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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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