(21 days)
The Signa 1.5T TwinSpeed Magnetic Resonance System is a whole body scanner designed for shorter scan times. The Signa TwinSpeed is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head or body. The images produced by the Signa TwinSpeed system reflect the spatial distribution of protons (hydrogen nucle) 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 Signa 1.5T TwinSpeed incorporates the Signa Horizon Cx (K962061) and the Signa CVMR Magnetic Resonance System (K980114) gradient performance into a single MR device with a 60 cm patient aperture. Previously cleared software options, coils, and other accessories may be used with the Signa 1.5T TwinSpeed.
This 510(k) summary describes the GE Signa 1.5T TwinSpeed Magnetic Resonance System, comparing it to previously marketed devices (Signa CVMR Magnetic Resonance System (K980114) and Signa Horizon Cx (K962061)).
Here's an analysis of the provided information regarding acceptance criteria and the study:
The provided document is a 510(k) summary for a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness or establishing performance criteria against specific disease outcomes. Therefore, the information typically found in a clinical study report (e.g., detailed acceptance criteria related to diagnostic accuracy, sample size of a clinical test set, expert qualifications for ground truth, MRMC studies, standalone performance details, training set information) is not present in this document.
The "acceptance criteria" and "study" described herein are primarily engineering and technical verifications ensuring the modified device performs similarly to its predicates, adhering to safety and performance standards for an MRI system.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from 510(k) context) | Reported Device Performance (Summary) |
|---|---|
| Design modifications meet predetermined engineering and performance specifications. | Testing demonstrates that design modifications meet predetermined acceptance criteria. |
| Device maintains "same basic technological characteristics" as predicate devices. | The Signa 1.5T TwinSpeed has the same basic technological characteristics as its predicates. |
| Device maintains "same basic design, construction, and materials" as predicate devices. | The Signa 1.5T TwinSpeed uses the same basic design, construction, and materials as its predicates. |
| Device maintains "same intended use" as predicate devices. | The Signa 1.5T TwinSpeed has the same intended use as its predicates. |
| Device maintains "same operating modes" as predicate devices. | The Signa 1.5T TwinSpeed has the same operating modes as its predicates. |
| Safety and effectiveness are equivalent to predicate devices. | The Signa 1.5T TwinSpeed is deemed substantially equivalent to the currently cleared Signa CVMR and Signa Horizon Cx magnetic resonance systems. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document does not specify a "test set" in the context of a clinical performance study with human subjects or patient data. The "testing" mentioned refers to engineering verification of the device's modifications. Therefore, details like sample size, country of origin, or retrospective/prospective nature are not applicable/not provided.
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 applicable/not provided as the "test set" described is not a clinical dataset requiring expert ground truth for diagnostic accuracy assessment. The ground truth for this type of submission would relate to engineering specifications and performance measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided as there is no clinical test set requiring adjudication of findings.
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
An MRMC comparative effectiveness study was not performed and is not relevant for this type of device submission (an MRI system, not an AI-assisted diagnostic tool). Therefore, there is no stated effect size for human reader improvement with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. The device is an MRI system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this type of device, the "ground truth" would be established through engineering specifications, technical measurements (e.g., signal-to-noise ratio, image uniformity, gradient linearity, etc.), and functional testing against established industry standards and internal design requirements. The document summarizes that "testing was performed to demonstrate that the design modifications... meet predetermined acceptance criteria," implying these technical ground truths were used.
8. The sample size for the training set
This information is not applicable/not provided as the device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable/not provided as the device is not an AI/ML algorithm that requires a training set.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.