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Tinearity G1 is intended to generate noise of sufficient intensity and bandwidth to mask ringing in the ears or internal head noise to provide relief for patients with normal hearing in the home healthcare environment. The device is for prescription use only. The target population is adult population over 18 years of age.

Tinearity G1 is applied on intact skin at the mastoid bone and transfers sound through bone conduction to the cochlea. Hearing health care professional shall be consulted for diagnosis, fitting of devices, and follow-up care.

The Tinearity G1 device is designed to generate sounds to be used in a Tinnitus Management Program to relieve patients suffering from tinnitus.

Tinearity G1 comprises of three components: a sound generator, an adapter and a charger. The sound generator is attached to the skin behind the ear by means of the adapter. The sound generator converts white noise into vibrations that are transmitted via the adapter through the skull to the inner ear. The device generates white noise within the frequency span of 700z-10Khz with a maximum output level of 48dB HL.

The adapter is a disposable device that serves as a mechanical connector between the sound generator and the user. The adapter is made up of a plastic holder that is compatible with the sound generator and a medical grade tape to be attached to the user's skin behind the ear. The adapter is a single use device and is designed to be removed daily after each treatment.

The sound generator uses a re-chargeable battery as power source which is charged with the charger.

The Tinearity G1 sound generator and adapter can be used during all times of the day, during sleep as well as during work and spare time.

The provided text describes the Tinearity G1 device, a tinnitus masker, and the studies conducted to support its substantial equivalence to a predicate device. However, it does not provide specific acceptance criteria or reported device performance in a numerical table format for the clinical or non-clinical studies. Instead, it describes generalized successful completion of tests and qualitative observations.

Therefore, I cannot fulfill all parts of your request with specific numerical data as it is not present in the provided text. I will address what is available and indicate when information is not provided.

Here's a breakdown based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table of acceptance criteria with numerical thresholds and corresponding reported device performance values. It generally states that tests were "successfully performed" or that performance was "found to be equivalent" to the predicate device.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size:
  • Clinical Testing (Customer Survey): The document states "Clinical testing was conducted on adult subjects with normal hearing suffering from tinnitus." However, the specific sample size (N) for this customer survey is not provided.
  • Biocompatibility:
    • In vitro: Not specified beyond "production equivalent samples."
    • In vivo: Conducted on "2 rabbits" and "the third rabbit" for irritation testing.
• Data Provenance:
  • Clinical Testing: The location where the customer survey was conducted is not specified. It is referred to as "Real World Evidence (RWE)." The type of study was a "customer survey... held as an interview with a pre-defined questioner," suggesting a prospective data collection method focused on immediate relief.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. For the clinical survey, while it mentions "Hearing health care professional shall be consulted for diagnosis, fitting of devices, and follow-up care," it does not specify if experts were used to establish "ground truth" for the survey results or their qualifications. The survey itself was based on self-reported perception of relief.

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

This information is not provided in the document. The clinical survey was based on interviews and self-reported perceptions, implying no formal adjudication process for the "ground truth" of tinnitus relief.

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 comparative effectiveness study was done as described.
• The device is a direct-to-user therapeutic device (tinnitus masker), not an AI-powered diagnostic imaging tool that would typically involve human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply to this device.

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

This question is not directly applicable in the context of this device. The Tinearity G1 is a physical device that generates sound, not a software algorithm that performs diagnostic analysis in isolation. Its performance is inherent in its sound generation capabilities and physiological effect, rather than a "standalone algorithm" performance.

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

• Clinical Performance: The "ground truth" for the clinical study (customer survey) was self-reported user perception of "immediate relief (suppression, masking) from the tinnitus sound." It's a form of outcomes data based on subjective patient experience.
• Non-Clinical Performance: For categories like sound output, biocompatibility, electrical safety, EMC, mechanical, the "ground truth" was established by bench testing against defined standards and specifications, and in the case of biocompatibility, specific ISO standards with in vitro and in vivo testing.

8. The sample size for the training set

The document does not mention any "training set" as this device is not described as being based on a machine learning model that would require a distinct training phase. It describes standard engineering and clinical validation processes for a medical device.

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

As there is no mention of a "training set" or a machine learning model, this information is not applicable and therefore, not provided.

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