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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. The use 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 MR 5300 and MR 7700 R11 MR Systems are 60 cm and 70 cm bore 1.5 and 3.0 Tesla (1.5T and 3.0T) Magnetic Resonance Diagnostic Devices, hereafter to be known as MR 5300 and MR 7700 MR Systems.

This Special 510(k) submission will include modifications of the proposed MR 5300 and MR 7700 R11 MR Systems as compared to our legally marketed devices, primary predicate device Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems R11 (K213583, 05/16/2022) and the secondary predicate devices Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition, and MR 7700 with distributed Multi Nuclei (K213516, 03/03/2022) and MR 5300 (K212673, 11/19/2021).

The proposed MR 5300 and MR 7700 MR systems will be brought up to the new baseline software R11. This R11 software is cleared on the Achieva, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems in the following primary predicate 510(k) Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems R11 (K213583, 04/15/2022). Both the proposed MR 5300 and MR 7700 MR systems are already cleared with the secondary predicate devices Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition, and MR 7700 with distributed Multi Nuclei (K213516, 03/03/2022) and MR 5300 (K212673, 11/19/2021).

Here's an analysis of the acceptance criteria and study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "The verification and/or validation test results demonstrate that the proposed MR 5300 and MR 7700 R11 MR Systems meet the acceptance criteria and are adequate for the intended use." and "The results of these tests demonstrate that the proposed MR 5300 and MR 7700 R11 MR Systems meet the acceptance criteria and are adequate for the intended use."

However, the provided text does not explicitly list specific acceptance criteria in a tabular format, nor does it quantify specific performance metrics for the device against such criteria. Instead, it refers to broad compliance with standards and successful completion of verification/validation tests. The device's performance is implicitly stated as "meeting the acceptance criteria" of these tests and compliance with recognized standards.

2. Sample Size Used for the Test Set and Data Provenance:

The document broadly mentions "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."

However, the text does not provide any details about the sample size (e.g., number of cases, number of images) used for these non-clinical verification and validation tests. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature) of any data used in these tests.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

The document makes no mention of experts being used to establish ground truth for a test set. The validation primarily focuses on technical compliance and functional verification against internal specifications and external standards.

4. Adjudication Method for the Test Set:

No information is provided regarding an adjudication method. This is consistent with the lack of expert involvement in establishing ground truth for a test set described in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document explicitly states: "The proposed Ingenia MR 5300 and MR 7700 R11 MR Systems did not require a clinical study since substantial equivalence to the legally marketed predicate device was proven with the verification/validation testing."

Therefore, no MRMC comparative effectiveness study was done, and consequently, no effect size of human readers improving with AI vs. without AI assistance is reported.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

The device is an MR System, a diagnostic imaging device. The various software enhancements (e.g., SmartSpeed AI, SmartSpeed MotionFree) listed are features of the MR system. The evaluation appears to be of the integrated system's technical and safety compliance rather than a standalone algorithm with distinct performance metrics evaluated without human intervention. The provided text does not describe a standalone algorithm-only performance study.

7. Type of Ground Truth Used:

Given that the document describes "Non-Clinical verification and or validation tests" and mentions compliance with "technical claims, the requirement specifications and the risk management results," the "ground truth" for the tests appears to be technical specifications, functional requirements, and established industry standards rather than expert consensus on medical images, pathology results, or outcomes data. The clearance is based on substantial equivalence to predicate devices demonstrated through these non-clinical tests.

8. Sample Size for the Training Set:

The document does not provide any information regarding a training set sample size. This is consistent with the nature of the submission, which focuses on hardware and software enhancements to existing medical devices rather than the development and validation of a new AI model requiring a separate training dataset. The AI functions mentioned (SmartSpeed AI) are integrated into the system, and their validation is part of the overall system's non-clinical testing.

9. How the Ground Truth for the Training Set Was Established:

As no training set is described, no information is provided on how ground truth for a training set was established.

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