(147 days)
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.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Safety & Essential Performance | Compliance with IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1: 2012 (General requirements for safety and essential performance) |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2:2014 (EMC Requirements and tests) |
| Radiation Protection | Compliance with IEC 60601-1-3:2008+A1:2013 (General requirements for radiation protection in diagnostic X-ray equipment) |
| Usability (General) | Compliance with IEC 60601-1-6:2010 +A1: 2013 (Usability) and IEC 62366-1:2015 (Application of usability engineering to medical devices) |
| CT Specific Safety & Performance | Compliance with IEC 60601-2-44:2009/AMD2:2016 (Particular requirements for CT X-ray equipment) |
| Laser Safety | Compliance with IEC 60825-1:2014 (Safety of laser products) |
| Software Life Cycle | Compliance with IEC 62304:2006 + A1: 2015 (Medical device software Software life-cycle processes) |
| Biological Evaluation | Compliance with ISO 10993-1:2018 (Biological evaluation of medical devices) |
| Risk Management | Compliance with ISO 14971:2007 (Application of risk management to medical devices) |
| Software Content in Medical Devices | Compliance with FDA Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued May 11, 2005) |
| Cybersecurity | Compliance with FDA Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (issued October 2, 2014) |
| Pediatric Use (X-ray Imaging) | Compliance with FDA Pediatric Information for X-ray Imaging Device Premarket Notifications - Guidance for Industry and Food and Drug Administration Staff (November 28, 2017), demonstrating safety and effectiveness for "patients of all ages". |
| Design Input Requirements | Design Verification (sub-system and system level tests meet established requirements), Design Validation (can be used as defined in clinical workflow and intended use), Risk analysis (risk mitigation testing). |
| Substantial Equivalence (Overall) | The device is considered substantially equivalent to the predicate device in terms of indications for use, design features, and fundamental scientific technology, and raises no new safety and/or effectiveness concerns. |
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.
§ 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.