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510(k) Data Aggregation
(88 days)
The UltraQuiet™ device is intended for use in the treatment and control of tinnitus. It consists of a low-level amplifier that converts pre-recorded sound into bone-conducted masking noise that is applied to the mastoid region of the head through a behind-the-ear transducer. The UltraQuiet™ device produces sound of sufficient intensity and bandwidth to mask tinnitus. This device is used in conjunction with diagnosis and therapy by a qualified audiologist or other hearing healthcare professional familiar with the diagnosis of tinnitus and subsequent rehabilitation therapy. UltraQuiet™ is indicated for the treatment of tinnitus in individuals over 18 years of age that report tinnitus.
The UltraQuiet™ consists of (1) a compact disc (CD) with recorded sound or an MP3 player, (2) an audio amplifier with AC adapter power supply, and (3) a headband/bone-conduction transducer assembly.
The UltraQuiet™ device, a tinnitus masker, did not undergo a study with specific acceptance criteria and reported device performance in the provided document. The submission is a 510(k) premarket notification, which establishes substantial equivalence to legally marketed predicate devices rather than proving performance against specific quantitative criteria.
The document highlights the intended use and technological characteristics of the UltraQuiet™ device and how they are substantially equivalent to existing predicate devices. The equivalence is based on similar principles of operation, general intended use, and technological features, rather than a clinical study demonstrating a specific level of performance or efficacy.
Here's a breakdown of the requested information based on the provided text, indicating where information is present and where it is not applicable for a 510(k) submission focused on substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Applicable (No specific quantitative acceptance criteria or performance metrics were defined or reported in the document for FDA clearance for this 510(k) submission. The clearance is based on substantial equivalence to predicate devices.) | Not Applicable (The document asserts functional equivalence to predicate devices based on shared features, such as providing broadband masking sound, delivering sound via bone conduction, tunability of sound, and using recorded noise. It does not provide quantitative performance data against acceptance criteria.) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. No test set or clinical study was conducted or reported in this 510(k) submission to demonstrate performance against specific criteria.
- Data Provenance: Not applicable. As no test set was used, there is no corresponding data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No ground truth establishment by experts was reported for a test set in this 510(k) submission.
4. Adjudication method for the test set
- Not applicable. No adjudication method was reported as no test set was used.
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 device is a tinnitus masker, not an AI-assisted diagnostic or interpretative tool. Therefore, an MRMC study and effects on human reader performance are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device (tinnitus masker), not an AI algorithm. Its function is to produce masking noise, not to interpret data or make a diagnosis independently.
7. The type of ground truth used
- Not applicable. No ground truth was established as part of this 510(k) submission’s review process. The submission focuses on substantial equivalence to predicate devices.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, there is no ground truth establishment for it.
Summary of the 510(k) Approach:
The K021202 submission for the UltraQuiet™ device sought clearance by demonstrating substantial equivalence to several predicate tinnitus maskers (Siemens TCI, ADM Tronics Aurex-3, Starkey TM-3/TM-5, and TTC's GHI-T & TN3-T-T). This approach, common for Class II medical devices, does not typically involve extensive clinical trials with pre-defined acceptance criteria and performance metrics for the new device. Instead, the focus is on showing that the new device has:
- The same intended use.
- Similar technological characteristics.
- Similar principles of operation.
- Does not raise different questions of safety and effectiveness compared to the legally marketed predicate devices.
The document states that UltraQuiet™ is "functionally equivalent" to its predicates in terms of providing broadband masking sound, bone conduction delivery, tunability, and use of recorded noise. This "functional equivalence" is the basis for its clearance, not a study demonstrating new performance metrics.
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