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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, 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 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nuclei R5.9 are provided on the 60 cm and 70 cm bore 3.0 Tesla (3.0T) Magnetic Resonance Diagnostic Devices.

This bundled abbreviated 510(k) submission will include modifications of the 3.0T systems, included in the legally marketed predicate device Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems R5.7 (K193215, 04/10/2020).

This 510(k) submission will address the following HW and SW modifications for the proposed Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nuclei R5.9 since the clearance of the last submission for each of the systems: New system MR 7700 which contains modified gradient system compared to Ingenia Elition X Modified Multi Nuclei option, now available for all 3.0T systems

This 510(k) submission will also address minor hardware and software enhancements: Universal Mains Distribution Unit (uMDU) 3.0T 1H RF Amplifier Extended Functionality Options

The proposed Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nuclei R5.9 are intended to be marketed with the following pulse sequences and coils that were previously cleared by FDA: mDIXON (K102344) SWIp (K131241) mDIXON-Quant (K133526) mDIXON XD (K143128) O-MAR K143253 3D APT (K172920) Coils compatible with Ingenia 3.0T, Ingenia 3,0T CX, Ingenia Elition and MR 7700

The proposed Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nuclei R5.9 are substantially equivalent to the legally marketed predicate device Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems R5.7 (K193215, 04/10/2020).

The provided text describes modifications to existing Philips Magnetic Resonance (MR) systems (Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition, and MR 7700) with the addition of "Distributed Multi Nuclei" functionality. The submission argues for substantial equivalence to a legally marketed predicate device (Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems R5.7, K193215).

However, the document does not describe a study that proves the device meets specific performance acceptance criteria in the way one might expect for a diagnostic AI device (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating substantial equivalence through non-clinical verification and validation testing, and compliance with recognized standards.

Here's an analysis based on the information provided, highlighting what is present and what is missing concerning your request:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document as a quantitative table of performance metrics. The document states: "Test results demonstrate that the proposed Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nuclei R5.9 meet the acceptance criteria and are adequate for its intended use." However, it does not specify what those acceptance criteria are nor what the reported performance values against those criteria are for the functional enhancements (Modified Gradient System, Distributed Multi Nuclei, uMDU, 3.0T 1H RF Amplifier).

The "acceptance criteria" appear to be related to compliance with international, FDA recognized consensus standards, and the intended use of the MR system as a diagnostic device. The performance is implied to be equivalent to the predicate device.

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

This information is not applicable in the context of a clinical study for a diagnostic algorithm. The document describes "non-clinical verification and/or validation tests." These would typically involve engineering tests, phantom studies, and system-level performance checks rather than a test set of patient data with ground truth for diagnostic accuracy.

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

This information is not applicable. Since no clinical study or diagnostic accuracy study with a "test set" in the context of expert-established ground truth is described, this detail is not present. The device enables physicians to obtain images and spectra; the interpretation by a "trained physician" is mentioned as part of the intended use, but not as part of a ground truth establishment process for the device's own performance evaluation.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as points 2 and 3.

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. The document explicitly states: "The proposed Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nuclei R5.9 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 study or AI assistance effect size is mentioned.

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

This information is not applicable. The device is an MR imaging system itself, not a standalone diagnostic algorithm that would typically undergo such testing. Its function is to acquire images and spectra for human interpretation.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

This information is not applicable in the context of evaluating diagnostic accuracy using a test set of patient data. The "ground truth" for the non-clinical tests would have been established through engineering specifications, physical measurements, and compliance with recognized standards for MR system performance.

8. The Sample Size for the Training Set

This information is not applicable. The document does not describe an AI or machine learning algorithm that requires a training set in the conventional sense for diagnostic classification. The modifications are to the physical and software components of an MR system for image acquisition and processing capabilities.

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

This information is not applicable for the same reasons as point 8.

Summary of what the document does provide regarding acceptance criteria and proof:

The document establishes "substantial equivalence" to a predicate device (K193215) by demonstrating that the modifications (Modified Gradient System, Distributed Multi Nuclei, uMDU, 3.0T 1H RF Amplifier, and minor software enhancements) do not raise different questions of safety and effectiveness, and that the device continues to meet its intended use.

The proof described is through:

• Non-clinical verification and validation tests: These tests were performed "with regards to the intended use, the technical claims, the requirement specifications and the risk management results."
• Compliance with international and FDA recognized consensus standards: A list of standards (e.g., IEC60601 series, IEC62366-1, IEC 62304, NEMA MS series, ISO 14971, and various FDA guidance documents) is provided.
• Risk management activities: To ensure all identified risks are sufficiently mitigated and overall residual risk is acceptable.

The acceptance criteria implicitly refer to successfully passing these non-clinical tests, complying with all listed standards, adequately mitigating risks, and maintaining the same safety and effectiveness profile as the predicate device such that no new clinical study was deemed necessary. The "reported device performance" is the successful fulfillment of these criteria, leading to the conclusion of substantial equivalence.

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