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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).

• Spectral Phantom Testing: No significant differences in Pulmo spectral results compared to non-Pulmo chest scans.
• Clinical External Image Quality Review: Overall image quality graded as satisfactory for use in CT simulation for radiotherapy planning, meeting defined success criteria. | - Motion Phantom Testing: "The review and the analysis showed that the level and magnitude of artifacts is similar to existing products under similar conditions and additionally that the differences seen are explainable based on design differences between the Spectral CT 7500 RT and the existing currently marketed and predicate device, Philips Big Bore system (K171850). Clinical evaluation determined the gated reconstruction is acceptable for RT simulation purposes."
• Spectral Phantom Testing: "Review of all of the spectral results did not reveal any significant differences between the Pulmo spectral results and the non-Pulmo chest scan that was used as a reference. This supports the conclusion that there are no significant differences in the Pulmo spectral results compared with the non-Pulmo spectral results."
• Clinical External Image Quality Review: "Clinical images were externally reviewed, by US board certified reviewers, grading their overall image quality for use in CT simulation for radiotherapy planning. The external IQ assessments of Pulmonary Gating 4DCT for both conventional 4DCT results and Spectral 4DCT results, were completed and the defined success criteria were met. All images were rated as satisfactory for radiation therapy planning/ simulation." |
  | Extended Field of View (EFOV) | - IQ Integration Tests: Meeting SRS IQ requirements for RT applications.
• Clinical External Image Quality Review: Overall image quality graded as satisfactory for use in CT simulation for radiotherapy planning, meeting defined success criteria. | - Overall Conclusion of the IQ Testing: "The review achieved its goal of reviewing the results of IQ integration tests for the extended FOV feature in the proposed Spectral CT 7500 RT system. The results showed that the IQ testing meets the SRS IQ requirements. These results are only intended to support RT applications."
• Conclusion of Clinical External Image Quality Review: "Clinical images were externally reviewed, by US board certified reviewers, grading their overall image quality for use in CT simulation for radiotherapy planning. The external IQ assessment of eFOV was completed and the defined success criteria were met. All images were rated as satisfactory for radiation therapy planning/ simulation." |
  | General System Performance | Compliance with recognized international and FDA consensus standards (listed in the document). Meets established system and sub-system level design input requirements. User needs and intended use are met. | The document states: "Non-clinical performance testing has been performed on the proposed Spectral CT 7500 RT system and demonstrates compliance with the following International and FDA recognized consensus standards and FDA guidance document(s)... System and sub-system verification activities demonstrate the system meet the established system and sub-system level design input requirements... All the validation tests as per validation plan were performed and acceptance criteria met for each of the requirements." |

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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Illumeo system is an image management system intended to be used by trained professionals, including but not limited to radiologists.

Illumeo system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, manipulation and quantification of images, communication and storage.

This device is not to be used for mammography.

Illumeo is an image management system intended to be used by trained professionals, including but not limited to radiologists.

Illumeo system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, manipulation and quantification of images, communication and storage.

This device is not to be used for mammography.

Illumeo is a medical software system offering a primary interpretation solution for visualization and evaluation a variety of medical images deriving from various imaging modalities as well as non-imaging information. Illumeo interconnects with clinical imaging and non-imaging data sources to present in addition to images non-imaging data in patient context.

The provided text describes a Special 510(k) submission for the Illumeo system, focusing on its substantial equivalence to a predicate device after minor modifications. It does not contain the specific details about acceptance criteria, device performance, sample sizes, expert qualifications, or MRMC studies that you requested.

The document states that:

• Acceptance Criteria and Device Performance: "Verification and Validation (V&V) activities were performed for proposed Illumeo system and demonstrated that the predetermined acceptance criteria were successfully met." However, it does not describe what those acceptance criteria were nor the specific quantitative results of the device performance against them. It only generally states that the system "Meets the acceptance criteria and is adequate for its intended use and user needs."
• Study Type: Non-clinical verification and validation tests were performed. No clinical studies were required or conducted to support the equivalence for this submission ("Illumeo system did not requires clinical studies to support equivalence.").
• Ground Truth: The document does not discuss ground truth as it would be understood in the context of an AI/ML device relying on diagnostic accuracy, given it's a PACS system subject to a Special 510(k) for modifications.
• Sample Sizes (Test/Training): These details are not provided as no diagnostic performance study was conducted.
• Experts and Adjudication Methods: Not applicable, as there was no diagnostic performance study involving human readers.
• MRMC Comparative Effectiveness Study: Not conducted. The device is a PACS system with improved features, not an AI assisting human readers for a specific diagnostic task.
• Standalone Performance: Not applicable as it's not a standalone diagnostic AI algorithm. It's an image management and viewing system.

Summary of available information:

The study described is a non-clinical verification and validation effort, demonstrating compliance with international and FDA-recognized consensus standards (ISO 14971, IEC 62304, IEC 62366-1, NEMA-PS 3.1-3.20 DICOM, and FDA guidance for software in medical devices). The modifications were deemed "minor technology changes mainly designated to provide users further support in visualization" and did not change the intended use or fundamental scientific technology, hence a Special 510(k) was submitted. The conclusion states that "all risks are sufficiently mitigated, that no new risks are introduced, and that the overall residual risks are acceptable."

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