Search Results

The Elscint Esteem 1.5T MRI system is designed as a general purpose whole-body MRI system for producing cross-sectional images of the internal structures of the head, body or extremities in transverse, sagittal, coronal or oblique planes. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) and image appearance is determined by proton density. NMR relaxation time (T1 and T2) and flow. When interpreted by a trained physician, these images yield information that can be useful in determination of a diagnosis, surgery planning or therapy planning.

The Elscint Esteem 1.5T MRI system is designed as a general purpose whole-body MRI system for producing cross-sectional images of the internal structures of the head, body or extremities in transverse, sagittal, coronal or oblique planes. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) and image appearance is determined by proton density. NMR relaxation time (T1 and T2) and flow. When interpreted by a trained physician, these images yield information that can be useful in determination of a diagnosis, surgery planning or therapy planning.

The major components changed or updated over that described in he predicate device submission are:

• A semi-flexible 4-element receive-only phased array pelvic coil for improved pelvic imaging.
• A semi-flexible 4-element receive-only phased array body coil for improved imaging of the liver, kidneys and hips.
• Additional receive-only surface coils for imaging the spine, shoulder, pelvis, and temperomandibular joint:
• A circular polarized spine coil to increase image performance . in the thoracic and lumbar spine when compared to the lumbar spine coil.
• A single loop shoulder coil pair for improved patient comfort . and general utility. Large and small coils for patients of different sizes are provided.
• A circular polarized pelvic coil to improve performance in . imaging pelvic anatomy compared to the body coil alone.
• A bilateral TMJ coil for specialized imaging of . the temperomandibular joint.

In addition, the existing system electronics which contained two RF channels per system has been modified to operate with four RF channels including switching and selection mechanisms for Phased Array operation.

The provided text describes an MRI system and its updated components, but it does not contain acceptance criteria or a study proving that the device meets such criteria.

Therefore, I cannot fulfill your request for the following information:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document focuses on describing device updates and ensuring safety parameters are unchanged from a predicate device, along with performance parameters being "substantially equivalent" with listed changes. There is no mention of a study involving acceptance criteria for diagnostic performance or accuracy.

Ask a specific question about this device