Search Results

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 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.

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.

Ask a specific question about this device

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 equipments 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.

Besides installed in hospital, the proposed Philips Incisive CT may also be installed on trailer and be transported to designated locations for use. And Incisive CT installed on trailer has the same intended use as installed in hospital.

The proposed Philips Incisive CT on Trailer 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 support, components, and accessories. The Philips Incisive CT has a 72cm bore and includes a detector array that provides 50cm scan field of view (FOV).

Besides installed in hospital, Philips Incisive CT can also be installed on trailer and be transported to designated locations.

The main components (detection system, the reconstruction algorithm, and the x-ray system) that are used in the proposed Philips Incisive CT on trailer are identical to the currently marketed and predicate Philips Incisive CT (K180015, 20/March/2018).

The components of the proposed Philips Incisive CT on trailer include the following:

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.
4. CT on Trailer Kit - Modified Incisive CT installed and secured on trailer requires locking motion parts during trailer transportation and unlocking motion parts before CT operations.

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 document is a 510(k) premarket notification for the Philips Incisive CT on Trailer. It seeks to demonstrate substantial equivalence to a predicate device, the Philips Incisive CT (K180015). This type of submission focuses on showing that the new device is as safe and effective as a legally marketed predicate device, rather than on providing extensive clinical performance data for an AI algorithm.

Therefore, the document does not contain the detailed information necessary to answer all parts of your request, especially those pertaining to AI/algorithm-specific studies. The device described is a CT scanner, not an AI algorithm for image analysis.

However, I can extract the relevant information regarding the device's performance criteria based on the context provided for a traditional 510(k) submission for an imaging device.

Here's an analysis based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document details that the "Philips Incisive CT on Trailer" is essentially the predicate "Philips Incisive CT" (K180015) installed on a trailer. The justification for substantial equivalence relies heavily on the fact that the core CT system (detection system, reconstruction algorithm, x-ray system) is identical to the predicate.

The primary performance evaluation mentioned, specifically for the "on Trailer" aspect, relates to robustness and image quality after transportation.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not explicitly stated as a number of patient cases. The "test set" in this context refers to the physical device undergoing vibration and QA tests. The tests were performed on "the proposed Philips Incisive CT on Trailer." This likely refers to one or more physical units of the device.
• Data Provenance: The testing was conducted by Philips Healthcare (Suzhou) Co., Ltd. within their development/validation process in China. The data is prospective in the sense that it's generated from testing the new "on Trailer" configuration.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• This question is not applicable in the context of this 510(k) submission. This filing is for a physical CT device (mobile CT scanner) and its ability to maintain performance after transport, not for an AI algorithm that generates a "ground truth" often established by expert readers. The "ground truth" here is the physical performance of the CT scanner measured by established imaging quality metrics.

4. Adjudication Method for the Test Set

• Not applicable for this type of device submission. Adjudication generally refers to expert consensus in interpreting medical images or data. The performance of the CT scanner is measured objectively (e.g., noise levels, spatial resolution) against pre-defined engineering and image quality specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

• No, an MRMC study was not done. This type of study is relevant for AI algorithms intended to assist human readers in diagnostic tasks. The device in focus is the CT scanner itself, not an AI software for image interpretation.

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

• No, a standalone AI algorithm performance study was not done. This 510(k) is for the CT imaging system, not an AI diagnostic algorithm.

7. The Type of Ground Truth Used

• For the physical performance of the CT scanner (MeanCT, Uniformity, Noise, Spatial Resolution, Slice Thickness, Linearity, Low Contrast Resolution), the "ground truth" is established by engineering specifications and phantoms/test objects yielding objective physical measurements, rather than clinical outcomes or expert consensus on patient images. The claim is that these measurements are "same as the predicate device," implying the predicate's performance serves as the benchmark.

8. The Sample Size for the Training Set

• Not applicable. This document is for a CT scanner hardware device (with integrated software for image acquisition and reconstruction), not a machine learning model that requires a "training set" of data.

9. How the Ground Truth for the Training Set was Established

• Not applicable. See point 8.

Ask a specific question about this device

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).

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.

Ask a specific question about this device