(70 days)
Due to its shape and size the RF external Synergy Shoulder coil allows a variety of applications but with the main purpose of optimal imaging of the shoulder structure. It is compatible to be used with the Philips GYROSCAN NT systems which are indicated for use as diagnostic devices that produce transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, based upon H and 31P metabolites, and that display the internal structure and/or function of the head, body or extremities. These images and/or spectra when interpreted by a trained physician, yield information that may assist in diagnosis.
The Synergy Shoulder coil is a synergy RF receive only coil which is compatible for use with the MRDD Philips GYROSCAN NT systems. It is designed for a variety of applications but with the main purpose for optimal imaging of the shoulder. The coil consists of a pair of elliptical flexible coil elements (dimensions 14x17cm per element). Two version of the coil will be available, i.e. for the 1.5 Tesla ( 63MHz) and 1.0 Tesla (42MHz) MRDD systems. Close to the coil elements the synergy pre-amplifiers and electronic circuitry are mounted in a box which is sealed together with the coil elements. A "bazooka" cable is applied for RF filtering. The "bazooka"cables are fed into a combined (driver) box and connected to MR system (scanner). The Synergy Shoulder coil is an external RF coil made of routinely-used materials. The technological characteristics are based on the same concept as with the other synergy coils which have been cleared as part of the MRDD Philips GYROSCAN NT Release 6 series systems (ref.K980645).
The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary and FDA clearance letter for the Philips Synergy Shoulder coil, primarily focusing on general safety, effectiveness, and substantial equivalence to a predicate device. It addresses the device's intended use and technological characteristics rather than specific performance metrics or clinical study results.
Therefore, I cannot fulfill the request to provide:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method.
- MRMC comparative effectiveness study results or effect size.
- Standalone performance study details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
§ 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.