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Imaging of: The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, . neck, TMJ, heart, blood vessels). [Application terms include MRCP (MR Cholangiopancreatography), MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynavic Scan and Cine Imaging.] - -Fluid Visualization - ・ 2D/3D Imaging - MR Angiography/MR Vascular Imaging -

Versions 2 (V2) software is a combination of modifications and the addition of new sequences to the existing software, which facilitate the acquisition and reconstruction of MR images.

The provided text is a summary of a 510(k) Premarket Notification for a software upgrade (Versions 2 (V2) software) for an existing Magnetic Resonance Diagnostic Device Accessory, the OPART™ (MRT-600). The submission focuses on demonstrating substantial equivalence to the previously cleared OPART™ system (K962933) and does not detail a study or specific acceptance criteria for a new device's performance.

Instead, the document asserts that the modifications and new sequences in V2 software do not "raise new questions of safety or efficacy" and do not introduce "any new indications for use." This type of submission relies on the established safety and efficacy of the predicate device, rather than requiring new performance studies with detailed acceptance criteria.

Therefore, the requested information regarding acceptance criteria and a study proving device performance cannot be extracted from the provided text because such a study was not performed or described. The submission's core argument is that the changes are minor and do not necessitate new performance data.

However, I can extract information related to the device and its intended use:

Device Information from the document:

• 1. A table of acceptance criteria and the reported device performance:
  • Acceptance Criteria: Not explicitly stated as this is a software upgrade claiming substantial equivalence. The "acceptance criteria" here implicitly refer to maintaining the performance and safety profiles of the predicate device (OPART™ K962933).
  • Reported Device Performance: The document provides "Imaging Performance Parameters" for the system, not specifically for the V2 software upgrade's new features. This suggests these are the general capabilities of the MR system.

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

  • Not applicable/Not provided. The submission states "Sample phantom images and clinical images are presented for new sequences" but does not detail a formal test set, sample size, or data provenance. This aligns with a substantial equivalence claim for a software upgrade.

• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

  • Not applicable/Not provided. Ground truth establishment for a test set is not described.

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

  • Not applicable/Not provided. Adjudication methods for a test set are not described.

• 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:

  • No. This device is a software upgrade for an MRI system, not an AI-assisted diagnostic tool.

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

  • Not applicable/Not provided. This is an MRI system software upgrade, not an algorithm being tested for standalone performance. "Sample phantom images and clinical images" were presented, which would be an algorithm-only output, but no formal standalone study is described.

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

  • Not applicable/Not provided. No specific ground truth methodology is detailed for the "sample clinical images."

• 8. The sample size for the training set:

  • Not applicable/Not provided. As this is not an AI/machine learning submission, there is no mention of a training set.

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

  • Not applicable/Not provided. No training set is mentioned.

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