(276 days)
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.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| IEC 60601-1:2005 (General requirements for basic safety and essential performance) | In compliance with the standard. |
| IEC 60601-1-2:2007 (Electromagnetic compatibility requirements and tests) | In compliance with the standard, demonstrated by test results. |
| IEC 60601-1-6:2010 (Usability) | In compliance with the standard. |
| IEC 60645-1:2012 (Electroacoustics Audiometric equipment Part 1: Equipment for pure-tone audiometry) | In compliance with the standard. |
| IEC 60645-6:2009 (Electroacoustics Audiometric equipment Part 6: Instruments for the measurement of otoacoustic emissions) | In compliance with the standard. |
| IEC 60645-7:2009 (Electroacoustics Audiometric equipment Part 7: Instruments for the measurement of auditory brainstem responses) | In compliance with the standard. |
| Functionality (recording and analysis of various auditory biopotentials, exam report generation, review, store, print) | Performance evaluation successfully completed utilizing 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.
§ 874.1050 Audiometer.
(a)
Identification. An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.(b)
Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.