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The Interacoustics DPOAE20 system is for use in the audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emission tone stimuli.

The presence of Otoacoustic emissions suggests normal outer hair cell function within cochlea, which in turn suggests normal hearing. OAEs are recorded using an OAE orobe which is placed in the ear canal. The OAE response from the ear is recorded and orocessed by the Eclipse and the DPOAE20 software and then displayed on the computer screen for evaluation.

This is of particular interest to Ear, Nose, and Throat doctors, Neurology specialists, Audiologist and other health professionals concerned with measuring auditory functions.

The patient group includes all ages and sexes.

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This document describes a 510(k) premarket notification for the DPOAE20, Eclipse audiometer system. The information provided is very limited in terms of what is typically included in a study proving device performance against acceptance criteria. There is no specific study described in the provided text that outlines acceptance criteria and corresponding device performance metrics.

However, based on the nature of a 510(k) submission, we can infer some general aspects and note the absence of detailed information for most of your requested points.

Here's an analysis based on the provided text, highlighting what is not available and what can be inferred:

1. A table of acceptance criteria and the reported device performance

• Not Available: The document does not provide a table of acceptance criteria or reported device performance metrics. For an audiometer, typical performance criteria might include accuracy of stimulus presentation (frequency, intensity), sensitivity, specificity, and reliability of OAE detection.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not Available: No information regarding the sample size used for any test set or the provenance of data (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 (e.g., radiologist with 10 years of experience)

• Not Available: The document does not mention any expert review process or ground truth establishment for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Available: No adjudication method is mentioned.

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/Not Available: This device is an audiometer for DPOAE (Distortion Product Otoacoustic Emission) measurements. It is a diagnostic tool, not an AI-assisted interpretation device that would involve "human readers" in the context of improving interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this type of device.

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

• Inferred (Standalone Functionality): The DPOAE20 system is described as a device that "records and processes" the OAE response and "then displayed on the computer screen for evaluation." This implies that the device itself performs the measurement and initial processing stand-alone to generate the OAE data. While human interpretation ("evaluation") is required, the core function of generating the OAE response is standalone. No specific "standalone performance study" details are provided, but the device's function is inherently standalone in its data acquisition and processing steps.

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

• Not Available/Implied Clinical Standard: For an audiometer like this, the "ground truth" for its performance would typically be established by comparing its measurements to established clinical standards for DPOAE acquisition and potentially against other validated audiometric tests or objective measures of hearing function. No specific ground truth method is detailed in this document.

8. The sample size for the training set

• Not Available: No information about a training set or its sample size is provided. This type of device (an audiometer) typically relies on engineering validation and calibration against known acoustic standards rather than machine learning training sets.

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

• Not Available/Applicable: As there's no mention of a training set, there's no information on how its ground truth would be established.

Summary:

This 510(k) submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, as opposed to providing a detailed clinical study report with acceptance criteria and performance data against those criteria. The provided text primarily establishes the device's identity, its indications for use, and the regulatory decision for market clearance. It does not contain the specific study details you've requested. For such information, one would typically need to review the full 510(k) submission or associated clinical validation reports if they were part of the submission.

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