(95 days)
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.
§ 874.1050 Audiometer.
(a)
Identification. An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.(b)
Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.