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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.

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The Tinnitus Sound Generator Module is a tool to generate sounds to be used in a Tinnitus 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 Module is targeted for healthcare professionals, which are treating patients suffering from tinnitus, as well as conventional hearing disorders. The fitting of the Tinnitus Sound Generator Module must be done by a hearing professional participating in a Tinnitus Management Program.

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 all day in all environments. The fitting of the digital device, which contains the Tinnitus Sound Generator Module, is performed by a healthcare professional, in order to meet the exact needs of the tinnitus patient.

The provided FDA 510(k) summary (K110932) for the "Tinnitus Sound Generator Module" does not contain information related to acceptance criteria or a study demonstrating the device meets such criteria in terms of analytical or clinical performance.

This submission is a Special 510(k), which typically relies on comparisons to a predicate device and verification that modifications do not raise new questions of safety or effectiveness. As such, the documented "Performance Data" section focuses on risk analysis and verification/validation activities in relation to design inputs, rather than a clinical performance study with specific acceptance criteria that demonstrate how well the device performs its intended function in a clinical setting (e.g., how effectively it relieves tinnitus).

Here's why the requested information is absent:

• Nature of the Device: The TSG Module is a sound generator designed to be used as part of a Tinnitus Management Program. Its direct "performance" in terms of clinical outcome (tinnitus relief) is inherently subjective and tied to the overall management program, not solely to the sound generator itself.
• 510(k) Pathway: A Special 510(k) is used for modifications to a legally marketed device where the modifications do not affect its intended use or fundamental technological characteristics and do not raise new questions of safety or effectiveness. The focus is on demonstrating that the modified device is still substantially equivalent to the predicate device, not on proving new clinical efficacy.
• Predicate Device Approach: The submission states, "Modifications to the cleared device... are not substantial and do not change the operating principle of the TSG Module. The intended use and fundamental technological characteristics remain the same as the predicate device, and modifications do not affect the safety or effectiveness of the device." This implies that the clinical effectiveness of the type of device (tinnitus masker) was established by the predicate (K073636), and the current submission is concerned with demonstrating that the modifications do not degrade that effectiveness.

Therefore, I cannot provide the requested table or describe a study proving the device meets specific acceptance criteria for clinical performance based on the provided text. The document refers to "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," but these are typically engineering and functional tests, not clinical performance studies with acceptance criteria for patient outcomes.

The information you've requested typically appears in traditional 510(k)s or PMAs where clinical performance or analytical performance of a diagnostic device is being established through new studies. This document does not describe such studies.

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The Tinnitus Sound Generator Module is a tool to generate sounds to be used in a tinnitus 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 module is targeted for healthcare professionals, which are treating patients suffering from tinnitus, as well as conventional hearing disorders. The fitting of the Tinnitus Sound generator module must be done by hearing professional participating in a tinnitus management program.

The Tinnitus Sound Generator provides a means for healthcare professionals to create a hearing instrument solution that provide relief for tinnitus patients. This software solution is embedded into a digital hearing instrument platform, so that the end-user can wear this device all day in all environments. The fitting of the mistrations portions, so that the sound generator module is fitted by a healthcare professional to fit the exact needs of the tinnitus patient.

The provided text is a 510(k) summary for the TSG Module, a Tinnitus Sound Generator. It describes the device, its intended use, and indicates that non-clinical tests were performed. However, it does not contain the detailed information needed to construct the requested table and answer the specific questions about acceptance criteria, study design, and performance metrics.

Specifically, the document states:

• "Testing performed on the TSG Module indicates that they are safe, effective, and perform as well as the predicate devices, when used in accordance with the instructions for use."
• "The functionality of the tinnitus sound generator is fulfilling its purpose, as providing means of shifting tinnitus emphasis, when in quiet environment."

These are general statements of conclusion, but they do not provide quantitative acceptance criteria or detailed study results. The document focuses on regulatory equivalence rather than a scientific study proving performance against defined criteria.

Therefore, many of the requested details cannot be extracted from the provided text.

Here's what can be gathered, and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The document refers to "testing performed," but not details of a clinical study.

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

• Not applicable. The document describes a general "tinnitus management program" involving "healthcare professionals" and "hearing professional," but no specific expert panel or ground truth establishment for a test set.

4. Adjudication method for the test set:

• Not applicable. No test set or adjudication method is 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:

• Not applicable. This is a medical device (sound generator), not an AI diagnostic or interpretive tool that would involve human readers or AI assistance in that context.

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

• Not explicitly stated or detailed. The device is a "Tinnitus Sound Generator Module" integrated into a hearing instrument, intended to be "fitted by a healthcare professional." Its performance is inherently linked to its use by a patient, facilitated by a professional. The "testing performed" is non-clinical, suggesting focus on the device's technical specifications and safety rather than a human-out-of-the-loop clinical trial.

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

• Not applicable. No "ground truth" establishment in a typical sense for algorithm evaluation is mentioned. The document refers to the device being used in a "tinnitus management program to relieve patients suffering from tinnitus," implying that the ultimate "ground truth" or effectiveness would be patient relief or outcomes in a clinical setting, but no such study is detailed.

8. The sample size for the training set:

• Not applicable. The device is a sound generator, not an AI model that requires a training set in the conventional sense.

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

• Not applicable.

In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on non-clinical tests regarding safety, effectiveness, and functional performance. It does not contain the detailed quantitative performance metrics, study designs, sample sizes, or ground truth methodologies that would typically be found in a clinical study report for an AI/CAD device. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document are presented at a very high, general level of "safe, effective, and perform as well as predicate devices."

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