Search Results

The Signa Ovation (formerly known as MFO/I) system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The Signa Ovation system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the entire body, including, but not limited to, the musculocskeletal, vascular, cardiac, and neuro systems. The images produced by the Signa Ovation system 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 diagnosis.

Due to the 'open' design of the system, the Signa Ovation may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in-room display, and MR safe biopsy needles.

The Extra Large Body Coil is a modification to the Signa MFO/i MR System (K002611) which includes the addition of a flexible extra large body coil.

This 510(k) summary describes a modification to an existing device, the GE Signa MFO/i MR System (K002611), by adding an "Extra Large Body Coil." The document focuses on demonstrating substantial equivalence to the predicate device rather than providing a detailed study of the new coil's performance against specific acceptance criteria in a clinical setting.

Therefore, many of the requested elements for a study proving a device meets acceptance criteria are not explicitly present in the provided text. The document states that "Testing was performed to demonstrate that the design modifications to the Extra Large Body Coil meet predetermined acceptance criteria," but it does not elaborate on what those criteria were, the specific tests conducted, or the results.

Based on the provided text, here is what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria or specific reported device performance metrics for the Extra Large Body Coil against those criteria. It broadly states that "Testing was performed to demonstrate that the design modifications to the Extra Large Body Coil meet predetermined acceptance criteria." These acceptance criteria would likely relate to image quality (resolution, signal-to-noise ratio), safety, and compatibility with the existing MR system, but details are not given.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided. The study design described is not a clinical study involving expert interpretation of images for ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided.

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

No MRMC study is mentioned. This device is an MRI coil, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance would not be applicable here.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable, as this is hardware (an MRI coil), not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" in the context of clinical diagnostic accuracy studies is not directly applicable here. The testing would have focused on engineering and performance specifications of the coil, not diagnostic accuracy based on clinical outcomes or pathology.

8. The sample size for the training set

Not applicable, as this is a hardware device, not a machine learning algorithm requiring a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary of Study from the document:

The study described is a technical verification that the "design modifications to the Extra Large Body Coil meet predetermined acceptance criteria." The purpose of this study was to support the claim of substantial equivalence to the predicate device (GE Signa MFO/i MR system, K002611). The document concludes that "Usage of the Extra Large Body Coil does not result in any new potential hazards." This type of submission (510(k)) primarily focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than providing detailed clinical performance data against specific diagnostic acceptance criteria.

Ask a specific question about this device