(88 days)
The Indications for Use for the Signa Profile 9 Inch Diameter Coil and Kinematic Positioner Options expands the capability of the Signa Profile System. The Kinematic Positioner accommodates and improves imaging of the knee and surrounding structures. The 9 inch Coil is intended for imaging of the cervical spine, shoulder, knee and surrounding structures.
Profile 9 Inch Coil consists of a linear solenoid coil. The lt is a split two part design that has a base and a removable top to facilitate patient positioning. It is designed for use with a vertical magnetic field MR imaging system.
The Kinematic Positioner provides support for the legs for MR scanning. It has two usages. One is for a scan when the scanned leg is fixed, and the other is while the scanned leg is moving down.
The provided text describes a 510(k) premarket notification for the GE Signa Profile 9 Inch Coil and Kinematic Positioner Options. It focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed performance studies with acceptance criteria in the manner one might expect for a novel AI device.
Here's an analysis based on the information provided:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| Performance | NEMA performance standards | "The 9 Inch Surface Coil was evaluated to the appropriate NEMA performance standards." | The specific NEMA standards (e.g., spatial resolution, signal-to-noise ratio, uniformity) and the actual numerical results are not provided. The statement only indicates compliance with appropriate standards. |
| Safety | International safety standards IEC 601-1 and IEC 601-2-33 | "Both options were evaluated to the International safety standards IEC 601-1 and IEC 601-2-33." | Similar to performance, the specific tests and detailed results are not provided, only compliance with the standards. |
| Functional | Stated specifications | "Both options performed to stated specifications." | The specific "stated specifications" are not detailed in the document. |
| Substantial Equivalence | Comparison to predicate device (Signa Profile System and Signa Profile Extremity Coil) | "The Profile 9 Inch Surface Coil is similar to the Profile Extremity Coil except that the Extremity coil is a quadrature receive only coil while the 9 inch coil is a linear receive only coil." and "It is the opinion of GE that the Signa Profile System with the 9 Inch Surface Coil and Kinematic Positioner options are substantially equivalent to the presently marketed Signa Profile System and the Signa Profile Extremity Coil." | This is the primary "acceptance criterion" for a 510(k) submission, and the manufacturer concludes it is met. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of clinical data or image samples for performance evaluation. The evaluation appears to be based on engineering and laboratory testing against NEMA and IEC standards, and direct comparison of specifications with the predicate device.
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)
Not applicable. The evaluation described is for physical medical devices (MRI coil and positioner) against technical standards, not for an AI algorithm requiring expert ground truth for interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no mention of a human expert adjudication process for image interpretation or diagnosis.
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
Not applicable. This submission concerns hardware components (an MRI coil and a positioner), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" here would be measurements and tests against established engineering and safety standards (NEMA, IEC) and the specifications of the predicate device.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
Summary of the Study:
The "study" described in this 510(k) summary is primarily an engineering and regulatory compliance exercise. GE Medical Systems evaluated the Signa Profile 9 Inch Coil and Kinematic Positioner Options against:
- NEMA performance standards: To ensure the coil performs adequately from a technical imaging perspective. Specific NEMA standards (e.g., for RF coils) would have been used.
- International safety standards IEC 601-1 and IEC 601-2-33: To ensure electrical and mechanical safety of the medical devices.
- Manufacturer's stated specifications: To confirm manufacturing quality and functionality.
- Comparison to a predicate device: The Signa Profile Extremity Coil (for the 9-inch coil) and the existing Signa Profile System (for both options). This comparison focused on identifying similarities and differences and demonstrating that any differences do not raise new safety or effectiveness concerns.
The conclusion is that these options are substantially equivalent to currently marketed devices and do not introduce new hazards, allowing them to expand the capabilities of the Signa Profile System for imaging various anatomical regions like the cervical spine, shoulder, and knee.
§ 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.