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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 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 (provided separately).

Here's an analysis of the provided text regarding the SoundCure Serenade Tinnitus Treatment System's acceptance criteria and studies:

Summary of Acceptance Criteria and Study Details for the SoundCure Serenade Tinnitus Treatment System

Based on the provided 510(k) summary, the SoundCure Serenade Tinnitus Treatment System's acceptance criteria and supporting studies are primarily focused on demonstrating substantial equivalence to a predicate device and meeting established design specifications through non-clinical (bench) testing. There is no mention of clinical studies involving human participants to establish efficacy or direct performance metrics against specific acceptance criteria for a clinical outcome.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this 510(k) relies heavily on substantial equivalence and non-clinical testing, the "acceptance criteria" are implied to be conformance with established engineering and safety standards, as well as demonstrating comparable technical characteristics to the predicate. Direct performance metrics for clinical efficacy are not reported in this document.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable in the context of a clinical test set for performance. The "test set" here refers to the actual device units subjected to non-clinical bench testing. The specific number of units tested for each "in-vitro bench study" (e.g., System Output, Environmental, etc.) is not explicitly stated in this summary.
• Data Provenance: The data is from in-vitro bench studies conducted by SoundCure, Inc. within the USA. It is retrospective in the sense that it evaluates manufactured devices against pre-defined specifications. There is no mention of data from human subjects or any country of origin for such data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The "ground truth" for the non-clinical test set was established by engineering specifications and industry standards, not by human experts adjudicating clinical outcomes or images. The "experts" would be the engineers and quality assurance personnel performing the tests and comparing results against established specifications.

4. Adjudication Method for the Test Set

Not applicable. This was engineering validation against objective specifications, not a subjective clinical assessment requiring adjudication among human reviewers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document does not mention any MRMC comparative effectiveness study or any other clinical study involving human readers or assessment of human improvement with or without AI assistance. The device is a "Tinnitus Masker" which generates sound, not an AI diagnostic tool that human readers would use in conjunction with.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

The concept of "standalone performance" typically applies to AI algorithms generating a diagnostic or predictive output. This device is a sound therapy system. Therefore, a "standalone" performance study in the AI sense is not relevant. The device's standalone performance was assessed through its non-clinical bench testing (e.g., sound output, safety, durability) to ensure it performs according to its design specifications.

7. The Type of Ground Truth Used

The "ground truth" for the testing performed was engineering specifications, industry standards (e.g., IEC60601-1 for safety), and design requirements. The device's components and overall system were tested to confirm they met these predefined technical and safety benchmarks. There is no mention of pathology, expert consensus, or outcomes data being used as ground truth for this 510(k) submission.

8. The Sample Size for the Training Set

Not applicable. This device is a sound therapy system, not an AI or machine learning algorithm in the typical sense that would require a "training set" of data to learn from. The device generates customized sounds based on a patient's individual tinnitus frequency match which is determined by a healthcare professional, not by an algorithm trained on a dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for an AI algorithm mentioned for this device.

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