(77 days)
The Incisive 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 Incisive 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 proposed Philips Incisive CT is a whole-body computed tomography (CT) X-Ray System featuring a continuously rotating x-ray tube, detectors, and gantry with 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 signal analysis and display equipment, patient and equipment supports, components, and accessories. The Philips Incisive CT has a 72cm bore and includes a detector array that provides 50cm scan field of view (FOV). The main components (detection system, the reconstruction algorithm, and the x-ray system) that are used in the proposed Philips Incisive CT have the same fundamental design characteristics and are based on comparable technologies as the current market predicate Philips Ingenuity CT (K160743, 08/08/2016). 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 - Containing a Host computer and display that is the primary user interface. In addition to the above components and the software operating them, each system includes 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.
The Philips Incisive CT scanner is compared to a predicate device, the Philips Ingenuity CT (K160743), for substantial equivalence. The provided document focuses on technical comparisons and non-clinical performance data rather than a clinical study with specific acceptance criteria that would typically be seen for a new AI-powered diagnostic device.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a quantitative sense with pass/fail thresholds for clinical performance. Instead, it demonstrates substantial equivalence to a predicate device by comparing technical specifications and imaging features. The core "acceptance criterion" is proving substantial equivalence to the predicate device, Philips Ingenuity CT (K160743).
| Category | Acceptance Criteria (Implied: Substantially Equivalent to Predicate) | Reported Device Performance (Philips Incisive CT) | Conclusion |
|---|---|---|---|
| Scan Characteristics | |||
| Number of Slices | 64/128 | 64/128 | Identical. Substantially equivalent. |
| Scan Modes | Surview, Axial Scan, Helical Scan | Surview, Axial Scan, Helical Scan | Identical. Substantially equivalent. |
| Minimum Scan Time | 0.42 sec for 360° rotation | 0.35 sec for 360° rotation | Faster rotation speed to meet wider heart rate application. Safety and effectiveness are not affected. Substantially equivalent. |
| Image (Spatial) Resolution | High resolution: 16 lp/cm, Standard resolution: 13 lp/cm | High resolution: 16 lp/cm, Standard resolution: 13 lp/cm | Identical. Substantially equivalent. |
| Image Noise | 0.27% at 120 kV, 250 mAs, 10 mm slice thickness | 0.27% at 120 kV, 230 mAs, 10 mm slice thickness | Identical (despite slightly different mAs, the noise level is the same). Substantially equivalent. |
| Slice Thicknesses | Helical: 0.67mm-5mm, Axial: 0.625mm-12.5mm | Helical: 0.67mm-5mm, Axial: 0.625mm-10.0mm | Essentially the same, does not affect safety and effectiveness. Substantially equivalent. |
| Scan Field of View | Up to 500 mm | Up to 500 mm | Identical. Substantially equivalent. |
| Image Matrix | Up to 1024 * 1024 | Up to 1024 * 1024 | Identical. Substantially equivalent. |
| Imaging Features | (Function/User Interface/Workflow similar to Predicate) | ||
| 2D Viewer | Yes | Yes | User interface, function, and workflow are similar/same. Substantially equivalent. |
| MPR | Yes | Yes | User interface, algorithm principle, function, and workflow are similar/same. Substantially equivalent. |
| 3D (volume mode) | Yes | Yes | Volume rendering protocol, function, and workflow are similar/same. Substantially equivalent. |
| Virtual Endoscopy (Endo) | Yes | Yes | VE rendering protocol, function, and workflow are similar/same. Substantially equivalent. |
| Filming | Yes | Yes | Basic function (display, layout, editing, print management) similar/same. Substantially equivalent. |
| Image matrix | 1024 * 1024 | 1024 * 1024 | Both are 1024 * 1024. Substantially equivalent. |
| O-MAR | Yes | Yes | Algorithm Principle and workflow are same. Substantially equivalent. |
| Dose Modulation | Yes | Yes | Function and workflow are same. Substantially equivalent. |
| iPlanning | Manual | iPlanning (automated adjustment) | Workflow improvement for user assistance. Safety and effectiveness are not affected. Substantially equivalent. |
| On line MPR | Yes (with tilt and trim) | Yes (without trim and tilt) | Can generate sagittal and coronal results. Other functions and workflow are same. Substantially equivalent. |
| iBatch | Manual Batch | iBatch (automated identification) | Workflow feature to improve productivity. Safety and effectiveness are not affected. Substantially equivalent. |
| Bolus Tracking | Yes | Yes (Post Threshold Delay longer) | Function and workflow are same (despite longer Post Threshold Delay). Substantially equivalent. |
| SAS (Spiral Auto Start) | Yes | Yes (manual trigger only) | Other functions and workflow are same. Substantially equivalent. |
| Worklist | Yes | Yes | User interface, function, and workflow are similar/same. Substantially equivalent. |
| MPPS | Yes | Yes | User interface, function, and workflow are similar/same. Substantially equivalent. |
| Reporting | Yes (including PDF) | Yes (no PDF support) | Format of exported report similar. Other functions and workflow are same. Substantially equivalent. |
| CCT (Continuous CT) | Yes (with Volume display) | Yes (no Volume display support) | Other functions and workflow are same. Substantially equivalent. |
| Brain Perfusion | Yes | Yes | User interface, principle, mechanism, and analysis parameters are similar/same. Substantially equivalent. |
| Dental (Dental planning) | Yes | Yes | User interface, function, and workflow are similar/same. Substantially equivalent. |
| iDose4 | Yes | Yes | User interface, function, and workflow are similar/same. Substantially equivalent. |
| Helical Retrospective Tagging | Yes | Yes | ECG viewer user interface, function, and workflow are similar/same. Substantially equivalent. |
| Axial Prospective Gating calcium scoring | Yes | Yes | ECG viewer user interface, function, and workflow are similar/same. Substantially equivalent. |
| Step & Shoot | Yes (with arrhythmia handling) | Yes (no arrhythmia handling) | Other functions and workflow are same. Substantially equivalent. The lack of arrhythmia handling is noted but not deemed to affect substantial equivalence. |
| CCS (Cardiac calcium scoring) | Yes | Yes | User interface, function, and workflow are similar/same. Substantially equivalent. |
| Supplementary Imaging Features (Compared to Philips MX 16 SLICE K091195) | |||
| CTC (CT Colonoscopy) | Yes | Yes | User interface, function, and workflow are similar/same. Substantially equivalent. |
| VA (Vessel Analysis) | Yes | Yes | User interface, function, and workflow are similar/same. Substantially equivalent. |
| LNA (Lung Nodule Analysis) | Yes | Yes | User interface, function, and workflow are similar/same. Substantially equivalent. |
| Supplementary Imaging Features (Compared to IntelliSpace Portal Platform K162025) | |||
| CAA (Cardiac Artery Analysis) | Yes | Yes | User interface, analysis of cardiac coronary artery, and workflow are similar/same. Substantially equivalent. |
| CFA (Cardiac Function Analysis) | Yes | Yes | User interface, function, and workflow are similar/same. Substantially equivalent. |
| Supplementary Imaging Features (Compared to BRILLIANCE DUAL ENERGY OPTION K090462) | |||
| DE (Dual Energy) | Yes | Yes | User interface, function, Algorithm Principle, and workflow are similar/same. Substantially equivalent. |
2. Sample size used for the test set and the data provenance
The document explicitly states: "The proposed Philips Incisive CT did not require clinical study since substantial equivalence to the legally marketed predicate device was proven with the verification/validation testing."
Therefore, there is no mention of a "test set" in the context of patient data, nor any information about data provenance (country of origin, retrospective/prospective). The evaluation was based on non-clinical performance data, primarily engineering verification and validation testing, as well as comparisons to the predicate device's specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Given that no clinical study was performed and no patient-based "test set" was described, there were no experts used to establish ground truth in the traditional sense of clinical outcome assessment for the Incisive CT device. The ground truth for the technical comparisons was the established performance and specifications of the predicate device.
4. Adjudication method for the test set
Not applicable, as no clinical test set requiring adjudication of findings was described.
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 applicable. This is a CT scanner, not an AI-powered diagnostic software that assists human readers. The context is about the substantial equivalence of the imaging hardware and associated software functionalities.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This refers to the performance of the CT scanner itself, a hardware device with integrated software, not a separate standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the "study" (which was non-clinical verification/validation and substantial equivalence comparison) was the established technical specifications and performance characteristics of the predicate device (Philips Ingenuity CT, K160743) and compliance with various international and FDA-recognized consensus standards.
8. The sample size for the training set
Not applicable. This device is a CT scanner, not a machine learning model that requires a training set of data in the AI sense. Its underlying technology and algorithms are based on established CT principles, and its performance is verified through engineering tests.
9. How the ground truth for the training set was established
Not applicable, for the same reason as point 8.
§ 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.