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The Zen program is intended to provide a relaxing sound background for adults (21 years and older) who desire to listen to such a background in quiet. It may be used as a sound therapy tool in a tinnitus treatment program that is prescribed by a licensed hearing healthcare professional (audiologists, hearing aid specialists, otolaryngologists) who is trained in tinnitus management.

The Zen program is intended to be used in quiet where hearing everyday sounds is not critical.

The Zen program is an optional listening program within the Widex Mind 440 digital hearing aid family. It is a tool that generates and delivers a relaxing sound background. It may also be used as a sound source to distract and/or mask tinnitus in tinnitus sufferers. A broadband noise and as many as 4 melodic tone patterns that are generated using fractal mathematics can be selected as Zen programs. The clinician can adjust the characteristics (intensity, pitch and tempo) of each program and the patient can retrieve up to 3 programs with the touch of a program button. The Zen can be used with or without amplification.

The Widex Zen program, an optional listening program within the Mind 440 digital hearing aid family, generates and delivers a relaxing sound background. It can also be used as a sound source to distract and/or mask tinnitus in tinnitus sufferers.

Here's an analysis of the acceptance criteria and the study that supports it:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: "A study on the acceptability of the Zen tones to hearing impaired people showed that the majority of listeners (85%) rated the Zen tones as 'somewhat relaxing' or 'very relaxing.'" The exact numerical sample size for this acceptability study is not provided.
• Data Provenance: Not explicitly stated, but given the manufacturer (Widex A/S, Denmark) and the contact person's location in the US (Illinois), it could be either a European or US study. The document does not specify if the study was retrospective or prospective.

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

• For the acceptability study, the "ground truth" was based on subjective ratings ("somewhat relaxing" or "very relaxing") from hearing-impaired individuals. There is no mention of experts establishing ground truth for this particular finding.
• For the tinnitus management aspect, the claim of effectiveness is based on substantial equivalence to predicate devices, rather than a new study with expert-established ground truth.

4. Adjudication Method for the Test Set

• Not applicable as the reported data for the acceptability study relies on individual participant ratings, not expert adjudication of a test set. For the tinnitus management claim, it's based on equivalence to predicate devices, not a separate adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• No MRMC comparative effectiveness study was mentioned or performed. The device is a sound-generating program within a hearing aid, not an AI diagnostic tool that assists human readers with interpretations. Therefore, the concept of "human readers improve with AI vs without AI" is not applicable here.

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

• Yes, for the "acceptability of the Zen tones," the performance was evaluated based on direct feedback from users, which can be considered standalone performance in terms of the device's ability to generate tones rated as relaxing.
• For the tinnitus management claim, the "standalone" performance is inferred through substantial equivalence to other devices that operate without continuous human intervention during their primary function (sound generation/masking).

7. The Type of Ground Truth Used

• For the reported acceptability data: Subjective user experience/perception ("somewhat relaxing" or "very relaxing") served as the ground truth.
• For the tinnitus management claim: Equivalence to the demonstrated effectiveness of predicate devices that serve similar functions. There is no new "ground truth" established for tinnitus relief in this specific submission.

8. The Sample Size for the Training Set

• Not applicable / not provided. The Zen program is described as generating "fractal mathematics" patterns and broadband noise. This implies a rule-based or algorithmically generated system rather than a machine learning model that requires a training set.

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

• Not applicable. As the device's sound generation mechanism is likely based on mathematical algorithms and digital synthesis rather than machine learning, there would be no "training set" or corresponding ground truth establishment in the conventional sense of AI/ML development. The design principles for the "relaxing sound background" would be based on audiological and psychoacoustic research.

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The Neuromonics Tinnitus Treatment System has been designed solely and specifically for delivering and monitoring the audio stimulus required for the Neuromonics Tinnitus Treatment.

The Neuromonics Tinnitus Treatment is intended to provide relief from the disturbance of tinnitus, while using the system, and with reqular use (over several months) may provide relief to the patient whilst not using the system.

The Neuromonics Tinnitus Treatment System comprises a SD Memory Card that is pre-recorded with selected relaxation audio and other sounds spectrally adapted to suit the particular patient's hearing thresholds. The system is indicated to provide a high degree of interaction (or masking) and intermittent interaction / masking with the patients' tinnitus perception, as part of the Neuromonics tinnitus management program. The addition of the music is to aid the promotion of relaxation during the tinnitus masking process.

The Neuromonics Tinnitus Treatment System is intended to interact and intermittently interact with the patients tinnitus as part of a tinnitus management program. The addition of the music is to aid the promotion of relaxation during the tinnitus interaction process.

The Neuromonics Tinnitus Treatment System comprises an SD Memory Card, the Neuromonics Processor, a portable, stereo, MP3 player, and Earphones. The Memory Card has been pre-recorded with selected relaxation music and other sounds spectrally adjusted to suit the particular patient's spectral hearing thresholds as shown by their audiogram. The sounds on the SD Memory Card are reproduced by the Neuromonics Processor and delivered to the ears by the Bang and Olufsen earphones. The device is indicated for adult (18 years and over) tinnitus sufferers who may or may not suffer hearing loss and are participating in the Neuromonics Tinnitus Treatment.

The Neuromonics Tinnitus Treatment System is for home use under the direction of an appropriately qualified healthcare professional such as an otolaryngologist. an audiologist, or a licensed hearing aid dealer.

Patients should receive a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear) to rule out medically or surgically treatable diseases for which tinnitus is a symptom before proceeding with the Neuromonics Tinnitus Treatment.

The Neuromonics Tinnitus Treatment System may be used to fully and intermittently interact with / mask their tinnitus perception.

The Neuromonics Tinnitus Treatment System comprises an SD Memory Card, the Neuromonics Processor, a portable, stereo, MP3 player, and Earphones. The Memory Card has been pre-recorded with selected relaxation music and other sounds spectrally adjusted to suit the particular patient's spectral hearing thresholds as shown by their audiogram. The sounds on the SD Memory Card are reproduced by the Neuromonics Processor and delivered to the ears by the Bang and Olufsen earphones.

The provided text is a 510(k) summary for the Neuromonics Tinnitus Treatment System (K043274). It establishes substantial equivalence to previously cleared devices rather than presenting a de novo study with acceptance criteria and performance data. Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in this document.

However, based on the information provided, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific acceptance criteria or quantitative performance metrics are provided in the 510(k) summary. The submission focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

No test set or associated data is described in this 510(k) summary for K043274. The submission relies on the prior clearance of predicate devices and their established performance.

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, as no new test set with ground truth establishment is described in this 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable, as no new test set requiring adjudication is described in this 510(k) summary.

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 described, the Neuromonics Tinnitus Treatment System, is a tinnitus masker and treatment system, not an AI-assisted diagnostic or interpretative tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this type of device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. The Neuromonics Tinnitus Treatment System is a device designed for patient use under the direction of a healthcare professional, delivering audio stimuli. It is not an algorithm performing a standalone analysis.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable, as no new clinical study with ground truth data is presented in this 510(k) summary. The efficacy of similar tinnitus maskers would have been established through clinical trials for predicate devices, demonstrating relief or masking of tinnitus symptoms, which would be considered "outcomes data."

8. The sample size for the training set:

Not applicable. The device is a medical device for treatment, not a machine learning algorithm that requires a training set in the conventional sense.

9. How the ground truth for the training set was established:

Not applicable, for the same reason as point 8.

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