(20 days)
Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the musculoskeletal structures, soft tissue and vascular structures within the anatomic regions from the chest to the pelvic region.
The AIRIS Elite Body Coil (hereby referred to as body coil) is a receive only RF phased array coil, used for obtaining diagnostic images of the abdominal region, in an open Magnetic Resonance Imaging (MRI) system. The body coil consists two mechanical sections: a rigid removable upper section and a base, which is positioned above and below the patient abdomen respectively. The upper section can be connected to the base by the electrical pins. There is a latch on the upper section. The coil consists of four coil elements: a two-turn solenoid, an anterior saddle, a posterior saddle and an anti-turn loop. All the elements are enclosed in a rigid plastic housing. The signal output of each element is independently processed by the system to enhance performance.
The provided text does not contain information about acceptance criteria, a study that proves the device meets specific criteria, or performance data in the format requested. The document is a 510(k) summary for a medical device (AIRIS Elite Rapid Body Coil) that outlines its intended use, function, scientific concepts, and concludes that it is substantially equivalent to a predicate device.
Specifically, the following information is not available in the provided text:
- A table of acceptance criteria and the reported device performance: The document does not define any specific acceptance criteria (e.g., sensitivity, specificity, accuracy, signal-to-noise ratio thresholds) or provide performance metrics from a study that evaluates the device against such criteria.
- Sample size used for the test set and the data provenance: There is no mention of a test set, its size, or the origin of any data (country, retrospective/prospective).
- Number of experts used to establish the ground truth for the test set and their qualifications: No test set means no ground truth establishment for it is discussed.
- Adjudication method for the test set: Not applicable as no test set is mentioned.
- Multi-reader multi-case (MRMC) comparative effectiveness study information: There is no mention of an MRMC study or any impact of AI assistance on human readers.
- Standalone (algorithm only) performance: This device is a hardware component (a coil for an MRI system), not an algorithm, so standalone algorithm performance is not applicable.
- Type of ground truth used: No ground truth is discussed in relation to performance evaluation.
- Sample size for the training set: Not applicable, as this is a hardware device, not an AI/ML algorithm.
- How the ground truth for the training set was established: Not applicable.
The document primarily focuses on establishing "substantial equivalence" to a predicate device based on similar technological characteristics and intended use. It describes the physical and performance characteristics of the body coil in a general sense, noting it's a "receive only RF phased array coil" and how it functions within the MRI system, but it does not present a formal study with acceptance criteria and measured performance outcomes. The "performance characteristics" mentioned are descriptive of the device's design (e.g., four channel vs. two in predicate) rather than quantitative results from a performance study.
§ 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.