(16 days)
The Pelvic Array Coil is a receive only phased array RF coil used for obtaining diagnostic images of the pelvis, including the hips, in magnetic resonance imaging systems. The Pelvic Array Coil is designed for use with the GE Signa 1.5T MRI system manufactured by GE Medical Systems.
The Pelvic Array Coil is designed to provide Magnetic Resonance Images of the pelvis, including the hips. The Pelvic Array Coil is designed for use with the GE Signa 1.5T MR scanner.
The indications for use are the same as for standard imaging:
The Signa 1.5T system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body, When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
The Pelvic Array Coil is a receive-only, quadrature phased array RF coil, used for obtaining diagnostic MR images of the pelvis, including the hips. The elements and associated circuitry are enclosed in a semi-flexible housing that is fire rated and has a high impact and tensile strength.
The provided document is a 510(k) summary for a Magnetic Resonance Imaging Accessory (Pelvic Array Coil), dated December 17, 2003. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a new AI/software-based device.
Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types is not available in this document.
This document describes a physical medical device (an MRI coil) and its intended use, rather than a diagnostic algorithm or AI product. The safety and effectiveness are established through comparison to a predicate device based on material, design, and function, not through clinical performance metrics against specific diagnostic criteria.
Key areas from your request that are NOT present in the provided document:
- A table of acceptance criteria and the reported device performance: This document does not establish specific performance metrics or acceptance criteria like sensitivity, specificity, accuracy, or image quality scores that would be typical for an AI/software device. Its acceptance is based on substantial equivalence.
- Sample size used for the test set and the data provenance: There is no mention of a test set, human subjects study, or data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there's no test set or ground truth in the context of an AI/software evaluation.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is for a physical MRI coil, not an AI system.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
What the document does provide regarding safety and effectiveness:
The document establishes safety and effectiveness by demonstrating "substantial equivalence" to a legally marketed predicate device (Insight Plus 9000 Torso and Pelvis Coil manufactured by USA Instruments, Inc. - K001209).
The comparison focuses on:
- Intended Use: Similar for imaging of the pelvis, including hips.
- Indications for Use: Identical to routine MRI imaging.
- Coil Enclosure Material: Similar materials (Delrin Acetal, Flame Retardant PVC, Flame Retardant Polyurethane, Vinyl Coated EVA Foam).
- Coil Design: Receive-only quadrature phased array coil, similar to the predicate.
- Decoupling: Switching diode decoupling, similar to the predicate.
- Prevention of RF Burns: Does not transmit RF power, decoupling isolates elements, and uses a non-conductive housing. These features are similar to the predicate.
- Radio Frequency Absorption: It's a receive-only coil and does not transmit RF power, consistent with the predicate.
- Formation of Resonant Loop: Decoupling isolates elements and the cable design prevents looping, similar to the predicate.
In essence, the "study" demonstrating the device meets acceptance criteria is a technical and functional comparison study against a predicate device, focusing on design, materials, and operational principles to show that it is as safe and effective as the already-cleared device. There are no performance metrics in the sense of diagnostic accuracy or reader improvement for this type of device.
§ 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.