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The Gyrex Prima 1TG 1.0T MRI system is a general purpose whole-body MRI system that produces images of the internal structures of the head, body, or extremities. The indications for use are not dissimilar to established indications for use for other general purpose whole-body MRI systems. The established indications for use are that when interpreted by a trained physician, MRI can be useful in determination of a diagnosis, surgery planning, or therapy planning and is used in a clinic or hospital setting.

The Elscint Prima 1TG 1.0T MRI system is designed as a general purpose whole-body MRI system for producing cross-sectional images of the internal structures of the head, body or extremities in transverse, sagittal, coronal or oblique planes. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) and image appearance is determined by proton density, NMR relaxation time (T1 and T2) and flow. When interpreted by a trained physician, these images yield information that can be useful in determination of a diagnosis, surgery planning or therapy planning.

The provided text describes a 510(k) submission for the Elscint Gyrex Prima 1TG 1.0T MRI System, asserting its substantial equivalence to a predicate device, the Prestige 2.0T MRI System. However, this document does not contain explicit acceptance criteria or a dedicated study section demonstrating the device meets such criteria.

The core of this submission is a declaration of substantial equivalence rather than presenting a performance study against specific, quantified acceptance criteria.

Here's an analysis based on the information not present in the document:

1. A table of acceptance criteria and the reported device performance:

   • Not provided. The document states that the new device has "changes to RF Coils, sequences and system electronics" and is "substantially equivalent" to the predicate. There are no specific quantitative performance metrics (e.g., sensitivity, specificity, resolution, signal-to-noise ratio) presented for either the new device or against any defined acceptance criteria.

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

   • Not provided. No test set or associated data is described. The submission focuses on device modifications and substantial equivalence.

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 provided. No test set or ground truth establishment is mentioned.

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

   • Not provided. No test set or adjudication method is mentioned.

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 provided. No MRMC study is mentioned. This device is an MRI system, not an AI-powered diagnostic tool, so such a study would not be applicable in this context. The document does mention "Operator selectable application of the Context Vision™ A imaqe filter," which might involve some image processing, but it's not framed as an AI assistance study for human readers.

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

   • Not provided. This is an MRI system, not a standalone algorithm. Its performance is inherent to its imaging capabilities, which are asserted as substantially equivalent to a predicate.

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

   • Not provided. No ground truth is mentioned as there is no specific performance study described.

8. The sample size for the training set:

   • Not applicable/Not provided. As a medical imaging device rather than a machine learning algorithm, the concept of a "training set" in the AI/ML sense is not relevant here. The device's design is likely based on engineering principles and prior knowledge of MRI technology.

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

   • Not applicable/Not provided. As above, a training set with established ground truth, in the context of AI/ML, is not relevant to this device's submission.

In summary, the provided document is a regulatory submission focused on demonstrating substantial equivalence of a new MRI system to an existing one, rather than a detailed report of a performance study against specific acceptance criteria. It highlights changes in hardware components (magnet, gradient system, coils) and a selectable image filter, asserting that these do not introduce new indications or hazards beyond the predicate device.

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