The ER35 ERO•SCAN Pro Hearing Test System is indicated for testing of cochlear and middle ear function in infants, children, and adults by measuring otoacoustic emissions (OAEs), tympanometry, and acoustic reflex.

Device Description

The ER35 is a microprocessor-controlled instrument designed to screen otoacoustic emissions, tympanic membrane performance, and acoustic reflex. Test information is stored in memory, displayed on a graphic LCD, and can be printed by a printer or stored on a computer. The product is manufactured and delivered completely assembled to the retailer using materials and techniques widely used by manufacturers of hearing devices.

AI/ML Overview

The provided text does not contain specific acceptance criteria or a detailed study proving the device meets said criteria in the format requested. Instead, it describes the ER35 ERO-SCAN Pro Hearing Test System, its intended use, and indicates that performance testing was conducted to support its substantial equivalence to predicate devices.

Here's an analysis of what can be extracted and what information is missing based on your request:

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

Acceptance Criteria: Not explicitly stated as specific numerical targets for performance metrics (e.g., sensitivity, specificity, accuracy). The document states that "Certain performance specifications may vary compared to predicate devices, but in these cases, sufficient performance testing has been done to support substantial equivalence determination." This implies the acceptance criteria were based on demonstrating comparable performance to predicate devices, rather than predefined quantitative thresholds.
Reported Device Performance: Not provided in the document. The text only says "Performance data collected supports a substantial equivalence determination."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size (Test Set): Not specified. The document only mentions "Subjects tested included both male and female participants, an appropriate age range, and variable audiometric profiles (i.e., subjects with normal range hearing and impaired hearing function)."
Data Provenance: Not specified. It's unclear if the study was prospective or retrospective, or the country of origin of the data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not specified. The document does not describe how ground truth was established, nor the involvement or qualifications of experts for this purpose.

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

Not specified.

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

MRMC Study: Not mentioned or applicable. This device is an audiometer, not an AI diagnostic tool primarily requiring human interpretation of images or complex data where AI assistance would be a factor. The "study" referenced is performance testing of the device itself.
Effect size of human readers with/without AI assistance: Not applicable to this device.

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

Yes, a standalone performance assessment was done. The "performance testing" referenced pertains to the ER35 device itself, which performs measurements of otoacoustic emissions, tympanometry, and acoustic reflex. This is inherently a standalone assessment of the device's measurement capabilities. The text states: "Non-clinical and clinical validation was performed in accordance with recognized consensus standards for this type of device. The ER35 has been demonstrated to be in compliance with the following performance and safety standards..."

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

Not explicitly stated. Given the nature of the device (measuring cochlear and middle ear function), the "ground truth" would likely be established through recognized clinical diagnostic methods or reference standards for otoacoustic emissions, tympanometry, and acoustic reflex, possibly involving expert clinical assessment or other validated diagnostic equipment. The document mentions "variable audiometric profiles (i.e., subjects with normal range hearing and impaired hearing function)," implying clinical classifications were used.

8. The sample size for the training set

Not applicable as this is not an AI/machine learning device that requires a training set. The device is a physical instrument for measurement.

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

Not applicable for the same reason as point 8.

Summary of what is available and what is missing:

The document describes the submission as a 510(k) for an updated medical device (an audiometer) demonstrating substantial equivalence to predicate devices. The "study" mentioned is "performance testing" conducted to show compliance with medical device standards (ANSI S3.39-1987 (R2007), IEC 60601-1:2000, ANSI S3.6-2004, IEC 60645-5:2004) and to support substantial equivalence.

It does not provide the granular detail requested common for AI/ML device evaluations, such as specific performance metrics (sensitivity, specificity, AUROC), sample sizes for test sets, details on ground truth establishment by experts, or MRMC studies. The key statement regarding performance is: "Certain performance specifications may vary compared to predicate devices, but in these cases, sufficient performance testing has been done to support substantial equivalence determination. Non-clinical and clinical validation was performed in accordance with recognized consensus standards for this type of device."

Summary

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Etymotic Research, Inc. Page 7

3.0 510(K) SUMMARY

Date Prepared:	December 5, 2011
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Submitter Information:

Company Name:	Etymotic Research, Inc.
Company Address:	Etymotic Research, Inc.61 Martin LaneElk Grove Village, IL 60007
Contact Person:	Steve IsebergManager of Instrumentation ProductsEtymotic Research, Inc.Tel: (847) 228-0006Fax: (847) 228-6836s iseberg@etymotic.com

Device Information:

Trade Name:	ER35 ERO-SCAN Pro Hearing Test System
Common Name:	ER35 ERO-SCAN Pro (ER35)
Classification Name:	Audiometer and Auditory Impedance Tester
Device Class:	Class II, 510(k) Exempt, 21 CFR §874.1050Class II, 21 CFR §874.1090
Predicate Devices:	ERO•SCAN Otoacoustic Test Instrument (K980533;K010165)Etymotic Research, Inc.
	GSI 2000 (TympStar™) Middle Ear Analyzer (K000097)VIASYS Healthcare (formerly Grason-Stadler Inc.)
	Interacoustics AT235H Impedance Audiometer (K994254)Interacoustics A/S
Device Description:	The ER35 is a microprocessor-controlled instrumentdesigned to screen otoacoustic emissions, tympanicmembrane performance, and acoustic reflex. Testinformation is stored in memory, displayed on a graphicLCD, and can be printed by a printer or stored on a

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computer. The product is manufactured and delivered completely assembled to the retailer using materials and techniques widely used by manufacturers of hearing devices.

Intended Use: The ER35 is intended to be a test instrument that measures otoacoustic emissions, tympanic membrane performance (tympanometry), and acoustic reflex.

Indications for Use: The ER35 ERO•SCAN Pro Hearing Test System is indicated for testing of cochlear and middle ear function in infants, children, and adults by measuring otoacoustic emissions (OAEs), tympanometry, and acoustic reflex.

Comparison to Predicate Device:

All device parameters are similar for the product which is the subject of this 510(k) and the predicate devices. The intended use (including patient population) for the ER35 is consistent with those of the cited predicate devices.

Technological characteristics (i.e., design, material, and energy source) are identical to the ERO.SCAN Otoacoustic Test Instrument (K980533; K010165). The device is powered by 4 AA Alkaline cells, storing data (test records) via internal flash memory. The added functionality beyond OAEs does not affect the overall technological function and operation, compared to the predicate devices.

Certain performance specifications may vary compared to predicate devices, but in these cases, sufficient performance testing has been done to support substantial equivalence determination.

Non-clinical and clinical validation was performed in accordance with recognized consensus standards for this type of device. The ER35 has been demonstrated to be in compliance with the following performance and safety standards:

. Specifications for Instruments to Measure Aural Impedance and Admittance (Aural Acoustic Emissions) (ANSI S3.39-1987 (R2007)), American National Standards Institute, New York, 1996;

Performance testing:

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Medical Electrical Equipment, Part 1: General . Requirements for Safety (IEC 60601-1:2000), International Electrotechnical Commission, Geneva, 2000; and
. Specification for Audiometers (Dental/ENT) (ANSI S3.6-2004), American National Standards Institute, New York, 2004.

The ER35 is also in compliance with the following voluntary performance and safety standards: Instruments for the Measurement of Aural Acoustic Impedance / Admittance (IEC 60645-5:2004), International Electrotechnical Commission, Geneva, 2004.

Subjects tested included both male and female participants, an appropriate age range, and variable audiometric profiles (i.e., subjects with normal range hearing and impaired hearing function). No adverse effects or complications occurred. Performance data collected supports a substantial equivalence determination.

Conclusion:

The ER35 utilizes the same technology and has the same intended use as the cited predicate devices, and is therefore substantially equivalent (21 §CFR 807.92(a)(3)).

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with healthcare, with three parallel lines forming the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.

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

DEC 1 6 2011

Etymotic Research, Inc. c/o Mr. Jack Kent Becker & Associates Consulting, Inc. 2001 Pennsylvania Avenue NW, Suite 950 Washington, DC 20006

Re: K112733

Trade/Device Name: ER35 ERO●SCAN Pro Hearing Test System Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO: ETY Dated: September 20, 2011 Received: September 20, 2011

Dear Mr. Kent:

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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Page 2 - Mr. Jack Kent

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.htmi 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 Small Manufacturers, International and Consumer Assistance 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,

Malvina B. Eydelman, M.D.

Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K112733

2.0 STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): K112733

Device Name:

ER35 ERO.SCAN Pro Hearing Test System

Indications for Use:

Prescription Use X (Part 21 CFR §801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

KI12733 510(k) Number_

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.