(90 days)
The SoundCure® Serenade® Tinnitus Treatment System is indicated for use in the temporary relief of tinnitus symptoms. The device is a tool to generate customized sounds to relieve patients suffering from tinnitus and can be used in a tinnitus management program. The target population is adults (18 years or older).
This is a medical device and should only be used with the advice of a physician, audiologist or other hearing healthcare professional.
The SoundCure® Serenade® Tinnitus Treatment System (Serenade System) is a personalized sound therapy system designed specifically to evaluate a patient's tinnitus, to create customized audio stimulus, and to deliver and monitor/data log the audio stimulus. The Serenade System is intended to provide relief from the debilitating effects of tinnitus through the use of a hand-held customized digital audio device (Serenade Patient Device) that generates sound therapy/masking. The Serenade System uses modulated tinnitus pitch matched tones (S-Tones) and narrow-band noise centered at the tinnitus frequency and provides broad-band noise. The Serenade System consists of the following components: Serenade Treatment Software, Earphones, Serenade Patient Device as well as the following Accessories: power supply, power cord and USB cable.
The Serenade System with Remote Programming modification is limited to changes to components of the Serenade Treatment Software (Web, PC & addition of Communications Software Component on patient's home computer), modifications to user interface and updates to labeling (Professional, Patient and Patient Remote Connection Quick Start Guide). The Serenade Patient Device and accessories are unchanged.
The provided document is a 510(k) summary for the SoundCure® Serenade® Tinnitus Treatment System. It details the device's characteristics, comparison to a predicate device, and performance data.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" with numerical targets for clinical performance and corresponding "reported device performance." Instead, the clinical study was designed to demonstrate "substantial equivalence" of the remote programming model to the in-office programming model, rather than achieving specific performance metrics against a defined standard.
The general acceptance criterion for the clinical study can be inferred as:
- Acceptance Criterion: The remote programming model for the Serenade System should not introduce new safety concerns and should result in successfully programmed devices, with parameters not significantly differing from the known test-retest variability of in-person programming.
- Reported Device Performance: "The results from this study demonstrated that the SoundCure Serenade Tinnitus Treatment System can be successfully programmed remotely without introducing new safety concerns."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states "a non-significant risk, prospective site study involving patients with confirmed tinnitus." However, the exact number of patients (sample size) used in the clinical study for the remote programming evaluation is not explicitly stated in the provided text.
- Data Provenance: "prospective site study." The country of origin of the data is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not describe the use of "experts" to establish a ground truth for the test set in the traditional sense of diagnostic accuracy studies (e.g., radiologists interpreting images). Instead, the clinical study focused on comparing programming parameters between in-office and remote methods.
The study involved "hearing healthcare professionals (HHP)" who performed the programming. Their qualifications are generally implied by the requirement that the device "should only be used with the advice of a physician, audiologist or other hearing healthcare professional," but specific details on their experience or number for establishing a ground truth are not provided.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
The document does not describe an adjudication method for the test set as it would pertain to resolving discrepancies in expert interpretations. The study's focus was on the equivalence of programming methods, not on diagnostic accuracy requiring adjudication of interpretations.
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 MRMC study was performed in the context of improving human reader performance with or without AI assistance.
- The device (SoundCure Serenade Tinnitus Treatment System) is a sound therapy system for tinnitus and not an AI-based diagnostic tool that would typically involve human readers interpreting AI output. The clinical study focused on the equivalence of remote programming functionality.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The device is a "personalized sound therapy system" that involves the assessment and programming by "hearing healthcare professionals." The "Serenade Patient Device" generates sound, but its customization and setup require human-in-the-loop interaction from an HHP. The clinical study specifically evaluated the remote programming model which still involves a human (HHP) accessing the patient's PC for programming. Therefore, a standalone (algorithm only) performance study, without human interaction, does not appear to have been performed or would be relevant for this type of device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The document mentions that the purpose of the study was to determine if "Differences between parameters obtained from in-person (local) evaluation or remote evaluation should not differ from the known test-retest variability with in-person (local) testing." This implies that the "ground truth" or reference for comparison were parameters obtained through established in-person (local) evaluation methods, and the variability known from those methods. It is not an expert consensus on a diagnosis, pathology, or direct outcomes data in the usual sense for a diagnostic device.
8. The Sample Size for the Training Set
The document focuses on a clinical study for the remote programming model's equivalence to the in-office model. There is no mention of a separate training set as would be used for training a machine learning algorithm. The "Serenade System" itself (the predicate device) was previously cleared, suggesting its underlying programming logic was developed, but the details of that development (e.g., training data) are not part of this 510(k) summary for a modification.
9. How the Ground Truth for the Training Set Was Established
As no training set is discussed or implied for the specific modification described in the 510(k), this information is not provided.
§ 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.