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510(k) Data Aggregation
(36 days)
TINNITECH LTD
The TinniTech ANMP System comprises two (2) mini compact disks and a portable, stereo, MP3 mini compact disc player with earphones. The discs have been prerecorded with selected relaxation music and other sounds spectrally adjusted to suit the particular patient's spectral hearing thresholds as shown by their audiogram. The sounds on the discs are reproduced by the mini compact disc player and delivered to the ears by the earphones supplied with the player. 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 TinniTech ANMP System is for home use under the direction of an appropriately qualified healthcare professional such as an otolaryngologist, an audiologist, or a licensed hearing aid dealer.
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 surqically treatable diseases for which tinnitus is a symptom before proceeding with non-medical tinnitus management.
The Tinnitech ANMP System may be used to completely mask and intermittently mask tinnitus.
The TinniTech ANMP system consists of:
One CD pre-recorded in the MP3 format with selected relaxation music and superimposed low amplitude, wide spectrum noise that is spectrally adapted to compensate for the individual patient's higher frequencies hearing loss. This CD is intended for the complete masking of tinnitus.
One CD pre-recorded in the MP3 format with selected relaxation music that is spectrally adapted to compensate for the individual patient's higher frequencies hearing loss however this CD has been recorded such that the dynamic characteristics of the sound allow the tinnitus to intermittently break through during the quieter passages of the recorded music.
A commercially available, battery powered, stereo, MP3 mini compact disc player with earphones with a performance specification that TinniTech has tested and shown to be suitable for the delivery of the ANMP treatment sounds or waveforms. At this time Tinnitech will supply the Phillips eXpanium 401™ MP3 mini compact disc player. Other suitable players will be offered as TinniTech tests and approves them for the ANMP System.
Here's an analysis of the acceptance criteria and study information for the TinniTech ANMP System, based on the provided 510(k) summary:
Important Note: The provided 510(k) summary is for a tinnitus masker, which is a device designed to provide temporary relief by masking the sound of tinnitus. It is not an AI/ML medical device. Therefore, many of the requested categories related to AI/ML device testing (like sample sizes for test and training sets, expert consensus for ground truth, MRMC studies, standalone performance, etc.) are not applicable to this type of traditional medical device. The submission focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving performance against specific quantitative acceptance criteria through clinical studies in the way an AI/ML device would.
Acceptance Criteria and Device Performance
Since this is a substantial equivalence submission for a traditional tinnitus masker, the "acceptance criteria" are primarily met through demonstrating similarity in intended use, technological characteristics, and safety/performance to legally marketed predicate devices. The "reported device performance" is descriptive and qualitative rather than quantitative metrics from a clinical trial.
| Characteristic/Acceptance Criteria (as implied by substantial equivalence) | Reported TinniTech ANMP System Performance |
|---|---|
| Intended Use Equivalence: Continuously and intermittently mask tinnitus as part of a tinnitus management program with masking noise and selected relaxation music. | Met: Indicated to completely mask and intermittently mask tinnitus as part of a tinnitus management program. Music added to promote relaxation. (Matches predicate K974501 for relaxation, and K011364 for continuous/intermittent masking). |
| Target Population Equivalence: Adults (18 years and over) with tinnitus, with or without high frequency loss, participating in a tinnitus management program. | Met: Adults (18 years of age and over) who present with tinnitus that may or may not be accompanied with hearing loss at the higher frequencies and who are participating in a tinnitus management program. (Broader than K974501, similar to K011364 for adults). |
| Audio Signal Technology: Digital audio. | Met: Digital (MP3 format on mini CDs). (Matches both predicates). |
| Available Noises/Sounds: Custom-tailored (spectrally adapted) and includes relaxation music. | Met: Pre-adapted to the patient's hearing characteristics, a wide selection of musical sounds incorporating Tinnitus Masking noise (20Hz - 20KHz) digitally recorded on mini compact discs in MP3 format. Custom-tailors sounds based on audiogram. (Matches K011364 for custom-tailoring; K974501 for masking noise + relaxation). |
| Medium: Portable digital storage medium (CDs). | Met: Two mini CDs (MP3 format). (Similar to K974501's four CDs/audio tapes; different from K011364's solid state memory but functionally equivalent for portability and delivery). |
| Volume Control: User-controlled with warnings. | Met: Yes, user controlled with warning in the User Instruction Manual stating "To prevent the possible damage to your hearing the volume setting of the disc player should not be set at levels where you are uncomfortable with the sound". (Similar to both predicates). |
| Distribution: Through qualified healthcare professionals. | Met: To be sold via direct and indirect channels involving an appropriately qualified healthcare professional. (Similar to K011364, more controlled than K974501). |
| Components: Sound files on storage, player, earphones, user manual. | Met: Sound files on digital mini CDs, high quality digital MP3 mini CD player, earphones, User's Manual. (Similar to K974501 components; K011364 is an in-the-ear device). |
| Energy Delivered/Safety (Acoustic Output): Maximum output considered, warnings provided if exceeding OSHA limits. | Met: Philips eXpanium 401 has a maximum power output per channel of 5mW. Maximum output from earphones could exceed 85 dBA (OSHA standard). Warnings included in User's Manual and on player. (Similar to K011364's warning; K974501 has no stipulated max). |
| Energy Used: Battery or mains powered. | Met: Operates from either one AA cell or 110 VAC mains adapter. (Similar to both predicates). |
| Transducer Type: Headphones/earphones. | Met: Use the earphones provided with the mini disc player. (Similar to K974501's headphones; K011364 is an in-the-ear device). |
| Where Used: Home use under professional management. | Met: Home use under the management of an appropriately qualified healthcare professional. (Similar to K011364; K974501 is home use only). |
| Safety: Warnings about preventing hearing damage and inability to hear external cues. | Met: ANMP therapy should never be undertaken when sounds might prevent hearing warnings of danger. Warnings about uncomfortable volume levels. (Similar safety considerations as K974501). |
| Materials: Typical audio product materials. | Met: Typical audio product materials such as plastic and diecast metals. (Similar to K974501). |
| Performance (User Determination): Enables user to determine if therapy assists in tinnitus management. | Met: The TinniTech ANMP system enables the user to determine whether the delivered therapy assists in the management of their tinnitus. (Similar to both predicates). |
| Instructions: User's Guide provided. | Met: The TinniTech ANMP System comes with a User's Guide. (Similar to K974501's Workbook). |
Study Information (Not applicable for this type of device seeking substantial equivalence via comparison to predicates for performance validation)
As this is a substantial equivalence submission for a non-AI/ML medical device, the typical "study" to prove performance is a comparison to legally marketed predicate devices, not a clinical trial with acceptance criteria for quantitative metrics. The document explicitly states it is claiming substantial equivalence to two predicate devices, leveraging their established safety and effectiveness.
- Sample size used for the test set and the data provenance: Not applicable. Performance is established through comparison of technological characteristics and intended use to predicate devices, not a separate test set. The submission does not describe a new clinical study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for device performance in this context is established by the existing regulatory approval and market history of the predicate devices.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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, as this is not an AI/ML device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is not an AI/ML device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this submission is effectively the established safety and effectiveness of the predicate devices through their own regulatory clearance and market experience. The demonstration of equivalent intended use and technological characteristics to these predicates serves as the basis for substantial equivalence.
- The sample size for the training set: Not applicable, as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.
Summary of Approach:
The TinniTech ANMP System did not undergo a formal clinical study with quantifiable performance metrics and acceptance criteria in the way a novel diagnostic or therapeutic device would. Instead, its acceptance was based on demonstrating substantial equivalence to two previously cleared predicate devices:
- K974501 (Dynamic Tinnitus Mitigation System, DTM-6): Used to establish equivalence for the masking function, inclusion of relaxation sounds, and overall concept of CD-based delivery.
- K011364 (Custom TCI Instrument): Used to establish equivalence for the custom-tailoring of sounds (spectral adaptation based on audiogram) and the concept of intermittent masking for habituation.
The 510(k) summary provides a detailed comparison table showing the technological characteristics, intended use, target population, and safety considerations of the TinniTech ANMP System against these two predicate devices. The successful clearance (K030791) by the FDA indicates that the agency found these comparisons sufficient to demonstrate substantial equivalence, meaning the new device is as safe and effective as the legally marketed predicates.
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