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The MAGNETOM Rhapsody system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The MAGNETOM Rhapsody system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the entire body, including, but not limited to, the musculoskeletal, vascular, cardiac, and neuro systems. The images produced by the Rhapsody system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spinspin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

Due to the 'open' design of the system, the Rhapsody may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in room display and MR safe biopsy needles.

The Modified MAGNETOM Rhapsody System is a 1.0 T open superconducting magnet designed scanner. It consists of the same types of hardware (with a modified SAFE designed bearing in the currently available MAGNETOM Rhapsody systems. These original systems were cleared under premarket notification K003628.

This document does not contain information about explicit acceptance criteria or a study designed to prove the device meets those criteria. Instead, it is a 510(k) summary for a modification to an existing MRI system (Modified MAGNETOM Rhapsody System). The core approach to demonstrating safety and effectiveness relies on substantial equivalence to a legally marketed predicate device (the original MAGNETOM Rhapsody System, cleared under K003628).

Here's an analysis of the provided text based on your request:

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

Explanation: The document states that the "Operation of the Modified MAGNETOM Rhapsody System is substantially equivalent to the commercially available MAGNETOM Rhapsody System." It then lists key safety and performance parameters. The acceptance criteria are implicitly the performance and safety levels specified by the FDA guidance document for MR Diagnostic Devices and NEMA/IEC standards. The reported device performance is that the modified device will conform to these standards and is "substantially equivalent" to the predicate. There are no specific numerical values provided for acceptance criteria or for the modified device's performance in this summary.

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

This information is not provided in the document. The submission relies on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with a specific test set.

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)

This information is not provided. As no new clinical study data is presented, there is no discussion of a test set requiring expert-established ground truth.

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

This information is not provided.

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

This information is not provided. The device is an MRI system, not an AI-powered diagnostic tool, and the submission does not mention any MRMC studies or AI assistance for human readers.

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

This information is not provided. The device is an MRI system, not a standalone algorithm. Its output (images) is explicitly intended to be interpreted by a "trained physician."

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

This information is not provided. Since no new clinical study data is presented, the concept of "ground truth" for a new test set does not apply in this submission. The "ground truth" for the predicate device would have been established through its own clearance process, but that detail is not in this document.

8. The sample size for the training set

This information is not provided. The device is a hardware modification (modified bearing) to an existing MRI system, not an AI/software device that would typically involve a training set.

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

This information is not provided. (See explanation for point 8).

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