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This system is a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities.

Magnetic Resonance images represent the spatial distribution of protons or other nuclei with spin. Image appearance is determined by many different physical properties of the tissue and the MR scan technique applied. The image acquisition process can be synchronized with the patient's breathing or cardiac cycle. The systems can use combinations of images to produce physical parameters, and related derived images.

Images, spectra, and measurements of physical parameters, when interpreted by a trained physician, provide information that may assist the diagnosis and therapy planning. The accuracy of determined physical parameters depends on system and scan parameters, and must be controlled and validated by the clinical user. The use of contrast agents for diagnostic imaging applications should be performed consistent with the approved labeling for the contrast agent.

In addition the Philips MR systems provide imaging capabilities, such as MR fluoroscopy, to guide and evaluate interventional and minimally invasive procedures in the head, body and extremities.

MR Interventional procedures, performed inside or adjacent to the Philips MR system, must be performed with MR Conditional or MR Safe instrumentation as selected and evaluated by the clinical user for use with the specific MR system configuration in the hospital. The appropriateness and use of information from a Philips MR system for a specific interventional procedure and specific MR system configuration must be validated by the clinical user.

The proposed Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 with ScanWise Implant and 3D ASL features are provided with a 60 cm magnet. The system and its control software are substantially equivalent to the currently marketed and primary predicate device Achieva R2.5 (K063559, 01/04/2007), enhanced by the digital receive coil architecture as in the currently marketed and reference device Ingenia R4 (K110151, 03/22/2011).

ScanWise Implant functionality enables MR technologists to implement an improved and controlled workflow for MR Conditional implants. The feature consists of an extension to the Patient Registration User Interface where the information relevant to MR Conditional device labeling can be assessed, controlled and reviewed. The ScanWise Implant feature allows the user at the examination level to define restrictions on the 'active fields' generated by the MR system.

3D ASL functionality enables MR technologists to assess perfusion in the brain without the usage of contrast agents. The feature consists of an extension to the available scan sequences and image reconstruction algorithms. The proposed Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 with ScanWise Implant and 3D ASL features also consolidate separatelycleared novel functionalities, and minor changes since the clearance of the currently marketed and predicate device, Achieva R2.5 (K063559, 01/04/2007). Following minor changes are covered in this submission: Enhanced Patient Communication User Interface Module, 1. IEC/ISO compliant symbols. 2. New computing platform and peripherals for MR Spectrometer (DDAS). 3. MultiTransmit 4. dStream architecture implementation and commercialize system name as Ingenia CX 5. Planning on cine images. 6. SAR related parameters (SED). Pregnancy status related to Normal Mode. 7. SED limit 8. Parameter optimization for the reconstruction algorithms. 9. Partial NSA algorithm in reconstruction. 10. AutoVoice, using pre-recorded spoken instructions. 11. VCG, optimized electrode placement and enhanced algorithm. 12. ComforTone: mechanical resonance frequency dependent timing adjustments of sequences for lower acoustic noise. 13. Enhanced sequences: a. LIPO b. Black Blood Imaging c. 4D TRAK XD d. Zoom Diffusion Imaging e. 3D Vane XD 4D TRANCE f. g. 3D NerveVIEW h. Fast B1 Mapping and B1 Shading filter i. AutoSpair. TSE flow compensation enhancement 1. k. Optimized 3D TSE flip angle sweeps per anatomy ENCASE: 3D encoding 1. m. CardiacQuant: triggered T1 mapping sequence n. pCASL o. DTI enhancements QA Tool and fMRI stability p.

The provided text describes the Philips Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 MR systems and their features, including "ScanWise Implant" and "3D ASL". However, it does not contain the detailed information required to fully answer all aspects of your request regarding acceptance criteria and a specific study proving those criteria were met.

Specifically, the document states: "The verification and or validation test results, combined with sample clinical images demonstrate that the proposed Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 with ScanWise Implant and 3D ASL features: Complies with the aforementioned international and FDA-recognized consensus standards and Device specific guidance document, entitled “Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices – November 14, 1998” Meets the acceptance criteria and is adequate for its intended use."

This indicates that acceptance criteria exist and were met, but the document does not explicitly list the quantitative acceptance criteria themselves, nor does it describe a detailed study that would allow for a precise breakdown of the device's performance against these criteria.

Therefore, much of the requested information cannot be extracted from this document.

Here's what can be answered based on the provided text, and what remains unknown:

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Unknown. The document states that "Non-Clinical verification and or validation tests have been performed with regards to the intended use, the technical claims, the requirement specifications and the risk management results," and mention "sample clinical images" were used. However, it does not specify the sample size of any test set (e.g., number of patients, number of images), nor its provenance (country, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Unknown. The document mentions the "interpretation by a trained physician" for general use but does not detail how ground truth was established for any specific test set, nor the number or qualifications of experts.

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

• Unknown. The document does not describe any adjudication method.

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 Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 with ScanWise Implant and 3D ASL features did not require clinical study since substantial equivalence to the primary currently marketed and predicate device was demonstrated with the following attributes: Design features; Indication for use; Fundamental scientific technology; Non-clinical performance testing; and Safety and effectiveness."
• Furthermore, the document describes the system as a diagnostic device that produces images for physicians to interpret, and features like ScanWise Implant and 3D ASL are described as enabling specific functionalities or workflows. It does not suggest these features involve AI assistance for human readers in the sense of a comparative effectiveness study.

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

• While "Non-Clinical verification and or validation tests" were performed, and software/algorithms are integral to the system's function (e.g., image reconstruction algorithms, ASL processing), the document does not describe a standalone algorithm performance study separate from the overall system performance verification. The device is an MRI system, and its performance would be evaluated as a complete system, not just individual algorithms in isolation.

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

• Unknown. The document vaguely mentions "sample clinical images" in the context of verification/validation, but does not specify the method for establishing ground truth for these images.

8. The sample size for the training set

• Not applicable / Unknown related to specific AI training. The document describes a medical device (MRI system) with advanced features (ScanWise Implant, 3D ASL) and various software enhancements. It does not explicitly state that these features were developed using machine learning or AI that required a distinct "training set" in the modern sense of AI/ML development. The document predates the widespread regulatory focus on AI/ML training data. It refers to "image reconstruction algorithms" but does not detail their development process.

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

• Not applicable. As above, the document does not mention a "training set" in the context of modern AI/ML.

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