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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 OASIS Specialty Coils are receive-only devices that detects the MR signal used to produce transverse, coronal, sagittal, oblique, and/or curved crosssectional images that display the internal structure of the images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

The indications for use for the OASIS Specialty Coils are as follows:

• The MR-IBC-120, OASIS RAPID Breast Coil is a recieve-only multiple array . device used for MRI imaging of the breast.
• The MR-NVC-120, OASIS NV Coil is a recieve-only multiple array device used . for MRI imaging of the head and neck.

The MR-IBC-120, OASIS RAPID Breast Coil is a recieve-only multiple array device used for obtaining diagnostic images of the breast with the OASIS MRI System. The MR-NVC-120, OASIS NV Coil is a recieve-only multiple array device used for obtaining diagnostic images of the head and neck with the OASIS MRI System.

The provided 510(k) summary (K080062) for the Hitachi Medical Systems America, Inc. OASIS RAPID Breast Coil and OASIS RAPID NV Coil does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

This document is a premarket notification for a Class II medical device, essentially asserting its substantial equivalence to previously cleared predicate devices. The focus of this type of submission is on demonstrating that the new device has "technological characteristics similar to the predicate devices" and is "substantially equivalent" in terms of its intended use, function, and scientific concepts. It is not a clinical performance study demonstrating the device meets specific acceptance criteria for diagnostic accuracy or other performance metrics.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Details on sample size, data provenance, number or qualifications of experts, or adjudication methods for any test set.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or human reader improvement with AI assistance. (This device is a receive-only coil, not an AI-powered diagnostic tool, so this would not be applicable).
• Details regarding standalone algorithm performance studies.
• Information on the type of ground truth used.
• Sample size for training sets or how ground truth for training sets was established. (Again, this is a hardware component, not a trainable algorithm).

The document is purely a regulatory submission focused on demonstrating substantial equivalence for an MRI coil, which is a hardware component of an MRI system, not a software algorithm that would typically undergo the types of performance validation studies you're asking about.

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