Search Results

To be used in conjunction with 1.5T GE HD series Magnetic Resonance scanners to produce diagnostic images of the chest, abdominal, and pelvic regions that can be interpreted by a trained physician.

The NeoCoil 1.5T 16-Channel Cardiac-Abdominal-Pelvic Array Coil is a multi-element phased array receive only coil used for obtaining diagnostic images of the chest, abdominal, and pelvic regions in Magnetic Resonance Imaging Systems. Compared to predicate device, the submitted device offers greater lateral coverage (60 cm v. 42 cm).

The submitted device consists of two dependent housings; an anterior and a posterior. The anterior housing consists of 11 antennas. It is rigid in the middle, below the covers, and laterally flexible to permit it to wrap about the patient. The posterior consists of 5 antennas. It is made of a hard plastic housing. A single cable connects the posterior housing to the junction box, which provides the interface with the anterior housing. The junction box provides the inter-connection for the anterior and posterior housings, which are mutually dependant, and the GE Healthcare 1.5T Signa Excite MRI scanner.

The antennas are uniquely positioned with the appropriate overlap to cancel out mutual coupling effects from adjacent antennas. Pre-amplifier decoupling reduces any remaining coupling between the antennas.

The posterior housing is covered with a padded surface, of the same foam material as the anterior housing (flexible region). Hospital gowns, sheets, and/or patient street clothing separate the patient from direct contact with the coil and housing materials.

The flexible portion of the anterior secures, about the patient, to the posterior with the provided straps. The posterior housing nests securely in the MRI scanner patient table.

To ensure safety, each antenna is equipped with active and passive transmit decoupling circuits. Active decoupling is achieved via diodes that receive signals from the scanner to turn the coil to a high impedance state during system RF transmit. Crossed diodes are installed on each antenna acting as passive switches. These passive switches provide additional safety in case the active circuitry does not receive signal from the scanner.

The provided document describes a medical device called the NeoCoil 1.5T 16-Channel Cardiac-Abdominal-Pelvic Array Coil. This device is a magnetic resonance specialty coil intended for use with 1.5T GE HD series Magnetic Resonance scanners to produce diagnostic images of the chest, abdominal, and pelvic regions.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document indirectly states acceptance criteria by indicating substantial equivalence to a predicate device and by conducting specific performance tests.

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

The document mentions "SNR and image uniformity testing was performed" but does not specify the sample size for this test set (e.g., number of patients, number of scans).

The data provenance (e.g., country of origin, retrospective or prospective) is also not explicitly stated. Given the context of a 510(k) summary, it's highly likely these were laboratory or phantom-based tests rather than human clinical trials, but this is not explicitly confirmed.

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

The document states that the images produced are "to be interpreted by a trained physician," which implies an expert. However, for the specific tests of SNR and image uniformity, the document does not specify the number of experts used to establish ground truth or their qualifications. These types of tests typically involve technical analysis rather than expert clinical interpretation for establishing ground truth.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method (e.g., 2+1, 3+1). This is consistent with the nature of the performance tests mentioned (SNR and image uniformity), which are objective measurements rather than subjective interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A MRMC comparative effectiveness study was not done as per the provided text. The document focuses on demonstrating substantial equivalence to a predicate device through technical performance metrics (SNR, image uniformity) rather than evaluating human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance:

This device is a physical MRI coil, not a software algorithm. Therefore, the concept of "standalone (i.e., algorithm only without human-in-the-loop performance)" is not applicable to this device. Its performance is inherent in the image acquisition, with human interpretation being the subsequent step.

7. Type of Ground Truth Used:

For the SNR and image uniformity testing, the "ground truth" would be technical specifications and objective measurements of the coil's performance against established benchmarks or the predicate device, rather than clinical outcomes, pathology, or expert consensus on clinical findings.

8. Sample Size for the Training Set:

This device is a hardware component (MRI coil). It is not an AI/ML algorithm that requires a "training set." Therefore, the concept of a training set and its sample size is not applicable.

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

As explained above, there is no training set for this type of device.

Ask a specific question about this device