(78 days)
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:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Quantitative performance metrics related to tinnitus relief (e.g., reduction in Tinnitus Handicap Inventory scores, duration of relief, sound generation fidelity, etc.) are not provided in this document. | The document states a general conclusion: "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." |
| And concerning functionality: "The functionality of the tinnitus sound generator is fulfilling its purpose, as providing means of shifting tinnitus emphasis, when in quiet environment." | |
| Specific thresholds for "safe, effective, and perform as well as the predicate devices" are not defined. |
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."
§ 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.