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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 available in three system configurations, the Oncology configuration the Radiology (Base) configuration, and the new Sliding Gantry 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:

• 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 detector array, fixed to the Rotor frame
• 2. Patient Support (Couch) supports the patient in a stationary position while the gantry moves in and out on a carriage.
• 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

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.

The Sliding Gantry Configuration provides the following features.

• . The patient table is stationary during the scan.
• . Patient is located on the stationary table.
• To perform imaging, CT gantry rides on a carriage and moves over the patient.

The Philips CT Big Bore Sliding Gantry Configuration is a Computed Tomography X-Ray System. The device has undergone non-clinical testing to demonstrate its substantial equivalence to the primary predicate device, Philips CT Big Bore (K171850).

1. Acceptance Criteria and Reported Device Performance

The document states that the validation test plan was executed as planned and acceptance criteria were met for each requirement. The "Values and ranges measured on phantoms" for the Philips CT Big Bore Sliding Gantry Configuration implies these were the performance metrics observed and deemed acceptable.

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

The testing involved phantom studies for basic CT performance tests. The document does not specify an exact "sample size" in terms of number of phantoms or scans. The data provenance is through bench testing of the device against international and FDA recognized consensus standards and FDA regulations and guidance documents. This is a non-clinical study.

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

This information is not applicable as the study was non-clinical bench testing using phantoms, not a study involving human experts establishing ground truth for diagnostic imaging.

4. Adjudication method for the test set

Not applicable as no human adjudication was performed; the study involved objective measurements of physical phantom properties.

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

No MRMC comparative effectiveness study was done. The document explicitly states: "The proposed Philips CT Big Bore Sliding Gantry Configuration did not require a clinical study since substantial equivalence to the legally marketed predicate device was proven with the verification/validation testing."

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

The device is a Computed Tomography X-Ray System, not an AI algorithm. The performance evaluation was of the system itself (hardware and embedded software) in producing images based on defined physical metrics. Therefore, this can be considered a "standalone" evaluation of the system's technical performance.

7. The type of ground truth used

The ground truth was based on objective physical measurements from phantoms as per established CT performance testing standards. For example, for CT number accuracy, the ground truth for water is 0 HU.

8. The sample size for the training set

Not applicable. This device is a CT imaging system and not an AI algorithm that typically requires a training set. The performance evaluation was based on non-clinical verification and validation testing against engineering requirements and established standards.

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

Not applicable. As stated above, this device is a CT imaging system and does not involve a training set that requires ground truth establishment in the context of machine learning.

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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:

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 detector 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 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.

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.

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