(32 days)
Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the bones, soft tissue, musculoskeletal structures and vascular structures of the upper and lower extremities.
Model 545GE-64 Phased Array Musculoskeletal Flex Coil Package consisting of Model 543GE-64 Phased Array Upper Extremity Flex Coil and Model 544GE-64 Phased Array Lower Extremity Flex Coil. Compatible with GE Signa 1.5T MRI systems with Phased Array option.
The provided text describes a 510(k) summary for the "Model 545GE-64 Phased Array Musculoskeletal Flex Coil Package." This document indicates that the device is a Magnetic Resonance Imaging Coil and its safety and performance were evaluated by demonstrating substantial equivalence to predicate devices, rather than through a study comparing its performance against specific acceptance criteria.
The acceptance criteria are not explicitly stated in numerical or performance-based targets, but rather are inferred from the claim of "No change" compared to existing predicate devices for several key parameters. This means the device is expected to perform at least as well as the legally marketed predicate devices without introducing new safety or imaging performance concerns.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Safety Parameters | ||
| Maximum Static Magnetic Field | No change from predicate device | No change |
| Rate of Magnetic Field Strength Change | No change from predicate device | No change |
| RF Power Deposition | No change from predicate device | No change |
| Acoustic Noise Levels | No change from predicate device | No change |
| Imaging Performance Parameters | ||
| Specification Volume | No change from predicate device | No change |
| Signal-to-Noise Ratio (SNR) | No change from predicate device | No change |
| Image Uniformity | No change from predicate device | No change |
| Geometric Distortion | No change from predicate device | No change |
| Slice Thickness and Gap | No change from predicate device | No change |
| High Contrast Spatial Resolution | No change from predicate device | No change |
Study Proving Acceptance Criteria:
The "study" described is a substantial equivalence comparison to legally marketed predicate devices. The document explicitly states:
"The GE 1.5T Signa MRI system operated with the Medical Advances Phased Array Musculoskeletal Flex Coil Package is substantially equivalent to the same system operated with the legally marketed predicate devices listed in section 4.0, within the Class II definition of Magnetic Resonance Diagnostic Device with respect to the safety parameter action levels: No change is observed for Maximum Static Magnetic Field, Rate of Magnetic Field Strength Change, RF Power Deposition, and Acoustic Noise Levels. For Imaging Performance Parameters, No change is observed for Specification Volume, Signal-to-Noise Ratio, Image Uniformity, Geometric Distortion, Slice Thickness and Gap, and High Contrast Spatial Resolution."
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a test set in the traditional sense of a clinical trial or performance study involving patient data. The evaluation appears to be based on technical specifications and comparisons to existing devices rather than a study on a set of patients or images. The data provenance is not mentioned, as it is a technical comparison, not a data-driven study.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This submission relies on technical parameters and comparison to predicate devices, not on expert-established ground truth from images or patient cases.
4. Adjudication Method
Not applicable. There is no mention of adjudication, as this is not a study involving interpretations or classifications of data by multiple readers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. No MRMC study was conducted or reported. The submission focuses on technical equivalence rather than a comparative effectiveness study involving human readers.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a passive component (an MRI coil) and does not perform algorithmic analysis. Therefore, a standalone algorithm performance study is not relevant or reported.
7. Type of Ground Truth Used
The "ground truth" for this submission is the technical specifications and established performance characteristics of the legally marketed predicate devices. The new device's performance is asserted to be equivalent to these established benchmarks.
8. Sample Size for the Training Set
Not applicable. This is a hardware component (an MRI coil), not an AI/ML algorithm. Therefore, there is no training set in the context of machine learning.
9. How Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, the method for establishing its ground truth is irrelevant.
§ 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.