(66 days)
The Spirit 5000 Cardiac Coil is a receive- only phased array RF coil, used for obtaining diagnostic images of the cardiovascular system in Magnetic Resonance Imaging Systems. The Spirit 5000 Cardiac Coil is compatible with SENSE technology and designed for use with the Altaire 0.7T MRI system manufactured by Hitachi Medical Systems, Inc. The indications for use are the same as for standard MR Imaging.
The Spirit 5000 Cardiac Coil is designed to provide Magnetic Resonance Images of the cardiovascular system. The Spirit 5000 Cardiac Coil is designed for use with the Hitachi Altaire 0.7T MR scanner manufactured by Hitachi Medical Systems, Inc.
The indications for use are the same as for standard imaging:
The 0.7T MRI system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time (1) spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
The Spirit 5000 Cardiac Coil is a four element receive only phased array coil. The coil is composed of rigid top and bottom pieces. A split top latch releases the coil from either side. The open, patient friendly design minimizes claustrophobic effects and maximizes patient comfort. The coil elements and accessory electronics are enclosed in a rigid plastic housing, which is fire rated and have a high impact and tensile strength.
The provided document is a 510(k) premarket notification for the Spirit 5000 Cardiac Coil. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies with specific acceptance criteria in the manner of a novel AI/software medical device.
Therefore, the document does not contain the information requested regarding acceptance criteria, a study proving device meets acceptance criteria, sample sizes, data provenance, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance.
Here's why and what information is available:
- Nature of the Device: The Spirit 5000 Cardiac Coil is a hardware component (a receive-only phased array RF coil) for an MRI system, not an AI/software device that generates diagnostic interpretations or measurements.
- 510(k) Process: For devices like this, the primary demonstration of safety and effectiveness is through comparison to legally marketed predicate devices, showing that the new device has "substantially equivalent" technological characteristics and intended use. This typically involves engineering tests, compatibility testing, and performance specifications, but not usually extensive clinical studies with expert-adjudicated ground truth and specific performance metrics like sensitivity/specificity in the context of diagnostic algorithms.
Information that can be extracted or inferred from the document:
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Acceptance Criteria and Reported Device Performance: This information is not provided in the format requested, as the submission focuses on equivalence. The "Safety and Effectiveness" section (page 1, section 9) details product features and compares them to predicate devices, indicating similarity rather than reporting distinct performance metrics against specific acceptance criteria. For example:
- Intended Use: "imaging of the cardiovascular system" - "Similar to the Spirit III TotalSENSE Cardiac Coil (K031172)"
- Indications for Use: "Identical to routine MRI imaging" - "Similar to the Spirit III TotalSENSE Cardiac Coil (K031172)"
- Coil Enclosure Material: "Flame Retardant Polyurethane, Flame Retardant Polycarbonate" - "Similar to the Spirit III TotalSENSE Cardiac Coil (K031172)"
- Coil Design: "Receive-only phased array coil" - "Similar to the Interventional Body Coil (K000437)"
- Prevention of RF Burns: "Does not transmit RF Power, Decoupling isolates the coil elements from RF fields during RF transmission, Coil elements and circuitry are enclosed in a non-conductive housing." - "Similar to the Interventional Body Coil (K000437)"
- Radio Frequency Absorption: "Coil is a receive only coil and does not transmit RF power." - "Similar to the Interventional Body Coil (K000437)"
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Sample size for the test set and data provenance: Not applicable/Not provided. The document does not describe a "test set" in the context of evaluating diagnostic performance with patient data or a specific algorithm.
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Number of experts used to establish the ground truth for the test set and qualifications: Not applicable/Not provided. Ground truth establishment by experts is not a requirement for this type of device and submission.
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Adjudication method for the test set: Not applicable/Not provided.
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MRMC comparative effectiveness study: No. This is a hardware component, not an AI system that assists human readers.
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Standalone (algorithm only without human-in-the loop performance) study: No. This is a hardware component.
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Type of ground truth used: Not applicable/Not provided. The "ground truth" for a cardiac coil would relate to its engineering specifications and imaging capabilities (e.g., signal-to-noise ratio, image uniformity), which are part of its technical characteristics, but not "ground truth" for diagnostic accuracy in the way it's used for AI.
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Sample size for the training set: Not applicable/Not provided. This device does not involve a "training set" in the context of machine learning.
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How the ground truth for the training set was established: Not applicable/Not provided.
In summary, the provided document outlines the FDA's decision regarding a traditional medical device hardware component (MRI coil) based on substantial equivalence, and therefore does not contain the detailed performance and study information typically associated with the evaluation of AI/software medical devices.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.