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510(k) Data Aggregation
(43 days)
The Optima MR430s MRI Scanner is indicated to use as a magnetic resonance imaging device of the leg (excluding the thigh), knee, ankle, foot, elbow, forearm, wrist, and hand. The device produces transverse, sagittal, coronal, and oblique crosssectional images, displaying the internal structure of the limbs and joints being imaged. If interpreted by a medical expert, these images can provide diagnostically useful information.
The Optima MR430s MRI Scanner utilizes a superconducting magnet to acquire 2D single-slice and multi-slice and 3D volume images. A wide variety of pulse sequences are provided to the operator, including spin echo, fast spin echo, 2D and 3D gradient echo acquisitions. Imaging options such as inversion recovery, flow compensation and fat/water suppression are provided to suppress artifacts due to physiological motion and improve image quality. The system is used as a stationary system.
The provided document is a 510(k) Premarket Notification Submission for the GE Healthcare Optima MR430s MRI Scanner. It details the device's description, intended use, and the basis for its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for diagnosis or detection. The submission is for a magnetic resonance imaging device rather than a software algorithm that provides a diagnostic output.
Instead, the acceptance criteria are implicit in the Substantial Equivalence determination. The core assertion is that the "modified Optima MR430s employs the same fundamental scientific technology as the unmodified predicate device" and that it is "as safe, as effective, and performance is substantially equivalent to the predicate device."
Therefore, the "reported device performance" is essentially that it meets the safety and effectiveness standards of its predicate device (K103238, Optima MR430s MRI Scanner).
Table:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Safety | The modified device must be as safe as the predicate device. This is assessed through risk analysis and compliance with voluntary standards. | "GE Healthcare considers the Optima MR430s to be as safe... as the predicate device." Compliance with voluntary standards and risk analysis performed. |
| Effectiveness | The modified device must be as effective as the predicate device in producing diagnostically useful images of the specified anatomical regions (leg, knee, ankle, foot, elbow, forearm, wrist, and hand). This implies producing high-quality transverse, sagittal, coronal, and oblique cross-sectional images displaying internal structures. | "GE Healthcare considers the Optima MR430s to be as... effective... as the predicate device." The device produces the required image types for medical expert interpretation. |
| Performance | The device's performance (e.g., image quality, operational characteristics) must be substantially equivalent to the predicate device. This is assessed through non-clinical tests (Performance Testing/Verification, System Validation Testing), design reviews, and requirements reviews. The "fundamental scientific technology" remains the same. | "GE Healthcare considers the Optima MR430s to be... performance is substantially equivalent to the predicate device." "The modified Optima MR430s employs the same fundamental scientific technology as the unmodified predicate device." Non-clinical tests were conducted (Performance Testing, System Validation Testing). |
2. Sample size used for the test set and the data provenance
The document explicitly states: "The modification that prompted this submission did not require clinical testing." This indicates that there was no clinical test set of patient data used for this specific 510(k) submission. The evaluation was based on non-clinical tests to demonstrate substantial equivalence to the predicate device, which would have had its own testing data.
Therefore, no information on sample size or data provenance for a clinical test set is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Given that clinical testing was not required for this submission, there were no experts used to establish ground truth for a clinical test set in this context. The "diagnostically useful information" from the images is expected to be interpreted "by a medical expert" in real-world clinical use, but this is not part of the current device's evaluation for this 510(k).
4. Adjudication method for the test set
Not applicable, as no clinical test set was required or used for this submission.
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 is for an MRI imaging device, not an AI-powered diagnostic algorithm or an assistive tool for human readers. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is an imaging device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical test set evaluating diagnostic performance was conducted for this submission. The ground truth for the device's technical specifications and image quality would have been established through engineering and performance testing against defined standards.
8. The sample size for the training set
Not applicable. This is an MRI imaging device, not a machine learning or AI algorithm that requires a training set of data.
9. How the ground truth for the training set was established
Not applicable. As noted above, this is not an AI/ML device that uses a training set.
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