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The ECHELON C MRI 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-latticë 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.

ECHELON C Magnetic Resonance Imaging System that utilizes a 1.5 Tesla superconductive short bore gantry design. The design was based on the ECHELON MRI system.

The provided document (K083533) is a 510(k) premarket notification for an MRI system, not a study evaluating software or AI performance against specific acceptance criteria for diagnostic accuracy. The document is primarily focused on demonstrating substantial equivalence to a predicate device based on identical technological characteristics and intended use. Therefore, much of the requested information regarding acceptance criteria and performance studies is not present or applicable.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not available in the provided document. The 510(k) for an MRI system typically assesses technical specifications (e.g., field strength, image resolution, signal-to-noise ratio) and safety, rather than diagnostic accuracy against defined clinical acceptance criteria like sensitivity/specificity for a specific condition. The document states "The technological characteristics of this device are identical to the primary predicate device," implying performance is expected to be equivalent to the predicate.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable. This 510(k) filing does not describe a clinical performance study with a "test set" of patient data in the typical sense of evaluating diagnostic accuracy of an AI or software device. It is a submission for a physical imaging device.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. As no clinical performance study for diagnostic accuracy is detailed, there's no mention of experts establishing ground truth for a test set. The document indicates that images produced by the MR system, when interpreted by a trained physician, provide information useful for diagnosis.

4. Adjudication Method for the Test Set:

Not applicable for the reasons stated above.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is not a software or AI device being evaluated for its impact on human reader performance. It is an MRI hardware system.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. The device is an MRI hardware system, not an algorithm. Its performance is inherent in its ability to produce images, which are then interpreted by a human.

7. Type of Ground Truth Used:

Not applicable. There is no mention of a ground truth in the context of diagnostic accuracy for this submission. The device produces images, and the "ground truth" for the intended use is that these images, when interpreted by a trained physician, provide information useful for diagnosis.

8. Sample Size for the Training Set:

Not applicable. The ECHELON C MRI System is a hardware device; it does not involve a "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established:

Not applicable for the reasons stated above.

Summary of the K083533 Document:

This 510(k) submission (K083533) for the ECHELON C Magnetic Resonance Imaging System outlines:

• Device Name: ECHELON C Magnetic Resonance Imaging System
• Intended Use: To provide physiological and clinical information via non-invasive, non-ionizing imaging of the head, body, or extremities. Images reflect spatial distribution of protons, useful for diagnosis when interpreted by a trained physician.
• Device Description: 1.5 Tesla superconductive short bore gantry, based on the ECHELON MRI system.
• Technological Characteristics: Stated to be identical to the primary predicate device (ECHELON Magnetic Resonance Imaging System, K052172). This is the core of its substantial equivalence argument.
• Regulatory Conclusion: FDA determined the device is substantially equivalent to the predicate device.

The document does not contain any information related to clinical performance studies, diagnostic accuracy, or AI evaluation because it is a filing seeking clearance for a new MRI hardware system based on its equivalence to an already cleared hardware system.

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