Search Results

The intended use of the SmartTrOAE device is to measure otoacoustic emissions, which allow the operator to get information on cochlear function without requiring a subjective response from the person being tested with the device. It is intended to be used by trained personnel in a hospital, nursery, clinic, audiologist's office or other appropriate setting.

SmartTrOAE is an otoacoustic emissions testing device that is capable of measuring transient and spontaneous otoacoustic emissions produced by the inner ear.

This 510(k) summary does not contain the detailed information necessary to fully answer all aspects of your request. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing a comprehensive study protocol and results for the SmartTrOAE device independently.

However, I can extract the available information regarding acceptance criteria and device performance based on similarity to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in terms of specific thresholds for performance metrics. Instead, it demonstrates substantial equivalence by comparing the technological characteristics of the SmartTrOAE to the predicate device, ILO88 (K890124). The implicit acceptance criterion is that the SmartTrOAE's performance in these listed parameters is similar enough to the predicate to be considered substantially equivalent.

2. Sample size used for the test set and the data provenance:

This document does not report on a specific test set, its sample size, or data provenance (country of origin, retrospective/prospective). The substantial equivalence is based on comparing technical specifications and intended use with a predicate device. There is no mention of a clinical study with a test set for the SmartTrOAE's performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This document does not report on any ground truth establishment by experts for a test set.

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

This document does not report on an adjudication method for a test set.

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:

This document does not report on an MRMC comparative effectiveness study. The SmartTrOAE is an otoacoustic emissions testing device, which typically provides objective measurements (otoacoustic emissions) and does not involve "human readers" in the interpretation of complex images or data that an AI might assist with.

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

This document does not explicitly detail a standalone performance study. The device itself is an "otoacoustic emissions testing device," implying it takes objective measurements. The intended use "without requiring a subjective response from the person being tested" suggests a standalone measurement capability. However, detailed performance metrics from such a study are not provided. The comparison is solely based on technical specifications.

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

This document does not describe a type of ground truth used as it does not present a formal clinical study for the SmartTrOAE. The basis for equivalence is the similarity in technical characteristics and intended use to a legally marketed predicate device.

8. The sample size for the training set:

This document does not report on a training set sample size. This type of device (otoacoustic emissions) typically uses established physiological principles and signal processing, rather than machine learning models that require a "training set" in the conventional sense of AI/ML devices.

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

This document does not report on the establishment of ground truth for a training set.

Ask a specific question about this device