(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."
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510(k) Notification for TSG Module 10 December, 2007 Rev. 31 January 2008 Rev. 12 February 2008
510(k) SUMMARY
| SUBMITTER: | GN Resound A/SLars Hagander | MAR 13 2008 |
|---|---|---|
| DATE PREPARED: | 10 December, 2007 | |
| DEVICE NAME: | TSG Module | |
| CLASSIFICATION NAMES: | Tinnitus masker | |
| CLASSIFICATION CODE: | KLW | |
| PREDICATE DEVICES: | Quiescence and Siemens TCI-Combi |
Device Description:
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.
Predicate Devices:
Quiescence K040330 Siemens TCI-Combi K003558
Intended Use:
The Tinnitus Sound Generator Module is a tool to generate sounds to be used in a tinnitus management ITIC Thinds Sound Generator Nieders is a tool ... The target population is primarily the adult population program to reneve pantis product may also be used with children 5 years of age or older.
Summary of Non-Clinical Tests:
The tinnitus sound generator is providing means to help tinnitus patients under the Tinnitus Retraining The timmus sound generator is provides neals to help not to provide a high masking sound of the timitus I herceived by the end-user, thereby causing implication of the performance of the end-user speech perception thresholds, but to provide them means to shift emphasis from the timitus dominantly perceived perception thresnows, out to provide in quiet environments. It the assumption that the timitus patients are not bothered significantly by their perceived timitus, when exposed to other sound stimuli originating from the environment. The functionality of the tinnitus sound generator is fulfilling its purpose, as providing means of shifting tinnitus emphasis, when in quiet environment.
fitcals of sinting thinked emplaasis with counselling done by the healthcare professional.
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510(k) Notification for TSC Module 10 December, 2007 Rev. 31 January 2008 Rey. 12 February 2008
Other:
Pedriatic use precautions
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. However, children and physically or mentally challenged users will require training by a doctor, audiologists, hearing care practitioner or the guardian for the insertion and removal of the device containing the TSG module.
Children and physically or mentally challenged users will require guardian supervision while wearing the device.
The volume control is an optional feature in the TSG module used for adjusting the sound generator output level. To prevent unintended usage by pediatric or physically or mentally challenged users, the volume control must, if enabled, be configured to only provide a decrease of the sound generator output level,
Conclusions:
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.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized depiction of an eagle or bird-like figure, represented by three curved lines that suggest wings and a tail.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
GN ReSound A/S c/o Lars Hagander Lautrupbjerg 9 DK-2750 Ballerup Denmark
MAR 1 3 2 2008
Re: K073636
Trade/Device Name: Tinnitus Sound Generator Module (TSG Module) Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus masker Regulatory Class: Class II Product Code: KLW Dated: December 20, 2007 Received: December 26, 2007
Dear Mr. Hagander:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M. B. Egerlton, mD
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Notification for TSG Module 10 December, 2007 Rev. 31 January 2008
KO1363
ndications for Us
510(k) Number (if known): K07 3636
Device Name: TSG Module
Indications for Use:
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 healtheare 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 munagement program.
CFR 801 Subpart D
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shullon Peng
ision Sign sion Sign-Of Ophthalmic
Ton of Ophthalmic
510(k) Numbe
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Page .
Prescription Use (Per 21 CFR 801.109)
§ 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.