(49 days)
The Alpha 5000 Wrist Coil is a receive-only quadrature RF coil, used for obtaining diagnostic images of the wrist and hand in Magnetic Resonance Imaging Systems. The Alpha 5000 Wrist Coil is designed for use with the Toshiba OPART 0.35T MRI system manufactured by Toshiba Medical Systems, Inc. The indications for use are the same as for standard MR Imaging.
The Alpha 5000 Wrist Coil is designed to provide Magnetic Resonance Images of the hand and wrist. The Alpha 5000 Wrist Coil is designed for use with the Toshiba OPART 0.35T MR scanner manufactured by Toshiba Medical Systesm, Inc.
Anatomic Regions: Wrist and hand Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The 0.35T 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 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 5000 Wrist Coil is a two element quadrature receive-only coil. The coil has a rigid enclosure with windows on top to facilitate patient handling. The open, patient friendly design eases patient handling and positioning and maximizes patient comfort. The coil elements and accessory electronics are enclosed in a rigid plastic housing, which is fire rated and has a high impact and tensile strength.
The provided text describes a submission for a Magnetic Resonance Imaging Accessory, specifically the Alpha 5000 Wrist Coil. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a standalone study with acceptance criteria and performance metrics for a novel AI device.
Therefore, many of the requested categories for AI/algorithm performance and study design are not applicable to this document. The submission explicitly states "No applicable performance standards have been issued under Section 514 of the Food, Drug and Cosmetic Act," indicating that formal acceptance criteria beyond substantial equivalence to existing devices were not required or provided.
Here's a breakdown of the relevant information from the provided text, and where information is not available:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state acceptance criteria in terms of numerical performance metrics for the Alpha 5000 Wrist Coil in the way one would for an AI device. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices. The reported "performance" focuses on shared design and functional characteristics with these predicate devices.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate Devices) | Reported Device Performance (Alpha 5000 Wrist Coil) |
|---|---|
| Intended Use: Imaging of the wrist and hand. | Similar to predicate device (Alpha 7000 Wrist Coil, K972205) |
| Indications for Use: Identical to routine MRI imaging. | Similar to predicate device (Alpha 7000 Wrist Coil, K972205) |
| Coil Enclosure Material: Flame Retardant Polyurethane, Flame Retardant Polycarbonate, Kydex Acryclic/PVC, Delrin. | Similar to predicate device (Hi-Res 9000 Phased Array Carotid Coil, K001210) |
| Coil Design: 2 element saddle receive-only quadrature coil. | Similar to predicate device (Alpha 7000 Wrist Coil, K972205) |
| Decoupling: Switching diode decoupling. | Similar to predicate device (Alpha 7000 Wrist Coil, K972205) |
| 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 predicate device (Alpha 7000 Wrist Coil, K972205) |
| Radio Frequency Absorption: Coil is a receive only coil and does not transmit RF power. | Similar to predicate device (Alpha 7000 Wrist Coil, K972205) |
| Formation of Resonant Loop: Decoupling isolates the coil elements from RF fields during RF transmission; length of cable and stiffness does not permit looping. | Similar to predicate device (Alpha 7000 Wrist Coil, K972205) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a medical device submission for an MRI coil, not an AI or algorithm-driven device that would involve a test set of data samples. The evaluation is based on engineering design, materials, and functional equivalence to existing devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. There is no "test set" or "ground truth" establishment in the context of an AI/algorithm for this device. The evaluation relies on regulatory review of the device's characteristics against predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. See #3.
5. 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 is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is an MRI coil, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. See #3.
8. The sample size for the training set
Not applicable. This device does not involve a training set as it's not an AI or machine learning product.
9. How the ground truth for the training set was established
Not applicable. See #8.
§ 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.