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The MAGNETOM Trio a Tim System is intended for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. These images and/or spectra, when interpreted by a trained physician yield information that may assist in diagnosis.

The MAGNETOM Trio a Tim System may also be used for imaging during interventional procedures performed with MR compatible devices such as in room display and MR safe biopsy needles.

The MAGNETOM Trio a Tim System is a 3.0 T closed superconducting magnet whole body designed scanner. It consists of the same types of hardware that are currently available with the MAGNETOM Trio and Avanto systems.

This 510(k) summary does not contain information on specific acceptance criteria or a study designed to prove the device meets those criteria in the way a clinical study for an AI/ML device would. Instead, this submission focuses on demonstrating substantial equivalence to previously cleared predicate devices.

Here's a breakdown of the information that is available and what is missing based on your requested categories:

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

• Missing from the provided text. The document states "Performance Standards: None established under Section 514 the Food. Drug. and Cosmetic Act." This indicates that the device is not subject to specific quantitative performance standards set by the FDA for its category at the time of submission. The submission relies on "substantial equivalence" to predicate devices.

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

• Missing from the provided text. Since no specific performance study is detailed (beyond demonstrating conformity to NEMA and IEC standards for hardware safety and performance), there is no mention of a test set, its sample size, or its data provenance.

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)

• Missing from the provided text. No information provided as there is no specific performance study involving ground truth assessment detailed.

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

• Missing from the provided text. No information provided as there is no specific performance study detailed.

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 / Missing from the provided text. This device is a Magnetic Resonance Diagnostic Device (MRDD), primarily a hardware system for acquiring images, not an AI/ML-based diagnostic assistant. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this type of device and is not mentioned.

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

• Not applicable / Missing from the provided text. This is a hardware system, not a standalone algorithm.

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

• Missing from the provided text. Not applicable as no specific performance study requiring ground truth is detailed.

8. The sample size for the training set

• Missing from the provided text. Not applicable, as this is a hardware device, not an AI/ML system requiring a training set in the conventional sense.

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

• Missing from the provided text. Not applicable.

Summary of Device Acceptance and Study as Performed (Based on provided text):

The acceptance of the MAGNETOM Trio a Tim System for 510(k) clearance was primarily based on demonstrating substantial equivalence to existing, legally marketed predicate devices:

• Siemens MAGNETOM 1.5 T Avanto (K032428, October 16, 2003)
• Siemens MAGNETOM 3.0 T Trio (K013586, December 28, 2001)

The study supporting this claim of substantial equivalence involved demonstrating that the MAGNETOM Trio a Tim System's operation is substantially equivalent to the predicate devices and that it conforms to recognized industry standards:

• NEMA Standards: For the measurement of performance and safety parameters.
• IEC Standard: For safety issues with Magnetic Resonance Imaging Devices.

The submission argues that adherence to these standards and the similarity in hardware types ("consists of the same types of hardware that are currently available with the MAGNETOM Trio and Avanto systems") ensures the device's performance is safe and effective in comparison to the predicates.

Essentially, for this 510(k) clearance, the "acceptance criteria" were met by establishing that the new device operates similarly to and adheres to the same safety and performance benchmarks as its already-cleared predecessors, rather than by conducting a de novo clinical performance study with specific quantitative performance metrics.

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