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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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AV Vascular is indicated to assist users in the visualization, assessment and quantification of vascular anatomy on CTA and/or MRA datasets, in order to assess patients with suspected or diagnosed vascular pathology and to assist with pre-procedural planning of endovascular interventions.

AV Vascular is a post-processing software application intended for visualization, assessment, and quantification of vessels in computed tomography angiography (CTA) and magnetic resonance angiography (MRA) data with a unified workflow for both modalities.

AV Vascular includes the following functions:

• Advanced visualization: the application provides all relevant views and interactions for CTA and MRA image review: 2D slides, MIP, MPR, curved MPR (cMPR), stretched MPR (sMPR), path-aligned views (cross-sectional and longitudinal MPRs), 3D volume rendering (VR).

• Vessel segmentation: automatic bone removal and vessel segmentation for head/neck and body CTA data, automatic vessel centerline, lumen and outer wall extraction and labeling for the main branches of the vascular anatomy in head/neck and body CTA data, semi-automatic and manual creation of vessel centerline and lumen for CTA and MRA data, interactive two-point vessel centerline extraction and single-point centerline extension.

• Vessel inspection: enable inspection of an entire vessel using the cMPR or sMPR views as well as inspection of a vessel locally using vessel-aligned views (cross-sectional and longitudinal MPRs) by selecting a position along a vessel of interest.

• Measurements: ability to create and save measurements of vessel and lumen inner and outer diameters and area, as well as vessel length and angle measurements.

• Measurements and tools that specifically support pre-procedural planning: manual and automatic ring marker placement for specific anatomical locations, length measurements of the longest and shortest curve along the aortic lumen contour, angle measurements of aortic branches in clock position style, saving viewing angles in C-arm notation, and configurable templated

• Saving and export: saving and export of batch series and customizable reports.

This summarization is based on the provided 510(k) clearance letter for Philips Medical Systems' AV Vascular device.

Acceptance Criteria and Device Performance for Aorto-iliac Outer Wall Segmentation

The reported device performance for all primary and secondary metrics meets the predefined acceptance criteria.

Study Details for Aorto-iliac Outer Wall Segmentation Validation

1. Sample Size used for the Test Set and Data Provenance:

   • Sample Size: 80 patients
   • Data Provenance: Retrospectively collected from 7 clinical sites in the US, 3 European hospitals, and one hospital in Asia.
   • Independence from Training Data: All performance testing datasets were acquired from clinical sites distinct from those which provided the algorithm training data. The algorithm developers had no access to the testing data, ensuring complete independence.
   • Patient Characteristics: At least 80% of patients had thoracic and/or abdominal aortic diseases and/or iliac artery diseases (e.g., thoracic/abdominal aortic aneurysm, ectasia, dissection, and stenosis). At least 20% had been treated with stents.
   • Demographics:
     • Geographics: North America: 58 (72.5%), Europe: 3 (3.75%), Asia: 19 (23.75%)
     • Sex: Male: 59 (73.75%), Female: 21 (26.25%)
     • Age (years): 21-50: 2 (2.50%), 51-70: 31 (38.75%), >71: 45 (56.25%), Not available: 2 (2.5%)

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

   • Number of Experts: Three
   • Qualifications: US-board certified radiologists.

3. Adjudication Method for the Test Set:

   • The three US-board certified radiologists independently performed manual contouring of the outer wall along the aorta and iliac arteries on cross-sectional planes for each CT angiographic image.
   • After quality control, these three aortic and iliac arterial outer wall contours were averaged to serve as the reference standard contour. This can be considered a form of consensus/averaging after independent readings.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • The provided document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done to measure human reader improvement with AI assistance. The study focused on the standalone performance of the AI algorithm compared to an expert-derived ground truth.

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance):

   • Yes, the performance data provided specifically describes the standalone performance of the AI-based algorithm for aorto-iliac outer wall segmentation. The algorithm's output was compared directly against the reference standard without human intervention in the segmentation process.

6. Type of Ground Truth Used:

   • Expert Consensus/Averaging: The ground truth was established by averaging the independent manual contouring performed by three US-board certified radiologists.

7. Sample Size for the Training Set:

   • The document states that the testing data were independent of the training data and that developers had no access to the testing data. However, the exact sample size for the training set is not specified in the provided text.

8. How the Ground Truth for the Training Set Was Established:

   • The document implies that training data were used, but it does not describe how the ground truth for the training set was established. It only ensures that the testing data did not come from the same clinical sites as the training data and that algorithm developers had no access to the testing data.

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The Azurion series (within the limits of the used Operating Room table) are intended for use to perform:

• Image guidance in diagnostic, interventional, and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular, and neuro procedures.
• Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures.

Additionally:

• The Azurion series can be used in a hybrid Operating Room.
• The Azurion series contain a number of features to support a flexible and patient centric procedural workflow.

The Azurion R3.1 is classified as an interventional fluoroscopic X-Ray system. The primary performance characteristics of the Azurion R3.1 include:

• Real-time image visualization of patient anatomy during procedures
• Imaging techniques and tools to assist interventional procedures
• Post processing functions after interventional procedures
• Storage of reference/control images for patient records
• Compatibility with hospital information systems (HIS) and image archiving systems via DICOM
• Built in radiation safety controls.

The only changes to the subject device, Azurion R3.1 includes the design change to the mattress accessory for all the existing mattresses of the predicate device (Azurion R3.1, K251827, 24 October 2025) and introduction of new gray color mattress. The change includes the addition of a hook and loop fastener (Velcro) solution for use between the mattress and the system integrated patient table (AD7X), to ensure that the mattress does not slip from the patient table.

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The Philips Neurovascular MR Coil is intended to be used in conjunction with a Philips 1.5T or 3T Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.

A general description of the subject devices, which are part of the Philips Neurovascular MR Coil Family is given below:

The dS Base 1.5T and dS Base 3.0T are lightweight, 8-channel, phased-array coil that are designed to be used independently or in combination with the dS Head or dS HeadNeck coil. The dS Base coil also can be used for extremities and pediatric examinations or can be combined with the dS Posterior coil which is integrated in the patient support of the compatible Magnetic Resonance (MR) Systems for total spine imaging. The dS Base coil can stay on the table for most examinations without exchanging coils, thereby, improving workflow. These coils are connected to the flex connect socket of the compatible MR System.

The dS Head 1.5T and dS Head 3.0T are 7-channel receive only coils, which are designed to be used in combination with the dS Base (bottom) coil to create a 15-channel coil with or without the dS Posterior coil which is integrated in the patient support of the compatible MR Systems for total spine imaging. The coil is most frequently used for imaging the head/brain and its vasculature. The coil can also be used for extremities and pediatric examinations. These coils are available in both 1.5T and 3.0T and are connected to the flex connect socket of the compatible MR System.

The dS HeadNeck 1.5T and dS HeadNeck 3.0T are 8-channel receive only coils, which are designed to be used in combination with the dS Base (bottom) coil to create a 16-channel coil with or without the dS Posterior coil which is integrated in the patient support of the compatible MR Systems for total spine imaging. The coil is used for brain, head, neck, cervical spine, and neurovascular imaging. The coil also can be used for extremities and pediatric examinations. These coils are available in both 1.5T and 3.0T and are connected to the flex connect socket of the compatible MR System

The dS HeadNeck coil can be used either alone or in combination with the dS Anterior coil and dS Posterior coil. When used in combination with the dS Anterior coil and dS Posterior coil for Whole Body exams this is called a 'Whole Body solution.

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The LumiGuide Equipment is a visualization device with Fiber Optic RealShape (FORS) technology intended to aid the positioning and navigation of a connected LumiGuide Wire and, optionally, a catheter during endovascular procedures of the peripheral, aortic and aortic side branch vasculature, by creating a 3D image in real-time of the connected LumiGuide Wire and, of an endovascular catheter, when combined with a LumiGuide 3D Hub.

The LumiGuide Wire is an angiographic guidewire with Fiber Optic RealShape (FORS) technology, intended to direct a catheter in endovascular procedures of the peripheral, aortic and aortic side branch vasculature.

The LumiGuide 3D Hub enables the visualization of a connected endovascular catheter, when used in combination with a LumiGuide Wire and the LumiGuide Equipment.

The LumiGuide system consists of the following primary devices:

The LumiGuide Equipment R2.1 is a visualization device with Fiber Optic RealShape (FORS) technology. Its function is to create a real time 3D image of a LumiGuide Wire and, optionally, an endovascular catheter when combined with LumiGuide 3D Hub, and overlay this on real time or pre-recorded X-ray images and/or on a pre-operative CT volume. The LumiGuide Equipment R2.1 comprises software and hardware components (such as lasers, optical components, computer hardware, electrical and optical cabling), and a single-use, sterile, detachable component.

The LumiGuide Wire is a sterile, single use, angiographic guidewire with Fiber Optic RealShape (FORS) technology that is available in two configurations: LumiGuide Navigation Wire 3D Ultra and LumiGuide Navigation Wire 3D Plus. The primary function of the LumiGuide Wire is to direct a catheter in endovascular procedures of the peripheral, aortic and aortic side branch vasculature. The LumiGuide Wire can be visualized in 3D in real time by the LumiGuide Equipment R2.1 using FORS technology.

The LumiGuide 3D Hub is a sterile, single use accessory to the LumiGuide Equipment R2.1 that connects to the luer connector of endovascular catheters. When the LumiGuide Hub is connected to an endovascular catheter and is used in combination with a LumiGuide Wire, the LumiGuide Equipment R2.1 enables real time 3D visualization of the connected endovascular catheter.

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The Azurion series (within the limits of the used Operating Room table) are intended for use to perform:

• Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures.
• Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures.

Additionally:

• The Azurion series can be used in a hybrid Operating Room.
• The Azurion series contain a number of features to support a flexible and patient centric procedural workflow.

Patient Population:
All human patients of all ages. Patient weight is limited to the specification of the patient table.

The Azurion R3.1 is classified as an interventional fluoroscopic X-Ray system. The primary performance characteristics of the Azurion R3.1 include:

• Real-time image visualization of patient anatomy during procedures
• Imaging techniques and tools to assist interventional procedures
• Post processing functions after interventional procedures
• Storage of reference/control images for patient records
• Compatibility with hospital information systems (HIS) and image archiving systems via DICOM
• Built in radiation safety controls

This array of functions offers the physician the imaging information and tools needed to perform and document minimally invasive interventional procedures.

The Azurion R3.1 is available in identical models and configurations as the predicate device Azurion R2.1. Configurations are composed of detector type, monoplane (single C-arm) or biplane (dual arm), floor or ceiling mounted geometry, standard or OR table type and available image processing.

Identical to the predicate device, the FlexArm option is available for the 7M20 configuration in Azurion R3.1 to increase flexibility in stand movement.

Additionally, identical to the predicate device, Azurion R3.1 can be used in a hybrid operating room when supplied with a compatible operating room table.

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Philips IntelliSpace Cardiovascular software product is an integrated multimodality image and information system designed to perform the necessary functions required for import, export, storage, archival, review, analysis, quantification, reporting and database management of digital cardiovascular images, waveforms and data related to cardiology.

Philips IntelliSpace Cardiovascular offers support for third party applications in order to enable the use of commercially available tools and specified applications for analysis, quantification and reporting. It allows multiple users fast access to, and exchange of specific and/or multiple cardiology exams.

Philips IntelliSpace Cardiovascular software runs on standard information technology hardware and software, utilizing the standard information technology operating systems and user interface. Communication and data exchange are done using standard protocols. Philips IntelliSpace Cardiovascular will also be made available for use on specified Cardiovascular Monitoring Systems, which use suitable hardware components.

The modular design allows configurability to tailor the image import, archive and communications solution to one's particular budgetary and performance needs. The number of modalities and reporting and/or viewing sites can be configured per system.

Philips IntelliSpace Cardiovascular is a comprehensive cardiac image and information management solution designed to provide clinicians with convenient access to the detailed records of all cardiac patients across their complete cardiovascular care continuum. The solution also provides hospital administrators and department managers with detailed operational information, as well as productivity and outcomes reporting. Key components include a wide range of detailed clinical modules that capture data during diagnostic/therapeutic procedures and patient follow–up encounters. Interfaces to other systems and devices within the cardiology departments as well as across the enterprise system, such as HIS/EMR, are available. The solution supports a remote deployment model.

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