "diagnostic quality" evaluation in animal models likely used established veterinary diagnostic criteria and potentially post-mortem examination or other correlative imaging as ground truth.
• Clinical Testing: The "clinical diagnostic value and image quality" in human subjects were evaluated by "qualified radiologists or cardiologists" against established clinical diagnostic criteria. While not explicitly stated as "expert consensus ground truth," the assessment by multiple, qualified experts serves as the de-facto ground truth for evaluating diagnostic utility. It does not mention pathology or long-term outcomes data for ground truth.

8. Sample Size for the Training Set

The document does not provide any information about a training set since this is a hardware device (CT scanner) with associated imaging software, not typically an AI/ML algorithm that requires a distinct "training set" in the common sense. The image reconstruction algorithm is described as "Stereo CT reconstruction algorithm based on common algorithms used in single source scanners that are modified to combine the data acquired from the two sources." This implies an engineered algorithm, not one trained on a dataset.

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

Not applicable, as there is no mention of an AI/ML algorithm requiring a training set in the document. The device uses an engineered image reconstruction algorithm.

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The Ingenuity CT is a Computed Tomography X-Ray System intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components and accessories. The Ingenuity CT is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages.

These scanners are intended to be used for diagnostic imaging and for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer*. The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical society.

*Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011: 365:395-409) and subsequent literature, for further information,

The Philips Ingenuity CT consists of three system configurations, the Philips Ingenuity CT, the Philips Ingenuity Core and the Philips Ingenuity Core128. These systems are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. These scanners are intended to be used for diagnostic imaging and for low dose CT lung cancer screening for the early detection of Jung nodules that may represent cancer*.

The main components (detection system, the reconstruction algorithm, and the x-ray system) that are used in the Philips Ingenuity CT have the same fundamental design characteristics and are based on comparable technologies as the predicate.

The main system modules and functionalities are:

• 1. Gantry. The Gantry consists of 4 main internal units:
  • a. Stator a fixed mechanical frame that carries HW and SW.
  • b. Rotor A rotating circular stiff frame that is mounted in and supported by the stator.
  • c. X-Ray Tube (XRT) and Generator fixed to the Rotor frame.
  • d. Data Measurement System (DMS) a detectors array, fixed to the Rotor frame.
• 2. Patient Support (Couch) carries the patient in and out through the Gantry bore synchronized with the scan.
• 3. Console A two part subsystem containing a Host computer and display that is the primary user interface and the Common Image Reconstruction System (CIRS) - a dedicated powerful image reconstruction computer.

In addition to the above components and the software operating them, each system includes a workstation hardware and software for data acquisition, display, manipulation, storage and filming as well as post-processing into views other than the original axial images. Patient supports (positioning aids) are used to position the patient.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Important Note: The provided document is a 510(k) submission for a CT scanner (Philips Ingenuity CT), which focuses on demonstrating substantial equivalence to a predicate device (Philips Plus CT Scanner), rather than establishing new performance claims with specific acceptance criteria and clinical trial results typical for entirely novel AI/ML devices. Therefore, much of the requested information, particularly regarding AI-specific performance (like effect size of human reader improvement with AI, standalone AI performance, ground truth for training AI models) is not directly present. The clinical evaluation described is a comparative image quality assessment rather than a diagnostic accuracy clinical trial.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) submission, the "acceptance criteria" are primarily established against international and FDA-recognized consensus standards for medical electrical equipment and CT systems, and against the performance of the predicate device. The "reported device performance" refers to the successful verification against these standards and equivalence to the predicate.

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

The document does not specify a distinct "test set" sample size in the sense of a number of clinical cases or patient images used for a diagnostic accuracy study. Instead, it refers to:

• Bench tests: These involved phantom images and physical testing of the system (e.g., patient support/gantry positioning repeatability and accuracy, laser alignment accuracy, CT image quality metrics testing). No sample size for these is given.
• Clinical Evaluation: An "image evaluation" was performed involving "images of the brain, chest, abdomen and pelvis/peripheral orthopedic body areas." The number of images or patient cases used for this evaluation is not specified.
• Data Provenance: Not explicitly stated, but given it's a Philips product, it's likely internal development and validation data. There is no mention of external datasets or specific countries of origin. The evaluation compares FBP and iDose4 reconstructions of the same images. The clinical evaluation implicitly relates to retrospective data as it compares reconstructed images.

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

• Number of Experts: "a qualified radiologist". So, one expert.
• Qualifications of Experts: Described only as "a qualified radiologist." No specific experience (e.g., years of experience, subspecialty) is provided.

4. Adjudication Method for the Test Set

The evaluation was performed by a single radiologist using a 5-point Likert scale. Therefore, no adjudication method (like 2+1, 3+1 consensus) was used as there was only one reviewer.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The document describes an image evaluation by a single radiologist, not multiple readers. It also describes a comparison of image quality between reconstruction techniques (FBP vs. iDose4), not a comparison of human reader diagnostic performance with vs. without AI assistance.

• Effect size of human readers improving with AI vs without AI assistance: This information is not applicable as this type of study was not performed. The study evaluated if iDose4-reconstructed images (which is an iterative reconstruction technique for image quality improvement and dose reduction, not an AI for diagnosis) maintained diagnostic quality compared to standard FBP.

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

Yes, in spirit, the primary evaluation is about the algorithm's output quality. The iDose4 iterative reconstruction algorithm directly produces images without human intervention, and these images were then evaluated by a radiologist. The core of this 510(k) is about the technical performance and safety of the CT scanner and its components, including its reconstruction algorithms. The evaluation described ("image evaluation...") is a standalone assessment of the image quality produced by the iDose4 algorithm compared to standard FBP. It is not an "AI diagnostic algorithm" standalone performance, but rather an "image reconstruction algorithm" standalone performance.

7. The Type of Ground Truth Used

For the clinical image evaluation, the "ground truth" was established by the evaluation of a qualified radiologist using a 5-point Likert scale to determine if images were of "diagnostic quality" and for comparing image quality between reconstruction methods. This could be considered a form of "expert consensus," albeit from a single expert in this case. There is no mention of pathology or outcomes data being used as ground truth for this specific image quality assessment.

8. The Sample Size for the Training Set

Not applicable in the context of this 510(k) as presented.

The device (Philips Ingenuity CT) is a hardware CT scanner with associated software, including image reconstruction algorithms (like iDose4). While iterative reconstruction algorithms might involve some form of "training" or optimization during their development, the document does not speak to a "training set" in the sense of a dataset used to train a machine learning model for a specific diagnostic task that would typically be described in an AI/ML device submission. The description focuses on technical modifications and adherence to engineering and safety standards, and performance against a predicate device.

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

Not applicable for the reasons stated above (no "training set" for an AI/ML diagnostic model described).

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The Philips IQon Spectral CT 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. This device may include signal analysis and display equipment, patient and equipment parts, and accessories.

The IQon Spectral CT system acquires one CT dataset – composed of data from a higher-energy detected x-ray spectrum and a lower- energy detected x-ray spectramay be used to analyze the differences in the energy dependence of the attenuation coefficient of different materials. This allows for the generation of images at energies selected from the available spectrum and to provide information about the chemical composition of the body materials and/or contrast agents. Additionally, materials analysis provides for the quantification and graphical display of attenuation, material density, and effective atomic number.

This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures.

The Philips IQon Spectral CT is a whole-body computed tomography (CT) X-Ray System featuring a continuously rotating x-ray tube and detectors gantry and multi-slice capability. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. This device also includes signal analysis and display equipment; patient and equipment supports; components; and accessories. The Philips IQon Spectral CT includes the detector array previously described in K131773 "Modified Brilliance iCT".

The IQon Spectral CT consists of three main components – a scanner system that includes a rotating gantry, a movable patient couch, and an operator console for control and image reconstruction; a Spectral Reconstruction System; and a Spectral CT Viewer. On the gantry, the main active components are the x-ray high voltage (HV) power supply, the x-ray tube, and the detection system.

In addition to the above components and the software operating them, the system includes workstation hardware and software for data acquisition; and image display, manipulation, storage, and filming, as well as post-processing into views other than the original axial images. Patient supports (positioning aids) are used to position the patient.

The Philips IQon Spectral CT is a Computed Tomography (CT) X-Ray System. The provided document is a 510(k) Summary, which describes the device and its intended use, and provides a summary of non-clinical and clinical testing to demonstrate substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, detailed study designs, or reported device performance metrics in the format requested, such as sensitivity, specificity, or AUC calculated from a clinical trial. The document focuses on regulatory compliance and the types of tests performed rather than the quantitative results against specific criteria.

Therefore, I cannot fully complete the requested table and answer all questions with the detailed information usually found in a clinical study report. I will extract what information is present.

Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list quantitative acceptance criteria in a table format for specific performance metrics (e.g., sensitivity, specificity, accuracy) that would be typically established for a diagnostic device. It focuses on demonstrating conformance to standards and the utility of new spectral imaging capabilities.

Instead of specific acceptance criteria, the document states general conformance to standards and demonstrates capabilities:

Study Details (Based on available information)

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

   • Test Set Sample Size: Not explicitly stated in terms of number of patients or cases. The document mentions "Clinical images were collected and analyzed," but does not provide a specific count.
   • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). It is a "Summary of Clinical Testing," suggesting real-world clinical data was used, but details are absent.

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

   • Not specified. The document states "This evaluation demonstrated that spectral images were useful for the visualization and analysis of anatomical and pathological structures," implying evaluation by trained healthcare professionals, but no details on the number or qualifications of these experts are provided.

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

   • Not specified.

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:

   • The document describes the Philips IQon Spectral CT as a device for generating images and quantitative data, not an AI software/algorithm that assists human readers. Therefore, a multi-reader, multi-case (MRMC) comparative effectiveness study focusing on the improvement of human readers with AI assistance is not applicable to this device as described. The clinical testing mentioned focused on the utility of the spectral images themselves for visualization and analysis.

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

   • The IQon Spectral CT is a CT scanner system that produces images and performs material analysis. Its core function is image acquisition and reconstruction, and spectral capabilities like quantification of iodine, calcium, and effective atomic number are inherent features of the device's processing capabilities. It's not an "algorithm only" in the sense of a separate AI-driven diagnostic tool. The "performance" in this context refers to the system's ability to generate these specific types of images and quantitative data accurately and consistently, which was assessed through non-clinical (phantom-based) and clinical evaluation. The clinical evaluation primarily confirmed the usefulness of the generated spectral images.

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

   • For non-clinical testing, the ground truth appears to be established through the specifications of phantoms and reference measurements (e.g., assessing CT linearity, spatial resolution, low contrast detectability against known values).
   • For clinical testing, the "ground truth" for demonstrating usefulness in "visualization and analysis of anatomical and pathological structures" would typically involve comparison with existing diagnostic methods, expert interpretation of images, or correlation with pathology/clinical outcomes. However, the document does not specify the exact type of ground truth used for the clinical evaluation. It only states that the images were found "useful."

7. The sample size for the training set:

   • The document describes a CT System, not a machine learning algorithm that requires a "training set" in the conventional sense. The "training" for such a system would involve engineering and calibration using diverse data to ensure robustness across various patient anatomies and conditions, but this is not a "training set" as understood in AI/ML performance studies.

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

   • As this is not an AI/ML algorithm requiring a "training set" with ground truth labels in the typical sense, this question is not applicable here. The system's design and calibration are based on physical principles of CT imaging and spectral analysis.

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