(108 days)
The Tinnitus Sound Generator Module is a tool to generate sounds to be used in a Timitus Management Program to relieve patients suffering from Tinnitus. The target population is primarily the adult population over 18 years of age. This product may also be used with children 5 years of age or older.
The Tinnitus Sound Generator provides a means for healthcare professionals to create a hearing instrument solution that provides relief for Tinnitus patients. This software solution is embedded into a digital hearing instrument platform, so that the end-user can wear this device in all environments. The fitting of the digital device, which contains the Timitus Sound Generator module, is performed by a healthcare professional, in order to meet the exact needs of the Tinnitus patient.
A mobile medical application (app) is available as an accessory to the Tinnitus Sound Generator. The mobile medical app allows the user to adjust the hearing aid within the limits set by the healthcare professional during fitting of the hearing aid. The app is known as the TSG Control App.
The provided text is a 510(k) summary for the Tinnitus Sound Generator Module. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical study data and acceptance criteria in the format typically seen for novel devices with specific performance metrics.
Based on the information provided, here's a breakdown of what can be extracted and what information is not present:
Acceptance Criteria and Device Performance (Not explicitly stated in the document)
The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics (e.g., sensitivity, specificity, accuracy, or noise reduction levels) with numerical results as typically expected for diagnostic or analytical devices. The focus is on software modifications that "improve the functionality" and a risk analysis demonstrating "design outputs... meet the design input requirements."
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned above, specific quantitative acceptance criteria and reported device performance are not detailed in this 510(k) summary. The document states: "GN ReSound has conducted a risk analysis and has performed the necessary verification and validation activities to demonstrate that the design outputs of the modified device meet the design input requirements." This is a general statement about meeting design requirements, not a specific performance table.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The document refers to "verification and validation activities" but does not specify the details of these tests, including the size or characteristics of any test sets. This device is a Tinnitus Sound Generator Module, which generates sounds for therapy, not a diagnostic device that processes patient data in the typical sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable and not provided. This device is a sound generator module, not a device that requires expert-established ground truth for its performance in the way a diagnostic algorithm would (e.g., for image interpretation).
4. Adjudication Method for the Test Set
This information is not applicable and not provided. As above, there's no diagnostic ground truth requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable and not provided. An MRMC study is typically for evaluating the effectiveness of a diagnostic tool, often an AI algorithm, on human reader performance. This device is a therapeutic sound generator, not a diagnostic tool where human readers' interpretation would be enhanced or evaluated.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)
This information is not explicitly detailed as a standalone study with specific metrics. The document mentions "verification and validation activities" which would likely involve testing the software's functionality independently. However, specific performance metrics for this type of "standalone" evaluation for a sound generator (e.g., sound waveform accuracy, frequency response) are not provided. The Tinnitus Sound Generator Module is designed to be embedded in a hearing instrument and fitted by a healthcare professional, implying a human-in-the-loop for its clinical application.
7. Type of Ground Truth Used
This information is not applicable in the context of typical AI/diagnostic device evaluation. For a sound generator, "ground truth" would relate to the accuracy of sound generation against specifications, not against clinical outcomes or diagnoses.
8. Sample Size for the Training Set
This information is not applicable and not provided. The device is a "Tinnitus Sound Generator Module" (software) which appears to be a rule-based or signal-processing system rather than a machine learning model that would require a "training set" in the conventional sense. The modifications are described as "technological software advancements."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided, for the same reasons as #8.
Summary of what's provided for acceptance criteria/performance:
The 510(k) summary focuses on demonstrating that modifications to an existing device (the Tinnitus Sound Generator Module) are "technological software advancements that improve the functionality of the device, whilst having minimal risk to the patient and are minor modifications in relation to the predicate device that do not change the operating principle of the TSG module."
The conclusion states: "Modifications to the device do not raise new or different questions of safety or effectiveness for the device's intended use. The results of risk analysis and design verification and validation activities provide evidence that the device is as safe and effective as its predicate. This therefore demonstrates that the TSG module is substantially equivalent to its predicate device."
This indicates an acceptance criterion rooted in substantial equivalence to an existing predicate device (K110932), supported by:
- A risk analysis (demonstrating minimal risk).
- Verification and validation activities (demonstrating design outputs meet design input requirements).
No specific quantitative performance metrics (e.g., sound output accuracy within x dB, frequency stability within y Hz) or a clinical study proving therapeutic effectiveness are detailed in this 510(k) summary, as it's primarily addressing software modifications to an already cleared therapeutic device.
§ 874.3400 Tinnitus masker.
(a)
Identification. A tinnitus masker is an electronic device intended to generate noise of sufficient intensity and bandwidth to mask ringing in the ears or internal head noises. Because the device is able to mask internal noises, it is also used as an aid in hearing external noises and speech.(b)
Classification. Class II. The special control for this device is patient labeling regarding:(1) Hearing health care professional diagnosis, fitting of the device, and followup care,
(2) Risks,
(3) Benefits,
(4) Warnings for safe use, and
(5) Specifications.