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The Echostar 1.5T and Echostar Spica 1.5 T MR Systems 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 fluid 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 device is intended for prescription use only.

The Echostar Spica 1.5T MR 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 Spica system reflect the spatial distribution fo 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. This device is intended for prescription use only.

The Echostar Spica 1.5 T MR System represents a modification to the previously cleared Echostar 1.5 T (K082100); 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, c-spine (neck) coil, shoulder coil, knee coil, small - 4 element torso coil, large - 12 element torso coil and wrist coil.

The provided 510(k) summary for the Alltech Echostar Spica 1.5 T MR System does not contain the detailed information requested regarding specific acceptance criteria for device performance and the study proving it meets these criteria in the context of diagnostic accuracy. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Alltech EchoStar 1.5 T) based on technological characteristics and safety.

Here's a breakdown of the available information in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table with explicit acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy for specific pathologies) nor does it report these metrics for the device. The "performance testing" described refers to engineering and safety verifications rather than clinical diagnostic outcome measures.

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

No information is provided regarding a specific "test set" for evaluating diagnostic accuracy. The performance testing mentioned involves "sample phantom and clinical images." The provenance of these clinical images (e.g., country of origin, retrospective/prospective) is not disclosed, and the sample size is not specified beyond "sample" images.

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

Since no diagnostic accuracy study using a specific test set is detailed, there's no information on the number or qualifications of experts used to establish a ground truth for such a set.

4. Adjudication Method:

Given the lack of a diagnostic accuracy study, there's no mention of an adjudication method (e.g., "2+1", "3+1") for establishing ground truth.

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

No MRMC study comparing human readers with and without AI assistance is mentioned. This device is an MRI system, not an AI-powered diagnostic tool, so such a study would not be applicable in this context.

6. Standalone (Algorithm Only) Performance:

This submission concerns an MRI system, not an AI algorithm. Therefore, "standalone (algorithm only)" performance is not evaluated or reported.

7. Type of Ground Truth Used:

For the performance testing that was conducted (NEMA standards, IEC 60601-2-33), the "ground truth" would relate to quantitative measurements from phantoms and qualitative assessment of image quality from clinical images, rather than a clinical diagnostic ground truth like pathology or outcomes data.

8. Sample Size for the Training Set:

This information is not applicable. The device is an MRI scanner, and the submission does not describe a machine learning algorithm with a training set.

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

This information is not applicable for the same reason as above.

Summary of Device Evaluation in the 510(k):

The 510(k) submission for the Echostar Spica 1.5 T MR System focuses on demonstrating substantial equivalence to a previously cleared predicate device (Alltech EchoStar 1.5 T, K082100). The changes introduced in the Spica system (additional RF coils, removal of amplifier option, optional respiratory gating, magnet manufacturer change, software/sequence updates) are presented as minor and not impacting the fundamental scientific technology, intended use, indications for use, design principles, performance effectiveness, or safety.

The "performance testing" described in the document primarily verifies that the modified device adheres to relevant engineering and safety standards (NEMA standards and IEC 60601-2-33), and that image quality (from "sample phantom and clinical images") remains comparable to the predicate device. This is a typical approach for demonstrating substantial equivalence for modifications to existing medical imaging hardware, where direct clinical diagnostic accuracy studies are often not required if the core technology and intended use remain unchanged.

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