(86 days)
The jump C TRT is addressed to the adult population with a chronological persistent ringing in the ears (Timitus), who do not need or desire amplification. It may be used for masking timitus as part of tinnitus management program that is prescribed by a licensed hearing healthcare professional, who is trained in subsequent rehabilitation therapy, or a qualified audiologist. Therefore it generates a broadband noise with sufficient bandwidth and intensity and is applied on the ear.
The jump C TRT is an analog noise generator that was developed to be used in a tinnitus retraining therapy. This product has a variable output level and an adjustable low-cut filter for a custom-tailored noise shape, which fits the individual user. It is housed in a standard housing for cymba application.
The provided text describes a 510(k) premarket notification for the Audifon jump C TRT tinnitus masker and related models. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials to prove device effectiveness or meeting specific performance acceptance criteria through studies.
Therefore, much of the requested information about acceptance criteria, clinical study details, and performance metrics is not available in the provided document. The document primarily focuses on comparing the new device's features and intended use to a predicate device.
Here's what can be extracted and what is not available based on the input:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable (No specific performance acceptance criteria are described for this 510(k) submission focusing on substantial equivalence). | RMS Output Characteristics: |
| White noise: 66 dB SPL | |
| Frequency range: 200 - 6600 Hz | |
| Volume Control Range: 23 dB |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. No clinical test set data is provided.
- Data Provenance: Not applicable. The submission relies on comparison to a predicate device and engineering specifications, not clinical data from a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No clinical test set or ground truth establishment by experts is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical 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. The device is a physical tinnitus masker, not an AI-assisted diagnostic or therapeutic tool that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is an analog noise generator, not an algorithm. Its operation is standalone in the sense that it generates noise independently, but it is intended for human use as part of a tinnitus management program.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The submission is a 510(k) based on substantial equivalence, which primarily relies on comparing technical specifications and intended use to a predicate device. There is no mention of a ground truth in the context of clinical outcomes or expert consensus for efficacy. The "Quality Assurance" mentions "Measurements following ANSI 3.22-2003 to ensure proper functioning," which refers to technical performance standards rather than clinical ground truth.
8. The sample size for the training set
- Not applicable. No training set is mentioned as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. No training set or ground truth for it is mentioned.
§ 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.