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Philips Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. This MR system enables trained physicians to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation, representing the spatial distribution of protons or other nuclei with spin.

Image appearance is determined by many different physical properties of the tissue and the anatomy, the MR scan technique applied, and presence of contrast agents for diagnostic imaging applications should be performed consistent with the approved labeling for the contrast agent.

The trained clinical user can adjust the MR scan parameters to customize image appearance, accelerate image acquisition, and synchronize 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 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.

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, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems with bFFE-XD, IRIS Zoom, MEGA, SENC, and SyntAc software features are provided on the 60 cm and 70 cm bore 1.5 Tesla (1.5T) and 3.0 Tesla (3.0T) MR systems. The systems and aforementioned software features of the proposed Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems are substantially equivalent to the legally marketed predicate device, Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CX R5.4 (K173079, 04/04/2018) and the legally marketed reference devices Ingenia Elition S and Ingenia Elition X (K173451, 03/20.2018) and the Ingenia Ambition S and Ingenia Ambition X (K180479, 08/03/2018). This submission includes the software modifications below for the proposed Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems, there are no hardware changes: 1. bFFE-XD 2. IRIS Zoom 3. MEGA 4. SENC (Spiral Cardiac) 5. SyntAc (MDME)* * This software feature is provided on the proposed Ingenia systems only (Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T and Ingenia 3.0T CX). Please note that this feature is already cleared and legally marketed on Ingenia Ambition and Elition systems. The proposed Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems submission also includes minor changes to the existing software features listed below since the clearance of the legally marketed predicate device Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CX R5.4 (K173079, 04/04/2018): 1. VAPOR 2. sLASER 3. Spiral Brain 4. 3D Non-selective 5. Diffusion XD TSE 6. 2KDTI 7. Advanced diffusion gradient control 8. K-t SENSE 9. Cardiac ZOOM 10. Retrospective EPI 11. mFFE Echo Summation* 12. Contrast Card* 13. Autostart* * This software feature is provided on the proposed Ingenia systems only (Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T and Ingenia 3.0T CX). Please note that this feature is already cleared and legally marketed on Ingenia Ambition and Elition systems. The proposed Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems are intended to be marketed with the following pulse sequences and coils that were previously cleared by FDA: 1. mDIXON (K102344) 2. SWIp (K131241) 3. mDIXON-Quant (K133526) 4. MRE (K140666) 5. mDIXON XD (K143128) 6. O-MAR K143253 7. MultiBand SENSE (K143606) 8. 3D APT (K172920) 9. Ingenia Coils, see Appendix 011

This Philips K183063 510(k) premarket notification describes new software features for their Ingenia MR Systems (Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition models). The submission states that no clinical study was required to demonstrate substantial equivalence to the legally marketed predicate device (Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CX R5.4 (K173079)). Therefore, the acceptance criteria and study details you requested for an AI/CAD-like device are not directly applicable in this context.

This submission focuses on non-clinical performance data (verification and validation tests) to prove that the proposed new software features of the MR systems meet acceptance criteria and are adequate for clinical use, and are substantially equivalent to the predicate device.

Here's a breakdown of the information provided within the context of a general medical device submission (even though it's not specifically an AI/CAD study):

1. Table of Acceptance Criteria and Reported Device Performance

Since this is not an AI/CAD performance study, there's no table presenting sensitivity, specificity, or similar metrics. Instead, the "acceptance criteria" are compliance with established international and FDA-recognized consensus standards, and the "performance" is the device's adherence to these standards and its functional capabilities.

Regarding AI/CAD-specific questions:

• 2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set data from an AI/CAD study.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth established for an AI/CAD test set.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 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. No MRMC study was conducted or required.
• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is describing new software features for an MR system, not a standalone algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI/CAD study. Ground truth in this submission refers to the established standards and specifications verified through non-clinical testing.
• 8. The sample size for the training set: Not applicable. There is no mention of an AI model being trained with a dataset.
• 9. How the ground truth for the training set was established: Not applicable.

Summary from the Document:

The document states: "The proposed Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems did not require a clinical study since substantial equivalence to the legally marketed predicate device was proven with the verification/validation testing."

The device's performance is demonstrated through compliance with a comprehensive list of international and FDA-recognized consensus standards (e.g., IEC, NEMA, ISO standards for medical electrical equipment, quality management systems, and specifically MR devices) and relevant FDA guidance documents. Non-clinical verification and validation tests were performed to confirm that the new software features function as intended, meet their specifications, and manage risks appropriately, thus demonstrating safety and effectiveness without requiring clinical data.

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This system is a Magnetic Resonance Medicated 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 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 Ambition S and Ingenia Ambition X R5.5 with sealed magnet, modified RF amplifier and Workflow Solution are modifications of the 70 cm Ingenia 1.5T system, included in the legally marketed predicate device Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CX R5.4 (K173079, 04/04/2018). The systems and control software provided with the proposed Ingenia Ambition S and Ingenia Ambition X are substantially equivalent to the legally marketed predicate device Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CX R5.4 (K173079, 04/04/2018).

Hereafter in this submission, Ingenia Ambition S and Ingenia Ambition X will be used to indicate the proposed device Ingenia Ambition S and Ingenia Ambition X R5.5 with sealed magnet, modified RF amplifier and Workflow Solution.

The proposed Ingenia Ambition S and Ingenia Ambition X also includes minor software changes since the clearance of the legally marketed predicate device, Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CX R5.4 (K173079, 04/04/2018).

The following modifications to the proposed Ingenia Ambition S and Ingenia Ambition X are included in this submission:

1. Introduction of sealed magnet and modified RF amplifier;
2. Introduction of new product name and covers;
3. VitalScreen: Touch Screen for guidance for patient setup: Touch screen at magnet facade to give user guidance on how to prepare a patient;
4. Autostart: automatic start of scanning at RF Door Closure: Possibility for an operator to start a sequence by pressing the Start button at the controls at the magnet facade, the scan will then start the necessary preparations to be able to start the sequence (transmitting and receiving of RF-signals and generating gradient waveforms) when the RF door is closed.
5. VitalEye: automatic breathing detection using camera: A camera solution for detecting breathing patterns of the patient. The MR scanner translates real-time camera images of the patient, to real-time breathing wave forms. The acquisition system of the MR scanner will use these breathing wave forms to synchronize the internals of the sequence:
6. ContrastCards: offers the ability to add information on the contrast agent. After applying the contrast agent, which is done independent from the MR system, information on the applied contrast is added to the DICOM images. When viewing these images on the MR system the images which have been taken while contrast was applied are marked with an indication "Contrast". The feature helps the operator to indicate which sequence needs contrast and after applying contrast it helps indicate which images are taken while contrast was injected. Still, the use of contrast agents for diagnostic imaging applications shall be performed consistent with the approved labeling for the contrast agent.
7. SyntAc (MDME): acquisition of Multi-Dynamic Multi-Echo (MDME) images. These images can be processed by 3rd party (Synthetic MRI) software to produce the relevant radiological contrasts.

Note: The VitalScreen (3), AutoStart (4), VitalEye (5), ContrastCards (6) and SyntAc (MDME) (7) features have been already cleared for the legally marketed reference device Ingenia Elition S and Ingenia Elition X systems (K173451) and are integrated in the proposed Ingenia Ambition S and Ingenia Ambition X without any further modifications compared to K173451.

The proposed Ingenia Ambition S and Ingenia Ambition X are intended to be marketed with the following pulse sequences and coils that were previously cleared by FDA:

1. mDIXON K102344
2. SWIp K131241
3. mDIXON-Quant K133526
4. MRE K140666
5. mDIXON XD K143128
6. O-MAR K143253
7. MultiBand SENSE K143606
8. Ingenia Coils, see Appendix 004

The provided text describes the Philips Ingenia Ambition S and Ingenia Ambition X MRI systems. However, it does not contain specific details about acceptance criteria or a dedicated study proving device performance against those criteria in a quantitative manner, as would be expected for an AI/CADe device.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Ingenia 1.5T, Ingenia 1.5T S, etc., K173079) and a reference device (Ingenia Elition S and X, K173451) through compliance with regulatory standards and non-clinical verification and validation tests. The "performance" discussed is related to the overall system functionality and safety rather than the diagnostic accuracy of a specific software feature.

Therefore, many of the requested categories for AI/CADe device performance studies cannot be directly answered from this document.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document states: "Additionally, a representative set of clinical images of the proposed Ingenia Ambition S and Ingenia Ambition X systems have also been generated and provided in DICOM format together with this submission."
• Sample Size: Not specified (only "a representative set").
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). This was likely an internal collection for verification/validation.

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

• Not specified. The clinical images were "generated and provided" as part of the submission, implying they were used for internal verification, but no explicit ground truth establishment by external experts/readers is mentioned in the context of a performance study. Interpretation of images is generally stated to be "by a trained physician" (Indications for Use).

4. Adjudication method for the test set:

• Not applicable as no formal reader study requiring adjudication is 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:

• No, an MRMC comparative effectiveness study involving human readers and AI assistance was not done or reported in this document. The device is a diagnostic imaging system, not an AI/CADe accessory. The "Workflow Solution" features (VitalScreen, AutoStart, VitalEye, ContrastCards) are workflow enhancements, not systems for diagnostic interpretation. SyntAc (MDME) enables image acquisition for 3rd party (Synthetic MRI) software, indicating the device itself doesn't perform diagnostic AI interpretation.

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

• No, a standalone algorithm performance study was not described. The device is an MRI system. While it includes "software changes" and "Workflow Solution" features, these are not standalone diagnostic algorithms whose performance is measured independently.

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

• Not specified for the "representative set of clinical images." Given the context of a new MRI system, the "ground truth" for these images would likely be related to image quality metrics, artifact assessment, and general diagnostic utility as interpreted by imaging specialists, rather than a specific disease outcome or pathology.

8. The sample size for the training set:

• Not applicable/Not specified. This document describes an MRI system, not a machine learning algorithm that requires a distinct training set. The "Workflow Solution" features are described as integrated features, some of which were "already cleared for the legally marketed reference device," implying they are established functionalities rather than newly trained AI models needing specific training data.

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

• Not applicable/Not specified. (See point 8).

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