Search Results

The Gemini III Hybrid Tx/Rx 4 Channel Head Coil consists of a transmit birdcage coil and a receive only 4 channel phased array RF coil, used for obtaining diagnostic images of the brain, cervical spine, soft tissue of the neck and upper chest in Magnetic Resonance Imaging Systems. The Gemini III Hybrid Tx/Rx 4 Channel Head Coil is compatible with SENSE technology and designed for use with the Allegra 3.0T MRI systems manufactured by Siemens Medical Solutions.

The Gemini III Hybrid Tx/Rx 4 Channel Head Coil is designed to provide Magnetic Resonance Images of the brain, upper cervical spine, and the soft tissues and vasculature of the head and neck. The Gemini III Hybrid Tx/Rx 4 Channel Head Coil is designed for use with the Siemens Allegra 3.0T scanner manufactured by Siemens Medical Solutions, Inc.

Anatomic Regions: brain, upper cervical spine, and the soft tissues and vasculature of the head and neck Nuclei Excited: Hydrogen

The indications for use are the same as for standard imaging:

The 3.0T MRI 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 Gemini III Hybrid Tx/Rx 4 Channel Head Coil consists of a transmit birdcage coil and a receive only 4 channel phased array RF coil. The coil has a rigid enclosure. The open, patient friendly design eases patient handling and positioning and maximizes patient comfort. The coil elements and accessory electronics are enclosed in a rigid plastic housing, which is fire rated and has a high impact and tensile strength.

This document is a 510(k) premarket notification for a medical device called the "Gemini III Hybrid Tx/Rx 4 Channel Head Coil." This device is an accessory for Magnetic Resonance Imaging (MRI) systems. The provided text, however, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance metrics in the way one might find for an AI/CADe device.

Therefore, many of the requested sections below cannot be fully extracted from the provided text as the nature of the document and the device itself (an MRI coil, not an image analysis algorithm) do not involve such a study design.

Here's an attempt to address your request based only on the provided information, highlighting where information is absent due to the document's content:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not define specific performance "acceptance criteria" or report quantitative "device performance" in terms of clinical accuracy (e.g., sensitivity, specificity, AUC) for the Gemini III Hybrid Tx/Rx 4 Channel Head Coil. Instead, it demonstrates substantial equivalence to a predicate device (Magnetom Trio 3.0T Head Coil, K021262) by comparing various features and safety aspects.

The table below summarizes the comparison points used to establish substantial equivalence, which serves as the "criteria" for this type of submission. The "reported device performance" here is that the features are "similar" to the predicate.

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

Not applicable. The document describes an MRI accessory (a head coil) and its technical features for substantial equivalence, not an algorithm that analyzes data or requires a test set of patient scans. Therefore, there is no mention of a "test set," sample size, or data provenance in this context.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This device is not an diagnostic algorithm requiring ground truth established by experts for performance evaluation. Its safety and effectiveness are established through engineering design, material specifications, and comparison to an already cleared device.

4. Adjudication Method for the Test Set

Not applicable, as there is no "test set" and no diagnostic challenge requiring adjudication in this type of submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for AI or CADe devices to assess improved reader performance, which is not relevant for an MRI coil accessory.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

Not applicable. This device is an MRI coil, not an algorithm. Therefore, "standalone performance" in the context of an algorithm is not relevant.

7. The Type of Ground Truth Used

Not applicable. As this is an MRI coil and not a diagnostic algorithm, the concept of "ground truth" (e.g., pathology, outcomes data) for clinical decision-making is not applied in this submission. The "ground truth" for the device's acceptable performance is its adherence to safety standards and engineering principles, and its similarity to the predicate device in terms of intended use, materials, design, and mechanisms to ensure patient safety.

8. The Sample Size for the Training Set

Not applicable. There is no algorithm or "training set" mentioned or implied for this device.

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

Not applicable. As there is no training set, there is no ground truth established for it.

Ask a specific question about this device