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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.

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.

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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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