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The intended use of the HearID+TE Transient-Evoked Otoacoustic Emissions Analyzer is to characterize inner-ear status and to assist in diagnosing inner-ear pathologies.

The HearID+TE system measures various acoustic properties of the inner ear, namely otoacoustic emission sound pressure level, signal-to-noise ratio, and reproducibility. These three properties may be measured within prescribed frequency bands or wideband. These measures allow for the evaluation of the functional condition of the inner ear, assuming a normal middle and outer ear. The HearID+TE system is suitable for all populations, including newborn infants. The HearID+TE system is to be used by trained personnel only.

HearID Transient-Evoked Otoacoustic Emission Analyzer (HearID+TE, T2001, and T2K)

This document is a 510(k) premarket notification for the "HearID+TE Transient-Evoked Otoacoustic Emissions Analyzer." It is a regulatory clearance letter and "Indications for Use" statement, not a study report detailing acceptance criteria and performance. Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred or stated from the provided text:

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

• Cannot be provided from the given text. This document does not contain acceptance criteria for device performance nor reported performance metrics. It primarily addresses the regulatory clearance of the device based on substantial equivalence.

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

• Cannot be provided from the given text. The document does not describe any specific test set, sample sizes, or data provenance from a study.

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)

• Cannot be provided from the given text. The document does not describe any test set or ground truth establishment process involving experts.

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

• Cannot be provided from the given text. The document does not describe any test set or adjudication method.

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

• Cannot be provided from the given text. The device described (an otoacoustic emission analyzer) is a diagnostic tool, not an AI-assisted reading system for humans. The document does not describe any MRMC study or AI assistance.

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

• The device itself is a standalone diagnostic tool. The "Indications for Use" states it "measures various acoustic properties of the inner ear" and is "to be used by trained personnel only." This implies it provides measurements and results directly, rather than assisting a human in interpreting other data. However, the document does not detail a specific "standalone performance study" in terms of methodology or results.

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

• Cannot be provided from the given text. The document does not describe how ground truth was established for any performance evaluation. The device is intended to "characterize inner-ear status and to assist in diagnosing inner-ear pathologies" based on its measurements, implying its output is directly related to the condition being assessed, rather than being compared to an external ground truth in this document.

8. The sample size for the training set

• Cannot be provided from the given text. The document does not describe a training set or a machine learning/AI model.

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

• Cannot be provided from the given text. As above, no training set or ground truth establishment is described.

Summary: The provided text is a regulatory clearance letter, specifically a 510(k) premarket notification decision. It affirms that the device is "substantially equivalent" to legally marketed predicate devices. It discusses the device's intended use and regulatory classifications but does not contain the detailed technical study data, acceptance criteria, or performance results typically found in a clinical study report or a more comprehensive technical submission.

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