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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, 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 Fukuda Denshi ECG Monitor Model DS-3130/3140 is being added to increase the clinical utility of the AIRIS and STRATIS in the stationary configuration. The new ECG Monitor is UL-listed, and is being added to meet UL/ETL listing requirements for the AIRIS and STRATIS. The Model DS-3140 ECG Monitor has a stripchart recorder, the Model DS-3130 does not. As with the previous version of the ECG Monitor, the Model DS-3130/3140 supports ECG, peripheral pulse and respiratory gating; respiratory gating is not supported on the AIRIS. The Fukuda Denshi ECG Monitor Model DS-3130/3140 is only intended for distribution in the US as an accessory to the Hitachi MRI systems.

This document describes a 510(k) submission for an ECG Monitor (Model DS-3130/3140) to be added as an accessory to existing Hitachi MRI systems (AIRIS and STRATIS). The submission essentially states that the new ECG Monitor is "Identical to the Predicate Device" (Hitachi AIRIS with ECG Monitor and Hitachi STRATIS with ECG Monitor).

Therefore, the acceptance criteria and study information provided in this document are minimal, as the submission relies on the substantial equivalence of the new accessory to previously cleared devices.

Here's an analysis of the provided text in relation to your request:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific acceptance criteria or performance metrics for the ECG monitor itself beyond it being "UL-listed" and meeting "UL/ETL listing requirements." The core of the submission is that the device's technological characteristics are "Identical to the Predicate Device."

Table of Acceptance Criteria and Reported Device Performance:

Where the document falls short on providing the requested information:

1. Sample size used for the test set and the data provenance: Not mentioned. Since the device is considered "identical," it's likely no new clinical testing data was deemed necessary for this specific 510(k) submission.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
3. Adjudication method for the test set: Not mentioned.
4. 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 relevant. This is an ECG monitor accessory for an MRI, not an AI-powered diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant. This is a monitoring device, not a standalone AI algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
7. The sample size for the training set: Not relevant. This is not an AI/machine learning model.
8. How the ground truth for the training set was established: Not relevant. This is not an AI/machine learning model.

In summary, this 510(k) submission is for an accessory (ECG Monitor) which is claimed to be technologically identical to devices already on the market. Therefore, it focuses on demonstrating safety (UL-listing) and functional equivalence rather than presenting new clinical study data with specific performance metrics or ground truth validation as would be expected for a novel diagnostic device or AI algorithm.

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