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The Audera Pro is intended to be used for the stimulation, recording and measurement of auditory evoked potentials, vestibular evoked myogenic potentials, auditory steady state responses and otoacoustic emissions. The device is indicated for use in the evaluation, identification, documentation and diagnosis of auditory and vestibular disorders. The device is intended to be used on patients of any age.

The Audera Pro is intended to be used by qualified medical personnel such as an audiologist, physician, hearing healthcare professional, or trained technician. The Audera Pro is intended to be used in a hospital, clinic, or other healthcare facility with a suitable quiet testing environment.

The anatomical sites of contact for auditory evoked potential (AEP) testing are the patient's ear canal (with the contact object being a sound delivery eartip or headphone, or an ear probe and eartip) and the patient's scalp and possibly other body sites (with the contact object being a bone transducer or electrodes that are capable of measuring bio-potentials). The anatomical sites of contact for vestibular evoked myogenic potential (VEMP) testing are the patient's ear canal (with the contact object being a sound delivery eartip or headphone, or an ear probe and eartip) and the patient's head and neck and possibly other body sites (with the contact object being a bone transducer or electrodes that are capable of measuring bio-potentials). The anatomical sites of contact for otoacoustic emission (DPOAE, TEOAE) testing are the patient's ear canal (with the contact object being an ear probe and eartip).

The device is a configurable platform used to aid in the screening and diagnosis of sensory-neural and hearing conditions. It is capable of performing the following procedures: Auditory Evoked Potentials (EP), Auditory Steady-State Response (ASSR), Distortion Products Otoacoustic Emissions (DPOAE), Transient Evoked Otoacoustic Emissions (TEOAE), and vestibular evoked myogenic potentials (VEMP). The device system consists of a laptop PC with Windows 10 Pro, placed on top of or beside a specialized hardware implementation interface (i.e. platform) for the procedures. Software in the laptop controls the specialized hardware and collects and analyzes the resulting signals. Transducers and various accessories connect to the specialized hardware via connectors on the back of the hardware package.

The provided FDA 510(k) summary for the GSI Audera Pro describes acceptance criteria and studies primarily through comparison to predicate devices and adherence to international standards.

Here's the information broken down as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The device's acceptance criteria are framed in terms of meeting the requirements of various international standards and demonstrating comparability to predicate devices. The "Reported Device Performance" column reflects the conclusions drawn from the testing against these standards or the comparison to the predicates.

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

The document does not specify a "sample size" in terms of patient data or clinical cases for a test set. The studies described are primarily non-clinical bench testing and comparative technical assessments against predicate devices and international standards. Therefore, there's no mention of data provenance (e.g., country of origin) as clinical data was not used.

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

Not applicable. As clinical testing was not performed and the studies were non-clinical bench tests and comparisons to predicate devices, there was no need for experts to establish ground truth in the context of patient diagnoses or outcomes. The "ground truth" for these tests would be the established specifications and performance characteristics defined by the relevant international standards and the predicate devices.

4. Adjudication method for the test set

Not applicable. Given that the studies were non-clinical bench tests and comparisons to predicate devices, there was no independent adjudication of results in the way it would be done for a clinical study with multiple human readers. The evaluation methods included "Bland-Altman analyses and correlation coefficient comparison" for the module comparison, which are statistical methods rather than adjudication by experts.

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 study was performed. The device is not an AI-assisted diagnostic tool that would typically involve human readers interpreting results. It is an "Evoked Response Auditory Stimulator" used for physiological measurements.

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

This concept doesn't directly apply because the device is hardware and software for stimulation, recording, and measurement of biological responses, not an algorithm providing a diagnosis or interpretation in a standalone capacity that would typically interface with human practitioners in an AI context. The performance evaluations described are of the device's ability to accurately generate and measure these physiological signals.

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

For the non-clinical studies described:

• International Standards: The primary "ground truth" for electrical safety, EMC, EMG, calibration, OAE, and ABR measurements are the specifications and performance requirements detailed within the referenced IEC and ISO standards (e.g., IEC 60601-1, IEC 60645 series).
• Predicate Device Performance: For the module comparison, the performance characteristics of the legally marketed predicate devices (K163326 and K061443) served as the benchmark for demonstrating comparability.
• Product Design Requirements: For software, cybersecurity, and mechanical evaluations, the established design requirements and FDA guidance documents served as the "ground truth" or criteria for successful performance.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model that undergoes a training phase with a dataset. It is a medical device system built on established principles of electronics, signal processing, and audiometry.

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

Not applicable, as there is no training set for this type of device.

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