(90 days)
The Sonix Hearing Aid Fitting and Programming System is a lightweight hand-held batterypowered device intended for use in fitting and programming Sonix hearing aids using individual patient audiogram and/or loudness data. It also provides database storage of patient identification information, audiogram, loudness information and hearing aid selection and fitting parameters.
The Sonix Hearing Aid Fitting and Programming System is a hand-held, battery-powered, portable device used to fit and program Sonix hearing aids and to store certain patient data.
The provided text is a very brief summary of safety and effectiveness for a 510(k) submission (K973880) for the Sonix Hearing Aid Fitting and Programming System. It states that the device is substantially equivalent to two predicate devices based on its intended use and general characteristics.
Crucially, the document does not contain any information about specific acceptance criteria or a study that proves the device meets those criteria. It only asserts substantial equivalence to existing devices.
Therefore, for the requested information, I have to state that it is not available in the provided text.
Here's how I would answer your request based on the provided input:
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A table of acceptance criteria and the reported device performance
- Not available. The provided document does not specify any quantitative acceptance criteria or report performance metrics for the Sonix Hearing Aid Fitting and Programming System. It only makes a claim of substantial equivalence to predicate devices based on shared intended use and general features.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available. The document does not describe any specific test set or clinical study data.
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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 available. The document does not describe any process for establishing ground truth as no specific test set or study is detailed.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not available. No test set or ground truth establishment method is described.
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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 (a hearing aid fitting and programming system) is not an AI-assisted diagnostic tool that would typically involve a multi-reader multi-case study with human readers. The document does not mention any AI components or MRMC studies.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not available. The document does not describe any standalone algorithm performance studies. The device is a system for programming hearing aids, implying human-in-the-loop operation by a dispenser.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not available. As no specific study or test set is described, the type of ground truth is not mentioned.
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The sample size for the training set
- Not available. The document does not mention any training set or machine learning components.
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How the ground truth for the training set was established
- Not available. As no training set is mentioned, the method for establishing its ground truth is also not.
§ 874.3300 Air-conduction hearing aid.
(a)
Identification. An air-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. An air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. The air-conduction hearing aid generic type excludes the group hearing aid or group auditory trainer, master hearing aid, and the tinnitus masker, regulated under §§ 874.3320, 874.3330, and 874.3400, respectively.(b)
Classification. Class I (general controls). This device is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 874.9.