(266 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:
- 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 - Patient Support (Couch) - carries the patient in and out through the Gantry bore synchronized with the scan
- 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 provided text is a 510(k) Summary of Safety and Effectiveness for the Philips Incisive CT, a computed tomography x-ray system. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance data for an AI/CADe device.
Therefore, the information required to fully answer your request regarding acceptance criteria and a study proving an AI device meets those criteria (especially points 3, 4, 5, 7, 8, 9) is largely missing from this specific document. The document describes a traditional CT scanner, not an AI feature or independent AI device.
However, I can extract the relevant information that is present and note the missing parts:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are based on demonstrating substantial equivalence to predicate devices in terms of technical characteristics and imaging features. The "performance" is implicitly the device meeting, matching, or improving upon these characteristics without raising new questions of safety or effectiveness.
| Acceptance Criteria (Implicit from Predicate Comparison) | Reported Device Performance (Philips Incisive CT) | Conclusion (vs. Predicate Philips Ingenuity CT K160743) |
|---|---|---|
| Scan Characteristics: | ||
| No. of Slices: 64/128 | 64/128 | Identical. Substantially equivalent. |
| Scan Modes: Surview, Axial, Helical | Surview, Axial, Helical | Identical. Substantially equivalent. |
| Minimum Scan Time: 0.42 sec for 360° rotation (predicate) | 0.35 sec for 360° rotation | Faster. Safety and effectiveness not affected. Substantially equivalent. |
| Image (Spatial) Resolution: High: 16 lp/cm, Standard: 13 lp/cm | High: 16 lp/cm, Standard: 13 lp/cm | Identical. Substantially equivalent. |
| Image Noise: 0.27% at 120 kV, 250 mAs, 10 mm slice (predicate) | 0.27% at 120 kV, 230 mAs, 10 mm slice | Identical. Substantially equivalent. |
| Slice Thicknesses: Helical: 0.67-5mm, Axial: 0.625-12.5mm (predicate) | 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. |
| Display: 1024 * 1280 (predicate) | 1920 * 1080 | Higher resolution. Safety and effectiveness not affected. Substantially equivalent. |
| Host Infrastructure: Windows 7 (predicate) | Windows 10 | Same supplier, same technology, similar function. Substantially equivalent. |
| Communication: Compliance with DICOM | Compliance with DICOM | Identical. Substantially equivalent. |
| Dose Reporting & Management: Compliance with NEMA XR25 and XR29 (predicate) | Compliance with NEMA XR25, XR28 and XR29 | Compliance with more NEMA standards. Safety and effectiveness not affected. Substantially equivalent. |
| Imaging Features: (Compared to Secondary Predicate Philips Incisive CT K180015) | ||
| 2D Viewer, MPR, 3D (volume mode), Virtual Endoscopy, Filming, Image matrix (1024x1024), O-MAR, Dose Modulation, Scan Preparation, On line MPR, Control Panel (iStation), iBatch, Bolus Tracking, SAS, Worklist, MPPS, Reporting, CCT, Brain Perfusion, Dental, iDose4, Helical Retrospective Tagging, Axial Prospective Gating calcium scoring, Step & Shoot Cardiac, CCS (Cardiac calcium scoring), CTC, VA, LNA, CAA, CFA, DE (Spin/Spin scan mode) | Yes (Identical functionality) | Identical. Functionally equivalent. |
| Precise image reconstruction (AI-driven) | No | Different. Referred to K210760 for safety and effectiveness. |
| Precise Cardiac (AI-driven) | No | Different. Referred to K203020 for safety and effectiveness. |
| Precise Position (AI-driven workflow) | No | Different. Referred to K203514 for safety and effectiveness. |
| Direct results (workflow enhancement) | No | Different. Workflow update, no impact on safety and effectiveness. |
| Parallel workflow | No | Workflow update, no impact on safety and effectiveness. |
2. Sample size used for the test set and the data provenance
The document 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."
This means there was no dedicated clinical test set in the traditional sense of patient data used for performance claims. The "testing" appears to be primarily engineering verification and validation against design specifications and industry standards, and comparison to the technical specifications of a predicate device. Therefore, no specific sample size, country of origin, or retrospective/prospective nature of a clinical test set is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
As there was no clinical study and no clinical test set for independent performance evaluation (rather, it was a substantial equivalence submission based on technical and functional comparison), this information is not applicable/provided. Ground truth establishment by experts for specific clinical findings is not described.
4. Adjudication method for the test set
Not applicable as no clinical test set and ground truth establishment by experts are 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. The submission is for a CT scanner itself, not an AI-assisted reading tool. While some newer "Precise" features mention deep learning (e.g., "Precise image reconstruction"), the document explicitly states these are "Different" and refers to other 510(k) clearances (K210760, K203020, K203514) for their safety and effectiveness. This document does not contain the MRMC study details for those specific AI features.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable for the CT scanner itself. For the "Precise" features that hint at AI, the performance data is referenced in other submissions, not detailed here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable for this submission's stated "verification/validation testing" which focuses on technical specifications and functional equivalence to predicates.
8. The sample size for the training set
Not applicable, as this document does not describe the development or training of an AI model.
9. How the ground truth for the training set was established
Not applicable, as this document does not describe the development or training of an AI model.
Summary of what the document does provide:
The document describes the Philips Incisive CT as a Computed Tomography X-Ray System. Its acceptance criteria and proving methodology revolve around demonstrating substantial equivalence to existing, legally marketed predicate CT devices (Philips Ingenuity CT K160743 and Philips Incisive CT K180015). This is achieved through:
- Comparison of technical specifications: Scan characteristics (slices, scan modes, scan time, resolution, noise, slice thickness, FOV, image matrix, display, infrastructure, communication, dose reporting).
- Comparison of imaging features/functionalities: A comprehensive list of features like 2D Viewer, MPR, 3D, O-MAR, Dose Modulation, Bolus Tracking, various analysis applications (Lung Nodule, Cardiac Artery, etc.), and others.
- Compliance with recognized consensus standards: A list of international and FDA-recognized standards (e.g., IEC 60601 series, IEC 62304, ISO 14971, NEMA XR standards) which the device is stated to comply with.
- Non-clinical design verification and validation testing: The document briefly states that "The systems pass the design verification, design validation and consensus standards test as nonclinical tests. The system verification is conducted against the system requirement specifications (SRS). ... Non-Clinical design validation testing covered the intended use and commercial claims. Validation testing included workflow validation."
The core assertion for the Philips Incisive CT's acceptance is that its design, intended use, technology, and principal technological components are substantially equivalent to the predicate devices, and that the product's differences do not raise new questions of safety or effectiveness. For specific features that appear to involve AI (like "Precise image reconstruction"), the document explicitly points to other 510(k) submissions, indicating that their clinical performance and acceptance would be detailed there.
§ 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.