(96 days)
The 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 supports, component 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 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.
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 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 xray transmission data is reconstructed by computer into crosssectional 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 IQon Spectral CT includes the detector array previously described in K133674 "Philips IQon Spectral CT".
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.
This document, a 510(k) Pre-Market Notification for the Philips IQon Spectral CT (K163711), indicates that no new clinical study was required to demonstrate substantial equivalence for the core device to its predicate (K133674). The addition of "Low Dose CT Lung Cancer Screening" to the Indications for Use was supported by a comparative assessment to another cleared device (K153444), rather than a de novo clinical study for the IQon Spectral CT itself.
Therefore, much of the requested information about acceptance criteria for a specific study conducted for this device, sample sizes for test sets, ground truth establishment, expert qualifications, and MRMC studies, is not present in this document as it pertains to this specific 510(k) submission for the IQon Spectral CT. The document relies heavily on the substantial equivalence to previously cleared devices.
However, I can extract information related to the general acceptance of the device based on non-clinical testing and its reliance on previously cleared predicate devices.
Acceptance Criteria and Device Performance (Based on Non-Clinical Data and Substantial Equivalence)
| Acceptance Criteria Category | Reported Device Performance (as per document K163711) |
|---|---|
| Compliance with recognized international standards | The IQon Spectral CT System complies with: |
- IEC 60601-1:2005+A1:2012
- IEC 60601-1-2:2007
- IEC 60601-1-3 Edition 2.0:2008
- IEC 60601-1-6:2010
- IEC 60601-2-44:2009
- ISO 14971:2007 (Application of risk management to medical devices) |
| Compliance with FDA device-specific guidance documents | The IQon Spectral CT System complies with: - Guidance for Industry and FDA Staff – "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005)
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (Oct 2, 2014) |
| Adequacy for intended use | "Non-Clinical verification and or validation tests have been performed with regards to the intended use, the technical claims, the requirement specifications and the risk management results."
"The results of these tests demonstrate that the IQon Spectral CT System met the acceptance criteria and is adequate for its intended use." |
| Image Quality and Technological Characteristics (for LDCT) | "The addition of lung cancer screening to the IFU statement was supported with a comparative assessment of image quality and technological characteristics to the devices cleared for this use in K153444 [Philips Multislice CT System with Low Dose CT Lung Cancer Screening]." (This implies that the IQon Spectral CT's performance for LDCT was deemed comparable to a previously cleared device for that specific indication, but specific metrics are not detailed in this document). |
| Safety and Effectiveness | "The IQon Spectral CT System is substantially equivalent to the currently marketed and predicate device, Philips IQon Spectral CT (K133674, Nov. 21, 2014) in terms of safety and effectiveness." |
Study Details (as inferable from the document):
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This 510(k) relies on non-clinical verification and validation testing, and comparative assessment to predicate devices, rather than a new clinical study. Therefore, there is no "test set" in the context of a new prospective or retrospective clinical study of patients, or information on data provenance, within this specific submission. The non-clinical tests would have involved phantom or laboratory testing.
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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):
- Not applicable, as no new clinical test set requiring expert ground truth establishment is described in this 510(k). The "ground truth" for compliance testing would be defined by the standards and technical specifications being verified.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, as no new clinical test set is described.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study is mentioned or appears to have been conducted for this 510(k) submission. The device is a CT scanner, not an AI-assisted diagnostic tool in the typical sense that would necessitate an MRMC study for improved reader performance for this submission. The "minor improvements to some spectral algorithms" are internal technical refinements, not standalone AI algorithms for interpretation.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. The IQon Spectral CT is a medical imaging device. Its function involves acquiring and processing images for interpretation by a human healthcare professional. There isn't a standalone algorithm performance evaluation described independent of the imaging system. The modifications mentioned ("minor improvements to some spectral algorithms") are part of the image generation/processing pipeline, not a separate diagnostic algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical performance data, the ground truth would be the established specifications and requirements defined by the international and FDA-recognized consensus standards (e.g., image quality metrics, dose measurements in phantoms, electrical safety parameters) and the technical design requirements of the device.
- For the Low Dose CT Lung Cancer Screening indication, the ground for clinical validity would stem from the clinical literature referenced (e.g., National Lung Screening Trial) and the established inclusion criteria/protocols of governmental/professional medical societies, which inherently rely on outcomes data and pathology for nodule malignancy. The IQon Spectral CT's role is to provide the imaging data.
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The sample size for the training set:
- Not applicable. This document describes a medical device clearance based on substantial equivalence and non-clinical testing, not a machine learning model requiring a training set. The "spectral algorithms" receiving "minor improvements" are likely image reconstruction and processing algorithms that have been refined based on engineering principles and potentially internal validation, not AI models trained on large datasets.
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How the ground truth for the training set was established:
- Not applicable, as no training set for a machine learning model is described in this 510(k) submission.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.