(85 days)
The Alpha 7000 Quadrature Wrist Coil is a receive-only quadrature RF coil, used for obtaining diagnostic images of the wrist and hand anatomy in Magnetic Resonance Imaging systems. The indications for use are the same as for standard MR Imaging. The Quadrature Wrist Coil is designed for use with GE Signa (1.5 Tesla) MRI scanner manufactured by GE Medical Systems.
The Alpha 7000 Quadrature Wrist Coil is designed to provide Magnetic Resonance Images of the wrist and hand anatomy. The Alpha 7000 Quadrature Wrist Coil is designed for use with the GE Signa (1.5 Tesla) MRI Scanner.
The GE Signa 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 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 Alpha 7000 Quadrature Wrist Coil consists of two volume RF coil elements in a quadrature design. The elements and the associated circuitry are enclosed in a durable housing made of polyurethane material, which is fire rated and has high impact and tensile strength.
The provided text describes a Medical Device Review for the Alpha 7000 Quadrature Wrist Coil, a magnetic resonance imaging accessory. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study.
Therefore, many of the requested sections (2-7, 9) regarding a study to prove acceptance criteria cannot be extracted because such a study is not described.
Here's the information that can be extracted:
Acceptance Criteria and Device Performance (based on substantial equivalence)
| Parameter | Acceptance Criteria (Predicate Device Feature) | Reported Device Performance (Alpha 7000 Quadrature Wrist Coil) |
|---|---|---|
| Intended Use | Wrist and Hand Imaging Applications (Quadrature Wrist and Hand Coil MRI Devices Corp., K931008) | Wrist and Hand Imaging Applications |
| Indications for Use | Identical to routine MRI imaging (Quadrature Wrist and Hand Coil MRI Devices Corp., K931008; Profile 7000 Quadrature Volume Neck Coil USA Instruments, Inc., K964531) | Identical to routine MRI imaging: Provides Magnetic Resonance Images of the wrist and hand anatomy. Used with GE Signa (1.5 Tesla) MRI Scanner. Images provide information useful for diagnosis when interpreted by a trained physician, based on proton distribution and NMR parameters. |
| Coil Body Material | Lower Extremity Coil, Head Coil, and Vascular Head and Neck Coil, OUTLOOK MRI System Picker International, Inc. (K945827) - (implied safe and durable material) | Flame retardant Polyurethane (enclosed in a durable housing made of polyurethane material, which is fire rated and has high impact and tensile strength.) |
| Coil Design | Quadrature design (Profile 7000 Quadrature Volume Neck Coil USA Instruments, Inc., K964531) | Quadrature design (two volume RF coil elements in a quadrature design) |
| Decoupling | RF Chokes with Switching Diodes (Profile 7000 Quadrature Volume Neck Coil USA Instruments, Inc., K964531) | RF Chokes with Switching Diodes |
| 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 (Profile 7000 Quadrature Volume Neck Coil USA Instruments, Inc., K964531) | 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. |
| Radio Frequency Absorption | Coil is a receive only coil and does not transmit RF power (Profile 7000 Quadrature Volume Neck Coil USA Instruments, Inc., K964531) | Coil is a receive only coil and does not transmit RF power. |
| Formation of Resonant Loops | Decoupling isolates coil elements from RF fields during RF transmission. Length of cable and stiffness do not permit looping (Profile 7000 Quadrature Volume Neck Coil USA Instruments, Inc., K964531) | Decoupling isolates coil elements from RF fields during RF transmission. Length of cable and stiffness do not permit looping. |
Study Details (or lack thereof, based on the provided text)
- Sample size used for the test set and the data provenance: Not applicable. The document describes a 510(k) premarket notification for demonstrating substantial equivalence based on device features and comparison to predicate devices, not a clinical study with a test set of patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set or ground truth establishment is described. The document mentions "trained physician" in the context of interpreting images from the MRI system but not for an evaluation study of the device itself.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set is described.
- 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: Not applicable. This device is an MRI coil accessory, not an AI-powered diagnostic tool. No MRMC study is described.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware device (MRI coil), not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth for device performance is described as part of a review. The substantial equivalence relies on comparing technical features and intended use to existing, legally marketed devices.
- The sample size for the training set: Not applicable. This device is a hardware accessory and does not involve AI/machine learning requiring a training set.
- How the ground truth for the training set was established: Not applicable. As above, no training set is relevant for this 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.