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The DTU-215 Programmable Electrophysiology Stimulator with the EPStim Electrophysiology Stimulator Control Program is indicated for patients that are candidates for electrophysiology studies for the diagnosis, and the planning of treatment of supraventricular and other miscellaneous arrhythmias.

The EPstim is intended for assisting a physician in performing an electrophysiology study by providing automated control of the DTU-215 Programmable Stimulator. The system provides for compilation, storage and rapid execution of a customized series of stimulator outputs and provides for automated detection of capture during cardiac electrophysiological testing.

The DTU-215 Programmable Stimulator is intended for use in the electrophysiology laboratory setting under the direction of qualified personnel trained to administer electrophysiological procedures.

EPStim Software and Bloom DTU Electrophysiology Program Stimulator

I am sorry, but the provided text does not contain the detailed information needed to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for the EPStim Software and Bloom DTU Electrophysiology Program Stimulator.

While it states that the device is "substantially equivalent" to legally marketed predicate devices and outlines its "Indications for Use," it does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method.
5. Information on any Multi-Reader Multi-Case (MRMC) comparative effectiveness study or effect sizes.
6. Details about standalone algorithm performance.
7. The type of ground truth used (e.g., pathology, outcomes).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document primarily focuses on the regulatory clearance process and the intended use of the device, rather than the specifics of its performance validation testing.

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