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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 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, 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 R 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.

This submission covers the proposed Achieva 1.5T, Achieva 3.0T, and the Intera 1.5T MR Systems R5.6, hereafter to be known as Achieva 1.5T, 3.0T, and Intera 1.5T MR Systems. The proposed Achieva 1.5T, 3.0T, and Intera 1.5T MR Systems are 60 cm bore 1.5 Tesla (1.5T) and 3.0 Tesla (3.0T) Magnetic Resonance Diagnostic Devices. This submission of the proposed Achieva 1.5T, 3.0T, and Intera 1.5T MR Systems contains a description of the software and hardware modifications made since the last 510(k) clearance of the primary predicate Achieva, Intera & Panorama 1.0T R2.5 (K063559, 01/04/2007). The Achieva 1.5T and Intera 1.5T systems differ in outside covers only, both systems function in an identical manner. The proposed Achieva 1.5T, 3.0T and Intera 1.5T MR Systems are substantially equivalent to the primary predicate Achieva, Intera & Panorama 1.0T R2.5 (K063559, 01/04/2007), and the 1st legally marketed reference device Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition (K183063, 02/14/2019) and the 2nd legally marketed reference device Achieva R4 1.5T and Achieva R4 3.0T (aka Ingenia, K110151, 03/22/2011). The proposed Achieva 1.5T, 3.0T, and Intera 1.5T 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. Achieva and Intera Coils

Here's a breakdown of the acceptance criteria and study information for the Philips Achieva 1.5T, 3.0T, and Intera 1.5T MR Systems, based on the provided text:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for a novel device. As such, information typically found in a clinical study report (like detailed statistical methods, effect sizes for human readers with and without AI, or specific ground truth methodologies for a novel algorithm) is not present in this type of submission. The device described is a Magnetic Resonance (MR) system, which is a diagnostic imaging device, not a specific AI-powered diagnostic algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable. This submission relies on non-clinical verification and validation tests rather than a separate clinical test set with patient data for assessing a new algorithm's performance. The device is an MR system, and the evaluation focuses on its technical performance and safety, not on the diagnostic accuracy of a new AI algorithm processing patient data.
• Data Provenance: Not applicable for a separate clinical test set. The non-clinical tests would involve engineering and performance evaluations in a controlled environment, not patient data from a specific country or collected retrospectively/prospectively for a new algorithm's evaluation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts/Qualifications: Not applicable. As this involves non-clinical verification and validation testing of an MR system's performance and safety features (e.g., image quality, electromagnetic compatibility, software functionality), the "ground truth" would be established by engineering and quality assurance standards, benchmarks, and regulatory requirements, not by expert interpretation of patient images for diagnostic accuracy.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Since there's no clinical test set requiring expert interpretation and consensus, there's no need for an adjudication method.

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

• MRMC Study Done: No. An MRMC study is typically performed to evaluate the impact of a new diagnostic algorithm on human reader performance (e.g., radiologists interpreting images with and without AI assistance). This submission pertains to an MR system, which is the imaging hardware and associated software to acquire images. The document explicitly states: "The proposed Achieva 1.5T, 3.0T, and Intera 1.5T MR Systems did not require a clinical study since substantial equivalence to the primary predicate device was proven with the verification/validation testing."
• Effect Size of Human Readers with vs. without AI: Not applicable, as no MRMC study was performed.

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

• Standalone Study Done: No. The device is an MR imaging system; it is not a standalone AI algorithm designed to provide diagnostic outputs independently. The output of the MR system (images, spectra, measurements) is intended to be interpreted by a trained physician.

7. Type of Ground Truth Used

• Type of Ground Truth: Not applicable in the context of diagnostic accuracy for a specific algorithm. For the non-clinical verification and validation, the ground truth would be defined by engineering specifications, regulatory standards, and established benchmarks for parameters like image quality, signal-to-noise ratio, spatial resolution, gradient linearity, safety limits (e.g., SAR), and software functionality.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. The document describes an MR imaging system, not a machine learning or AI algorithm that would typically require a training set of data. While the system's software components were developed and tested, the information provided does not indicate the use of a data-driven training set in the context of an FDA-cleared AI/ML algorithm.

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

• Ground Truth for Training Set: Not applicable, as there is no mention of a training set or an AI/ML algorithm requiring such.

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