The Interacoustics AT235 Impedance Audiometer is an electroacoustic test instrument 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. It features tympanometry, acoustic reflex and air conduction audiometry.

Device Description

AT235 is an auditory impedance analyser. The device is intended to change the air pressure in the external auditory canal and measure and graph the mobility characteristics of the tympanic membrane to evaluate the functional condition of the middle ear. The device is used to determine abnormalities in the mobility of the tympanic membrane due to stiffness, flaccidity, or the presence of middle ear pathologies. The device is also used to measure the acoustic reflex threshold which occurs due to contractions of the stapedial muscle following exposure to a strong stimulus. This test allow to assess between central and peripheral pathologies and to identify where the patients uncomfortable loudness level may reside. The uncomfortable loudness level is useful when providing rehabilitative amplification methods and determining the correct management process for the patient. The AT235 also includes basic audiometry functions. The instrument is software controlled. The software controls the probe (tone and pressure) stimuli, measures the result and presents the result on a built in display. All functions are set and interpreted by the operator (There are no interpretations of results in the device). The technological characteristics are substantially equivalent with predicate device. All technological characteristics are in compliance with the consensus standard ANSI S3.39 for auditory impedance testers

AI/ML Overview

The provided document is a 510(k) summary for the Interacoustics AT235 Impedance Audiometer. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study proving device performance against those criteria in a typical AI/software-as-a-medical-device (SaMD) context.

Therefore, many of the requested points related to acceptance criteria, specific performance metrics, ground truth establishment, training sets, and MRMC studies are not applicable to this type of regulatory submission. The submission relies on demonstrating that the new AT235 maintains the same safety and effectiveness as its previously cleared version (K994254).

Here's a breakdown based on the available information:

1. A table of acceptance criteria and the reported device performance:

This information is not explicitly stated in the document in the format of specific acceptance criteria and performance results (e.g., sensitivity, specificity, accuracy). The document states that the device was found in compliance with current standards and demonstrated substantial equivalence with the predicate device.

The technological characteristics are stated to be in compliance with the consensus standard ANSI S3.39 for auditory impedance testers. This implicitly means the device meets the performance requirements outlined in that standard, but the specific metrics and targets are not detailed in this summary.

2. Sample sized used for the test set and the data provenance:

Test set sample size: Not applicable. This document refers to device verification and validation activities, not a study involving a test set of patient data with a defined sample size for performance evaluation in the way an AI/SaMD would.
Data provenance: Not applicable for performance evaluation against a specific test set. The validation activities are described as "following the design control procedure."

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

Not applicable. Ground truth establishment for a patient-level test set is not described as part of this submission. The device is an electroacoustic test instrument; its performance is validated against physical and instrument standards, not typically against expert-labeled patient data in this context.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. There is no mention of an adjudication process for a test set of patient data.

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 an audiometer, an electroacoustic test instrument, not an AI-powered diagnostic imaging tool that would typically involve human readers interpreting results.

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

Not applicable. This device is a measurement instrument. Its "performance" is its ability to accurately measure and present electroacoustic data, not to interpret or diagnose. The document explicitly states: "All functions are set and interpreted by the operator (There are no interpretations of results in the device)."

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

The ground truth for this type of device would primarily be instrument calibration standards, physical measurements, and compliance with recognized industry standards (e.g., ANSI S3.39 for auditory impedance testers). The document states: "The device was found in compliance with current standards and demonstrated substantial equivalence with the predicate device."

8. The sample size for the training set:

Not applicable. This device does not use machine learning or AI that requires a training set of data.

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

Not applicable. As there is no training set for an AI/ML algorithm, there is no ground truth establishment for such a set.

Summary of what the document does state regarding verification and validation:

The "Nonclinical tests summary" section on page 4-5 clearly states:

"Following the design control procedure the design verification and validation were performed according to current standards for medical device safety and EMC and performance of impedance tester."
"The device was found in compliance with current standards and demonstrated substantial equivalence with the predicate device."
"Clinical tests None applicable"

The "Conclusion" further reiterates:

"The AT235 as a modification to the predicate device (the previous cleared revision of AT235) uses the same or identical technology and has the same intended use as the predicate device."
"We trust that the verification and validation activities show substantial equivalence with the predicate device and that the modified AT235 is as safe and effective as the predicate device for its claimed purpose."

In essence, the "study" proving the device meets its acceptance criteria is the comprehensive design verification and validation process against relevant medical device standards (including safety, EMC, and the ANSI S3.39 performance standard) to demonstrate substantial equivalence to its predicate. The specifics of these tests (e.g., specific measurement ranges, accuracy tolerances, etc.) are not detailed in this summary document but would be part of the full 510(k) submission.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract image of three human profiles facing to the right, with flowing lines above them that resemble hair or wings.

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

July 15, 2015

Interacoustics A/S c/o Mr. Eric Nielsen Director, Regulatory & Compliance Drejervaenget 8 5610 Assens Denmark

Re: K151616

Trade/Device Name: AT235 Regulation Number: 21 CFR 874.1090 Regulation Name: Auditory Impedance Tester Regulatory Class: Class II Product Code: ETY Dated: June 11, 2015 Received: June 15, 2015

Dear Mr. Nielsen:

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.

{1}------------------------------------------------

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 of medical device-related 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" (21CFR 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K151616

Device Name AT235

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(K) SUMMARY

AT235

Company Name
Address

Telephone Fax e-mail Contact Person Interacoustics A/S Drejervaenget 8 5610 Assens Denmark +45 6371 3555 +45 6371 3522 erni@dgs.com Erik Nielsen, Director, Regulatory & Compliance, June 12, 2015

Date Summary Prepared

Device Identification:

Trade Name Common Name Classification Name Product Code Panel Device Class
AT235 Audiometric equipment Tester, Auditory Impedance ETY Ear Nose & Throat Class II (According to 21 CFR 874.1090)

Predicate Devices:

Predicate Device Manufacturer 510(k) No. Date Cleared

AT235 Interacoustics K994254 03/14/2000

{4}------------------------------------------------

Device Description	AT235 is an auditory impedance analyser. The device is intended tochange the air pressure in the external auditory canal and measureand graph the mobility characteristics of the tympanic membraneto evaluate the functional condition of the middle ear. The device isused to determine abnormalities in the mobility of the tympanicmembrane due to stiffness, flaccidity, or the presence of middle earpathologies. The device is also used to measure the acoustic reflexthreshold which occurs due to contractions of the stapedial musclefollowing exposure to a strong stimulus.This test allow to assess between central and peripheralpathologies and to identify where the patients uncomfortableloudness level may reside. The uncomfortable loudness level isuseful when providing rehabilitative amplification methods anddetermining the correct management process for the patient.The AT235 also includes basic audiometry functions.The instrument is software controlled. The software controls theprobe (tone and pressure) stimuli, measures the result andpresents the result on a built in display. All functions are set andinterpreted by the operator (There are no interpretations of resultsin the device). The technological characteristics are substantiallyequivalent with predicate device. All technological characteristicsare in compliance with the consensus standard ANSI S3.39 forauditory impedance testers
Indications for Use	The Interacoustics AT235 Impedance Audiometer is anelectroacoustic test instrument that produces controlled levels oftest tones and signals intended for use in conducting diagnostichearing evaluations and assisting in the diagnosis of possibleotologic disorders. It features tympanometry, acoustic reflex andair conduction audiometry.
Intended operator	The AT235 tympanometer is intended to be used by an audiologist,hearing healthcare professional, or trained technician.
TechnologicalCharacteristics	The instrument is software controlled. The software controls theprobe (tone and pressure) stimuli, measures the result andpresents the result on a built in display. All functions are set andinterpreted by the operator (There are no interpretations of resultsin the device). The technological characteristics are substantiallyequivalent with predicate device. All technological characteristicsare in compliance with the consensus standard ANSI S3.39 forauditory impedance testers
Nonclinical tests summary	Following the design control procedure the design verification andvalidation were performed according to current standards formedical device safety and EMC and performance of impedance

{5}------------------------------------------------

tester. The device was found in compliance with current standards and demonstrated substantial equivalence with the predicate device.

Clinical tests None applicable The AT235 as a modification to the predicate device (the previous Conclusion cleared revision of AT235) uses the same or identical technology and has the same intended use as the predicate device. We trust that the verification and validation activities show substantial equivalence with the predicate device and that the modified AT235 is as safe and effective as the predicate device for its claimed purpose.

Regulation Number and Section

§ 874.1090 Auditory impedance tester.

(a)
Identification. An auditory impedance tester is a device that is intended to change the air pressure in the external auditory canal and measure and graph the mobility characteristics of the tympanic membrane to evaluate the functional condition of the middle ear. The device is used to determine abnormalities in the mobility of the tympanic membrane due to stiffness, flaccidity, or the presence of fluid in the middle ear cavity. The device is also used to measure the acoustic reflex threshold from contractions of the stapedial muscle, to monitor healing of tympanic membrane grafts or stapedectomies, or to monitor followup treatment for inflammation of the middle ear.(b)
Classification. Class II (special controls). The device, when it is a tympanometer or auditory impedance tester that complies with FDA-recognized consensus standard ANSI S3.39, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.