(51 days)
The Crystal 5000 Phased Array TMJ Coil is a receive-only phased array RF coil used for obtaining diagnostic images of the temporo-mandibular joint, condyle, and mandible in Magnetic Resonance Imaging systems. The indications for use are the same as for standard MR Imaging. The Crystal 5000 Phased Array TMJ Coil is designed for use with the Proview™ (0.23Tesla) MRI scanner manufactured by Marconi Medical Systems Finland.
The Crystal 5000 Phased Array TMJ Coil is designed to provide Magnetic Resonance Images of the temporo-mandibular joint. The Crystal 5000 Phased Array TMJ Coil is designed for use with the Marconi Medical Systems' Proview 0.23Tesla scanner.
The indications for use are the same as for standard imaging:
The Marconi Medical Systems Proview 0.23Tesla system is indicated for use as a diagnostic imaging device that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton 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 Crystal 5000 Phased Array TMJ Coil is a phased array receive only coil. The elements and associated circuitry are enclosed in housing made of plastic materials, which are fire rated and have high impact and tensile strength.
The provided document is a 510(k) premarket notification for a medical device cleared in 2001. This type of regulatory submission, particularly for
a device developed at this time, focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a clinical study with detailed acceptance criteria and performance metrics typically found in efficacy studies for newer, more complex devices
or AI/ML-driven technologies.
Therefore, many of the requested items (e.g., sample size for test/training sets, ground truth establishment, expert qualifications, MRMC studies,
standalone performance) are not applicable to this type of submission. The safety and effectiveness are established through comparison to a predicate device.
Here's a breakdown based on the information available:
Acceptance Criteria and Device Performance
The "acceptance criteria" for this 510(k) submission are implicitly demonstrating substantial equivalence to existing predicate devices. The
performance is described by comparing the features of the Crystal 5000 Phased Array TMJ Coil to these predicates.
| Feature / Acceptance Criteria (demonstration of substantial equivalence) | Reported Device Performance (as compared to predicate) |
|---|---|
| Intended Use: Imaging of the temporo-mandibular joint, condyle, and mandible. | Similar to 405GE-64 Phased Array TMJ Coil manufactured by IGC Medical Advances (K944773) |
| Similar to the Hi-Res 9000 Phased Array Carotid Coil manufactured by USA Instruments (K001210) | |
| Indications for Use: Identical to routine MRI imaging. | Similar to the Hi-Res 9000 Phased Array Carotid Coil manufactured by USA Instruments (K001210) |
| Coil Enclosure Material: PVC Plastic Alloy, Polyurethane. | Similar to the Hi-Res 9000 Phased Array Carotid Coil manufactured by USA Instruments (K001210) |
| Coil Design: Receive-only phased array coil. | Similar to the Hi-Res 9000 Phased Array Carotid Coil manufactured by USA Instruments (K001210) |
| Decoupling: Switching Diode decoupling. | Similar to the Hi-Res 9000 Phased Array Carotid Coil manufactured by USA Instruments (K001210) |
| 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 Hi-Res 9000 Phased Array Carotid Coil manufactured by USA Instruments (K001210) |
| Radio Frequency Absorption: Coil is a receive-only coil and does not transmit RF power. | Similar to the Hi-Res 9000 Phased Array Carotid Coil manufactured by USA Instruments (K001210) |
| 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 the Hi-Res 9000 Phased Array Carotid Coil manufactured by USA Instruments (K001210) |
Study Details:
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Sample size used for the test set and the data provenance: Not applicable. This submission relies on substantial equivalence to predicate devices, not on a new clinical study with a test set of patient data to evaluate performance. The comparison is feature-based against existing cleared devices.
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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. There was no specific "test set" in the context of diagnostic performance evaluation for which ground truth needed to be established by experts.
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Adjudication method for the test set: Not applicable. No test set was used in this manner.
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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: Not applicable. This device is a passive MRI accessory (a coil), not an AI-driven image analysis tool. It does not involve human readers interpreting images with or without AI assistance.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is an MRI coil, not an algorithm.
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The type of ground truth used: The "ground truth" for this type of submission is implicitly the established safety and effectiveness of the predicate devices. The new device is shown to be substantially equivalent in its design and function to these already-cleared devices, implying a similar safety and performance profile.
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The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no "training set."
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How the ground truth for the training set was established: Not applicable.
§ 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.