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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.

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