(25 days)
The Tinnitus Phase-Out's intended use is to provide temporary relief of tinnitus symptoms.
The Tinnitus Phase-Out consists of a personalized sound recorded onto a patient treatment device. The recorded sound is equivalent to that generated by the Tinnitus Rx. The treatment regimen for the Phase-Out is identical to that of the Rx. The only difference is the use of a patient treatment device instead of a customized CD.
This document is a 510(k) summary for the Tinnitus Phase-Out device, which is a tinnitus masker. The core claim is substantial equivalence to a predicate device, Tinnitus Rx (K030791). The document describes the device, its intended use, and the performance testing conducted to support the substantial equivalence claim.
Here's an analysis of the provided text with respect to your questions:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, the primary "acceptance criteria" is demonstrating substantial equivalence to the predicate device, Tinnitus Rx. The device performance reported is audio equivalence and meeting specific certifications/guidances.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Tinnitus Rx (K030791) | - Device generates sound equivalent to Tinnitus Rx |
| UL electrical certification | Met |
| FDA Guidance: Special 510(k)s: The New 510(k) Paradigm | Met |
| Class II Special Control Guidance, 21 CFR 874.3400(b) | Met |
| Conformance to the EU Medical Device Directive | Met |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "bench testing demonstrating audio equivalence." However, it does not specify the sample size used for this bench testing, nor does it provide details about the data provenance (e.g., country of origin, retrospective/prospective). This testing appears to be focused on the technical characteristics of the sound generated by the device, rather than patient data.
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)
The document does not describe any expert-based ground truth establishment for a test set. The "audio equivalence" appears to be based on technical measurements, not human perception or clinical outcomes evaluated by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No adjudication method is mentioned as there is no indication of a test set involving human assessment or expert review.
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
No such MRMC study was performed or described. The Tinnitus Phase-Out is a Tinnitus Masker, not an AI diagnostic or assistance tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a Tinnitus Masker. The "standalone performance" is implicitly its ability to generate an "equivalent" sound to the predicate device for temporary relief of tinnitus symptoms. The bench testing focused on this technical equivalence. There's no "algorithm only" performance study in the context of a typical AI/ML medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "audio equivalence" testing, the ground truth is the sound generated by the predicate device, Tinnitus Rx. The new device's sound production is compared directly to this existing, cleared device. There is no mention of clinical outcomes data, pathology, or expert consensus serving as ground truth for this technical performance claim.
8. The sample size for the training set
This is not applicable. The Tinnitus Phase-Out is a sound-generating device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reason as above.
§ 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.