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.

Device Description

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.

AI/ML Overview

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.

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 12, 2015

TELEEMG, LLC USA % Mr. Barry Ashar President Enter consultant name here, or erase this if there is none 88 Stiles Road Salem, NH 03079

Re: K141524 Trade/Device Name: NEURO-AUDIO Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO, GWJ Dated: February 6, 2015 Received: February 10, 2015

Dear Mr. Ashar,

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Eric A. Mann -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K141524

Device Name Neuro-Audio

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY Neuro-Audio

1. SUBMITTER/510(K) HOLDER

TeleEMG, LLC 65 Arlington Road Woburn. MA 01801. USA Contact Person: Barry V. Ashar, Makromed, Inc. Telephone: (603) 890-3311 Date Prepared: August 19, 2014

2. DEVICE NAME

Proprietary Name: Neuro-Audio Common/Usual Name: Audiometer Classification Name: Audiometer; Stimulator, Auditory, Evoked Response Regulation Number: 21 CFR §874.1050; 21 CFR §882.1900 Device Class: Class II Product Code: EWO; GWJ

3. PREDICATE DEVICES

Interacoustics EP25, Eclipse System, K052562 ●
Interacoustics TEOAE25, Eclipse System, K030016
Interacoustics DPOAE2O, Eclipse System, K060539 ●
Interacoustics ASSR. Eclipse System, K070696
Interacoustics Affinity (AC440), K043219 ●
. GSI Audera, K011135

4. DEVICE DESCRIPTION

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)

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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.

5. INTENDED USE

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, documentation and diagnosis of ear disorders in humans using evoked potentials (EP), electrocochleography (ECochG), auditory brainstem response (ABR), auditory steadystate 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.

6. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICE

All the necessary electromagnetic compatibility and electrical safety tests were performed. The results demonstrate that the Neuro-Audio is in compliance with both the standards IEC 60601-1-2 and IEC 60601-1; therefore it is as safe as the predicate devices.

Each system consists of an electronic unit connected to a personal computer to monitor, record, and display the signals. Some accessories are not included in the Neuro-Audio (for example, in the case of "Footswitch for hands-free operation"). However, this is entirely optional (most predicate devices don't have it either) and will not harm the intended use. Each clinically relevant feature and supported medical diagnostic test of the Neuro-Audio is also implemented in at least one (or more) predicate device(s) The differences between the Neuro-Audio and the predicate devices are limited to the design, materials and the individual sets of medical hearing diagnostic tests they support (e.g. one predicate device may support one of the Neuro-Audio's diagnostic tests, some other predicate devices may support another test). There is no single predicate device possess all the functions the Neuro-Audio supports, that's the reason several predicate devices are included to demonstrate the substantial equivalency. The software may differ in visual appearance, layout of control elements, the way of displaying test results. But the underlying principles and all the provided test results are substantially the same among the Neuro-Audio and the predicate devices (e.g., if the software should show the averaged response trace for ABR test, the Neuro-Audio may show it in different color than its predicate devices, but it still shows the averaged response trace; if there is a PASS/REFER result for TEOAE

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screening test, different software may show different additional information, but the Neuro-Audio still covers the most important part -PASS/REFER result; etc.). Therefore, TeleEMG concludes that design differences (both hardware and software) are minor and do not affect the safety and effectiveness of the proposed device.

Based on the comparison and the discussion above, TeleEMG claims that the Neuro-Audio and all predicate systems are substantially equivalent.

7. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE

Performance Testing

Performance evaluation of the features described in the Neuro-Audio user manual has been successfully completed utilizing hardware and software tests and validations. Hardware qualification is performed using the following industry standards:

. IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility requirements and tests
IEC 60601-1-6:2010 Medical electrical equipment Part 1-6: General requirements for ● safety and essential performance - Collateral standard: Usability
IEC 60645-1:2012 Electroacoustics Audiometric equipment Part 1: Equipment for ● pure-tone audiometry
IEC 60645-6:2009 Electroacoustics Audiometric equipment Part 6: Instruments for ● the measurement of otoacoustic emissions
IEC 60645-7:2009 Electroacoustics Audiometric equipment Part 7: Instruments for ● the measurement of auditory brainstem responses

8. SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE

No clinical testing was conducted to support this submission.

9. SUMMARY OF OTHER INFORMATION

No other information is available.

10. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS

Based on the information and supporting documentation provided in the premarket notification, the Neuro-Audio is substantially equivalent to the cited predicate devices. Testing demonstrates that the Neuro-Audio fulfills prospectively defined design and performance specifications.

Regulation Number and Section

§ 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.