(24 days)
The coil is indicated for use on the order of a physician, in conjunction with Philips 1.5T MR scanners as an accessory to produce images, as an aid to diagnosis.
The SENSE MSK S 8ch 1.5T magnetic resonance coil is designed and intended for use with a Philips 1.5T Magnetic Resonance Imaging (MRI) system. The coil device has a one-piece flexible housing made of polycarbonate and polyethylene. The device works in unison with the Body Coil of the MRI system, which will transmit the radio frequency (RF) signals, so the coil may receive the resultant RF signal from the excited nuclei. The coil is designed as receive only for high resolution diagnostic imaging of the small regional structures of the body, such as the shoulder, elbow, wrist and hand.
The provided text is a 510(k) summary for a medical device (SENSE MSK S 8ch 1.5T magnetic resonance coil). This type of document focuses on establishing substantial equivalence to a predicate device, rather than presenting a clinical study with detailed acceptance criteria and performance data.
Therefore, the requested information regarding acceptance criteria, a study proving the device meets them, sample sizes, ground truth establishment, expert qualifications, and MRMC effectiveness studies is not available in the provided text. The document does not describe a performance study or clinical trial in the way the questions imply.
The text primarily focuses on:
- Device Description: What the device is and how it functions.
- Intended Use: The purpose for which the device is to be used.
- Technological Characteristics: The fundamental science behind the device.
- Substantial Equivalence: A comparison to a legally marketed predicate device to demonstrate that the new device is as safe and effective.
The provided information simply states that "substantial equivalence is based on similarities in design features, indications for use, and technological characteristics" to the predicate device (K111673). There is no mention of a performance study to demonstrate that the device meets specific acceptance criteria, as the regulatory pathway for this device is based on demonstrating equivalence, not necessarily de novo proof of meeting performance metrics through a new clinical trial.
§ 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.