Search Results

The intended use of the ClearMRI Helios-RG8 Coil Accessory Kit is to enable the GE Signa Horizon Cx MR System to perform MR scans of the head or body utilizing newer FDA-cleared coils (up to 8 channels), without hindering its current capability utilizing the legacy GE FDA-cleared 4-channel coils. The ClearMRI Helios-RG8 Coil Accessory Kit inherits the same limitations of the GE Signa Horizon Cx MR system. The ClearMRI Helios-RG8 Coil Accessory Kit has only been validated for and is for use strictly with the GE Signa Horizon Cx MR System, software build 9.1.0311b. The ClearMRI Helios-RG8 Coil Accessory Kit allows the GE Signa Horizon Cx MR System to continue to produce transverse, sagittal, coronal and oblique images of the internal structures of the head or body with the GE Signa Horizon Cx MR System. The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

The Helios-RG8 Coll Accessory Kit will support coil anatomies from Resonance Innovations, LLC: Long Bone Array in large (model 168GE1501).

Accessories to medical devices are regulated under the same classification regulation as the device(s) with which they are intended to be used. The ClearMRI Helios-RG8 Coil Accessory Kit is intended to be used strictly as an accessory to the GE Signa Horizon Cx MR System, software build 9.1.0311b, and does not change the existing indications for the GE Signa Horizon Cx MR System (K962061).

The ClearMRI Solutions, Inc. Helios-RG8 Coil Accessory Kit is designed as an accessory to a previously cleared GE Signa Horizon Cx MR (K962061), software build 9.1.0311b, receiver subsystem with the main modification allowing the operator to use newer RF receive coils with up to 8 channels. The accessory includes a digital receiver, multi-coil driver, and a computer system containing the ClearMRI software and functions in a similar way to the predicate device's comparable subsystem. The ClearMRI hardware is seamlessly background-driven from the GE Signa Horizon Cx system'.

The ClearMRI Solutions Helios-RG8 Coil Accessory Kit includes a digital receiver, multi-coil driver and a computer system containing the ClearMRI software. The accessory kit is available as an add-on to a GE Signa Horizon Cx MR, software build 9.1.0311b, receiver subsystem that allows the operator to scan using a digital imaging system resulting in the benefits of newer multi-channel RF coils. The ClearMRI hardware is controlled by software running independently and in parallel with the GE Signa Horizon Cx System. It does not alter the existing operator workflow. The Helios-RG8 has no new technological characteristics that raise new safety or effectiveness questions.

The provided document describes the ClearMRI Helios-RG8 Coil Accessory Kit, an accessory designed to enable the GE Signa Horizon Cx MR System to utilize newer RF receive coils (up to 8 channels). However, it does not contain a specific study designed to prove the device meets explicit acceptance criteria in terms of clinical performance or image quality, as would typically be seen for an AI-powered diagnostic device.

Instead, the documentation focuses on demonstrating substantial equivalence to a predicate device (GE Signa Horizon Cx Magnetic Resonance System K962061) by asserting that the accessory does not significantly affect the performance of the legally marketed predicate system and adheres to safety and regulatory standards.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for image quality or diagnostic performance of the ClearMRI Helios-RG8 Coil Accessory Kit, nor does it present a study with reported device performance against such criteria. The focus is on demonstrating that the accessory does not negatively impact the existing capabilities and safety of the MR system.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a clinical performance study with a distinct "test set" in the context of diagnostic accuracy or image quality evaluation for the accessory. Instead, the evaluation seems to have focused on engineering and regulatory compliance, such as NEMA and IEC standards. Therefore, information on sample size and data provenance for a test set for diagnostic performance is not provided.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Since a clinical performance study with a diagnostic test set and ground truth establishment is not described, this information is not available in the provided text.

4. Adjudication Method for the Test Set

As no clinical performance study with expert-adjudicated ground truth is described, the adjudication method is not applicable or mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance

No MRMC comparative effectiveness study is mentioned. This device is an accessory to an existing MR system, not an AI diagnostic algorithm, so a study comparing human readers with and without AI assistance is not relevant to its intended function as described.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This device is not an algorithm that performs diagnostic analysis; it's a hardware accessory. Therefore, a standalone performance study for an algorithm is not applicable and not mentioned.

7. The Type of Ground Truth Used

No clinical performance study requiring a specific type of ground truth (e.g., expert consensus, pathology, outcomes data) is described for this accessory. The evaluation appears to be based on technical standards and functional equivalence.

8. The Sample Size for the Training Set

This device is a hardware accessory and not an AI algorithm that requires a training set. Therefore, this information is not applicable.

9. How the Ground Truth for the Training Set Was Established

As this device does not involve an AI algorithm with a training set, the establishment of ground truth for a training set is not applicable.

Ask a specific question about this device