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The Interacoustics Model AD229 Diagnostic Audiometer is indicated for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.

Because of its master hearing aid capability this device is also indicated for simulating a hearing aid during audiometric testing thus it may help in the selection and adjustment of a patient's hearing aid.

The Interacoustics Model AD229 Diagnostic Audiometer is an electroacoustic device that produces controlled levels of test tones and signals. The unit employs digital readouts and includes an external power supply that contains an isolation transformer. The tones and sound signals are directed to the patient by means of the following transducers: TDH39 Audiometric Headset (standard); EAR-Tone 3A Insert Phones (optional); and B71 Bone Conductor (standard). This device also has master hearing aid capability and utilizes either the TDH39 Headset or the Ear-Tone 3A Insert Phones for the acoustical outputs.

This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics for a novel AI/software device. Therefore, many of the requested details are not available in the provided text.

Here is the information that can be extracted or reasonably inferred from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The device is evaluated against recognized performance and safety standards, which serve as its "acceptance criteria" for basic functionality and safety. The reported device performance is its compliance with these standards.

2. Sample Size Used for the Test Set and the Data Provenance

This information is not provided in the 510(k) summary. The summary focuses on compliance with standards and comparison to a predicate device, not a clinical study on a specific test set of data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided. As this is a medical device (audiometer) and not an AI/software device requiring human interpretation of results, the concept of "ground truth" established by experts in the context of a test set for diagnostic accuracy does not directly apply here. The device itself generates the "result" (e.g., hearing thresholds).

4. Adjudication Method for the Test Set

This information is not provided. This concept is not relevant for the type of device and submission described.

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 information is not provided. An MRMC study is not applicable to an audiometer, which is a diagnostic tool used by a clinician to measure hearing, not an AI system that interprets images or data requiring human-in-the-loop assistance.

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

This information is not provided. The device is an electroacoustic device that measures hearing; it's not an "algorithm only" device in the context of typical AI/software. Its performance is inherent in its measurement capabilities, which are assessed against standards.

7. The Type of Ground Truth Used

The "ground truth" for an audiometer is its ability to accurately and reliably produce and measure sound levels and frequencies according to established audiological standards. Therefore, the "ground truth" would be established by compliance with scientific and engineering standards (IEC 645-1-1991 Type 2, ANSI 3.6-1996 Type 2), verified through calibration and performance testing.

8. The Sample Size for the Training Set

This information is not provided. Audiometers are not typically developed using "training sets" in the way AI/Machine Learning models are. Their design and calibration are based on physical principles and established audiological standards.

9. How the Ground Truth for the Training Set Was Established

This information is not provided and is not applicable for this type of medical device submission.

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