The Type 1077 device is indicated for use in the recording and automated analysis of human physiological data (screening auditory brainstem responses and/or otoacoustic emissions) necessary for the diagnosis of auditory and hearing-related disorders.

Distortion Product Otoacoustic Emissions and Transient Evoked Otoacoustic Emissions: The Type 1077 DPOAE module and TEOAE module can be used for patients of all ages, from children to adults, including infants and geriatric patients. It is especially indicated for use in testing individuals for whom behavioral audiometric results are deemed unreliable, such as infants, young children, and cognitively impaired adults.

Auditory Brainstem Response: The Type 1077 ABR module is especially intended for infants from 34 weeks (gestational age) up to 6 months of age.

When the device is used to screen infants. they should be asleep or in a quiet state at the time of screening. The device is intended for use by audiologists. ENT's and other healthcare professionals.

Device Description

The device is identical to our own device described in K122067. Only the indications for use has changed. The age range has been expanded. Different models of the device are capable of the following list of tests: AccuScreen TE (TEOAE), AccuScreen DP (DPOAE), AccuScreen TE/DP (TEOAE and DPOAE), AccuScreen ABR (ABR), AccuScreen ABR/TE (ABR and TEOAE), AccuScreen ABR/DP (ABR and DPOAE), AccuScreen ABR/TE/DP (ABR, TEOAE and DPOAE). The measurement application is controlled from a self-contained firmware (software) module installed in the handheld device. The firmware module can be configured to allow different OAE measurement types (DPOAE and/or TEOAE) by a license key stored in the device. For automated OAE measurements, the handheld device uses an OAE probe, designed and manufactured by PATH Medical GmbH. The OAE probe is fitted with an ear-tip (constructed of biocompatible material) and inserted in the ear canal of the patient. The AccuScreen device plays stimulus sounds in the ear canal via small speakers in the OAE probe. The AccuScreen device measures the patient's response to the stimulus sounds via a microphone in the probe. The measured response is processed by the AccuScreen device using statistics to help deter or not a hearing loss may be present. When the OAE measurement is a DPOAE measurement, the stimulus signal is composed of two pure tone signals, each presented by a speaker in the OAE measurement is a TEOAE measurement, the stimulus signal is a series of broadband clicks presented by one speaker in the OAE probe.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study details for the MADSEN AccuScreen Type 1077, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The clinical study's primary objective was to demonstrate comparable performance to the predicate device (Echo-Screen T, TA, TD, TDA, TC, K013977) across an expanded age range for OAE measurements. The acceptance criteria essentially translate to reaching a high percentage agreement with the predicate device.

Test Type	Acceptance Criteria (Implicit from comparator study design)	Reported Device Performance (Agreement with Predicate)
DPOAE	Assumed high agreement with predicate across age groups	Overall 93.8% agreement
TEOAE	Assumed high agreement with predicate across age groups	Overall 91.5% agreement

2. Sample Size and Data Provenance for Test Set

Sample Size for Test Set: 130 ears were tested. (This implicitly refers to 65 individuals if testing both ears.)
Data Provenance: Not explicitly stated, but the study was conducted to compare against a predicate device, which implies a prospective data collection for the comparison. The country of origin is not mentioned.

3. Number of Experts and Qualifications for Ground Truth for Test Set

The ground truth for the primary comparison was the predicate device's result.
In cases of discrepancy between the device under review (Type 1077) and the predicate, a "diagnostic OAE device" was used to re-test the subjects. The summary does not specify the number or qualifications of experts involved in operating this diagnostic device or interpreting its results to resolve discrepancies.

4. Adjudication Method for the Test Set

The primary method was a direct comparison between the Type 1077 and the predicate device.
For discrepant results (where Type 1077 and the predicate did not agree), a "diagnostic OAE device" was used for re-testing. This acts as an adjudication method, essentially using a third, presumably more accurate or established, method to determine the "correct" result in ambiguous cases. The document does not specify if expert consensus was involved in interpreting the diagnostic OAE device results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This study focuses on device performance comparison rather than human reader improvement with or without AI assistance. The device is an automated screening tool, not an AI-assisted diagnostic aid for human readers.

6. Standalone Performance Study

Yes, a standalone performance was done in the sense that the device's output (Pass/Refer for DPOAE and TEOAE) was directly compared to the predicate device's output. The goal was to establish that the Type 1077 provides results comparable to a legally marketed equivalent device without human intervention in the interpretation of the screening result.

7. Type of Ground Truth Used

The primary "ground truth" for the comparison was the result from the predicate device (Echo-Screen).
For discrepant cases, the ground truth was derived from re-testing using a "diagnostic OAE device." This implies a more definitive diagnostic result was used to resolve discrepancies between the two screening devices.

8. Sample Size for the Training Set

The document does not provide information about a training set. This is a medical device clearance for an auditory stimulator and analysis system, not a machine learning algorithm that typically requires a distinct training set. The device likely relies on established signal processing and statistical methods for OAE analysis, which were developed and validated during its initial design (pre-K122067 and K122067).

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

Not applicable, as no training set is mentioned in the provided documentation.

Summary

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

510(K) Summary, 510(k) K132957 Submitter: GN Otometrics A/S Hoerskaetten 9 Taastrup, DENMARK DK-2630 Registration number: 9612197 (US) Phone: (612) 865-7862 Contact: Tom Riniker, Director RA/OA triniker@gnotometrics.com Date Prepared: February 20, 2014

Identification of the Device:

Proprietary-Trade Name: MADSEN AccuScreen Type 1077 Classification Name: Stimulator, Auditory, Evoked Response Common/Usual Name: Auditory Evoked Response Stimulator. Product code: GWJ Classification Panel: Neurology Device Class: Class II FDA CFR Section: FDA 21CFR 882.1900

Equivalent legally marketed devices:

Predicate Devices
Product Name:	Echo-Screen T, TA, TD, TDA, TC	Type 1077 AccuScreen
510(k) Number:K013977 K122067
Classification Name:	Stimulator, Auditory, Evoked	Stimulator, Auditory, Evoked
	Response	Response
FDA CFR Section:	FDA 21CFR 882.1900	FDA 21CFR 882.1900
Device Product Code:	GWJ	GWJ
Manufacturer Name:	Fischer-Zoth Audiologic Systems	GN Otometrics

Description of the Device: The device is identical to our own device described in K122067. Only the indications for use has changed. The age range has been expanded. Different models of the device are capable of the following list of tests:

Device type	Test types
AccuScreen TE	TEOAE (Transiently Evoked Otoacoustic Emissions)
AccuScreen DP	DPOAE (Distortion Product Otoacoustic Emissions)
AccuScreen TE/DP	TEOAE and DPOAE
AccuScreen ABR	ABR (Auditory Brainstem Response)
AccuScreen ABR/TE	ABR and TEOAE
AccuScreen ABR/DP	ABR and DPOAE
AccuScreen ABR/TE/DP	ABR, TEOAE and DPOAE

The measurement application is controlled from a self-contained firmware (software) module installed in the handheld device. The firmware module can be configured to allow different OAE measurement types (DPOAE and/or TEOAE) by a license key stored in the device.

For automated OAE measurements, the handheld device uses an OAE probe, designed and manufactured by PATH Medical GmbH. The OAE probe has been granted marketing clearance by the

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

FDA following the submission of a 510(k) (K100661). The OAE probe is fitted with an ear-tip (constructed of biocompatible material) and inserted in the ear canal of the patient. The AccuScreen device plays stimulus sounds in the ear canal via small speakers in the OAE probe. The AccuScreen device measures the patient's response to the stimulus sounds via a microphone in the probe. The measured response is processed by the AccuScreen device using statistics to help deter or not a hearing loss may be present.

When the OAE measurement is a DPOAE measurement, the stimulus signal is composed of two pure tone signals, each presented by a speaker in the OAE measurement is a TEOAE measurement, the stimulus signal is a series of broadband clicks presented by one speaker in the OAE probe.

While the device has not changed from our 2012 510(k) submission K122067, the target population has been expanded as described in the indications statement directly below:

Indications for Use:

Auditory Brainstem Response:

The Type 1077 ABR module is especially intended for infants from 34 weeks (gestational age) up to 6 months of age.

Safety and Effectiveness, comparison to predicate device has the same indications for use as the predicate device K013977and employs similar technology to accomplish the same tasks. The device is identical to our product described in K122067 except for the indications statement. We have expanded the subject population to include persons of all ages. A detailed comparison table is provided below.

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

Substantial Equivalence Chart

	Echo-Screen T, TA, TD,TDA, TC, Fischer-ZothAudiologic SystemsK013977	MADSEN AccuScreen Type1077 K122067	MADSEN AccuScreen Type1077
Indicationsfor Use:	The Fischer-Zoth AudiologicSystems model family Echo-Screen T consisting of Echo-screen T, Echo-Screen TA,Echo-Screen TD, Echo-ScreenTDA and Echo-Screen TC arebased upon OtoacousticEmissions (OAE) and AuditoryBrainstem Response (ABR)technology. The device isintended to screen hearing fornewborns through adults,including geriatric patients. Thedevice does not measurehearing per se, but helps todetermine whether or not ahearing loss may be present.The "Echo-Screen T" productfamily consists of handheld,automated OAE and ABRbased hearing screeningsystems which are easy to use.The measurement flow is menuguided and the evaluation isbased upon signal statistics.The "Echo-Screen T" devicesare intended to be used bytrained personnel in a medicalor school environment. The"Echo-Screen T" models arenot intended for fitting assistivelistening devices such ashearing aids or cochlearimplants.	AccuScreen is a portableinstrument used to screen infantsfor hearing loss. The instrumentuses the Distortion ProductOtoacoustic Emissions (DPOAE),Transient Evoked OtoacousticEmissions (TEOAE) andAuditory Brainstem Response(ABR) technologies. Theinstrument is intended forscreening infants from 34 weeks(gestational age) up to 6 monthsof age that are well enough to beready for discharge from thehospital. Infants should be asleepor in a quiet state at the time ofscreening. AccuScreen isintended for use by audiologists,ENTs and other health careprofessionals.	The Type 1077 device is indicatedfor use in the recording andautomated analysis of humanphysiological data (screeningauditory brainstem responses and/orotoacoustic emissions) necessary forthe diagnosis of auditory and hearing-related disorders.Distortion Product OtoacousticEmissions and Transient EvokedOtoacoustic Emissions:The Type 1077 DPOAE module andTEOAE module can be used forpatients of all ages, from children toadults, including infants and geriatricpatients. It is especially indicated foruse in testing individuals for whombehavioral audiometric results aredeemed unreliable, such as infants,young children, and cognitivelyimpaired adults.Auditory Brainstem Response:The Type 1077 ABR module isespecially intended for infants from34 weeks (gestational age) up to 6months of age.When the device is used to screeninfants, they should be asleep or in aquiet state at the time of screening.The device is intended for use byaudiologists, ENT's and otherhealthcare professionals.
Config-uration	Hand held battery operated,rechargeable battery	Hand held battery operated,rechargeable battery	Hand held battery operated,rechargeable battery
	Echo-Screen T, TA, TD,TDA, TC, Fischer-ZothAudiologic SystemsK013977	MADSEN AccuScreen Type1077 K122067	MADSEN AccuScreen Type1077
Photo	Image: Echo-Screen T, TA, TD, TDA, TC, Fischer-Zoth Audiologic Systems K013977	Image: MADSEN AccuScreen Type 1077 K122067	Image: MADSEN AccuScreen Type 1077
TestsPerformed	DPOAE, TEOAE, ABR	SAME	SAME as MADSEN AccuScreenType 1077 K122067
Weight	Echo-Screen includingbattery pack and probe: 550g(1.2 lbs)	240 g (8.5 oz) excludingbattery280 g (9.9 oz) includingbattery	SAME as MADSEN AccuScreenType 1077 K122067
Size	Echo-Screen incl. batterypack: 230 x 95 x 53 mm(9.06 x 3.74 x 2.09 inches)	202 x 73 x 30 mm (8 x 2.8 x1.2 inches)	SAME as MADSEN AccuScreenType 1077 K122067
Battery	6V 1500mAh NiMH,exchangeable	Rechargeable Li-ion 3.7V/1800 mAh (6.7 Wh), fullycharged	SAME as MADSEN AccuScreenType 1077 K122067
Operatingtime	> 10 hrs with fully chargedbattery	8 hours of continuous use(based on a typical usescenario. Actual use caninfluence the battery lifetime.)	SAME as MADSEN AccuScreenType 1077 K122067
Display	128 x 64 dot graphic LCDw/ switchable backlight	Color, TFT, touch screen,Dimensions: 89.4 mm (3.5inches) Resolution: 240 x 320pixels Backlight type: LED,adjustable	SAME as MADSEN AccuScreenType 1077 K122067
Datamemory	128 kB built-in flashmemory, unlimited storagetime	Patient memory capacity:Max. 250 patientsTest memory capacity: Min.500 tests	SAME as MADSEN AccuScreenType 1077 K122067
Interfaces	RS232 up to 115 kbps,infrared (optionalmodem feature available)	IR data transmission todocking station - USBinterface from docking station	SAME as MADSEN AccuScreenType 1077 K122067

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

្រឡូ

র প্র

网站

19 - 16 ン (2) 2017 12:00 13:00 10:00 10:00 10:00 10:00 10:00 10:00 10:00 10:00 10:00 10:00 10:00 10:00 10:00 10:00 10:00 10:00 10:00 10:00 10:00 10:00 10:00 10:00 10:00 10:00 10:00

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

	Echo-Screen T, TA, TD,TDA, TC, Fischer-ZothAudiologic SystemsK013977	MADSEN AccuScreen Type1077 K122067	MADSEN AccuScreen Type1077
Safetystandards	EN 60601-1 + A1 + A2EN 60601-1-2 EN 60601-2-26 EN 60601-2-40	• EN 60601-1, InternallyPowered, Type BF, IPXO• U2601-1; CAN/CSA-C22.2NO 601.1-90,• IEC 60601-2-26• IEC 60601-2-40EMC: EN 60601-1-2	SAME as MADSEN AccuScreenType 1077 K122067

Summary of non-clinical testing: (Performed in K122067): Standards testing demonstrated compliance with the safety standards in the table above, as well as:

ISO 10993-5 Biological Evaluation of Medical Devices: Tests for Cytotoxicity

ISO 10993-10 Biological Evaluation f Medical Devices: Tests for Irritation and delayed-type hypersensitivity ISO 10993-1 Biological Evaluation of Medical Devices: Evaluation and Testing

ISO 10993-12 Biological Evaluation of Medical Devices: Sample Preparation and Reference Materials

Bench testing also demonstrated compliance with system hardware and software specifications. A revised risk analysis was also conducted.

Summary of clinical testing: Clinical testing was performed to confirm that the Type 1077 can produce valid results in patients of all age groups and performed in a comparable manner to the predicate Echo-Screen, Fischer-Zoth Audiologic Systems K013977. Subjects were tested on Type 1077 and again on the Echo-Screen. The goal was to test and compare a minimum of 16 ears per age group. Overall 130 ears were tested and compared, with overall DPOAE agreement of 93.8% and TEOAE agreement of 91.5%. The results are shown below.

Age	6 mo-9 y	10-19 y	20-39 y	40-59 y	>59 y	Total
Number of earsrecommended	20	20	20	20	20	100
Achieved/tested	26	22	30	36	16	130
DPOAEagreement	26/26(100.0 %)	22/22(100.0 %)	30/30(100.0 %)	33/36(91.7 %)	11/16(68.8 %)	122/130(93.8 %)
TEOAEagreement	26/26(100.0 %)	22/22(100.0 %)	30/30(100.0 %)	30/36(83.3 %)	11/16(68.8 %)	119/130(91.5 %)

After identifying that there were some discrepant results between our device and the predicate device. (40-59 y & >59 y age groups) we used a diagnostic OAE device to re-test all test subjects for which there was not a match between the Type 1077 and predicate device. Our intent was to determine which of the two devices (Type 1077 or Predicate) provided the correct result. After performing the diagnostic OAE testing, we discovered that the predicate device was found to have provided incorrect results in 11 of the 19 cases. Overall the results showed that the Type 1077 performed in a comparable manner to the Echo-Screen on the expanded patient population shown in the revised indications for use.

Conclusion: After analyzing bench testing, safety, EMC, software, and clinical validation testing we conclude that the MADSEN AccuScreen Type 1077 (with expanded indications for use) is as safe and effective as the predicate device, and has essentially the same technological characteristics, thus rendering it substantially equivalent to the predicate devices.

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

Public Health Service

Food and Drug Administmlion 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MID 20993-002

February 27, 2014

GN Otometrics A/S c/o Daniel Kamm, P.E. 8870 Ravello Ct. Naples. FL 34114

Re: K132957

Trade/Device Name: Madsen accuscreen type 1077 Regulation Number: 21 CFR 882.1900 Regulation Name: Evoked Response Auditory Stimulator Regulatory Class: Class II Product Code: GWJ Dated: January 20, 2014 Received: January 28, 2014

Dear Mr. Kamm:

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. Ilisting 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 (sec above) into cither 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.

{6}------------------------------------------------

Page 2 - Daniel Kamm, P.E.

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.htm 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.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 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,

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

{7}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K132957

Device Name

MADSEN AccuScreen Type 1077

Indications for Use (Describe)

Distortion Product Otoacoustic Emissions and Transient Evoked Otoacoustic Emissions:

The Type 1077 DPOAE module and TEOAE module can be used for patients of all ages, from children to adults, including infants and geriatric patients. It is especially indicated for use in testing individuals for whom behavioral results are deemed unreliable, such as infants, young children, and cognitively impaired adults.

Auditory Brainstem Response:

The Type 1077 ABR module is especially intents from 34 weeks (gestational age) up to 6 months of age.

When the device is used to screen infants, they should be asleep or in a quiet state at the time of screening. The device is intended for use by audiologists, ENT's and other healthcare professionals.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLYConcurrence of Center for Devices and Radiological Health (CDRH) (Signature)	Digitally signed by Shuchen Peng -SDN: c=US, o=U.S. Government, ou=HHS, ou=FDA,ou=People, cn=Shuchen Peng -S,0.9.2342.19200300.100.1.1=1300399622 .Date: 2014.02.27 15:53:15 -05'00'Shuchen Peng -S
--------------------------------------------------------------------------------------------------	-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

{8}------------------------------------------------

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."

Regulation Number and Section

§ 882.1900 Evoked response auditory stimulator.

(a)
Identification. An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.(b)
Classification. Class II (performance standards).