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Imaging of:

• . The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, neck, TMJ, heart, blood vessels). [Application terms include MRCP (MR Cholangiopancreatography), MR Cisternography, MR Myelography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan, Cine Imaging and Cardiac tagging.] { K002531 }
• Fluid Visualization { K002531 } ●
• . 2D / 3D Imaging { K002531}
• . MR Angiography / MR Vascular Imaging {K002531}
• Blood Oxygenation Level Dependent (BOLD) imaging { K002531} ●
• Perfusion / Diffusion Imaging {K993803, K002531}
• . Proton Spectroscopy { K010129}

The EXCELART™ with Pianissimo XG/AG SPIN Edition system has the following features compared to the current EXCELART™ with Pianissimo XG/AG system.

• Extension of a receiving system is enabled a maximum of 8 ch. .
• Use of QD Torso SPEEDER corresponding to Parallel imaging which can shorten scan time is . enabled.
• The computer only for reconstruction was carried for high-speed image processing. .
• . dB/dt enabled use by 1st operating mode specified in IEC 60601-2-33 by the TrueSSFP sequence.
• Max. field strength is changed 25mT/m to 30mT/m. .
• . The marginal performance (Min.TR/Min.TE / Min.Slice thickness / Imaging area) of a sequence has been improved.
• The user interface of software was changed for the improvement of operativity. '
• . Gating unit was redesigned to improve the making triggers for sequence.

The provided text is a 510(k) summary of safety and effectiveness for a Magnetic Resonance Diagnostic Device Accessory. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

Crucially, this document does not contain an independent study with acceptance criteria and a detailed analysis of device performance against those criteria in the way a clinical trial or performance study would typically be structured for a new device claiming improved diagnostic accuracy.

Instead, the submission aims to demonstrate substantial equivalence by showing that the new device (EXCELART™ with Pianissimo XG/AG SPIN Edition) has comparable safety and imaging performance parameters to its predicate device (current EXCELART™ with Pianissimo XG/AG, cleared under K002531), while highlighting specific hardware and software changes.

Therefore, the requested information elements related to acceptance criteria, a specific study proving it, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not explicitly present in this type of submission.

However, I can extract and present the available information in a structure that addresses your points where possible, along with explaining why other points cannot be answered from this document.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

This 510(k) submission does not present a standalone study with defined acceptance criteria for diagnostic performance of the device against a gold standard in the typical sense of a clinical trial for a new diagnostic claim.

Instead, the device seeks substantial equivalence to a predicate device (EXCELART™ with Pianissimo XG/AG, K002531). The "acceptance criteria" can be inferred as maintaining similar or improved safety and imaging performance characteristics as the predicate device, especially regarding the new features. The study, implicitly, is the comparison of technical specifications and performance against the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

As explicit acceptance criteria with specific thresholds for performance metrics (like sensitivity, specificity, accuracy) are not provided in a 510(k) summary focused on substantial equivalence based on technical changes, I will present the key safety parameters where changes or comparisons were made. The "reported device performance" in this context refers to the parameters of the new device relative to the predicate.

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