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The MR system is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR 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 diagnosis determination.

The Transmit/Receive Coil is a radial type, multiple element resonator coil used to obtain diagnostic images of the body when used with the Altaire MR Imaging system.

The Altaire MR Imaging system is an imaging device, and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MRI system produces axial, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. Among the NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

The ALTAIRE is a Magnetic Resonance Imaging System that utilizes a 0.7 Tesla superconducting magnet in an open gantry design. The design was based on the AIRIS II Open MRI system. The ALTAIRE has been designed to enhance clinical utility by taking advantage of the imaging properties of the 0.7T magnet.

This 510(k) submission (K021751) describes a Magnetic Resonance Imaging (MRI) system (ALTAIRE) and an associated Transmit/Receive Coil. It is important to note that this document is for a new coil accessory for an existing MRI system, not a new AI-powered diagnostic device. Therefore, the questions related to AI device performance, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, and MRMC studies are not applicable to this submission.

The acceptance criteria and "study" described are focused on demonstrating substantial equivalence to a predicate MRI device, primarily regarding the safety and basic performance of the new coil.

Here's a breakdown of the requested information based on the provided text:

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

Since this is a submission for an MRI system and its coil, the "acceptance criteria" are related to its fundamental technical specifications and intended use, rather than a diagnostic performance metric like sensitivity/specificity for an AI algorithm. The core "performance" demonstrated is its ability to produce images and its substantial equivalence to a predicate device.

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

• Not Applicable. This submission does not describe a clinical study in the sense of a test set for diagnostic performance or AI algorithm validation. The "study" here is a technical comparison and declaration of substantial equivalence to an existing, legally marketed device. Therefore, no patient data test set or provenance is mentioned.

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)

• Not Applicable. See point 2. There is no test set or ground truth establishment in this context for diagnostic performance.

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

• Not Applicable. 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

• Not Applicable. This is not an AI device.

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

• Not Applicable. This is not an AI device.

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

• Not Applicable. As this is a submission for an MRI system and coil, the "ground truth" implicitly refers to the established safe and effective operation of the predicate device (Hitachi Altaire MRI System K002420) and the scientific principles of MRI, rather than a diagnostic ground truth for a specific condition.

8. The sample size for the training set

• Not Applicable. This is not an AI device, therefore, no training set is described.

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

• Not Applicable. See point 8.

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