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The Neuro-Audio system is indicated for use in the recording and analysis of human physiological data used for the diagnosis of auditory and hearing-related functions. It is intended as an aid to healthcare professionals trained and skilled in audiology. The system assists in the evaluation and diagnosis of ear disorders in humans using evoked potentials (EP), electrocochleography (ECochG), auditory brainstem response (ABR), auditory steady-state response (ASSR), otoacoustic emission (OAE) and pure tone audiometry (PTA).

The device is intended for use in the patient care institutions, diagnostics centers, neurosurgical hospitals and experimental laboratories.

The patient group includes all ages and genders.

The Neuro-Audio system provides for audiology biopotentials recording and input to personal computer (PC) by 1-2 channels, and measurement, calculation and analysis of its parameters. It can be used in patient care institutions, diagnostics centers, neurosurgical hospitals and experimental laboratories of the research institutions for auditory tract study and brain functional state study.

General functionalities provided by the system are:

• biopotentials acquisition by 1-2 channels in any unshielded room
• auditory stimulation
• electrocochleography (ECochG) acquisition
• auditory brainstem response (ABR) acquisition (air and bone conduction)
• middle- and long-latency auditory evoked potentials (AEP: MLR, LLR) acquisition
• cognitive evoked potentials (MMN, P300) acquisition
• auditory steady-state response (ASSR) acquisition
• otoacoustic emission study using transient evoked otoacoustic emission (TEOAE) and distortion product otoacoustic emission (DPOAE)
• spontaneous otoacoustic emission study (SOAE)
• pure tone audiometry (PTA; air and bone conduction)
• exam report generation
• review, store, and print of the recorded traces, results of their analysis and exam reports.

In addition, the Neuro-Audio system provides the healthcare professional with:

• A means of adjusting or activating all of the unit's settings and controls.
• Multiple ways in which a user can carry a task, such as from a menu, using the mouse or the keyboard or by double-clicking on an icon.
• Configurable function keys and fields that enable the user to customize the interface to meet their requirements.
• Single-stroke keyboard function keys for key tasks carried out during a patient examination.

The Neuro-Audio system is a medical device intended for recording and analyzing human physiological data related to auditory and hearing functions. The provided document, a 510(k) summary, outlines the process of establishing its substantial equivalence to predicate devices, focusing on non-clinical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Neuro-Audio device are primarily based on compliance with established industry standards for medical electrical equipment and audiometric devices. The device's performance is reported as successfully meeting these criteria through hardware and software tests and validations.

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

The document does not explicitly mention a "test set" in the context of human subjects or a clinical study for performance evaluation. The performance evaluation was focused on compliance with technical standards through hardware and software testing. Therefore, sample sizes for human subjects or specific data provenance (country of origin, retrospective/prospective) are not applicable in the context of this 510(k) summary, as it states "No clinical testing was conducted to support this submission."

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

This information is not applicable. Since no clinical testing was conducted and the performance evaluation focused on compliance with technical standards, there was no "test set" requiring ground truth established by human experts in the sense of clinical diagnosis or interpretation.

4. Adjudication Method for the Test Set

This information is not applicable as no clinical test set requiring adjudication was used.

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

There is no MRMC comparative effectiveness study reported in this document. The submission explicitly states, "No clinical testing was conducted to support this submission." The device's substantial equivalence is based on non-clinical performance testing and comparison to predicate devices' technical specifications and functionalities, not on human reader performance with or without AI assistance. This device is described as assisting healthcare professionals who are "trained and skilled in audiology," implying it is a tool for their use, but not an AI diagnostic system itself, and no "AI assistance" effect size is mentioned or relevant to this submission.

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

This information is not applicable in the context of a standalone "algorithm" performance as might be seen with AI. The Neuro-Audio is described as a system that records and analyzes data for diagnosis and is intended as an aid to healthcare professionals. Its performance is evaluated based on its technical compliance and ability to perform specific functions (e.g., biopotential acquisition, audiometry) in line with established standards, not as a standalone diagnostic algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance evaluation is primarily the established industry standards (e.g., IEC 60601-1, IEC 60645 series) for medical electrical equipment and audiometric devices. The device's hardware and software tests and validations confirmed its compliance with these technical specifications and performance requirements.

8. The Sample Size for the Training Set

This information is not applicable. The Neuro-Audio system is not described as an AI/ML device that requires a "training set" in the machine learning sense. Its performance evaluation relies on traditional engineering verification and validation testing against defined technical standards and comparison to predicate devices, not on a machine learning model's training data.

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

This information is not applicable as there is no mention of a training set for an AI/ML model. The "ground truth" for the device's functionality is the adherence to the technical specifications outlined by the relevant IEC standards for audiometric equipment and general medical device safety and performance.

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The Focus is intended for use by a healthcare provider to perform nerve conductions and EMG studies as an aid in the evaluation of patients with diseases of muscle and nerves. The machine can also use electrical stimulus or sound stimulus for evoked potentials (EP) studies.

The Focus is a 2-channel neurodiagnostic testing system designed to enable reliable recording, display and documentation of electrophysiological information from the human nervous and muscular systems in a clinical environment. The system enables the healthcare provider to perform evoked potentials, nerve conductions and needle EMG studies as an aid in the evaluation of patients with central and peripheral nervous system symptoms. The device provides functionality for the Electromyography (EMG), Nerve Conduction Studies (NCS), and Evoked Potential (EP) testing for a range of clinical applications and has a fast, intuitive and flexible graphical user interface (GUI) that conforms to a Windows philosophy. The Focus EMG Device consists of a handheld electronic unit, a stimulator unit with steel electrodes and felt pads, and a footswitch.

The TeleEMG Focus EMG Device is intended for use by healthcare providers to perform nerve conduction and EMG studies, and for evoked potentials (EP) studies using electrical or sound stimulus.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for a neurodiagnostic testing system (hardware and software) and not an AI/ML device making diagnostic claims, the acceptance criteria are based on compliance with established medical device safety and performance standards rather than specific diagnostic accuracy metrics. The "reported device performance" refers to the successful completion of these compliance tests.

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

The document explicitly states: "No clinical testing was conducted to support this submission."
Therefore, there is no test set in the sense of patient data for clinical evaluation, and no data provenance in that context. The testing was non-clinical (hardware, software, and safety standard compliance).

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

Not applicable. As no clinical testing was performed, there was no "test set" requiring expert-established ground truth. The acceptance criteria were based on engineering, safety, and performance standards.

4. Adjudication method for the test set

Not applicable. No clinical test set.

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. This device is a diagnostic electromyograph machine, not an AI-assisted diagnostic tool that interprets or analyzes data to improve human reader performance. Its function is to acquire and display electrophysiological data for a healthcare provider to interpret.

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

Not applicable. The device is a hardware and software system for data acquisition and display, designed for human-in-the-loop use by a healthcare provider. It does not perform standalone diagnostic interpretation.

7. The type of ground truth used

For the non-clinical performance testing, the "ground truth" would be the specifications defined by the relevant international standards (IEC 60601 series, IEC 62471) and the functional specifications and design requirements internally established for the device itself. For example, for noise levels, the ground truth is that the device noise should be less than 0.6 µVrms, or for the LED goggles, the luminance should be below the 10,000 cd/m² admissible limit.

8. The sample size for the training set

Not applicable. This device is not an AI/ML product that relies on a "training set" of data in the conventional sense. Its software performs signal acquisition, processing, and display based on established algorithms and embedded logic, not learned patterns from a large training dataset.

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

Not applicable, as there is no training set.

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