(57 days)
The coil is indicated for use on the order of a physician, in conjunction with an MR scanner as an accessory to produce images of the upper and lower extremities, as an aid to diagnosis.
The design of the 1.5T and 3.0T 8-Channel Small Extremity Coils are based on design features of the predicate device Musculoskeletal Flex Coil Package: Upper Extremity Flex Coil. The Small Extremity Coils are designed as receive only for high resolution diagnostic imaging of bone, soft tissue, musculoskcletal and vascular structures in small extremity Coils are manufactured of materials that are similar to those used to manufacture the predicate device and other Invivo Corporation coils.
This document pertains to a 510(k) summary for a medical device called the "1.5T and 3.0T 8-Channel Small Extremity Coil." This device is an accessory for MR scanners, designed to produce images of the upper and lower extremities. It is a premarket notification for demonstrating substantial equivalence to a legally marketed predicate device, not a study showcasing device performance against specific acceptance criteria.
Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets them. The document focuses on:
- Device Description: Comparing the subject device's design to a predicate device.
- Indications for Use: What the device is intended for.
- Technological Characteristics: Stating that the fundamental technology has not changed from the predicate device.
- Substantial Equivalence Information: Arguing similarities in intended use and technological characteristics to the predicate device.
- FDA Clearance Letter: Confirming the FDA's determination of substantial equivalence.
Without a performance study or defined acceptance criteria within the provided text, it's impossible to populate the table or answer the specific questions about sample size, ground truth, expert qualifications, or MRMC studies.
No study proving the device meets acceptance criteria is described in the provided text.
§ 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.