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The Spectral CT system is a Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment support, component parts, and accessories.

The 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 spectrum. The two spectra may 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 in patients of all ages, and to be used for diagnostic imaging in radiology, interventional radiology, and cardiology and in oncology as part of treatment preparation and radiation therapy planning. The Extended field of view images and respiratory correlated scanning (4DCT) are for treatment preparation and radiation therapy planning/simulation usage only.

This device is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages.

The system is also intended to be used 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.

Spectral CT system 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 system also includes signals analysis and display equipment, patient and equipment support, components, and accessories.

The 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 spectrum. The two spectra may 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 provides 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.

The Spectral CT system 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.

The fundamental design and characteristics of the main components used in the proposed Spectral CT system are identical to the currently marketed primary predicate device, Spectral CT system (K203020).

This document is a 510(k) clearance letter for a Spectral CT System, indicating its substantial equivalence to previously cleared predicate devices. While it focuses heavily on design features and compliance with general safety and performance standards for CT systems, it does not contain the detailed clinical study information typically found in submissions for AI/ML-based medical devices that require specific performance metrics and human reader studies.

The provided text only briefly mentions "Clinical Image Evaluation" and "Comparison of performance data against internal performance requirements" as supporting the evaluation of new features. It does not provide specific acceptance criteria or performance results for these "new features" (Pulmonary Gating 4DCT and Extended Field of View (EFOV)) in the context of a clinical study, nor does it detail how substantial equivalence was demonstrated clinically for these features beyond a generic statement.

Therefore, many of the requested items cannot be extracted from this document, as it primarily covers the device's technical specifications and regulatory compliance for a general CT system, rather than specific performance studies for new AI/ML functionalities.

Given the information provided, here's what can be extracted and what cannot:

Acceptance Criteria and Study for Spectral CT System (K244008)

Based on the provided FDA 510(k) clearance letter, the primary method for demonstrating the device meets acceptance criteria and proving its performance is through substantial equivalence to predicate devices and adherence to recognized consensus standards and guidance documents. The document does not detail specific performance metrics, acceptance criteria, or a clinical study for the new features (Pulmonary Gating 4DCT and Extended Field of View (EFOV)) in the format requested for AI/ML device performance.

The document states:

• "Non-clinical performance testing has been performed on the proposed Spectral CT system and demonstrates compliance with the following International and FDA recognized consensus standards and FDA guidance document(s)..."
• "Design verification planning and testing were conducted at the system level. The system is tested against the System Requirements Specifications (SRS)."
• "Design Validation tests the user needs and intended use that are documented in the top-level User Requirement Specification (PRS)."
• "All the validation tests as per validation plan were performed and acceptance criteria met for each of the requirements."
• "Non-clinical design validation testing demonstrates that the proposed Spectral CT system can be used as defined in its clinical workflow and intended use."
• "To support the evaluation of the new features, the submission includes: - Phantom-based image quality (IQ) testing, assessing parameters such as noise, resolution, and artifacts - A representative clinical image assessment - Comparison of performance data against internal performance requirements"

This indicates that the "acceptance criteria" are primarily framed around compliance with established engineering and regulatory standards and internal performance requirements verified through non-clinical and limited clinical assessment, rather than a specific clinical trial with defined performance endpoints for the new features.

Information Extracted from the Document:

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

   The document does not provide a table of specific quantitative acceptance criteria and corresponding reported device performance metrics from a clinical study for the new features (Pulmonary Gating 4DCT and Extended Field of View (EFOV)). Instead, it states that "All the validation tests as per validation plan were performed and acceptance criteria met for each of the requirements." without detailing these.
   The primary "performance" discussed is the technological equivalence to predicate devices. Below is a summary of the technological characteristics being presented as "met" by being identical or substantially equivalent to the predicate.

   Table: Technological Characteristics (Implicit Acceptance Criteria - Equivalence to Predicate)

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

   Not explicitly stated in the provided text. The document refers to "Phantom-based image quality (IQ) testing" and "A representative clinical image assessment" but does not give sample sizes or provenance (country/retrospective/prospective) for these.

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

   Not explicitly stated. The document refers to "A representative clinical image assessment" but does not detail how ground truth was established or the experts involved.

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

   Not explicitly stated.

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:

   Not explicitly stated. This type of study is typically done for AI/ML diagnostic tools where human interpretation of medical images is directly affected by the AI output. This 510(k) is for a CT system itself, with new acquisition and reconstruction features (4DCT, EFOV) that are likely intended to provide better images for human interpretation, rather than an AI reading a dataset. The document's statements about "clinical image evaluation" do not elaborate on how this was conducted or whether it involved comparative effectiveness with human readers.

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

   This question is more applicable to diagnostic algorithms. For a CT system with new acquisition/reconstruction capabilities, the "standalone" performance would typically refer to the "Phantom-based image quality (IQ) testing," where the system's output (images) are assessed against objective physical metrics (noise, resolution, artifacts) without human interpretation of clinical findings. The document states this was done: "Phantom-based image quality (IQ) testing, assessing parameters such as noise, resolution, and artifacts."

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

   For the "Phantom-based IQ testing," the ground truth would be the known physical properties and measurements of the phantoms.
   For the "representative clinical image assessment," the type of ground truth is not specified.

8. The sample size for the training set:

   Not applicable. This 510(k) is for a CT hardware and software system, not an AI/ML diagnostic algorithm that would typically have a "training set" in the machine learning sense. The "new features" (Pulmonary Gating 4DCT and EFOV) are descriptions of how the system acquires and processes data, not separate AI algorithms trained on massive datasets to perform a diagnostic task.

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

   Not applicable, as there's no mention of a "training set" in the context of an AI/ML algorithm.

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The Spectral CT 7000 family 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 Spectral CT 7000 family system acquires one CT dataset - composed of data from a higher energy detected x-ray spectrum and a lower- energy detected x-ray spectra may 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 in patients of all ages, and to be used for diagnostic imaging in radiology, interventional radiology, and cardiology as part of treatment preparation and radiation therapy planning. The Extended field of view images and respiratory correlated scanning (4DCT) are for treatment and radiation therapy planning/simulation usage only.

This device is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages.

The system is also intended to be used 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 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.

Spectral CT 7500 RT system 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 system also includes signals and display equipment, patient and equipment support, components, and accessories.

The Spectral CT 7500 RT system acquires one CT dataset – composed of data from a higher energy detected X-ray spectrum and a lower- energy detected X-ray spectra may 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 provides 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. The Spectral CT 7500 RT system consists of three main components – a scanner system that includes a rotating gantry, a movable patient couch, and an operator 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.

The provided documentation describes the acceptance criteria and the study that proves the Philips Medical Systems Technologies Ltd. Spectral CT 7500 RT device meets these criteria.

Here's the detailed breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the successful verification and validation of the device against System Requirements Specifications (SRS) and User Requirement Specification (URS), as well as compliance with recognized standards. The reported device performance is presented as meeting these criteria for the key features considered in the 510(k) submission: Pulmonary Gating 4DCT and Extended Field of View (EFOV).

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

• Sample Size for Test Set: The document does not explicitly state the numerical sample size (number of patients or scans) used for the "Clinical External Image Quality Review" for either Pulmonary Gating 4DCT or EFOV.
• Data Provenance: The document states that "Clinical images were externally reviewed." It also mentions "US board certified reviewers." While not explicitly stated, this suggests the clinical images are likely from a relevant patient population, and the review was conducted by US-based experts. The studies appear to be retrospective clinical evaluations of image quality rather than prospective patient studies, as there is no mention of patient enrollment, intervention, or clinical outcomes. The focus is on image quality review for simulation purposes.

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

• Number of Experts: The document does not specify the exact number of experts used. It refers to "US board certified reviewers" in the plural, indicating more than one.
• Qualifications of Experts: The experts were "US board certified reviewers" who are involved in "CT simulation for radiotherapy planning." This implies they are likely board-certified radiologists or radiation oncologists with expertise in CT imaging for radiation therapy planning.

4. Adjudication Method for the Test Set

The document does not explicitly mention an adjudication method (e.g., 2+1, 3+1). It states "Clinical images were externally reviewed, by US board certified reviewers, grading their overall image quality..." This phrasing suggests that each reviewer likely provided their individual assessment against the success criteria, and the "defined success criteria were met," implying a consensus or a pass/fail threshold based on these independent gradings rather than a formal adjudication process to resolve disagreements.

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

No multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was done. The device is a CT imaging system with new features (Pulmonary Gating 4DCT and EFOV) primarily for radiation therapy planning, not an AI-assisted diagnostic tool for human readers. The evaluation focused on the image quality of the device output itself.

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

Yes, a standalone performance study in terms of technical image quality was performed. For both Pulmonary Gating 4DCT and EFOV, there were:

• Motion Phantom Testing (for Pulmonary Gating 4DCT): Evaluated artifacts and reconstruction.
• Spectral Phantom Testing (for Pulmonary Gating 4DCT): Evaluated spectral results.
• IQ Integration Tests (for EFOV): Evaluated image quality against SRS requirements.

These phantom and integration tests assess the device's technical performance and image output without direct human interpretation in a clinical decision-making loop. The "Clinical External Image Quality Review" also assessed the images themselves, albeit by human experts, to confirm their suitability.

7. Type of Ground Truth Used

The ground truth for the test set was:

• Expert Consensus/Grading: For the "Clinical External Image Quality Review," the ground truth was established by "US board certified reviewers" who graded the overall image quality as "satisfactory for radiation therapy planning/simulation" against "defined success criteria."
• Phantom Measurements/Technical Specifications: For the phantom tests and IQ integration tests, the ground truth was based on pre-defined technical specifications and expected phantom characteristics (e.g., artifact levels, spectral properties, adherence to SRS IQ requirements).

8. Sample Size for the Training Set

The document does not mention a training set. This is because the Spectral CT 7500 RT is a hardware and software system for image acquisition and reconstruction, not a machine learning or AI model that typically requires a separate training set. The changes described are new software features and an extended field of view for an existing CT system.

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

As no training set is mentioned or implied for this type of device, this question is not applicable. The device's performance demonstration relies on verification against design inputs, validation against user needs, and comparison to predicate devices, along with phantom and clinical image quality evaluations.

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The Spectral CT on Rails 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 supports, component parts, and accessories. The Spectral CT on Rails system acquires one CT dataset – composed of data from a higher-energy detected x-ray spectrum and a lower- energy detected x-ray spectra may 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 in patients of all ages, and to be used for diagnostic imaging in radiology, interventional radiology, and cardiology and in oncology.

The system is also intended to be used 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 proposed Spectral CT on Rails System 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. The proposed Spectral CT on Rails System consists of three main components: a rotating gantry that slides on a carriage in the horizontal direction, stationary patient support and an operator console for scan control and image reconstruction. On the gantry, the main active components are the X-ray HV power supply, the X-ray tube and the detection system. The fundamental design and characteristics of the main components used in the proposed Spectral CT on Rails System, are identical to the cleared to market primary predicate device, Spectral CT System (K203020). The proposed Spectral CT on Rails System consists of main components that are similar to the cleared for market primary predicate device, Spectral CT (K203020) Gantry. The Gantry consists of the following main internal units: Stator - a fixed mechanical frame that carries HW and SW Rotor - A rotating circular stiff frame that is mounted in and supported by the stator. X-Ray Tube (XRT) and its power Generator, and the upper beam mechanism – fixed to the Rotor frame Rails - the rails system includes a carriage which the gantry sits on so that it may be moved back and forth on the rails horizontally relative to a stationary patient support that the patient lays on. The moving gantry functionality has previously been cleared in, Philips CT Big Bore Sliding Gantry Configuration (K181797), secondary predicate device. Data Measurement System (DMS) – a detectors array, fixed to the rotor in front of the XRT.

Console - A computer and display that interfaces between the system and the user. Common Image Reconstruction Unit (CIRS) – a dedicated powerful image reconstruction system

In addition to the above components and the operating software, 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. Spectral Reconstruction System Spectral CT Viewer.

Here's a breakdown of the acceptance criteria and study information for the Philips Medical Systems Nederland B.V. Spectral CT on Rails (K212875), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Spectral CT K203020) rather than listing explicit quantitative acceptance criteria for each image quality metric. Instead, the acceptance criterion for the Spectral CT on Rails is that its performance is "equivalent" to the predicate device.

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

• Sample Size for Anthropomorphic Phantom Image Review Testing: Not explicitly stated, but it involved "an anthropomorphic phantom" scanned on both the proposed device and the predicate device. It implies a single phantom, however, multiple "scans" were performed.
• Sample Size for Image Quality Performance Testing: Not explicitly stated, but involved "physics image quality test phantoms" scanned on both devices. It implies multiple phantoms covering different image quality metrics.
• Data Provenance: The data is generated internally by Philips through testing of their devices (proposed and predicate). It is not retrospective or prospective clinical data from patients but rather non-clinical phantom-based image quality data. The country of origin of the data is not specified beyond being Philips' internal testing.

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

• Anthropomorphic Phantom Image Review Testing: The review was performed to "determine if the two scanners produced comparable image quality." It does not specify the number or qualifications of experts involved in this review. It states "After the review of the clinical scenarios it was concluded..." This suggests a qualitative assessment by an unnamed reviewer(s).
• Image Quality Performance Testing: This involved quantitative measurements on physics phantoms. Ground truth is established by the known physical properties and measurement methods for metrics like CT number, uniformity, noise, spatial resolution, etc., rather than expert reader consensus. Therefore, no "experts" in the sense of radiologists establishing ground truth for clinical cases are mentioned for this type of test.

4. Adjudication Method for the Test Set:

• For the anthropomorphic phantom image review, the document simply states "Each scan was reviewed to determine if the two scanners produced comparable image quality" and "it was concluded that the image quality... was equivalent." No specific adjudication method (e.g., 2+1, 3+1) is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No MRMC comparative effectiveness study was done. The submission states: "The subject of this premarket submission, the proposed Spectral CT on Rails did not require clinical studies to support equivalence Clinical Performance Data." The studies performed were non-clinical image quality comparisons.

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

• The Spectral CT on Rails is a complete computed tomography x-ray system, not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" doesn't directly apply here in the way it would for an AI-powered diagnostic software. The device's performance, as a system, was evaluated.
• However, the image quality performance testing can be considered an objective, quantitative assessment of the system's output (images) without human interpretation influencing the primary metrics being measured (CT number, noise, spatial resolution, etc.). The anthropomorphic phantom review has a human qualitative component, but the quantitative image quality metrics are standalone.

7. The Type of Ground Truth Used:

• Phantom-based Ground Truth: For the "Image quality performance testing," the ground truth is established by the known physical characteristics of the test phantoms (e.g., Catphan phantom for low contrast resolution) and the objective physical measurements performed on the acquired images.
• Qualitative Comparison for Anthropomorphic Phantom: For the "Anthropomorphic phantom image review testing," the ground truth for "comparable image quality for typical clinical applications" is based on a qualitative review, implicitly against established expectations for CT image quality and the predicate device's performance.

8. The Sample Size for the Training Set:

• This submission describes a hardware and software system ("Spectral CT on Rails"), not an AI/Machine Learning model that requires a "training set" in the conventional sense. The "training" for such a system typically involves engineering design, development, and validation against specifications, not data-driven machine learning training. Therefore, no training set sample size is applicable or provided.

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

• As concluded in point 8, this question is not applicable as there is no "training set" for an AI/ML model described in this submission for this device.

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The 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 supports, component parts, and accessories.

The 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 spectra may 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 in patients of all ages, and to be used for diagnostic imaging in radiology, interventional radiology, and cardiology as part of treatment preparation and radiation therapy planning.

The system is also intended to be used 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 proposed Spectral CT System 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 proposed Spectral CT System includes a detector array, which has spectral capability same as the cleared to market predicate device - Philips IQon Spectral CT System (K193454).

The proposed Spectral CT System consists of main components that are similar to the cleared to market predicate device, Philips IQon Spectral CT cleared under (K193454):
➤ Gantry -
On the rotating gantry, the main active components are:
• x-ray high voltage (HV) power supply,
• the x-ray tube,
• detection system
➤ Patient couch
➤ Operator console for control
➤ Common Image Reconstruction Unit (CIRS)
In addition to the above components and the operating software, 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.
• Spectral Reconstruction System
• Spectral CT Viewer.

This document is a 510(k) summary for the Philips Spectral CT system (K203020). It seeks to demonstrate substantial equivalence to a predicate device, the Philips IQon Spectral CT (K193454).

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present acceptance criteria in a quantitative table with specific performance metrics (e.g., sensitivity, specificity, accuracy thresholds). Instead, the acceptance criteria are generally described as compliance with consensus standards and guidance documents, and meeting design input requirements.

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

The document explicitly states: "There was no clinical testing conducted for the submission." This means there is no "test set" in the sense of patient data used to evaluate device performance on clinically relevant outcomes. The testing described is non-clinical performance testing.

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

Since no clinical testing was performed and therefore no clinical "test set" was used, there were no experts used to establish ground truth from patient data.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used.

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

No. The document explicitly states: "There was no clinical testing conducted for the submission." Therefore, no MRMC study comparing human readers with and without AI assistance was performed.

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

The device is a Computed Tomography X-Ray System, not a standalone AI algorithm. The performance evaluation focuses on the system's ability to acquire and reconstruct images and provide spectral analysis, not on an algorithm's diagnostic performance without human input. The "spectral results for cardiac" improvement is an algorithmic modification, but its performance is assessed as part of the overall system's technical capabilities and compliance with standards, not as a standalone diagnostic tool.

7. The Type of Ground Truth Used

For the non-clinical performance testing, the "ground truth" or reference was based on:

• Engineering specifications and design input requirements.
• International and FDA-recognized consensus standards (e.g., IEC 60601 series, ISO 14971).
• FDA guidance documents.
• The performance and characteristics of the predicate device (Philips IQon Spectral CT K193454).

8. The Sample Size for the Training Set

Not applicable. This submission is for a CT scanner system, not a machine learning model that requires a "training set" of data for its core functionality as described. While there are "Software life-cycle processes" compliant with IEC 62304, these relate to the overall development and verification of the software components of the CT system, not the training of a predictive AI model from a distinct dataset. The mention of "modification of the previously cleared classification method to target calcified structures" within the "Improved Spectral results" does imply some form of algorithm (or "classification method") development, but the document does not provide details on a specific training set size for this, nor does it present this as a primary subject of the 510(k) submission requiring clinical validation with a training set.

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

Not applicable, as there's no defined "training set" in the context of this 510(k) summary for a CT system. Any underlying algorithms for spectral analysis would have had their "ground truth" derived from physics principles, material science, and possibly phantoms or validated datasets, but these details are not provided as part of this regulatory submission.

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