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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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The MAGNETOM Systems with the syngo MR 2002B are indicated for use as magnetic resonance diagnostic devices (MRDD's) that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that display 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 syngo MR 2002B (Numaris 4 VA21A) software upgrade will be available for the following MAGNETOM Family systems:

• The MAGNETOM 1.0 Tesla Harmony system
• The MAGNETOM 1.5 Tesla Symphony system
• The MAGNETOM 1.5 Tesla Sonata system
• The MAGNETOM 0.2 Tesla Concerto system
• The MAGNETOM 3.0 Tesla Allegra system
• The MAGNETOM 3.0 Tesla Trio system
  This includes Siemens upgrades of currently used MAGNETOM Impact/Expert, Vision, and Open (Viva) systems to systems described above. Siemens Medical Solutions is adding an upgrade in software and hardware to the currently available MAGNETOM Systems. The MRI systems are exactly the same as what was described and cleared in the predicate premarket notifications.

The provided text is a 510(k) Summary for the Siemens syngo MR 2002B software upgrade for MAGNETOM MRI systems. It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study proving a new device meets specific performance acceptance criteria.

Therefore, much of the requested information regarding acceptance criteria, specific device performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not present in this document. The document describes a software upgrade and asserts that the safety and performance parameters are not significantly changed from the predicate devices.

However, I can extract and infer some contextual information based on the document's content:

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

The document does not specify quantitative acceptance criteria for new performance metrics or report specific performance values for the syngo MR 2002B. Instead, it states that the performance parameters of the device are not significantly changed compared to its predicate devices, implying that they meet the same implicit standards. The listed performance parameters examined are:

For safety parameters (Maximum Static Field, Rate of Change of Magnetic Field, RF Power Deposition, Acoustic Noise Level), the document states they "remain below the level of concern."

2. Sample size used for the test set and the data provenance

The document does not explicitly mention a specific "test set" or its sample size. It states that "Laboratory testing were performed to support this claim of substantial equivalence," but provides no details on the data used for these tests. Data provenance (country of origin, retrospective/prospective) is also not specified.

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

The document does not describe the use of experts to establish ground truth for any specific test set. The nature of this submission (software upgrade for a diagnostic imaging device) suggests that the "ground truth" for evaluating image quality and safety would be established through technical specifications and physical measurements, and interpreted by qualified engineers and radiologists, but no details are provided.

4. Adjudication method for the test set

Not applicable, as no specific test set or adjudication process is described for establishing ground truth from experts.

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 MRMC study is mentioned. This document pertains to an MRI system software upgrade, not an AI-assisted diagnostic tool.

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

This document describes a diagnostic imaging device and its software upgrade, not an algorithm meant for standalone diagnostic performance. The device is intended to produce images and/or spectra "when interpreted by a trained physician yield information that may assist in diagnosis." Therefore, a standalone algorithm performance evaluation would not be applicable in this context.

7. The type of ground truth used

The ground truth implicitly used for validating the performance and safety of the MRI system would be based on physical phantom measurements and technical specifications compared against established engineering standards and regulatory limits for MRI devices. This is inferred from the listed "Performance" and "Safety" parameters that were evaluated, which are standard metrics for MRI scanner performance.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that would require a "training set" in the conventional sense. The "training" for the device's development would involve engineering and software development processes, not data-driven machine learning.

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

Not applicable, as there is no mention of a training set for an AI/ML model.

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