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This system is a Magnetic Resonance Medical Electrical System 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 Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 are 60 cm bore 1.5 Tesla (1.5T) magnetic resonance diagnostic devices. The systems and control software are substantially equivalent to the currently marketed predicate device Ingenia 1.5T CX R5.3 (K162931, 01/06/2017). The system includes a new 1.5T magnet, new set of RF receive coils, new patient support, new in-house Gradient system and RF transmit system and adapted RF receive system which is substantially equivalent to the currently marketed predicate device Ingenia 1.5T CX R5.3.

The provided document is a 510(k) Summary of Safety and Effectiveness for the Philips Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 Magnetic Resonance Diagnostic Devices. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the context of an AI/algorithm-driven device.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, especially in the context of AI performance, ground truth, sample sizes for test/training sets, experts, and MRMC studies, cannot be fully extracted as such studies are not described for this type of device submission.

Here's an attempt to answer based on the provided text, highlighting what is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "The verification and validation test results... demonstrate that the proposed Prodiva 1.5T CX and Prodiva 1.5T CS R5.4... Meets the acceptance criteria and is adequate for its Intended Use."
However, the specific numerical acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy, SNR thresholds, geometric distortion limits) are not detailed in this summary document. Instead, the acceptance criteria are implicitly linked to compliance with various international and FDA-recognized consensus standards for medical electrical equipment and MR devices.

2. Sample size used for the test set and the data provenance

The document states: "The proposed Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 did not require clinical study since substantial equivalence to the legally marketed predicate device was proven with the verification/validation testing."
"Clinical sample images were provided to support the ability of proposed Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 to generate diagnostic quality images."

• Test Set Sample Size: Not specified. This submission relies on "sample clinical images" rather than a formal test set with a specified sample size.
• Data Provenance: Not specified. It only mentions "sample clinical images" without details on their origin (e.g., country, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This is not applicable as a formal "test set" with expert-established ground truth as typically understood for AI performance evaluation is not described. The document indicates that images, spectra, and measurements are to be "interpreted by a trained physician" for diagnosis and therapy planning, but this refers to the intended use of the device, not a specific ground truth establishment for a performance study within this 510(k) submission.

4. Adjudication method for the test set

• Not applicable, as a formal test set and expert review process for ground truth establishment are not described.

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. This is a submission for a Magnetic Resonance Diagnostic Device (hardware and software system), not an AI-assisted diagnostic algorithm. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed or referenced. The document states its indications for use involve images "when interpreted by a trained physician," implying human interpretation of the device's output, not AI assistance for that interpretation.

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

• No. This is an MR system, not an algorithm being evaluated in a standalone capacity.

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

• Not applicable as a formal establishment of ground truth for a performance study is not described. The submission focuses on demonstrating that the MR system meets performance standards related to image quality and safety, and its output is intended for interpretation by trained physicians.

8. The sample size for the training set

• Not applicable. This is a 510(k) for an MR system, not an AI/ML algorithm that requires a training set. The "verification/validation testing" relies on compliance with established engineering and medical device standards.

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

• Not applicable. As there is no AI/ML algorithm requiring a training set, no ground truth needed to be established in this context.

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