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Vantage Fortian/Orian 1.5T systems are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.

MRI (magnetic resonance imaging) images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluids are:

• Proton density (PD) (also called hydrogen density)
• Spin-lattice relaxation time (T1)
• Spin-spin relaxation time (T2)
• Flow dynamics
• Chemical Shift

Depending on the region of interest, contrast agents may be used. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.

The Vantage Fortian (Model MRT-1550/WK, WM, WO, WQ)/Vantage Orian (Model MRT-1550/U3, U4, U7, U8) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. These Vantage Fortian/Orian models use 1.4 m short and 4.1 tons light weight magnet. They include the Canon Pianissimo Σ and Pianissimo Zen technology (scan noise reduction technology). The design of the gradient coil and the whole-body coil of these Vantage Fortian/Orian models provide the maximum field of view of 55 x 55 x 50 cm and include the standard (STD) gradient system.

The Vantage Fortian (Model MRT-1550/WS, WU)/Vantage Orian (Model MRT-1550/AV, AZ) with modified ASGC is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. These Vantage Fortian/Orian models use 1.4 m short and 4.1 tons light weight magnet. They include the Canon Pianissimo Σ and Pianissimo Zen technology (scan noise reduction technology). The design of the gradient coil and the whole-body coil of these Vantage Fortian/Orian models provide the maximum field of view of 55 x 55 x 50 cm and include the standard (STD) gradient system.

The Vantage Orian (Model MRT-1550/ UC, UD, UG, UH, UK, UL, UO, UP) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Orian models use 1.4 m short and 4.1 tons light weight magnet. They include the Canon Pianissimo and Pianissimo Zen technology (scan noise reduction technology). The design of the gradient coil and the whole-body coil of these Vantage Orian models provide the maximum field of view of 55 x 55 x 50 cm. The MRT-1550/ UC, UD, UG, UH, UK, UL, UO, UP models include the XGO gradient system.

The Vantage Orian (Model MRT-1550/AK, AL, AO, AP, A3, A4, A7, A8, AC, AD, AG, AH (Upgrade only)) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Orian models MRT-1550/A3, A4, A7, A8 use 1.4 m short and 4.1 tons light weight magnet while the Vantage Orian models MRT-1550/AK, AL, AO, AP, AC, AD, AG, AH use 1.4 m short and 3.8 tons light weight magnet. All of the aforementioned models include the Canon Pianissimo and Pianissimo Zen technology (scan noise reduction technology). The design of the gradient coil and the whole-body coil of these Vantage Orian models provide the maximum field of view of 55 x 55 x 50 cm. The Model MRT-1550/AK, AL, AO, AP includes the XGO gradient system. The MRT-1550/A3, A4, A7, A8, AC, AD, AG, AH models include the standard (STD) gradient system.

The Vantage Orian (Model MRT-1550/AS, AT, AW, AX (Upgrade only)) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Orian uses 1.4 m short and 4.0 tons light weight magnet. It includes the Canon Pianissimo and Pianissimo Zen technology (scan noise reduction technology). The design of the gradient coil and the whole body coil of the Vantage Orian provides the maximum field of view of 55 x 55 x 50 cm and include the standard (STD) gradient system.

This system is based upon the technology and materials of previously marketed Canon Medical Systems MRI systems and is intended to acquire and display cross-sectional transaxial, coronal, sagittal, and oblique images of anatomic structures of the head or body.

Based on the provided FDA 510(k) clearance letter and summary for the "Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR" (K253625), here's a description of the acceptance criteria and the study that proves the device meets them:

I. Acceptance Criteria and Reported Device Performance

The submission K253625 is for a modification of a previously cleared device (K250901). Therefore, the acceptance criteria are primarily focused on demonstrating that the modified device remains as safe and effective as the predicate device. The performance parameters listed relate to safety and overall function rather than specific diagnostic accuracy metrics, as no image quality testing was conducted for this specific submission.

Important Note: The document explicitly states "No image quality testing was conducted" for this specific K253625 submission. This implies that the acceptance criteria and performance evaluation for image quality were established and met in the predicate device (K250901), and the current modifications do not impact those aspects, thus not requiring re-testing.

II. Study Details Pertaining to K253625 (Modification of a Cleared Device)

Since this submission is a modification of a cleared device, the "study" primarily consists of verification and validation testing related to the changes, rather than a full clinical efficacy study.

1. Sample Size used for the test set and the data provenance:

   • The document does not specify sample sizes for any test sets. The testing mentioned is "bench testing," "risk analysis and verification/validation testing," and "Software Documentation" testing. These typically do not involve patient data or conventional "test sets" in the clinical study sense.
   • Data Provenance: Not applicable as no explicit clinical test set data from patients is described. The testing refers to internal verification and validation activities.

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

   • Not applicable. The document does not describe a clinical test set requiring expert ground truth establishment for diagnostic performance.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. No clinical test set with adjudicated ground truth is described.

4. 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 does not mention any MRMC comparative effectiveness study. The AiCE Reconstruction Processing Unit was already part of the predicate device (K250901) and previous versions (K240238, K191662). This submission focuses on system and software modifications, not a new evaluation of AI assistance.

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

   • Not explicitly stated for this particular submission. The device, being an MRI system with an AiCE (presumably AI-enhanced) reconstruction unit, inherently involves an algorithm. However, the performance assessment described in K253625 is about validating the modifications to the system itself, ensuring it meets safety and functional parameters, and that the software changes are correctly implemented. It does not provide data on the standalone performance of the AiCE algorithm in this context. Such data would have been part of the predicate device's clearance.

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

   • Not applicable for this submission. The testing is described as "bench testing" and "verification/validation testing," which implies validation against design specifications, functional requirements, and safety standards, rather than diagnostic ground truth from patient studies.

7. The sample size for the training set:

   • Not applicable for this submission. This is a modification of an existing device; no new training of an AI model is described. The original AiCE training set (if applicable) would have been used for the predicate or earlier versions.

8. How the ground truth for the training set was established:

   • Not applicable for this submission as no new training set is mentioned.

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The general-purpose magnetic resonance imaging (MRI) device is designed to scan any targeted area of the body, to collect, display and analyse MR images and other real-time imaging procedures.

The indications for use are the following: imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh, hip, imaging the temporomandibular joint, imaging the cervical, the thoracic, the lumbar and the sacral sections as portions of the spinal column, and imaging the head.

The S-scan Open device is a Magnetic Resonance (MR) system that produces cross-section images of the internal structures of the body. Images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and chemical shift. When interpreted by a medical expert trained in use of MR equipment, the images can provide diagnostically useful information.

S-scan Open represents the evolution of its predicate device, the Esaote S-scan, cleared under K161973 (initial clearance K063207). Compared to the predicate device, the following modifications have been introduced:

• Changes to the external design and shape, and an update of the electronics.
• Integration of the new software version MRI EVOlution 25, which provides compatibility with updated electronics, improvements in cybersecurity management, bug fixing and optimization, and includes the following features: management of new coils, 3D viewer, prone patient positioning management, SPED sequence, updated operating system, new graphical user interface, flow compensation feature extension, operator-selectable gradients direction, DWI (Diffusion Weighted Imaging) sequence, 2D SST1 sequence, and HyperClarity. Note: the subject device integrates the AI-based algorithm HyperClarity (SwiftMR, K230854) without any modification. The algorithm is classified under a different regulation in its 510(K) and this is out-of-scope from the current submission of the subject device.
• Introduction of a patient alert system.
• Addition of new receiving Coils: XL flex L-Spine coil 10, Flex Coil 11, Knee Coil 21.

S-scan Open is substantially equivalent to the predicate device with respect to intended use, technical specifications, fundamental scientific technology and principle of operation.

The provided FDA 510(k) clearance letter for K260746, S-scan Open, does not contain detailed information about the acceptance criteria and a specific study proving the device meets those criteria, particularly for an AI-based algorithm. The letter explicitly states that the integrated AI-based algorithm, HyperClarity (SwiftMR, K230854), is out-of-scope for this particular submission and is classified under a different regulation in its own 510(k) (K230854).

Therefore, based solely on the provided text for K260746, I cannot provide the requested information regarding the acceptance criteria and study proving the device's performance related to the AI component.

However, I can extract information about the overall device's (S-scan Open) non-clinical testing and the lack of clinical studies for this submission:

Based on the provided K260746 submission, for the S-scan Open MRI system as a whole (excluding the detailed performance of the integrated AI component which is out-of-scope for this submission):

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific acceptance criteria or tabulated performance metrics for the S-scan Open device (beyond compliance with standards). It mentions that "predefined acceptance criteria were successfully met" through verification and validation activities, but these criteria themselves are not detailed.

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

• Sample Size: Not specified. The document states that "Sample clinical images acquired using the proposed updated device and reviewed by a U.S. board-certified radiologist have been included to demonstrate acceptable diagnostic image quality." However, the number of images or cases is not quantified.
• Data Provenance: The document does not specify the country of origin of the data. It mentions "clinical images acquired using the proposed updated device," implying they are retrospective or prospective images generated for the purpose of this submission, but does not clarify further.

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

• Number of Experts: "a U.S. board-certified radiologist" (singular).
• Qualifications: U.S. board-certified radiologist. No mention of years of experience.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable or specified for this submission, as only one radiologist was mentioned for review of sample images. There's no indication of a consensus or multiple-reader process.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No. The document does not mention an MRMC study comparing human readers with and without AI assistance. The AI component (HyperClarity) is explicitly stated as "out-of-scope" for this submission, suggesting its comparative effectiveness would have been established in its own K230854 filing.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study: Not addressed in this submission for the S-scan Open system itself. For the integrated AI algorithm (HyperClarity), such a study would likely have been part of its independent 510(k) (K230854), but details are not provided here.

7. Type of Ground Truth Used

• Ground Truth Type: For the "sample clinical images" reviewed, the ground truth appears to be based on the expert opinion/review of a U.S. board-certified radiologist assessing "acceptable diagnostic image quality" in accordance with FDA guidance. There is no mention of pathology or outcomes data for this specific review.

8. Sample Size for the Training Set

• Sample Size: Not applicable/not provided for the 510(k) submission of the S-scan Open system as a whole. This information would be relevant for the AI component (HyperClarity, K230854) if it were the subject of the submission. The S-scan Open is an MRI hardware and software system, not solely an AI algorithm.

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

• Ground Truth Establishment: Not applicable/not provided for the S-scan Open system as a whole. This information would be relevant for the AI component (HyperClarity, K230854) if it were the subject of the submission.

Crucially, to get the detailed acceptance criteria and study information for the AI component (HyperClarity/SwiftMR), you would need to consult the 510(k) submission K230854. The K260746 document only states the S-scan Open integrates this already-cleared AI algorithm without modification, thereby deferring its evaluation to its own separate clearance.

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The Smart Fit TorsoCardiac 1.5T coil is designed to be used in conjunction with a Philips 1.5T MR system to produce diagnostic images of the torso (including chest, abdomen, and pelvis), cardiac, long bones, and neck that can be interpreted by a trained physician.

The Smart Fit Torsocardiac 1.5T is a 16-channel phased array receive-only coil for high resolution diagnostic imaging of the torso (including chest, abdomen, and pelvis), cardiac, long bones, and neck. The coil foam is composed of PU foil, flexible PCB and EVA to provide sufficient flexibility along Left-Right direction for patient body scan. The layers from outside to patient side are: PU foil (outer surface), EVA30 foam, PCBA of the coil and PU foil (inner surface). The foam looks flat at the top surface. A few parts, two feed-board boxes, cable housing and a small connector placed across the central Head-Feet axis are also at the top surface. Inner surface is naturally flat and is bendable along slots to fit well to the patient body.

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The nordicAudio allows auditory signals from a source in the control room to enter the Magnet room and to be presented to the subject. The system consists of headphones connected through an access point. From this unit the system is connected to an audio hub unit in the control room, through a fiber cable. Standard audio sources can be connected to the audio hub and by this bring the audio to the subject.

Indications for use

The device is used to present audio to a subject during an MRI examination. It also facilitates communication between the operator and subject during the examination. The nordicAudio is intended to be used by trained professionals within the MRI environment.

nordicAudio is an MR conditional audio System used to reduce acoustic noise, present auditory stimuli and enable subject operator communication during MR imaging.

nordicAudio consisting of an MR compatible headset with optical data transmission, Battery unit for powering the headphones, Audio Hub for interfacing between commercial audio and optical transmission to headset.

The device shall be deigned to fit into commonly used head coils from the main OEMs and provide noise attenuation during common MRI sequences.

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The Embrace Neonatal MRI System is indicated for use as a magnetic resonance imaging device for producing axial, sagittal, coronal and oblique images that display the internal structure of neonatal head with circumference of up to 38 cm and weight between 1Kg and 4.5 Kg. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

The Embrace Neonatal MRI System is a 1 Tesla Permanent magnet MRI system producing MR images of the neonatal head. During MRI scan, body parts to be imaged are held within a uniform static magnetic field, and are subject to sequences of RF pulses and gradient magnetic fields. The signal from the precession of the magnetization created by these fields is sampled and processed to produce image data.

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The device is indicated for use as a magnetic resonance diagnostic device software application for non-invasive assessment of liver health and the generation, display and review of magnetic resonance medical image data.

The device produces quantified metrics and composite images from magnetic resonance medical image data which, when interpreted by a trained healthcare professional, yield information on liver tissue characteristics that may assist in clinical decisions.

LiverMultiScan is a standalone, post processing software as a medical device (SaMD). It enables the generation, display and review of magnetic resonance (MR) medical image data for non-invasive assessment of liver health based on imaging acquired during a single patient visit.

LiverMultiScan quantifies liver tissue characteristics from appropriately acquired MR datasets. It produces three quantitative metrics: iron-corrected T1 (cT1): which reflects fibro-inflammatory disease activity of the liver parenchyma, proton density fat fraction (PDFF): a measure of liver fat content, and liver iron concentration (LIC). Each of these metrics is standardized to a single reference, ensuring that reference ranges and clinical thresholds can be applied consistently, regardless of the MRI scanner used to acquire the measurement. cT1, PDFF and LIC all have a valid and well-founded correlation with liver histology and are associated with pathological processes such as fibro-inflammation, steatosis, and iron overload, respectively.

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The general-purpose magnetic resonance imaging (MRI) device is designed to scan any targeted area of the body, to collect, display and analyse MR images and other real-time imaging procedures.

The indications for use are the following:

Imaging portions of calf, knee, ankle, foot, thigh, hand, wrist, forearm, elbow, arm, shoulder, hip, lumbar column, sacral column, cervical column, thoracic spine, pelvis, temporomandibular joint (included only for "Open" configuration), head (included only for "Open" configuration) and upper abdomen (included only for "Open" configuration under option).

Magnifico device is a Magnetic Resonance (MR) system that produces cross-section images of the internal structures of the body. Images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and chemical shift.

When interpreted by a medical expert trained in use of MR equipment, the images can provide diagnostically useful information.

The updated Magnifico is the evolution of its predicate device, the Magnifico device cleared via K241133. Compared to the predicate device, the following modifications have been introduced:

• A new software version (MRI EVOlution 25), including:
  • The optional functionality "HyperClarity", an AI-based algorithm for MRI image enhancement (K230854), integrated without any modification. The algorithm is classified under a different regulation in its 510(K) and this is out-of-scope from the current submission of the subject device.
  • Abdominal Imaging package for abdomen examination, which delivers:
    • Patient's breathing management (including respiratory movement reduction techniques)
    • ROTAR sequences
    • 3D FSE sequences
• Introduction of a patient breathing detection device (Respiratory Gating System)
• Introduction of a support for spontaneous movements of the knee (flexion/extension)
• A modification of the maximum gradient intensity
• New receiving Coils: DPA Shoulder Coil, Flex Coil, 4 ch. Foot/Ankle coil

Magnifico is substantially equivalent to the predicate device with respect to the fundamental scientific technology, technological characteristics and the principle of operation. The core components remain unchanged and are identical to those of the cleared Magnifico device.

The provided FDA 510(k) clearance letter and summary for the Magnifico Open MRI System (K251901) describes an updated version of a previously cleared device. While it mentions the integration of an AI-based algorithm called "HyperClarity" for MRI image enhancement, the document explicitly states that this algorithm is "out-of-scope from the current submission of the subject device" as it was cleared under a separate 510(k) (K230854).

Therefore, the acceptance criteria and study details for the Magnifico Open MRI System itself primarily focus on demonstrating substantial equivalence to its predicate device (K241133) and the safety and effectiveness of its new features (abdominal imaging, breathing management, gradient intensity modification, new coils, etc.). The document indicates a "validation based on radiologists' expert opinions" for HyperClarity, but the specifics of that study are not included in this submission.

Based on the provided document, here's a breakdown of the requested information for the Magnifico Open MRI System (K251901) as a whole, with the caveat that the detailed study for HyperClarity is referenced but not fully described here:

Acceptance Criteria and Device Performance (Magnifico Open MRI System K251901)

The document does not explicitly present a table of quantitative acceptance criteria for the entire Magnifico Open MRI system in the same way one might find for a standalone algorithm. Instead, the acceptance is implied by meeting safety and performance standards and demonstrating diagnostic image quality.

Study Information (for Magnifico Open MRI System K251901)

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated as a numerical count of patients or images. The document mentions "Sample clinical images" and "A comparative evaluation."
   • Data Provenance: Not explicitly stated in terms of country of origin. The document refers to "clinical images acquired using the proposed updated device." It does not specify if the studies were retrospective or prospective, though the nature of acquiring "sample clinical images" suggests either freshly acquired images or a selection from an existing dataset.

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

   • Number of Experts: "a U.S. board-certified radiologist" (singular, for image quality review).
   • Qualifications of Experts: "U.S. board-certified radiologist." Specific years of experience are not mentioned.
   • For the HyperClarity feature, it mentions "radiologists' expert opinions" (plural), but further details are not provided within this document.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not specified. For the general image quality review, a single radiologist is mentioned, suggesting "none" in the sense of consensus or arbitration.

4. 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:

   • MRMC Study: Not explicitly mentioned for the Magnifico Open MRI System itself. The document refers to "A comparative evaluation of conventional images and images acquired using the Respiratory Gating System" to demonstrate clinical benefit, which likely involved comparison but not necessarily a formal MRMC study with AI assistance.
   • For the HyperClarity AI feature, the document mentions "validation based on radiologists' expert opinions," which could imply a comparative aspect (with and without the enhancement), but the details (including effect size or MRMC design) are not provided in this specific submission. Given HyperClarity is out-of-scope for this 510(k), that information would be in K230854.

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

   • The Magnifico Open MRI System is a hardware device (MRI scanner) with integrated software and features, not a standalone algorithm. Its performance is intrinsically tied to producing images for human interpretation.
   • For the HyperClarity AI feature, its performance as an image enhancement algorithm would be considered in a standalone context (algorithm output vs. original image), but the details are not part of this 510(k).

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

   • Expert Opinion/Clinical Review: For diagnostic image quality, the ground truth was established by the "U.S. board-certified radiologist's" review of the images.
   • For respiratory motion artifact reduction, the clinical benefit was demonstrated through "comparative evaluation," implying expert assessment of artifact presence.
   • For the HyperClarity feature, it refers to "radiologists' expert opinions."

7. The sample size for the training set:

   • The document describes the Magnifico Open MRI System (K251901), an MRI scanner, not a machine learning algorithm that undergoes a "training set" in the conventional sense. The "training set" concept would apply to the HyperClarity AI algorithm (K230854), but that information is not part of this submission.

8. How the ground truth for the training set was established:

   • This question is not applicable to the Magnifico Open MRI System itself, as it's a hardware device. For the HyperClarity AI algorithm, this information would be detailed in its own 510(k) submission (K230854).

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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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The MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, and that displays, depending on optional local coils that have been configured with the system, the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

The MAGNETOM system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.

MAGNETOM Flow.Ace & MAGNETOM Flow.Plus with software Syngo MR XB10 include new and modified hardware and software compared to the predicate devices, MAGNETOM Flow.Ace & MAGNETOM Flow.Plus with software syngo MR XA70A.

New compared to predicate:

• Spine support respiratory (Cushion) as a part of BM Spine Coil Set 1.5T (including new surface material)
• Gradient Configuration Upgrade

Modified same as predicate, but with new claim introduced:

• PETRA (new claim for the existing sequence)

In addition, the following hardware and software are transferred from the reference device MAGNETOM Flow.Neo with software Syngo MR XB10 (K252838), to the subject devices without any modifications:

Hardware (New compared to predicate, same as reference):

• BioMatrix Dockable Table with / without eDrive
• Comfort Sound: Cushion

Hardware (Modified compared to predicate, same as reference):

• Comfort Sound: BM Head/Neck Coil
• Relocatable Option

Software (New compared to predicate, same as reference):

• Open Workflow

Software (Modified compared to predicate, same as reference):

• BioMatrix Motion Sensor (SAMER)
• CS_VIBE
• SPAIR FatSat Improvements: SPAIR "Abdomen & Pelvis" mode and SPAIR Breast mode
• Deep Resolve Boost for FL3D_VIBE and SPACE
• Deep Resolve Sharp for FL3D_VIBE and SPACE
• Preview functionality for Deep Resolve Boost
• myExam Implant Suite
• GRE_PC
• Open Recon 2.0
• Deep Resolve Boost for TSE
• "MTC Mode" for SPACE

Other Modifications and / or Minor Changes (New compared to predicate, same as reference):

• Eco Power Mode Pro

Other Modifications and / or Minor Changes (Modified compared to predicate, same as reference):

• Off-Center Planning Support
• Flip Angle Optimization (Lock TR and FA)
• ID Gain (re-naming)
• Marketing bundle "myExam Companion"

Acceptance Criteria and Study Details for Siemens MAGNETOM Flow.Ace and Flow.Plus

Based on the provided 510(k) clearance letter, the acceptance criteria and study details are as follows. It's important to note that this document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed de novo clinical trial for device efficacy. Therefore, specific metrics like sensitivity, specificity, or AUC for diagnostic performance are not explicitly stated as acceptance criteria in the typical sense for a new diagnostic claim.

The acceptance criteria are generally focused on demonstrating that the new and modified features of the MAGNETOM Flow.Ace and Flow.Plus systems maintain equivalent safety and performance to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a specific sample size for a test set in the context of clinical images or patient data.

• Data Provenance: "Sample clinical images" were provided as "claim evidence." The origin (e.g., country) and whether this data was retrospective or prospective are not specified in the provided text. The clinical publications referenced are peer-reviewed articles, which would typically involve patient data.

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

The document does not provide information regarding the number of experts, their qualifications, or how ground truth was established for any "test set" of images. The phrase "interpreted by a trained physician" is used in the Indications for Use, which is a general statement about MR diagnostic devices.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not explicitly done or reported in this document. The submission relies on "sample clinical images" as "claim evidence" and references existing clinical publications for certain features to demonstrate substantial equivalence, rather than a direct comparative study showing improvement with AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Study was Done

The document discusses "software verification and validation" and "nonclinical tests" which would imply standalone performance testing of the algorithms and features. However, it does not provide specific metrics or results for standalone algorithm performance (e.g., sensitivity, specificity, or AUC if applicable to specific features). The focus is on the performance of the integrated system.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for any specific evaluation. The "Indications for Use" mention that images "when interpreted by a trained physician yield information that may assist in diagnosis." For the referenced clinical publications, the ground truth would depend on the methodology of those studies (e.g., pathology, clinical follow-up, expert consensus in a research setting), but this information is external to the 510(k) summary itself.

8. The Sample Size for the Training Set

The document does not provide any information regarding the sample size for a training set. This is a 510(k) submission for an updated MR system, not a de novo AI/ML device where training data details are typically prominent. While features like "Deep Resolve Boost" and "Deep Resolve Sharp" likely leverage AI/ML, the details of their development and training are not disclosed in this summary.

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

The document does not provide any information on how ground truth was established for a training set.

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The 1.5T GEM Flex Suite manufactured by Shenzhen RF Tech Co., Ltd. is receive-only coil and is designed for use as general-purpose coil. It includes of three coils: 16-L Array, 16-M Array, and 16-S Array. The 1.5T GEM Flex Suite is designed for use with GEHC 1.5T MRI systems to produce diagnostic images of the Head, Torso, Hip, Spine, Shoulder, Knee, Foot, Ankle, Elbow, and Wrist that can be interpreted by a trained physician.

The three Coils are receive only phased array coil to produce diagnostic images of the Head, Torso, Hip, Spine, Shoulder, Knee, Foot, Ankle, Elbow, and Wrist.

The three Coils are tuned to receive RF frequency corresponding to the proton precession in a 1.5 Tesla magnetic field, which is governed by the Larmor equation.

N/A

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