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The Magnetom Trio Head Coil is a quadrature transmit receive coil used for obtaining diagnostic images of the head at the 3.0Tesla field strength in Magnetic Resonance Imaging. The indications for use are the same as for standard MR imaging. The Magnetom Trio Head Coil is designed for use with the Siemens Magnetom Trio 3.0Tesla MRI Scanner.

The Magnetom Trio Head Coil is designed to provide Magnetic Resonance Images of the brain, cervical spine, soft tissues and vasculature of the head, neck and upper chest. The Magnetom Trio Head Coil is designed for use with the Magnetom Trio 3.0Tesla scanner manufactured by Siemens Medical Systems.

The 3.0Tesla MRI system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal. (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images vield information that can be useful in the determination of a diagnosis.

The Magnetom Trio Head Coil is a 16 z-element quadrature transmit receive coil. The coil elements and associated circuitry are enclosed to prevent any exposure to patient or environment. The coil electronics are enclosed in a rigid former. The former is a split top design with latching device and a large open viewing window on the top. The coil design facilitates the scanning of patients with different head sizes and maximizes patient comfort and ease of use.

This document describes a 510(k) premarket notification for a medical device, specifically the Magnetom Trio Quadrature T/R Head Coil. This type of submission is for demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving efficacy through clinical trials with specific acceptance criteria and performance metrics traditionally associated with AI or advanced diagnostic devices.

Therefore, the requested information elements (acceptance criteria, specific study details like sample size for test sets, expert-established ground truth, MRMC studies, standalone performance, training set details) are not applicable to this document as it pertains to a traditional medical device (an MRI coil) and its submission for market clearance based on substantial equivalence.

Here's an explanation based on the provided text:

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

  • N/A. This document doesn't present a specific set of performance-based acceptance criteria for a diagnostic output in the way one might expect for an AI algorithm (e.g., sensitivity, specificity, AUC). The coil's "performance" is implicitly tied to its ability to produce diagnostic images that are equivalent to those produced by its predicate device. The acceptance criteria for a 510(k) of this nature relate to safety, efficacy, and intended use being substantially equivalent to a predicate device.

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

  • N/A. There is no "test set" in the context of clinical performance evaluation for this 510(k). The regulatory submission focuses on demonstrating the technical and functional equivalence of the new head coil to an existing, legally marketed head coil (the Allegra 3.0Tesla Tx/Rx Head Coil). This typically involves engineering tests, compatibility assessments with the MRI system, and potentially phantom imaging, rather than patient-level test sets.

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

  • N/A. See point 2. No clinical test set with ground truth established by experts is described or implied in this 510(k) summary.

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

  • N/A. See point 2.

• 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:

  • N/A. This is a hardware component (an MRI head coil), not an AI algorithm. Therefore, no MRMC study or AI assistance evaluation was conducted or is relevant here.

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

  • N/A. This is a hardware component.

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

  • N/A. No clinical ground truth is discussed in the context of this 510(k) submission. The "ground truth" for the submission itself is the predicate device and its established safety and effectiveness.

• 8. The sample size for the training set:

  • N/A. This device does not involve machine learning or a "training set."

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

  • N/A. This device does not involve machine learning or ground truth for a training set.

Summary of Safety and Effectiveness (as presented):

The document provides a "SUMMARY OF SAFETY AND EFFECTIVENESS K021330" which establishes substantial equivalence to a predicate device (Allegra 3.0Tesla Tx/Rx Head Coil, K002179).

The key aspects of safety and effectiveness are addressed by comparing the new device against the predicate. The document highlights the following similarities to the predicate device, implying these represent the "criteria" for substantial equivalence:

• Intended Use: Head Imaging including diffusion weighted imaging, angiography, functional MRI, CSI imaging, and 3D TOF imaging. (Identical to routine MRI imaging indications).
• Indications for Use: Identical to routine MRI imaging.
• Coil Enclosure Material: Polyurethane Plastic, Vinyl coated Foam.
• Coil Design: 16 z-element transmit receive Quadrature design.
• Decoupling: Actively switched PIN diodes during transmit and receive mode.
• Prevention of RF Burns: The coil's transmit/receive switch uses pin diodes to isolate the receive channel from the transmit channel; coil elements and circuitry are enclosed in a non-conductive housing.
• Radio Frequency Absorption: Power deposition during imaging is limited by the SAR algorithm.
• Formation of Resonance Loops: Active diodes and fast RF blowing fuses isolate the coil elements from RF fields; length of cable and stiffness does not permit looping.

The letter from the FDA confirms that "the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This is the ultimate "acceptance criterion" for a 510(k) submission. The study proving this is the 510(k) submission itself, which details the comparison to the predicate device across various parameters (design, materials, intended use, functionality, safety mechanisms).

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