(88 days)
The Quadrature and Phased Array Flexible Body Coils do not change the intended use of the Picker 1.5T EDGE system.
The 1.5T EDGE system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, 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 Quadrature and Phased Array Flexible Body Coils are indicated for use in the following anatomic regions and with the designated nuclei:
Anatomic Regions: Liver, kidneys, adrenal glands, spleen, bilateral hips and associated abdominopelvic structures
Nuclei Excited: Hydrogen
The Picker Flexible Body Coils have either a Quadrature or Phased Array coil architecture enclosed in a flexible package that can be wrapped around the area of interest. The coils are designed to give improved signal-to-noise ratio, image resolution and image acquisition time over that of the standard EDGE body coil.
The provided text describes a medical device, the "Quadrature and Phased Array Flexible Body Coils," and establishes its substantial equivalence to another previously cleared device (MAI Quadrature and Phased Array Abdominal Flex Coils, K954190). The text does not detail a study with specific acceptance criteria and performance metrics for the new device in a way that aligns with typical AI/software device studies. Instead, it relies on demonstrating equivalence based on device parameters and intended use.
Therefore, many of the requested elements for a detailed AI study (like sample sizes for test/training sets, expert qualifications, ground truth methodology, MRMC studies, standalone performance) are not applicable to this type of device submission as described in the provided text, which predates modern AI device regulations and focuses on hardware equivalence.
However, I will extract the relevant information where it exists and state "Not Applicable" or "Not Provided" where the information is not present in the given text, interpreting "acceptance criteria" and "device performance" in the context of this equivalence claim.
Acceptance Criteria and Reported Device Performance
The core "acceptance criteria" for this submission appear to be demonstrating substantial equivalence to the predicate device (MAI Quadrature and Phased Array Abdominal Flex Coils, K954190) across various technical and functional parameters, and that the new coils do not alter the intended use of the MRI system.
| Acceptance Criteria (Implicit from Equivalence Claim) | Reported Device Performance (Flexible Body Coil) |
|---|---|
| Compatibility with MRI Systems: Match or be compatible with the specified MRI system. | Picker International 1.5T EDGE |
| Mode of Operation: Match predicate device's mode of operation. | Receive-Only |
| Antenna Configuration: Match predicate device's antenna configuration for Quadrature and Phased Array. | Quadrature: Co-rotating saddle coil pairs |
| Phased Array: Co-rotating saddle coils and loops | |
| Tuning/Impedance Matching: Match predicate device's tuning/impedance matching method. | Fixed tuning and matching. Factory set. |
| Method of Decoupling: Match predicate device's decoupling method. | Active PIN diode decoupling |
| Coil Enclosure: Match predicate device's coil enclosure material. | Flame rated foam and fabric |
| Number of Receive Channels: Match predicate device's number of receive channels. | Quadrature: 1 |
| Phased Array: 4 | |
| Intended Use (Device): Must be for receive-only antenna of RF energy, signal dependent on MRI parameters (T1, T2, density, flow velocity, chemical shift), and images correspond to distribution of nuclei exhibiting NMR. Must be indicated for specific anatomic regions and nuclei. (This is the most critical acceptance criterion for a substantial equivalence claim regarding intended use.) | The Picker Quadrature and Phased Array Flexible Body Coils do not change the intended use of the Picker 1.5T EDGE system. The 1.5T EDGE system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, 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. |
Indicated for use in: Liver, kidneys, adrenal glands, spleen, bilateral hips and associated abdominopelvic structures. Nuclei Excited: Hydrogen. |
| Safety and Effectiveness: Demonstrate substantial equivalence to the predicate device in terms of safety and effectiveness. | Stated as "substantially equivalent to the MAI Quadrature and Phased Array Abdominal Flex Coils (K954190) in safety and effectiveness." The detailed parameter comparison table serves as the evidence for this claim. |
| Performance claims: Improved signal-to-noise ratio, image resolution, and image acquisition time over that of the standard EDGE body coil. | The coils are designed to give improved signal-to-noise ratio, image resolution and image acquisition time over that of the standard EDGE body coil. (No specific quantitative data provided in this summary to "prove" this claim beyond the design intention.) |
Study Details (Interpreted for Hardware Equivalence)
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Sample size used for the test set and the data provenance:
- Sample Size: Not applicable in the context of an AI study. For this hardware equivalence, the "test set" implicitly refers to the device itself and its specifications.
- Data Provenance: Not applicable. The "data" here is the device's technical specifications and intended use comparison to a predicate device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth as typically defined for AI studies (e.g., diagnostic labels) is not part of this hardware equivalence submission. The "ground truth" for the equivalence claim is the predicate device's already cleared specifications and intended use. The assessment would have been made by the manufacturer's engineers and approved by regulatory reviewers.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There's no "adjudication" in the sense of resolving disagreements among experts on diagnostic labels for a test set. The process involves comparing documented technical specifications.
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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, an MRMC comparative effectiveness study was not done. This device is a hardware component (MRI coil) and is not an AI-powered diagnostic tool, so "human readers improve with AI" is not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. This is a hardware component, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this submission is the established technical specifications, functional characteristics, and intended use of the predicate device (MAI Quadrature and Phased Array Abdominal Flex Coils, K954190), combined with the regulatory understanding of MRI coils. There is no diagnostic "ground truth" in play here.
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The sample size for the training set:
- Not applicable. This is not an AI-powered device, so there is no "training set."
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How the ground truth for the training set was established:
- Not applicable. There is no "training set" or corresponding ground truth establishment for this hardware device.
§ 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.