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The Interacoustics EP systems, EP15 and EP25, are intended to assist in the evaluation, documentation and the automatic recording of ABR waveforms makes it EP15/25 is a 2 channel ABR and the automatic recording of ABR waveforms makes it EF 15/2013 a 2 channon ADA and the manual programmability options well suited for waverom baood occorning and and and and specific threshold test to operating room applications and cochlear implant tests. operating foom applications and over over of the Auditory Brainstem Response The E. 1915 a bacil unk allowing of the ABR and earlier and later potentials. The Interacoustics TEOAE25 system is intended for determining Cochlear function using Transient Evoked Otoaccoustic Emission click stimuli. Both of these systems are of particular interest to Ear, Nose, and Throat doctors, Doll of these byotone are of paist and other health professionals concerned with measuring auditory functions.

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I'm sorry, but the provided text does not contain the detailed information necessary to fully answer your request regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for the Interacoustics Eclipse system.

The document is a 510(k) premarket notification letter from the FDA to Interacoustics AS, indicating that the device is substantially equivalent to legally marketed predicate devices. It lists the trade/device name, regulation numbers, and indications for use.

Specifically, it lacks the following information that would be needed to answer your questions:

• A table of acceptance criteria and reported device performance: The document confirms the FDA found the device "substantially equivalent" but does not detail specific performance metrics or acceptance criteria used in a study.
• Sample sizes used for the test set and data provenance: No information on test sets, sample sizes, or data origin (country, retrospective/prospective).
• Number of experts and their qualifications for ground truth: No mention of experts or their roles in establishing ground truth.
• Adjudication method for the test set: Not discussed.
• Multi-reader multi-case (MRMC) comparative effectiveness study: No indication that such a study was performed or any effect sizes.
• Standalone algorithm performance: The document describes the system's intended use in diagnosis and evaluation, implying human interaction, but doesn't detail standalone algorithm performance.
• Type of ground truth used: Not specified.
• Sample size for the training set: Not mentioned.
• How ground truth for the training set was established: Not mentioned.

The document primarily addresses the regulatory approval process (510(k) clearance) based on substantial equivalence to predicate devices, rather than a detailed clinical study report with specific performance metrics and study methodologies.

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TEOAE25 is an accessory to the EP15 or EP25 platform and provides the ability to test the cochlea functions of infants, children and adults in hospitals, nurseries, ENT clinics or audiology offices. It measures the amount of otoacoustic emission (OAE) present in the ear after a stimulus, and it allows a trained operator to get objective information about the cochlea function.

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The provided text is a 510(k) clearance letter from the FDA for a device called TEOAE25, an accessory to the EP15 or EP25 platform used to test cochlea functions.

While the document confirms that the device has been reviewed and found "substantially equivalent" to legally marketed predicate devices, it does not contain the specific information required to complete the table and answer the questions related to acceptance criteria and device performance studies.

The letter focuses on regulatory approval based on equivalence, not on a detailed breakdown of performance studies with acceptance criteria, sample sizes, expert qualifications, or ground truth methods. Therefore, I cannot extract the requested information from this document.

Ask a specific question about this device