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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 anatomy, 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 Elition S and Ingenia Elition X R5.4 with new gradient system/specifications are modifications of the 70 cm Ingenia 3.0T system, included in the legally marketed predicate device Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 (K163116, 01/06/2017).

The systems and control software are substantially equivalent to the legally marketed predicate device Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 (K163116, 01/06/2017).

Hereafter Ingenia Elition S and Ingenia Elition X R5.4 will be used to indicate the proposed device Ingenia Elition S and Ingenia Elition X R5.4 with new gradient system/specifications

The proposed Ingenia Elition S and Ingenia Elition X R5.4 also includes minor software changes since the clearance of the legally marketed predicate device, Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 (K163116, 01/06/2017).

The following modifications are covered compared to legally marketed predicate device:

1. Upgrade of SW platform to Windows 10 and PSC 6.1 (to be compatible with Windows 10);
2. PerformanceBridge Protocol Manager Release 1.0;
3. Introduction of new gradient system hardware with new gradient specifications;
4. Introduction of new product name and covers.

The proposed Ingenia Elition S and Ingenia Elition X R5.4 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

This document describes the 510(k) summary for the Philips Ingenia Elition S and Ingenia Elition X R5.4 Magnetic Resonance Diagnostic Devices. The submission focuses on demonstrating substantial equivalence to a predicate device (Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3, K163116) rather than proving performance based on specific clinical outcomes for a novel application. Therefore, the details requested in the prompt, which are typically associated with performance studies for AI/CADe devices, are largely not present in this type of submission.

Based on the provided text, here's what can be extracted:

• Device: Ingenia Elition S and Ingenia Elition X R5.4 (Magnetic Resonance Diagnostic Device - MRDD)
• Submission Type: 510(k) Premarket Notification, Abbreviated 510(k)
• Purpose of Submission: To demonstrate substantial equivalence to a legally marketed predicate device due to modifications (new gradient system/specifications, software upgrades like Windows 10 compatibility and PerformanceBridge Protocol Manager, new product name/covers).

Here's an analysis of the provided text in relation to your specific questions:

1. A table of acceptance criteria and the reported device performance

The document states: "The verification and/or validation test results demonstrate that the proposed Ingenia Elition S and Ingenia Elition X R5.4: • 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 18, 2016" • Meets the acceptance criteria and is adequate for its intended use."

It further concludes: "The results of these tests demonstrate that the proposed Ingenia Elition S and Ingenia Elition X R5.4 meet the acceptance criteria and is adequate for its intended use."

However, the specific "acceptance criteria" (e.g., in terms of image quality metrics, diagnostic accuracy, or specific performance thresholds) and the "reported device performance" against those criteria are not detailed in this 510(k) summary. This type of submission relies on demonstrating compliance with recognized standards and that the modifications do not raise new questions of safety or effectiveness compared to the predicate device. The performance is implied to be equivalent to the predicate, which presumptively met certain performance standards.

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

This information is not provided in the document. The submission states, "The proposed Ingenia Elition S and Ingenia Elition X R5.4 did not require a clinical study since substantial equivalence to the legally marketed predicate device was proven with the verification/validation testing." This indicates that formal clinical studies with distinct test sets, common for AI/CADe devices, were not performed or submitted for this 510(k). The "verification/validation testing" likely refers to engineering, phantom, and perhaps limited clinical image quality checks, rather than a full-scale clinical trial.

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)

This information is not provided. As no clinical study needing ground truth establishment was conducted for this 510(k) submission, there's no mention of experts or their qualifications for establishing ground truth on a test set.

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

This information is not provided. As no clinical study needing a test set with ground truth was conducted for this 510(k) submission, there's no mention of an 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 as part of this submission. This device is a Magnetic Resonance Diagnostic Device (an MRI scanner itself), not an AI/CADe algorithm designed to assist human readers. The clearance is for the hardware and basic software functionality rather than an AI-driven interpretive aid.

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

This question is not directly applicable. This is an MRI device, not a standalone algorithm. The "performance" relates to its ability to acquire images, not to automatically interpret them.

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

This information is not provided. Given that no clinical study was performed for this 510(k) submission (as stated: "The proposed Ingenia Elition S and Ingenia Elition X R5.4 did not require a clinical study..."), the concept of ground truth for a clinical validation set is not applicable here. The "ground truth" for the performance of an MR system typically relies on physical measurements in phantoms and comparison against established image quality metrics, rather than clinical outcomes or expert consensus for diagnosis.

8. The sample size for the training set

This information is not provided and is not relevant for this type of device submission. This is not an AI/ML device that requires a training set. The changes are hardware (gradient system) and basic software (OS upgrade, protocol manager).

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

This information is not provided and is not relevant for this type of device submission, as there's no training set mentioned for an AI/ML model.

Summary of the Study Proving Acceptance (as implied by the document):

The "study" proving the device meets acceptance criteria was a series of non-clinical verification and validation tests. These tests were designed to demonstrate:

• Compliance with recognized standards: IEC 60601-1 (medical electrical equipment), IEC 60601-1-2 (EMC), IEC 62366 (usability), IEC 60601-1-8 (alarms), IEC 60601-2-33 (MR specific safety), IEC 62304 (software life cycle), NEMA MS-1, MS-4, MS-8, PS 3.1-3.20 (MR performance and DICOM standards), ISO 14971 (risk management).
• Compliance with FDA guidance documents: Specifically, "Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices – November 18, 2016" and other relevant guidances for software, human factors, cybersecurity, biocompatibility, and EMC.
• Equivalence to the predicate device: The new gradient system and software changes were evaluated to ensure they did not negatively impact the imaging performance (image quality, safety parameters) or introduce new risks compared to the predicate device.

The document states that these tests demonstrate the device "Meets the acceptance criteria and is adequate for its intended use." The "acceptance criteria" are intrinsically tied to meeting these regulatory standards and demonstrating that the modifications do not alter the substantial equivalence to the predicate. The document does not provide quantitative performance metrics from these tests.

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