(105 days)
The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used.
The images produced by the 1.5T Signa HDx family and 3.0T Signa HDx family reflects the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The 1.5T Signa HDx family and 3.0T Signa HDx family systems are a whole body magnetic resonance system designed to support high resolution, high signal-to-noise ratio, and short scan times. The Signa HDx family of scanners is available in two different field strengths of 1.5T and 3.0T. The system uses a combination of time-varying magnetic fields (gradients) and RF transmissions to obtain information regarding the density and position of elements exhibiting magnetic resonance. The data acquisition system accommodates up to 32 independent receive channels in various increments and multiple independent coil elements per channel during a single acquisition series. The System can image axial, sagittal, coronal, and oblique anatomical images, spectroscopic data, parametric maps, or dynamic images of the structures or functions of the entire body.
The provided text describes a 510(k) summary for the GE Healthcare 1.5T Signa HDx family and 3.0T Signa HDx family Magnetic Resonance Imaging System.
Here's an analysis of the acceptance criteria and study information as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The submission is for a Magnetic Resonance Imaging System, and the document focuses on regulatory compliance and substantial equivalence to predicate devices, rather than specific performance metrics directly comparable to a typical AI/CADe device. The acceptance criteria in this context are related to meeting established medical device standards and demonstrating similar functionality to previously cleared devices.
| Acceptance Criterion (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Compliance with Voluntary Standards (e.g., electrical safety, risk management, software) | Complies with: |
| - IEC60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) | |
| - IEC60601-2-33 (Particular requirements for the basic safety and essential performance of medical electrical equipment in the magnetic resonance environment) | |
| - IEC60601-1-1 (General requirements for safety - Collateral standard: Safety requirements for medical electrical systems) | |
| - IEC60601-1-2 (Electromagnetic compatibility - Requirements and tests) | |
| - IEC60601-1-4 (Programmable electrical medical systems) | |
| - IEC60601-1-6 (Usability) | |
| - ISO14971 (Medical devices - Application of risk management to medical devices) | |
| - ISO10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process) | |
| - IEC62304 (Medical device software - Software life cycle processes) | |
| Quality Assurance Measures applied during development | Applied: |
| - Risk Analysis | |
| - Requirements Reviews | |
| - Design Reviews | |
| - Testing on unit level (Module verification) | |
| - Integration testing (System verification) | |
| - Performance testing (Verification) | |
| - Safety testing (Verification) | |
| - Simulated use testing (Validation) | |
| Substantial Equivalence to Predicate Devices (K052293 and K103327) | Determined to be substantially equivalent in terms of safety, effectiveness, and performance. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "The subject of this premarket submission, 1.5T Signa HDx family and 3.0T Signa HDx family did not require clinical studies to support substantial external equivalence. Internal scans were conducted as part of validation for workflow and image quality and that sample clinical images are included in the submission."
- Sample Size for Test Set: Not specified quantitatively. It mentions "sample clinical images" and "internal scans," implying a limited, internal dataset, not a formal statistically powered test set for clinical performance.
- Data Provenance: Not explicitly stated (e.g., country of origin). The nature of "internal scans" suggests they were likely acquired at GE Healthcare facilities or partner sites. The data is retrospective in the sense that it was used for internal validation, not a prospective clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Given that formal clinical studies were not required and only "internal scans" were used for validation of workflow and image quality, the document does not specify the number or qualifications of experts involved in establishing ground truth for a test set. Interpretation of the "sample clinical images" would implicitly be by qualified personnel, but this is not detailed for the purpose of ground truth for a device performance study.
4. Adjudication Method for the Test Set
No formal adjudication method is mentioned as there was no formal clinical study with a distinct "test set" and ground truth establishment explicitly described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The submission explicitly states no clinical studies were required to support substantial equivalence. This type of study would be relevant for AI-assisted diagnostic devices, which this MRI system is not described as.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable in the typical sense for an MRI scanner. An MRI system is a diagnostic imaging device that produces images for a physician to interpret. It's not an "algorithm only" device where performance is measured in isolation from human interpretation. The system's performance is inherently tied to the quality of images it produces, which are then used by human readers.
7. The Type of Ground Truth Used
For the internal validation mentioned ("workflow and image quality"), the ground truth would implicitly be based on the established technical specifications for image quality (e.g., signal-to-noise ratio, resolution, artifact levels) and visual assessment by experts against known anatomical structures shown in the "sample clinical images." There is no mention of pathology, outcomes data, or expert consensus in the context of a "test set" for performance metrics.
8. The Sample Size for the Training Set
The document does not mention a training set in the context of AI/machine learning. This submission is for a conventional MRI system, not an AI-driven diagnostic algorithm. Therefore, the concept of a "training set" as it applies to machine learning models is not relevant here.
9. How the Ground Truth for the Training Set was Established
As there is no mention of a training set for an AI/machine learning algorithm, this question is not applicable.
§ 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.