(141 days)
The Philips CT Big Bore 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 equipments and accessories. These systems are indicated for head and whole body X-ray Computed Tomography applications in oncology, vascular and cardiology, for 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 Philips CT Big Bore is currently available in two system configurations, the Oncology configuration and the Radiology (Base) configuration.
The main components (detection system, the reconstruction algorithm, and the x-ray system) that are used in the Philips CT Big Bore have the same fundamental design characteristics and are based on comparable technologies as the predicate.
The main system modules and functionalities are:
- 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 detector array, fixed to the Rotor frame - Patient Support (Couch) carries the patient in and out through the Gantry bore synchronized with the scan
- Console A two part subsystem containing a Host computer and display that is the primary user interface and the Common Image Reconstruction System (CIRS) - a dedicated, powerful image reconstruction computer
In addition to the above components and the software operating them, each system includes workstation 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.
This document describes the Philips CT Big Bore, a Computed Tomography X-Ray System. The submission focuses on demonstrating substantial equivalence to a predicate device rather than a standalone clinical efficacy study with acceptance criteria in the typical sense of a diagnostic AI product. Therefore, much of the requested information regarding clinical studies and expert review for ground truth is not directly applicable in the same way.
However, based on the provided text, we can infer and extract the following:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are framed in terms of achieving similar or improved performance compared to the predicate device and meeting established industry standards for CT systems. The reported device performance is primarily a comparison to the predicate device's specifications and measurements on phantoms.
| Metric | Acceptance Criteria (Implicit: Similar to/Better than Predicate & Standards) | Reported Device Performance (Philips CT Big Bore / Tested Values) |
|---|---|---|
| Design/Fundamental Scientific Technology | ||
| Application | Head/Body (Identical to Predicate) | Head/Body |
| Scan Regime | Continuous Rotation (Identical to Predicate) | Continuous Rotation |
| No. of Slices | Up to 40 (Predicate) | 16/32 (with optional WARP/DAS for 32 slices) |
| Scan Modes | Surview, Axial Scan, Helical Scan (Identical to Predicate) | Surview, Axial Scan, Helical Scan |
| Minimum Scan Time | 0.42 sec for 360° rotation (Identical to Predicate) | 0.42 sec for 360° rotation |
| Image (Spatial) Resolution | 15 lp/cm max. (Predicate) | 16 lp/cm (±2 lp/cm) |
| Image Noise, Body, STD Res. | 10.7 at 16.25 mGy (Predicate) | 10.7 |
| Image Matrix | Up to 1024 x 1024 (Identical to Predicate) | Up to 1024 x 1024 |
| Display | 1024 x 1280 (Identical to Predicate) | 1024 x 1280 |
| Host Infrastructure | Windows XP (Predicate) | Windows 7 (Essentially the same, Windows based) |
| CIRS Infrastructure | PC/NT computer based on Intel processor & custom Multiprocessor Array (Predicate) | Windows Vista & custom Multiprocessor Array (Identical, Windows based) |
| Communication | Compliance with DICOM (Identical to Predicate) | Compliance with DICOM |
| Dose Reporting and Management | No (Predicate) | Compliance with MITA XR25 and XR29 |
| Generator and Tube Power | 60 kW (Predicate) | 80 kW (Software limited to 60kW) |
| mA Range | 30-500mA (Predicate) | 20-665mA (Software limited to 500mA) |
| kV Settings | 80, 120, 140 (Predicate) | 80, 100, 120, 140 |
| Focal Spot | Dynamic Focal Spot (Identical to Predicate) | Dynamic Focal Spot in X axis |
| Tube Type | MRC 800 (Predicate) | MRC Ice Tube (880) (Identical tube technology) |
| Detectors Type | 2.4 or 4 cm NanoPanel detector (Predicate) | 2.4 cm NanoPanel (Revision, slightly better performance stated) |
| Scan Field of View | Up to 600 mm (Identical to Predicate) | Up to 600 mm |
| Detector Type | Single layer ceramic scintillator plus photodiode array (Identical to Predicate) | Single layer ceramic scintillator plus photodiode array |
| Gantry Tilt | $\pm 30^0$ (Identical to Predicate) | $\pm 30^0$ |
| Gantry Rotation Speed | 143 RPM (Identical to Predicate) | 143 RPM |
| Bore Size | 850 mm (Identical to Predicate) | 850 mm |
| Low dose CT lung cancer screening | Yes (Predicate) | Yes (Configuration with Brilliance Big Bore cited in K153444) |
| Communication between injector and scanner | SAS (Spiral Auto Start) (Predicate) | SAS and SyncRight |
| DoseRight / Dose Management | Yes (K012238) (Predicate) | Yes and iDose4 |
| Dose Modulation | D-DOM and Z-DOM (Predicate) | D-DOM (Angular DOM) and Z-DOM FDOM, 3D-DOM |
| Cone Beam Reconstruction Algorithm - COBRA | Yes (Identical to Predicate) | Yes |
| Axial 2D Reconstruction | Yes (Identical to Predicate) | Yes |
| Lung Nodule Assessment | Yes (K023785) (Identical to Predicate) | Yes |
| ECG Signal Handling | Yes (Identical to Predicate) | Yes |
| Cardiac Reconstruction | Yes (Identical to Predicate) | Yes |
| Bolus Tracking | Yes (K02005) (Identical to Predicate) | Yes |
| Calcium Scoring | Yes (Identical to Predicate) | Yes |
| Heartbeat Calcium Scoring (HBCS) | Yes (Identical to Predicate) | Yes |
| Virtual Colonoscopy | Yes (Identical to Predicate) | Yes |
| Pediatric Applications Support | Yes (Identical to Predicate) | Yes |
| Remote Workstation Option | Yes - MxView - later renamed Extended Brilliance Workstation (Predicate) | Yes - IntelliSpace Portal (K162025) |
| Volume Rendering | Yes (Identical to Predicate) | Yes |
| Liver Perfusion | Yes (Identical to Predicate) | Yes |
| Dental Planning | Yes (Identical to Predicate) | Yes |
| Functional CT | Yes (Identical to Predicate) | Yes |
| Stent Planning | Yes (Identical to Predicate) | Yes |
| Retrospective Tagging | Yes (Identical to Predicate) | Yes |
| Prospective Cardiac Gating | Yes (Identical to Predicate) | Yes |
| CT Performance Metrics (Phantoms) | ||
| MTF | Cut-off: High Mode 16±2lp/cm; Standard Mode: 13±2 lp/cm (Measured) | |
| CTDIvol (Head) | 10.61mGy/100mAs±25% at 120kV (Measured) | |
| CTDIvol (Body) | 5.92mGy/100mAs±25% at 120kV (Measured) | |
| CT number accuracy (Water) | 0±4HU (Measured) | |
| Noise | 0.27% ± 0.04% at 120 kV, 250 mAs, 12 mm slice thickness, UA filter (Measured) | |
| Slice Thickness (Nominal 0.75mm) | 0.5mm - 1.5mm (Measured) | |
| Slice Thickness (Nominal 1.5mm) | 1.0mm - 2.0mm (Measured) |
2. Sample Size for Test Set and Data Provenance
The document does not explicitly state a "test set" in the context of an AI/algorithm-driven diagnostic study. Instead, it refers to "bench testing included basic CT performance tests on phantoms" and "Sample clinical images were provided with this submission, which were reviewed and evaluated by radiologists."
- Sample Size for Test Set: Not specified for clinical images. For bench testing, it refers to "phantoms."
- Data Provenance: Not specified for the "sample clinical images." Given the context of a 510(k) for a hardware device, it's highly likely these were internal and possibly from a variety of sources. It's not stated whether they were retrospective or prospective.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: "radiologists" (plural, but exact number not specified).
- Qualifications of Experts: Only "radiologists" are mentioned. No details on years of experience or subspecialty.
4. Adjudication Method for Test Set
- Adjudication Method: Not specified. The document states, "All images were evaluated to have good image quality," suggesting a qualitative assessment rather than a structured adjudication process for a specific diagnostic task.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a typical MRMC comparative effectiveness study was not performed as described. This submission is for a CT scanner itself, not an AI-assisted interpretation tool where human readers' performance with and without AI would be compared.
- Effect Size of Human Readers with AI vs. without AI: Not applicable, as this was not an AI-assistance study.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study: No, this was not a standalone algorithm performance study. The submission is for a complete CT imaging system. The performance metrics reported are for the overall system, not an isolated algorithm. The document mentions "optional software algorithm called WARP or DAS" for increasing slice count, and features like "iDose4" (an extension of DoseRight) and "FDOM, 3D-DOM" for dose modulation, but their standalone performance is not detailed in terms of a clinical study.
7. Type of Ground Truth Used
- Type of Ground Truth: For the "sample clinical images," the ground truth seems to be expert opinion / qualitative assessment by radiologists that the image quality was "good." For the technical performance parameters (MTF, CTDIvol, CT number accuracy, Noise, Slice Thickness), the ground truth was derived from physical phantom measurements against established technical specifications.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This document describes a CT scanner (hardware and embedded software), not a machine learning model that would have a separate "training set" in the conventional sense. The "training" for the system's development would be through engineering design, iterative testing, and adherence to established physical and software engineering principles.
9. How Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable. (See point 8). The development of the CT system likely involved extensive engineering design, simulations, and validation against known physical principles and performance targets, which are fundamentally different from establishing ground truth for a machine learning training set.
§ 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.