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The Philips iCT CT systems 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 iCT 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 Philips iCT CT System is a whole-body computed tomography (CT) X-ray system designed for diagnostic imaging. It features a continuously rotating X-ray tube and multi-slice detector gantry, enabling the acquisition of X-ray transmission data from multiple angles and planes. The system reconstructs these data into cross-sectional images using advanced image reconstruction algorithms, supporting a wide range of clinical applications.

The system consists of a gantry, which houses the rotating X-ray tube, detector array, and key imaging subsystems; a patient support couch, which moves the patient through the gantry bore in synchronization with the scan and is available in multiple configurations; an operator console, which serves as the primary user interface for system controls, image processing, and data management; and a Data Measurement System (DMS), which captures X-ray attenuation data to support high-quality image reconstruction.

The provided FDA 510(k) clearance letter for the Philips iCT CT System (K250648) focuses on demonstrating substantial equivalence to a predicate device (K162838) based on hardware and software enhancements.

However, there is no information within this document that describes specific acceptance criteria in terms of algorithm performance metrics (e.g., sensitivity, specificity, AUC) for an AI/ML-driven diagnostic task, nor does it detail a study proving the device meets such criteria in a clinical context.

The document primarily addresses:

• Physical and technical characteristics of the CT system (e.g., spatial resolution, low contrast resolution, noise, scan speeds).
• Safety and performance of system modifications (e.g., OS upgrade, cybersecurity enhancements, new phantom kit) through non-clinical verification and validation activities.
• Substantial equivalence to a predicate device based on these engineering and system-level tests.

The mention of "low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer" refers to a general indication for the CT system itself, not a specific AI/ML diagnostic algorithm for nodule detection or characterization within the system. The note to "refer to clinical literature, including the results of the National Lung Screening Trial" further supports that the clinical efficacy of CT for lung screening is established and not being re-proven by this submission for a new AI feature.

Therefore, I cannot populate the requested table or answer the specific questions about AI/ML study design directly from the provided text, as this information is not present. The document focuses on the CT scanner as the device, not a specific AI-powered diagnostic algorithm within it that would require the detailed studies outlined in your request.

If the "Philips iCT CT System" were to include an AI component with an explicit diagnostic function beyond general image acquisition and display, the FDA submission would typically contain a dedicated section on its performance evaluation, including the types of studies you are asking about. This document does not describe such an AI component or its associated clinical performance study.

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The Philips iCT CT System 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. The iCT 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 Philips iCT is currently available in two system configurations, iCT and iCT SP. Identical to the predicate, the Philips iCT CT System produces cross-sectional images of the body head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. The main components (detection system, the reconstruction algorithm, and the x-ray system) that are used in the Philips iCT have the same fundamental design characteristics and are based on comparable technologies as the predicate.

The main system modules and functionalities are:

1. Gantry. The Gantry has an aperture of 700mm and consists of the following internal units:
   a. Stator a fixed mechanical frame that carries hardware and software.
   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. The generator has a power rating of 100kW with optional 120kW.
   d. Data Measurement System (DMS) a detectors array, fixed to the rotor frame. The DMS provides 8cm of coverage (4cm for the iCT SP configuration) and up to 256 slices (128 slices for the iCT SP configuration).The gantry offers 0.3 second rotation time (with optional 0.27s rotation).
2. Patient Table (aka Couch or Support) carries the patient in and out through the Gantry bore synchronized with the scan. There are three available patient supports:
   a. Standard Table provides maximum scannable range of 1750mm, longitudinal speed of 0.5mm/s-185mm/s and a maximum load capacity of 450 lbs.(204kg)
   b. Bariatric Table provides maximum scannable range of 1750mm, longitudinal speed of 0.5mm/s-185mm/s and a maximum load capacity of 650 lbs.(295kg)
   c. Extended Table provides maximum scannable range of 2100mm, longitudinal speed of 0.5mm/s-185mm/s and a maximum load capacity of 450 lbs.(204kg)
3. 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.
4. Monitors
5. Software features to view and analyze images.

This document is a 510(k) premarket notification for the Philips iCT CT System, which is a Computed Tomography X-Ray System. The document details the device's indications for use, description, and a comparison with a predicate device (Philips Brilliance Volume) to establish substantial equivalence.

Based on the provided text, the Philips iCT CT System is a Computed Tomography (CT) X-Ray System. The document outlines that the system is intended to produce images of the head and body by computer reconstruction of x-ray transmission data. It also explicitly states its indication for "low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer."

Regarding acceptance criteria and the study proving the device meets these criteria:

The document focuses on demonstrating substantial equivalence to a predicate device (Philips Brilliance Volume) rather than presenting a performance study with explicit acceptance criteria for a novel AI/ML-driven diagnostic device. This means the 510(k) submission primarily relies on comparing the design, technology, and specified performance parameters of the new device to an already legally marketed device, and showing that any differences do not raise new questions of safety or effectiveness.

Therefore, many of the requested elements for an AI/ML diagnostic device study (like sample size for test sets, expert adjudication, MRMC studies, standalone performance with specific metrics like sensitivity/specificity, or ground truth establishment for novel findings) are not detailed or applicable in the traditional sense for this 510(k) submission. This submission is for hardware (CT scanner) with associated software for image reconstruction, not primarily a sophisticated AI/ML diagnostic algorithm operating on those images for making clinical decisions beyond image acquisition and display.

Here's an attempt to address the requested information based on the provided document:

1. Table of acceptance criteria and the reported device performance:

Since this is a 510(k) for a CT system demonstrating substantial equivalence, the "acceptance criteria" are implicitly met by showing that the proposed device's characteristics are either identical to or comparable to the predicate device, and any changes do not adversely affect safety or effectiveness. The document presents a comparative table, not a table of specific numerical performance acceptance criteria for a diagnostic algorithm.

2. Sample size used for the test set and the data provenance:

The document mentions "Design Verification planning and testing was conducted at the sub-system and at the system level." It also states "Design validation of user needs and intended use was conducted via simulated use testing with production equivalent Philips iCT CT Systems."

• Test Set Sample Size: Not specified in terms of patient data or clinical cases for diagnostic performance. The document refers to "system and sub-system level verification" and "simulated use testing." This suggests engineering and functional testing rather than a large-scale clinical performance study on a specific number of patient scans.
• Data Provenance: Not specified. Given it's a Philips product for a global market, the data provenance for engineering/simulated testing is likely internal R&D, not necessarily specific patient data sets from particular countries. "Retrospective or prospective" is not applicable in the context of hardware/software functional testing described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This 510(k) is not for an AI/ML diagnostic algorithm that requires expert-established ground truth on clinical images for its performance evaluation. The "ground truth" for a CT system's performance in this context would be its physical specifications, image quality metrics (like spatial resolution, contrast resolution, noise), and safety parameters (radiation dose). These are typically verified against engineering specifications, phantoms, and regulatory standards, not clinical ground truth established by experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. No clinical image or diagnostic performance adjudication is 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 submission is for a CT hardware system, not an AI-assisted diagnostic tool that integrates with human readers. The "low dose CT lung cancer screening" indication refers to the capability of the scanner, and refers to existing clinical literature (National Lung Screening Trial) as evidence for the efficacy of low-dose CT screening in general, not specific AI augmentation.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable for a diagnostic algorithm. The device, the Philips iCT CT System, is the standalone imaging system for image acquisition and reconstruction. Its performance is evaluated against engineering specifications and industry standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the device's technical performance (e.g., image quality, scan range, rotation times) would be established by:

• Engineering specifications: The designed parameters of the CT system components.
• Physical phantoms: Standardized objects used to measure image quality characteristics (e.g., spatial resolution, contrast-to-noise ratio, slice thickness accuracy).
• Calibration procedures: Ensuring the system's measurements are accurate.
• Compliance with international standards: (e.g., IEC 60601 series for medical electrical equipment safety and performance).

For the lung cancer screening indication, the document refers to "clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature." This means the ground truth for the clinical utility of low-dose CT screening, in general, is based on outcomes data from large clinical trials. The device's "acceptance" for this indication is based on its capability to perform scans at low dose within established protocols, implying it meets the technical requirements to participate in such screening programs.

8. The sample size for the training set:

Not applicable. This is not for a machine learning model that requires a "training set" of clinical data in the typical sense.

9. How the ground truth for the training set was established:

Not applicable. No machine learning training set is described.

In summary: This 510(k) document is a regulatory submission for a general-purpose CT scanner. Its "acceptance criteria" and "proof" primarily revolve around demonstrating that its technical specifications, design, and functionality are substantially equivalent to a previously cleared predicate device, and that any modifications (like extended scan range, increased slices, or removal of gantry tilt) do not compromise safety or effectiveness. The inclusion of "low dose CT lung cancer screening" as an indication relies on the device's ability to perform scans compatible with established clinical guidelines, rather than presenting novel AI performance data for nodule detection or characterization.

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