AccuScreen is a portable instrument used to screen infants for hearing loss. The instrument uses the Distortion Product Otoacoustic Emissions (DPOAE), Transient Evoked Otoacoustic Emissions (TEOAE) and Auditory Brainstem Response (ABR) technologies. The instrument is intended for screening infants from 34 weeks (gestational age) up to 6 months of age that are well enough to be ready for discharge from the hospital. Infants should be asleep or in a quiet state at the time of screening. AccuScreen is intended for use by audiologists, ENTs and other health care professionals.

Device Description

GN Otometrics Type 1077 AccuScreen is a handheld examination system based on Otoacoustic Emissions (OAE) and/or Auditory Brainstem Response (ABR). The Type 1077 AccuScreen is designed to be easy to use, and employs automated OAE and/or ABR tests. The measurement flow is menu-guided and evaluation is based upon signal statistics. The Type 1077 AccuScreen is designed for trained personnel in a medical or home environment to examine hearing in infants from 34 weeks (gestational age) up to 6 months of age that are well enough to be ready for discharge from the hospital.

The Type 1077 AccuScreen OAE system consists of the AccuScreen handheld device, a Docking Station with mains adapter, OAE probe with disposable probe- and ear-tips, and AccuLink software for installation on a PC. When ABR is included an optional ear coupler cable and disposable ear couplers can be included in the system, as well.

The AccuScreen handheld device comes in two hardware versions; one for OAE screening only and one for both OAE and ABR screening. Both versions are based on a common hardware platform (printed circuit board), but with different configurations.

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 determine whether or not a hearing loss may be present.

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

For automated ABR measurements, the device uses the OAE probe, or an ABR ear coupler cable for providing the acoustical stimulus for the patient. When the ABR ear coupler cable is used, its speakers are inserted in the ABR Ear Couplers, which are then placed over the patient's ear with a biocompatible adhesive gel on the ear coupler rim. The stimulus signal is a series of broadband clicks and the AccuScreen device measures the patient's response as an electrical signal from three electrodes placed on the head of the patient. The measured response is processed by the AccuScreen device using statistics to help determine whether or not a hearing loss may be present.

The 1077 Docking Station serves as a means of providing power to charge the rechargeable battery in the AccuScreen handheld device. The Docking Station also provides an interface to an optional label printer or to a PC. The label printer is used for printing test results from the AccuScreen handheld device. The PC is used for transferring patient demographical data to the AccuScreen handheld device and for collecting measurement results from the AccuScreen handheld device by using the AccuLink PC software.

AI/ML Overview

The provided text is a 510(k) summary for the GN Otometrics Type 1077 AccuScreen device. It primarily focuses on demonstrating substantial equivalence to a predicate device (Echo-Screen) by comparing design, functionality, and compliance with various medical device standards. Crucially, this document does not contain details about specific acceptance criteria or a dedicated study proving the device meets performance claims through clinical evaluation.

The “performance data” mentioned refers to compliance with safety, EMC, software lifecycle, usability, and biocompatibility standards, rather than clinical performance metrics like sensitivity or specificity for hearing loss detection against a ground truth.

Therefore, many of the requested sections cannot be answered from the provided document.

Here's what can be extracted and what cannot:

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

Based on the provided document, there are no specific performance-based acceptance criteria (e.g., sensitivity, specificity, accuracy) or reported clinical performance metrics for the device to screen for hearing loss. The document focuses on demonstrating substantial equivalence through:

Design and principal similarity to the predicate device (Echo-Screen).
Compliance with recognized electrical, software, and biocompatibility standards.

The "performance data" section in the document refers to compliance with standards, not clinical performance metrics.

Acceptance Criteria (as implied by the document for substantial equivalence)	Reported Device Performance (as stated in the document)
Design and Working Principles: Similar to predicate (Echo-Screen)	* "Design and working principals of Type 1077 AccuScreen are very similar to the Echo-Screen with the technological improvements added to the design."
Measurement Methods: Utilizes DPOAE, TEOAE, ABR (same as predicate)	* "Both systems use a battery driven handheld and portable device with attached OAE probe- and ABR electrode cables."
	* "From a measurement perspective, the two devices utilize the same measurement methods (DPOAE, TEOAE and ABR) and use very similar probes and electrodes."
Signal Processing and Detection: Similar to predicate	* "The signal processing and detection methods within the devices are also very similar, and both devices give a Pass/Refer result as an automated screening result."
Compliance with Safety Standards: IEC 60601-1	* Compliance affirmed: "equivalent results... evaluated to determine compliance with... standards clearly demonstrates the substantial equivalence."
Compliance with EMC Standards: IEC 60601-1-2	* Compliance affirmed.
Compliance with Programmable Medical Systems Standards: IEC 60601-1-4	* Compliance affirmed.
Compliance with Medical Device Software Life Cycle Process Standards: IEC 62304	* Compliance affirmed.
Compliance with Usability Engineering Standards: IEC 62366	* Compliance affirmed.
Compliance with Biological Evaluation Standards (Cytotoxicity): ISO 10993-5	* Compliance affirmed.
Compliance with Biological Evaluation Standards (Irritation/Hypersensitivity): ISO 10993-10	* Compliance affirmed.
Compliance with Biological Evaluation Standards (Evaluation/Testing): ISO 10993-1	* Compliance affirmed.
Compliance with Biological Evaluation Standards (Sample Prep/Reference Materials): ISO 10993-12	* Compliance affirmed.

The following information cannot be determined from the provided text:

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

The document does not describe a clinical performance study with a test set. It relies on demonstrating substantial equivalence to a predicate device and compliance with standards.

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 applicable, as no clinical performance study with a test set and ground truth establishment is described.

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

Not applicable, as no clinical performance study with a test set is described.

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

This device is an automated screening tool, not an AI assistance tool for human readers. No MRMC study is mentioned.

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

The document implies standalone performance comparison to the predicate, as both are automated screening devices ("both devices give a Pass/Refer result as an automated screening result"). However, specific performance metrics (sensitivity, specificity) of this standalone operation are not provided beyond the claim of being "very similar" to the predicate. No dedicated standalone validation study with concrete performance data is detailed.

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

Not applicable, as no clinical performance study with a ground truth is described.

8. The sample size for the training set

This document describes a device whose "measurement application is controlled from a self-contained firmware (software) module." There is no mention of a machine learning or AI model that would require a "training set" in the conventional sense. The device's "statistics" for determining hearing loss are likely based on pre-programmed algorithms and thresholds, not a learned model from a large training dataset.

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

Not applicable, as no training set for a machine learning model is mentioned.

Summary

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K|22 067

Section 5.0

510(k) Summary

otometrics SEP 2 7 2012

510(k) Information

New Device
Submission Type:	Traditional
Reason for Submission:	New Device
Device/Trade Name:	Type 1077 Accuscreen / Type 1077 MadsenAccuscreen
Common Name:	Evoked Response Auditory Stimulator
Classification Name:	Stimulator, Auditory, Evoked Response
FDA CFR Section:	FDA 21CFR 882.1900
Classification Panel:	Neurology
Device Class:	Class II
Device Product Code:	GWJ

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

Submitter/Owner:	GN Otometrics A/S
	Hoerskaetten 9
	DK-2630 Taastrup
	Denmark
Establishment Registration No .:	9612197
Contact: »	Tom Riniker
	Director RA/QA
	triniker@gnotometrics.com
	(612) 865-7862
Date of Preparation:	October 10, 2011

Dybendalsvænget 2 DK-2530 Taastrup Demmark

5 -

Phone + 45 45 75 55 55 www.otometrics.com info@gnotometrics.dk + 45 45 75 55 59 Fax

Co. Reg. No. 25384687

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

Section 5.0 510(k) Summary

Image /page/1/Picture/1 description: The image shows the word "otometrics" in a sans-serif font. Above and to the right of the word is a black abstract shape. The shape appears to be a stylized representation of an ear. The text is in a simple, clean font, making it easily readable.

Description of the Device

GN Otometrics Type 1077 AccuScreen is a handheld examination system based on Otoacoustic Emissions (OAE) and/or Auditory Brainstem Response (ABR). Identical techniques are used - among others - on Fischer-Zoth model, Echo-Screen. The Type 1077 AccuScreen is designed to be easy to use, and employs automated OAE and/or ABR tests. The measurement flow is menu-guided and evaluation is based upon signal statistics. The Type 1077 AccuScreen is designed for trained personnel in a medical or home environment to examine hearing in infants from 34 weeks (gestational age) up to 6 months of age that are well enough to be ready for discharge from the hospital.

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 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 determine whether or not a hearing loss may be present.

GN Otometrics A/S

Dybendalsvænget 2 DK-2630 Taastru Denmark

www.otometrics.com Phone info@gnotometrics.dk Fax

Co. Reg. No. 25384687

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Section 5.0 510(k) Summary

Image /page/2/Picture/1 description: The image shows the word "otometrics" in a sans-serif font. To the right of the word is a black abstract shape that looks like three circles connected together. The word is in lowercase letters and is positioned horizontally. The image is in black and white.

Intended Use

Comparison to Predicate Device

The system most similar to the Type 1077 AccuScreen in terms of system components, features and measurement principals is the Echo-Screen (Models T, D, TD, TA, DA, TDA) from Fischer-Zoth Audiologic Systems. The Echo-Screen device has been granted marketing clearance by FDA following the submission of a 510(k).

The following table identifies the existing models of the Echo-Screen device and the corresponding models planned for the 1077 Accuscreen. With the exception of the 1077 Accuscreen ABR model for ABR screening only, all other model combinations between the two devices are the same.

GN Otometrics A/S

Dybendalsvænget 2 DK-2630 Taastrup Denmark

45 45 75 55 55 | www.otometrics.com Phone info@gnotometrics.dk Fax + 45 45 75 55 59

Co. Rog. No. 25384687

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Section 5.0

Image /page/3/Picture/1 description: The image shows the word "otometrics" in lowercase letters, with a stylized atom-like symbol to the right of the word. The symbol consists of a central circle with three smaller circles attached to it, resembling an atom or a stylized flower. The text and symbol are both in black against a white background.

510(k) Summary

Echo-ScreenModelName	Echo-ScreenDescription	Echo-ScreenModel No.	AccuscreenModelName	AccuscreenDescription	AccuscreenModel No.
Echo-Screen T	Echo-ScreenTEOAE	010109-T	AccuscreenTE	AccuscreenTEOAE	8-04-13900
	Echo-ScreenDPOAE	010109-D	AccuscreenDP	AccuscreenDPOAE	8-04-13901
Echo-Screen TD	Echo-ScreenTEOAE &DPOAE	010109-TD	AccuscreenTE/DP	AccuscreenTEOAE &DPOAE	8-04-13902
Echo-Screen TA	Echo-ScreenTEOAE &AABR	010109-TA	AccuscreenABR/TE	AccuscreenABR &TEOAE	8-04-13904
	Echo-ScreenDPOAE &AABR	010109-DA	AccuscreenABR/DP	AccuscreenABR &DPOAE	8-04-13905
Echo-ScreenTDA	Echo-ScreenTEOAE,DPOAE, &AABR	010109-TDA	AccuscreenABR/TE/DP	AccuscreenABR,TEOAE, &DPOAE	8-04-13906
			AccuscreenABR	AccuscreenABR	8-04-13903

The design and working principals of Type 1077 AccuScreen are very similar to the Echo-Screen with the technological improvements added to the design. This similarity is due largely to the fact that the same engineers at Fischer-Zoth Audiologic Systems that designed the Echo-Screen also provided significant input to the design of the 1077 Accuscreen.

Both systems use a battery driven handheld and portable device with attached OAE probe- and ABR electrode cables.

From a measurement perspective, the two devices utilize the same measurement methods (DPOAE, TEOAE and ABR) and use very similar probes and electrodes. The signal processing and detection methods within the devices are also very similar, and both devices give a Pass/Refer result as an automated screening result.

The primary difference between the two devices is in the mechanical design, display technology and graphical user interface. Here the Echo-Screen uses a larger standard off-the-shelf box for housing, a small and low resolution monochrome display and the off the short of the reading, while the Type 1077 AccuScreen uses a

GN Otometrics A/S

Dybendalsvænget 2 DK-2630 Taastrup Denmark

Phone + 45 45 75 55 55 | www.otometrics.com info@gnotometrics.dk + 45 45 75 55 59 Fax

Co. Reg. No. 25384687

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

Section 5.0 510(k) Summary

Image /page/4/Picture/1 description: The image shows the word "otometrics" in a sans-serif font. Above and to the right of the word is a black abstract shape that resembles an ear. The word is in lowercase letters and is centered horizontally below the shape. The image is in black and white.

specially designed plastic cabinet, a larger, higher resolution color display and the user interface is via a touch sensitive screen.

Substantial Equivalence Performance Data

Substantial equivalence to the Echo-Screen is based not only on a side-by-side design comparison, but also on the compliance of both devices to the standards listed below:

1.	IEC 60601-1	Medical Electrical Equipment. Part 1: Generalrequirements for safety
2.	IEC 60601-1-2	Medical Electrical Equipment. Part 1: Generalrequirements for safety. 1. Collateral standard:Electromagnetic compatibility - Requirements and tests
3.	IEC 60601-1-4	Medical Electrical Equipment. Part 1: Generalrequirements for safety. 4. Collateral standard:Programmable electrical medical systems (Designprocess)
4.	IEC 62304	Medical device software life cycle process
5.	IEC 62366	Medical devices – Application of usability engineeringto medical devices
6.	ISO 10993-5	Biological Evaluation of Medical Devices: Tests forCytotoxicity
7.	ISO 10993-10	Biological Evaluation of Medical Devices: Tests forIrritation and delayed-type hypersensitivity
8.	ISO 10993-1	Biological Evaluation of Medical Devices: Evaluationand Testing
9.	ISO 10993-12	Biological Evaluation of Medical Devices: SamplePreparation and Reference Materials

The equivalent results from both the Type 1077 Accuscreen and the Echo-Screen The equivalent results from of all evaluated to determine compliance with the of other woned standards clearly demonstrates the substantial equivalence between these two devices.

Based on the results of testing to the applicable requirements of the aforementioned Bused on the rodate of toompliance to them, we hereby conclude that the Type 1077 Accuscreen device is substantially equivalent to the identified predicate device.

Dybendalsvænget. 2 DK-2630 Taastrup Dennatk

ನ

Phone 45 45 75 55 55 www.otometrics.com + 45 45 75 55 59 Info@gnotometrics.dk Fax

Co. Reg. No. 25384687

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

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

SEP 27 2012

GN Otometrics c/o Ms. Paula Wilkerson, RAC, CRA Program Manager Intertek Testing Services NA, Inc. 2307 East Aurora Road, Unit B7 Twinsburg, OH 44087

Re: K122067

Trade/Device Name: Type 1077 Accuscreen Regulation Number: 21 CFR 882.1900 Regulation Name: Evoked Response Auditory Stimulator Regulatory Class: Class II Product Code: GWJ Dated: August 6, 2012 Received: August 7, 2012

Dear Ms. Wilkerson:

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 - Ms. Paula Wilkerson, RAC, CRA

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Qub. Riem, us for

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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K122067

Section 4.0 Indications for Use

510(k) Number (if known):

Device Name: Type 1077 AccuScreen

Indications for Use:

Type 1077 AccuScreen

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)

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

K122067

510(k) Number.

4 - 1

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).