(39 days)
Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the musculoskeletal structures, soft tissue and vascular structures in various anatomic regions.
The HHF Echelon Multi-purpose Coil (hereby referred to as GP coil) is a receive only RF coil for obtaining diagnostic images of the abdominal region, in an open Magnetic Resonance Imaging (MRI) system.
The General-purpose coil consists of two independent parts A and B. The two parts can be used individually or together. The main body of each coil is housed in a flexible structure to conform to the body. The coil consists of a single element. The signal output of each part is independently processed by the system to enhance performance.
This document (K061950) is a 510(k) premarket notification for the HHF1™ Echelon™ Multi-purpose Coil, a component of an MRI system, not a standalone AI device. Therefore, the provided text does not contain the information requested regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methods for an AI or imaging diagnostic algorithm.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (T/R Body coil cleared in HHF1 Echelon MRI System, Cf. K052172).
Here's why the requested information is absent:
- No AI/Algorithm: The device is a "receive-only" radiofrequency (RF) coil for an MRI system. It detects MR signals. It is not an imaging algorithm or an AI-powered diagnostic device.
- Substantial Equivalence: The 510(k) submission seeks to demonstrate that the new coil is "substantially equivalent" to an already legally marketed predicate device. This typically involves showing similar technological characteristics and intended use, rather than conducting new performance studies that would generate the kind of data you're asking for.
- Performance Data Type: While the document describes the scientific concepts of MRI, it does not present performance metrics (like sensitivity, specificity, AUC) that would be relevant for an AI diagnostic tool. It describes the physical and functional characteristics of the coil.
Therefore, it is not possible to fill in the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, experts, or ground truth based on the provided text. The document does not describe a study proving the device meets acceptance criteria in the context of an AI-driven diagnostic.
§ 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.