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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 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-lattice 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.

The AIRIS Operating System Software is revised to Version 3.7 to increase the clinical utility of the AIRIS in the stationary configuration. The MRP-7000 Operating System Software is revised to Version 3.7 to increase the clinical utility of the MRP-7000 in both stationary and mobile configurations.

Version 3.7 Operating System revisions include the addition of Dynamic Scan measurement and analysis, MTC (magnetization transfer contrast) and SSP (sloped slab profile) for 3D TOF MRA, additional 2D TOF, 2D, and 3D SARGE sequences (steadystate acquisition with gradient rephasing), increased SE and FSE Flip Angle range to 60° - 120°, addition of Fast IR and High Resolution / High Definition Fast IR image acquisition software, addition of High Resolution / High Definition FSE, three additional adaptive filter image post-processing techniques, and Receiver Coil sensitivity correction image post-processing.

Here's an analysis of the provided text, focusing on the acceptance criteria and study information:

The provided 510(k) summary for the Hitachi Medical Systems America Version 3.7 Operating System Software does not contain the information requested in your prompt regarding acceptance criteria and performance study details.

This 510(k) submission is primarily about software updates to an existing Magnetic Resonance (MR) imaging system, not a new diagnostic device that would require extensive clinical performance studies with specific statistical acceptance criteria for diagnostic accuracy.

Here's why the information is missing and what the document does describe:

• Focus: The document describes revisions to existing operating system software (Version 3.7) to "increase the clinical utility" of the AIRIS and MRP-7000 MR systems. These revisions include adding new imaging sequences, post-processing techniques, and expanding existing functionalities.
• Predicate Device: The document explicitly states the "DEVICE TECHNOLOGICAL CHARACTERISTICS: 5.0 Identical to the Predicate Device." This is a key aspect of 510(k) submissions, where substantial equivalence to a legally marketed device is demonstrated. For software updates to an existing MR system that primarily enhance imaging capabilities rather than introduce new diagnostic claims, a direct comparison to a predicate device's performance in terms of clinical accuracy might not be required in the same way as for a novel diagnostic algorithm.
• "Acceptance Criteria" and "Study": When a new diagnostic device or algorithm is submitted, it typically has specific performance metrics (e.g., sensitivity, specificity, AUC) and predefined acceptance criteria (e.g., "sensitivity must be at least X% with a 95% confidence interval") that are then validated through a clinical study. The provided document does not mention any such acceptance criteria or a study designed to prove new diagnostic performance targets.
• "Device Performance": The document lists features and capabilities (e.g., "Dynamic Scan measurement and analysis," "MTC (magnetization transfer contrast)," "additional 2D TOF, 2D, and 3D SARGE sequences"). These are descriptions of technical capabilities and imaging modalities, not measured diagnostic performance metrics like accuracy or error rates.

Therefore, I cannot populate the table or answer most of your questions based on the provided text.

Here's what I can extract, noting the absence of most requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Not explicitly stated. The document describes software updates and enhanced imaging capabilities, implying that the demonstration of these capabilities would likely involve internal testing and possibly images acquired for technical validation rather than a clinical "test set" for diagnostic performance. No information on data provenance (country, retrospective/prospective) is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not stated. No clinical study for diagnostic performance is described, so no ground truth establishment by experts is mentioned.

4. Adjudication method for the test set:

• Not applicable/Not stated. No clinical study is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. The device is an MR system's operating software, not an AI diagnostic algorithm. No MRMC study is mentioned.

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

• Not applicable. This submission is for MRI operating software providing imaging capabilities, not a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable/Not stated. No clinical study for diagnostic performance requiring ground truth is described.

8. The sample size for the training set:

• Not applicable/Not stated. The document describes software development and enhancement for an MR imaging system. There's no mention of a "training set" in the context of an AI/ML algorithm requiring such data.

9. How the ground truth for the training set was established:

• Not applicable/Not stated. As no training set is mentioned, no ground truth establishment process is described.

In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence and describing technical enhancements to an existing MR imaging system's operating software. It does not contain the kind of detailed clinical study performance data (acceptance criteria, test sets, ground truth, expert review, etc.) that would be expected for a novel diagnostic device or AI algorithm with specific diagnostic claims.

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