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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 subject Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades are 60 cm and 70 cm bore 1.5 and 3.0 Tesla (1.5T and 3.0T) Magnetic Resonance Diagnostic Devices.

The following software features are contained in software R13 for the Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades:

• SmartHeart includes an automated cardiac MRI planning feature that uses a CNN-based deep learning model to analyze 3D survey images and suggest standard cardiac imaging planes. The technologist can fully edit these suggestions if needed. The model was trained on de-identified 3D survey images of adult patients from multiple geographies using expert-annotated reference planes. Testing on separate datasets showed performance is within the range expected from trained human operators. This feature supports workflow optimization only and does not perform any image reconstruction or diagnosis.

• CardiacQuant Perfusion enables assessment of the myocardial blood flow. It is a dual sequence method to allow for the simultaneous acquisition of both the Arterial Input Function and the perfusion data.

• Cardiac Motion Correction enables inline motion correction for the following 2D CMR sequences: Late Gadolinium enhancement (LGE), CardiacQuant Perfusion and T1 mapping. It makes use of Fast Elastic Image Registration between images across time points for the same slice to compensate for motion caused by breathing or differences in cardiac phase.

• CINE FreeBreating is a free-breathing sequence for Cine imaging using respiratory gating to reduce respiratory motion. It allows the user to perform a 2D CINE acquisition in a patient without breath hold commands.

• 4D MR-RT is a free-breathing scanning method to acquire 3D images for multiple respiratory phases. 4D MR-RT enables radiotherapy planning using MR for moving targets in the abdomen, and breath holds are not mandatory.

• IRIS is a Multi-shot SE-EPI diffusion imaging technique which enables higher resolution imaging of the (female) pelvis, prostate and breast.

The introduction of these software features required updates only to the MR system software.

The provided FDA 510(k) clearance letter and summary for K253648 focuses on the substantial equivalence of the Philips MR Systems (Ingenia family, MR 5300, MR 7700) to a predicate device, primarily through non-clinical performance testing and outlining new software features.

However, the document does not contain specific acceptance criteria or detailed study results for the performance of the new software features, particularly the SmartHeart AI-based cardiac MRI planning feature. It states general compliance with international and FDA consensus standards for safety and essential performance of medical electrical equipment.

The information regarding acceptance criteria and a study proving those criteria are met, as requested in your prompt, is largely absent from this particular FDA document for the SmartHeart feature. The provided text indicates that the SmartHeart feature is for "workflow optimization only and does not perform any image reconstruction or diagnosis." This classification likely means less rigorous clinical performance studies are required compared to a diagnostic AI device.

Below, I've extracted all available relevant information and noted where information is missing based on your request.

1. Table of Acceptance Criteria and Reported Device Performance

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

• SmartHeart:
  • Test Set Size: Not specified in the document.
  • Data Provenance (Training Data): "de-identified 3D survey images of adult patients from multiple geographies." (The text refers to training data for provenance, not explicitly for the test set, but implies similar data characteristics for testing.)
  • Data Provenance (Test Set): "separate datasets" (No explicit geography or whether prospective/retrospective mentioned for the test set, only for training).

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

• SmartHeart:
  • Number of Experts: Not specified.
  • Qualifications of Experts: "expert-annotated reference planes" (No specific qualifications like "radiologist with 10 years of experience" are provided).

4. Adjudication Method for the Test Set

• SmartHeart: Not specified. The document only mentions "expert-annotated reference planes" for training, implying a consensus or single expert approach for ground truth creation. No specific adjudication method for the test set's ground truth is detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• SmartHeart: No MRMC comparative effectiveness study was explicitly described in this document for the SmartHeart feature in the context of human reader improvement. The statement "performance is within the range expected from trained human operators" suggests a comparison, but not an MRMC study with specific effect sizes of AI assistance.
• The document states that the SmartHeart feature "supports workflow optimization only and does not perform any image reconstruction or diagnosis," which might explain the absence of an MRMC study focused on diagnostic improvement.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

• SmartHeart: Yes, a standalone evaluation of the algorithm's performance was implied by the statement: "Testing on separate datasets showed performance is within the range expected from trained human operators." This indicates the algorithm's output was compared against expert annotations directly.

7. The Type of Ground Truth Used

• SmartHeart: "expert-annotated reference planes." This implies expert consensus or individual expert delineation of anatomical landmarks for cardiac imaging planes.

8. The Sample Size for the Training Set

• SmartHeart: Not specified in the document.

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

• SmartHeart: "expert-annotated reference planes."

Summary of Missing Information:

The provided FDA document is a clearance letter, which typically summarizes the information provided in the 510(k) submission, rather than containing exhaustive details of every study. Key missing details for a comprehensive understanding of the SmartHeart feature's validation include:

• Specific metrics for "performance within the range expected from trained human operators" (e.g., plane alignment accuracy, deviation from expert-defined landmarks).
• Exact sample sizes for both training and test sets.
• Specific countries of origin for the data, and whether the test set was prospective or retrospective.
• The number and precise qualifications of the experts establishing ground truth.
• The specific adjudication method used to determine ground truth.
• Details of any comparative studies with human performance.

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