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The "MAGNETOM Symphony a Tim System" is indicated 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 Symphony 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.

Device Deseripati designed scanner. It consists of the same types of hardware that are currently available with the MAGNETOM Avanto and Symphony systems.

The provided text is a 510(k) summary for the MAGNETOM Symphony a Tim System. It focuses on establishing substantial equivalence to previously cleared devices rather than presenting a performance study with detailed acceptance criteria and reported device performance.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance: The document does not define specific performance metrics or acceptance criteria for a new study, but rather refers to conformance with existing standards.
• Sample sizes used for the test set and the data provenance: No new test set is described as a performance study was not conducted.
• Number of experts used to establish the ground truth for the test set and their qualifications: No new ground truth establishment is described.
• Adjudication method: Not applicable as no new test set was used.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable as no such study is mentioned.
• If a standalone performance study was done: Not applicable as a standalone study to prove performance was not done, rather substantial equivalence was claimed.
• The type of ground truth used: Not applicable as no new ground truth was established for a performance study.
• The sample size for the training set: Not applicable as this is not an AI/ML device that requires a training set.
• How the ground truth for the training set was established: Not applicable.

Instead, the submission relies on the concept of substantial equivalence to predicate devices. Here's what can be extracted regarding the device's "performance" and the "study" that proves it:

Acceptance Criteria and Reported Device Performance (based on Substantial Equivalence):

The "study" in this context is the comparison against predicate devices and adherence to established standards.

Summary of the "Study" Proving Acceptance Criteria:

The "study" described in the 510(k) summary is not a traditional clinical trial or performance evaluation of the new device's capabilities against specific quantitative metrics. Instead, it's a demonstration of substantial equivalence to previously cleared devices.

1. Sample size used for the test set and the data provenance: Not applicable. No new test set of patient data was used for a performance study. The "test" is the comparison of the new device's design, hardware types, and intended use against the predicate devices.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth was established by experts for a new test set.
3. Adjudication method: Not applicable.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done. The submission relies on substantial equivalence.
5. If a standalone performance (i.e. algorithm only without human-in-the loop performance) was done: No, a standalone performance study was not done.
6. The type of ground truth used: Not applicable. The "ground truth" for this submission is the prior FDA clearance and established safety and effectiveness of the predicate devices (Siemens MAGNETOM 1.5 T Avanto and Siemens MAGNETOM 1.5 T Symphony) and their compliance with NEMA and IEC standards.
7. The sample size for the training set: Not applicable. This is a medical imaging system, not an AI/ML algorithm that requires a training set.
8. How the ground truth for the training set was established: Not applicable.

In essence, the "proof" that the MAGNETOM Symphony a Tim System meets its (implied) acceptance criteria is its demonstration of not introducing new questions of safety and effectiveness compared to predicate devices and its conformance to recognized industry standards. The FDA's review and subsequent clearance (K050199) affirmed this substantial equivalence.

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