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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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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 extremites, 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 R5.8 with Breeze Workflow Solution is a 70 cm bore 1.5 Tesla (1.5T) Magnetic Resonance Diagnostic Device, hereafter to be known as MR 5300. Philips Medical Systems Nederland B.V. believes that the proposed MR 5300 is a modification of our legally marketed devices Achieva, Intera, Ingenia, Inqenia CX, Ingenia Elition and Ingenia Ambition MR systems (K193215, 04/10/2020), among which MR 5300 is specifically predicated to the Ingenia Ambition S. In this 510(k) submission, Philips Medical Systems Nederland B.V. will be addressing the following modifications to the proposed MR 5300 when compared to the legally marketed predicate Ingenia Ambition S: 1. Introduction of new product model: MR 5300 2. Introduction of Breeze Workflow Solution: a. dS Interface: newly developed 16 channel dS interface to connect coils to the MR 5300 system. The dS Interface allows to connect two coils at the same time to one dS Interface. dS Interface is available in two variants: dS interface S 1.5T with a short cable o dS interface L 1.5T with a longer cable O b. Rearrangement of connector layout of the patient table to fit to the dS Interface. Connectors are not changed. Comfort Mattress Partner to improve patient setup, C. patient comfort and cable management. Besides enable the new product model MR 5300 and the coils mentioned above. There is no new software features introduced in SW R5.8. The proposed MR 5300 is intended to be marketed with the following pulse sequences and coils that are previously cleared by FDA: 1. mDIXON (K102344) 2. SWlp (K131241) 3. mDIXON-Quant (K133526) 4. mDIXON XD (K143128) 5. O-MAR (K143253) 6. MultiBand SENSE software application (K162940), to support MutiBand SENSE for 1.5T and to support diffusion body imaging on 1.5T and 3.0T.

Based on the provided text, the device in question is the Philips MR 5300, a Magnetic Resonance Diagnostic Device. This submission is an abbreviated 510(k) and focuses on modifications to a legally marketed predicate device (Ingenia Ambition S).

It is crucial to understand that this document does not describe acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/algorithm. Instead, it is a 510(k) summary for a hardware magnetic resonance imaging (MRI) system (MR 5300) and its software release R5.8, along with a "Breeze Workflow Solution" that includes interface and patient comfort improvements.

The document explicitly states that the proposed MR 5300 is demonstrated to be substantially equivalent to its predicate device through non-clinical performance (verification and validation) tests that comply with international and FDA-recognized consensus standards. Crucially, it states: "The proposed MR 5300 did not require a clinical study since substantial equivalence to the legally marketed predicate device was proven with the verification/validation testing."

Therefore, I cannot provide the information requested about acceptance criteria and a study proving the device meets an AI/algorithm-specific acceptance criteria, as this information is not present in the provided text. The device described is a medical imaging system, not an AI or algorithm that generates a diagnostic output requiring a performance study in the way requested for AI.

However, I can extract information related to the general acceptance of the device's safety and effectiveness based on the non-clinical testing performed:

1. Table of Acceptance Criteria and Reported Device Performance (as inferred from the provided text for a hardware MRI system):

Since this is a hardware device clearance based on substantial equivalence and compliance with standards, the "acceptance criteria" are compliance with various technical and safety standards, and the "performance" is that it meets these standards and is comparable to the predicate.

2. Sample size used for the test set and data provenance:
Not applicable as this is not an AI/algorithm performance study. The "tests" are non-clinical verification and validation of the hardware against engineering requirements and safety standards. No patient data "test set" in the context of an AI algorithm is mentioned or implied.

3. Number of experts used to establish the ground truth for the test set and qualifications:
Not applicable. No ground truth for an AI/algorithm test set was established. The "ground truth" for a hardware device is compliance with its engineering specifications and safety standards.

4. Adjudication method for the test set:
Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
"The proposed MR 5300 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 was done.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a hardware MRI system.

7. The type of ground truth used:
For a hardware device, the ground truth is its compliance with validated engineering specifications, safety standards (e.g., electrical, mechanical, RF safety, EMC), and functional performance parameters (e.g., field homogeneity, gradient linearity, signal-to-noise ratio, image quality metrics) established through non-clinical testing. This is not derived from clinical outcomes or expert consensus in the typical sense for AI, but from objective physical measurements and adherence to regulations.

8. The sample size for the training set:
Not applicable. This is a hardware MRI system, not a machine learning model that requires a training set in this context.

9. How the ground truth for the training set was established:
Not applicable.

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