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The Echostar Comfort 1.5T MRI System is a whole-body magnetic resonance imaging (MRI) system intended for general diagnostic use. Transverse, sagittal, coronal and oblique planes may be imaged. MRI images produced by the Echostar Comfort system reflect the spatial distribution for the density of hydrogen nuclei (protons) spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images yield information that can be useful in the determining of a diagnosis.

The Echostar Comfort 1.5T MRI System and Echostar Spica 1.5T MR system are indicated for use as a whole body magnetic resonance diagnostic device (MRDD) that uses transverse, sagittal, coronal and oblique planes to image internal structures or functions of the body including head and extremities. MRI images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluids are hydrogen density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow dynamics. These images, when interpreted by a trained physician, yield information that can be useful in diagnosis.

The Echostar Comfort 1.5T MRI System represents a modification to the previously cleared Echostar Spica 1.5T MR system (K113511); both utilize a superconducting magnet, gradients, RF transmission, various sequences and reconstruction algorithms to acquire 2D single slice, multi-slice and 3D volume images. The data acquisition system supports multiple coil elements including a body coil, head coil, spine coil, cspine (neck) coil, shoulder coil, knee coil, small-4 element torso coil, large-12 element torso coil, wrist coil, medium-8 element torso coil, small flex coil and large flex coil.

This document describes the Echostar Comfort 1.5T MRI System, which is a modification of a previously cleared device (Echostar Spica 1.5T MR system). The submission focuses on demonstrating substantial equivalence to the predicate device rather than presenting a de novo performance study with specific acceptance criteria directly related to clinical diagnostic accuracy.

Therefore, much of the requested information regarding clinical study design, sample sizes, expert adjudication, MRMC studies, and standalone performance for diagnostic tasks is not explicitly available within this 510(k) summary. The summary focuses on engineering and regulatory compliance, ensuring the modified device maintains the same safety and effectiveness as its predicate.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity for a specific condition) for the Echostar Comfort 1.5T MRI System. Instead, the acceptance criteria are based on technical and safety standards compliance and equivalence to the predicate device.

• AAMI ANSI ES 60601-1:2005/(R)2012
• IEC 60601-1-2:2007
• IEC 60601-2-33:2010
• NEMA MS-1 2008
• NEMA MS-2 2008
• NEMA MS-3 2008
• NEMA MS-4 2010
• NEMA MS-5 2010
• NEMA MS-6 2008
• NEMA MS-8 2008 |
  | Image Quality & Functionality | Sample phantom and clinical images, and test reports were presented to demonstrate conformance with standards and equivalent performance with the predicate device. The system can acquire 2D single slice, multi-slice and 3D volume images, and images reflect spatial distribution for hydrogen nuclei density, T1, T2, and flow. |
  | Safety | Nonclinical testing for safety was conducted. No new or additional safety concerns have been raised compared to the predicate device. |
  | RF Coils & System Components | Modifications include:
• Additional RF coils.
• Magnet modifications for a 70+ cm clear bore opening.
• RF transmit components specified for required RF transmit performance.
• Gradient subsystem specified for higher gradient strength and slew rate.
  These modifications are designed to maintain or improve performance while ensuring equivalence. |
  | Software Sequences & Applications | Includes the same software sequences and applications, modified for scan performance improvements. |

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

The document states: "Sample phantom and clinical images, and test reports are presented for the changes, demonstrating conformance with the standard and equivalent performance with the predicate device."

• Sample Size for Test Set: Not specified quantitatively. It mentions "sample phantom and clinical images," implying a limited set used for technical verification rather than a large-scale clinical trial to establish diagnostic accuracy against a ground truth.
• Data Provenance: Not explicitly stated (e.g., country of origin). It mentions "clinical images," suggesting real patient data, but whether it was retrospective or prospective is not detailed. Given the context of a 510(k) for a modified device, it's likely images were collected to demonstrate equivalence, possibly from a mix of retrospective and prospective technical validation scans.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided. The assessment appears to be primarily technical validation (phantom images, engineering tests) and a comparison of image characteristics to the predicate device, rather than a clinical study requiring expert diagnosis against a clinical ground truth for the new device. The Indications for Use state, "When interpreted by a trained physician, these images yield information that can be useful in the determining of a diagnosis," implying that the interpretation relies on existing medical expertise once the image quality is deemed acceptable.

4. Adjudication Method for the Test Set

Since a formal clinical study with a diagnostic ground truth is not detailed, an adjudication method is not applicable or described in this summary. The assessment focuses on meeting technical standards and demonstrating image quality equivalence.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done or described. This submission is for an MRI system, not an AI-powered diagnostic algorithm alongside human interpretation.

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

No, a standalone performance study for an algorithm was not done or described. This device is an MRI hardware and basic software system, not an AI or standalone diagnostic algorithm.

7. The Type of Ground Truth Used

For the technical performance aspects, the "ground truth" would be established through:

• Physical Phantoms: Known physical properties and structures within phantoms are used to assess image quality metrics (signal-to-noise ratio, spatial resolution, contrast, uniformity, etc.) according to NEMA standards.
• Predicate Device Performance: The primary "ground truth" for the new device's performance is its substantial equivalence to the performance of the legally marketed predicate device (Echostar Spica 1.5T MR system), which itself would have demonstrated diagnostic capability in general use.
• Clinical Image Evaluation: As mentioned, "clinical images" were presented, which would implicitly be evaluated by qualified personnel for acceptable diagnostic quality, even if not against a specific pathological ground truth within this particular submission.

8. The Sample Size for the Training Set

Not applicable/Not mentioned. This document describes an MRI hardware system, not a device that relies on a trained algorithm or AI model. Therefore, there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set was Established

Not applicable/Not mentioned. As there is no training set for an AI model, this question does not apply to this submission.

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