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The Tinnitus Rx consists of a personalized sound recorded onto a compact disc (CD) that can be played on commercially available players and listened to through commercially available headphones. The recorded sound is equivalent to that generated by a qualified hearing healthcare professional who has followed the treatment regimen utilized in the clinical study (provided in the 210(k)). The device is indicated for adult (18 years and over) tinnitus sufferers who may or may not suffer higher frequencies hearing loss and are participating in a tinnitus management program.

The Tianitus Rx is for home use under the direction of an appropriately qualified healthcare professional.

Patients should receive a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear) to rule out medically or surgically treatable diseases for which timitus is a symptom before proceeding with non-medical tinnitus management.

The Tinnitus Rx is intendod for the temporary relief of timnitus symptoms.

The Tinnitus Rx consists of a personalized sound recorded onto a compact disc (CD) that can be played on any commercially available player and listened to through commercially available headphones or speakers.

This document outlines the acceptance criteria and supporting study for the Tinnitus Rx device, a personalized sound recording on a compact disc designed for temporary tinnitus relief.

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of quantitative acceptance criteria for the Tinnitus Rx device. Instead, the basis for substantial equivalence is primarily established by comparing its characteristics and intended use to legally marketed predicate devices (TTCGHI-T, TTCTM-3, and TinniTech ANMP) and by demonstrating its ability to relieve tinnitus through a clinical study.

The core performance claim is the temporary relief of tinnitus symptoms. The device achieves this by providing a personalized sound matching the pitch of the patient's tinnitus, derived through a "scientifically studied clinical protocol."

The comparison table provided in the submission highlights the following aspects related to performance and safety, which can be interpreted as implicit acceptance criteria:

Note on Quantitative Data: The 510(k) summary does not include specific quantitative performance metrics (e.g., percentage of patients experiencing relief, average reduction in tinnitus distress scores, etc.) or pre-defined thresholds for these metrics. The approval is based on "substantial equivalence" and the demonstration of the intended effect through the clinical study.

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

The document explicitly states that "a clinical study showing that the device relieves tinnitus was included in the submission" (referring to the 210(k) instead of 510k). However, the specific sample size used for this clinical study (test set) is not provided in the given excerpt.

Similarly, the data provenance (e.g., country of origin, retrospective or prospective nature) of the clinical study is not mentioned in the provided text.

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

The document mentions that the recorded sound is "equivalent to that generated by a qualified hearing healthcare professional who has followed the treatment regimen utilized in the clinical study." It also states the device is for "home use under the direction of an appropriately qualified healthcare professional."

However, the number of experts used to establish the ground truth for the test set and their specific qualifications (e.g., audiologist with X years of experience, ENT physician) are not specified in the provided information. The "ground truth" here would likely refer to the patient's personalized tinnitus pitch and the effectiveness of the treatment as assessed by professionals.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test set. The clinical study is mentioned as having a "scientifically studied clinical protocol," but the details of how outcomes were assessed or adjudicated are not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The study described focuses on demonstrating the device's ability to relieve tinnitus symptoms, likely in comparison to baseline or an internal control within the study protocol, rather than comparing human readers' performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The Tinnitus Rx device is a a personalized sound recording, not an AI algorithm in the contemporary sense. Its operation involves a "qualified hearing healthcare professional" determining the personalized sound based on a "clinical protocol." Therefore, a "standalone algorithm only" performance study in the context of AI is not applicable to this device. The device's performance is inherently linked to the human professional's initial assessment and customization.

7. Type of Ground Truth Used

The "ground truth" in this context refers to the patient's subjective experience of tinnitus relief, as assessed by the clinical study protocol and guided by qualified healthcare professionals. It would likely involve patient-reported outcomes following the use of the personalized sound, potentially compared to a baseline or through other clinical assessments. The personalized sound itself is based on expert assessment of the patient's tinnitus pitch.

8. Sample Size for the Training Set

The concept of a "training set" as typically understood for machine learning algorithms does not directly apply to the Tinnitus Rx device. The "personalized sound" is derived from individual patient assessment following a "scientifically studied clinical protocol," not from a machine learning model trained on a large dataset. Therefore, a sample size for a training set is not mentioned and is not relevant in the context of this device.

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

As noted above, a "training set" in the machine learning sense is not applicable. The "ground truth" for the personalized sound is established on an individual patient basis by a "qualified hearing healthcare professional" who follows a "scientifically studied clinical protocol" to match the pitch of the patient's tinnitus. This process is akin to a professional assessment rather than a data-driven model training.

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