(17 days)
The Gore 3.0T Torso Array is intended for multiple imaging applications with GE Signa® 3.0T MR Systems. It will allow for high resolution images of the thorax, abdomen, pelvis, and spine.
The Gore 3.0T Torso Array is a receive only phased array coil, consisting of an anterior and a posterior "paddle." The phased array design includes 4 elements in a flexible coil, which conforms to different body sizes. The coil produces high resolution images with GE Signa® 3.0T MR Systems.
Here's an analysis of the provided text regarding the Gore 3.0T Torso Array:
This document describes a 510(k) premarket notification for an MRI surface coil, not an AI/ML medical device. Therefore, many of the requested criteria related to AI/ML device performance and study design (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or cannot be extracted.
The document focuses on demonstrating substantial equivalence to predicate devices for a hardware component (an MRI coil). Substantial equivalence is primarily proven through comparing technical characteristics, materials, and intended use, rather than rigorous performance metric studies against defined acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria | Reported Device Performance |
---|---|
Intended Use: For multiple imaging applications with GE Signa® 3.0T MR Systems to allow high resolution images of the thorax, abdomen, pelvis, and spine. | Substantially Equivalent Intended Use: "The Gore 3.0T Torso Array is substantially equivalent to the predicate devices with regard to intended use." This was demonstrated by "imaging a variety of anatomical locations and comparing the clinical images." |
Mode of Operation: Function as a receiving coil. | "The Gore 3.0T Torso Array uses the same mode of operation, a receiving coil, as the predicate devices can employ." |
Decoupling: Utilize active decoupling. | "The Gore 3.0T Torso Array utilizes active decoupling as do the predicate devices." |
Patient Safety Features: Include passive decoupling and MR safe cable. | "The Gore 3.0T Torso Array further enhances patient safety by including passive decoupling, and the MR safe cable." (This is presented as an enhancement, not a direct criterion for equivalence unless the predicate lacked it, which isn't explicitly stated as a requirement for the predicate.) |
Biocompatible Materials: Patient contact areas composed of biocompatible closed cell polyethylene foam. | "The patient contact areas for both coils [applicant and predicate] are composed of a biocompatible closed cell polyethylene foam." |
High Resolution Imaging: Produce high resolution images. | "The coil produces high resolution images with GE Signa® 3.0T MR Systems." (No specific quantitative metric for "high resolution" is provided, it's a qualitative claim for equivalence.) |
Compatibility: Compatible with GE Signa® 3.0T MR Systems. | "The Gore 3.0T Torso Array is intended for multiple imaging applications with GE Signa® 3.0T MR Systems." |
2. Sample size used for the test set and the data provenance
- Not Applicable / Not Provided. This is a hardware device (MRI coil) undergoing a 510(k) for substantial equivalence based on technical characteristics and clinical image comparison. The concept of a "test set" for performance metrics in the way an AI/ML device would have one is not described. The document states "imaging a variety of anatomical locations and comparing the clinical images" was done, but no specifics on quantity of images, subjects, or data provenance (country, retrospective/prospective) are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Provided. This is not an AI/ML device. "Ground truth" in the context of diagnostic accuracy via expert consensus is not relevant here. The evaluation relies on comparing images qualitatively to demonstrate similarity to predicate device output.
4. Adjudication method for the test set
- Not Applicable / Not Provided. No formal adjudication method is mentioned as it's not a diagnostic performance study.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable / Implicit Comparability: For a hardware device like an MRI coil, "ground truth" isn't established in the same way as for a diagnostic algorithm. The "truth" is that the device should produce images of comparable quality and diagnostic utility to the predicate devices. This is assessed qualitatively by comparing clinical images.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/ML 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.