The Grason-Stadler Inc. model GSI 70 AudioPath™ Hearing Screener is similar to and predicated upon the Grason-Stadler Inc. model GSI 60 Otoacoustic Emissions/Screening Audiometer, the GSI 37 Auto Tymp Middle Ear Analyzer, and the GSI 17 Pure Tone Screening Audiometer. The purpose of this device is to detect as well as track hearing loss and abnormal middle ear conditions in all ages of patients (from premature infants through adults). The instrument has combined a battery of testing capabilities such as Otoacoustic Emission Screening, Tympanometry, and Pure Tone Audiometry within one hand held instrument. The device is intended to be used by trained personnel within a medical or school environment. This device is not intended for use in prescribing or fitting assistive listening devices such as hearing aids, cochlear implants or wireless microphones, or to diagnose the causes of detected hearing losses.

Device Description

The Grason-Stadler Inc. model GSI 70 AudioPath™ Screener is similar to and predicated upon the Grason-Stadler Inc. model GSI 60 Otoacoustic Emissions/Screening Audiometer, the GSI 37 Auto Tymp Middle Ear Analyzer, and the GSI 17 Pure Tone Screening Audiometer. The purpose of this device is to detect as well as track hearing loss and abnormal middle ear conditions in all ages of patients (From premature infants through adults age). The instrument has a battery of testing capabilities such as Otoacoustic Emission Screening, Tympanometry, and Pure Tone Audiometry. The device is intended to be used by trained personnel in a medical or school environment. This device is not intended for use in prescribing or fitting assisstive listening devices such as hearing aids, cochlea implants or wireless microphones.

AI/ML Overview

This 510(k) summary does not contain a typical "study" that would demonstrate the device meets specific performance acceptance criteria in a quantitative sense as might be expected for an AI/ML device. Instead, it argues for substantial equivalence primarily based on technological characteristics and safety.

The document does not provide a dedicated study with quantitative acceptance criteria and results for the GSI 70 AudioPath™ Screener's effectiveness in detecting and tracking hearing loss. Instead, it asserts its effectiveness by stating it is "equivalent or better in effectiveness" than its predicate devices, which are individual audiometric products.

Here's a breakdown of the requested information based on the provided text, highlighting the absence of some details for this particular submission:

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

Since this is a 510(k) for a medical device that combines existing technologies rather than introducing a new diagnostic AI/ML algorithm, the acceptance criteria are focused on safety and functional equivalence to predicate devices, rather than performance metrics like sensitivity or specificity for hearing loss detection.

Acceptance Criteria Category	Reported Device Performance
Safety Compliance	Meets IEC 601-1, UL2601, and CSA 601-1-M90.
	Watchdog timers monitor the system and disable tone generation when disparity is detected to prevent excessive tone levels.
	Speakers are incapable of producing enough decibels to permanently damage the ear.
	Tympanometry pump volume is incapable of producing pressure exceeding ANSI S3.39 safe levels.
Electromagnetic Compatibility (EMC)	Certified to: - EMI EN55011 (Group 1 Class B requirements for medical equipment, conducted and radiated emissions). - IEC801-2 (ESD Susceptibility). - IEC801-3 (Radiated Electromagnetic Field Susceptibility). - IEC801-4 (Conducted Susceptibility to Line Transients).
CE Mark Compliance	Conforms with provisions of European Council Directive 93/42/EEC concerning medical devices.
Functional Equivalence (Audiometry)	"Tones are presented by a miniature speaker within the probe which if perceived is indicated by the patient using a response switch. Tone quality and frequency specified per ANSI S3.6." (Functionally equivalent to GSI 17 which uses a speaker headset).
Functional Equivalence (Tympanometry)	"Same as GSI 37" (Tones presented during pressurization of the ear by a miniature pump; response recorded by a microphone; tone quality and frequency controlled by ANSI S3.39).
Functional Equivalence (OAE Probe Design & DSP Software)	"Same as GSI 60" (Two speakers and a microphone present and record response from cochlea; uses GSI 60 DSP Software).
Overall Effectiveness	"Equivalent or better in effectiveness for the detection and tracking of hearing loss and abnormal middle ear conditions in all ages of patients (from premature infants through adults)" compared to the combined individual predicate devices (GSI 60, GSI 37, GSI 17). This is an assertion of equivalence rather than a quantitative performance metric from a study.

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

Not Applicable / Not Provided: The document does not describe a clinical study with a "test set" in the context of diagnostic performance (e.g., for sensitivity/specificity) for the GSI 70 AudioPath™ Screener itself. The submission relies on the established performance and safety of its predicate devices and the technical comparison to demonstrate substantial equivalence.

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 / Not Provided: No such ground truth establishment by experts for a specific test set is mentioned for the GSI 70 AudioPath™ Screener in this summary.

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

Not Applicable / Not Provided: No adjudication method is described as there's no clinical performance study presented that would require it.

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

No: No MRMC study was conducted or reported. This device is not an AI-assisted diagnostic tool for interpretation by human readers. It's a screening instrument.

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

Yes, implicitly, but not as an AI/ML algorithm: The device itself performs the audiometry, tympanometry, and OAE screenings standalone. Its "performance" is based on its ability to generate tones, measure responses, and process signals according to established audiological standards (ANSI S3.6, ANSI S3.39 for the respective functions) which are derived from the predicate devices. There isn't an "algorithm" in the modern AI/ML sense being evaluated independently, but rather the integrated functionality of the hardware and embedded software. The provided text doesn't offer quantitative standalone performance metrics like sensitivity/specificity for hearing loss detection from a new study for the combined device.

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

Not Applicable / Not Provided for this specific device: For the predicate devices, the "ground truth" would implicitly be the established audiological standards for detecting hearing loss and middle ear conditions. The current submission for the GSI 70 relies on the equivalence to these predicate devices rather than generating new ground truth data to validate new performance claims.

8. The sample size for the training set

Not Applicable / Not Provided: There is no mention of a "training set" as this device does not utilize a machine learning model that would require one.

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

Not Applicable / Not Provided: As there is no training set mentioned, this information is not relevant.

Summary

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"510(k) SUMMARY" Summary of Safety and Effectiveness

Submitter's Name & Address:	Grason-Stadler Inc.1 Westchester DriveMilford, N.H. 03055-3056			FEB 10 1998
Contact Person & Telephone:	Norman L. Schultz(603) 672-7303
Date Summary Prepared:	September 12, 1997
Device Name:	Classification Name - AudiometerCommon/Usual Name - Screening AudiometerProprietary Name - GSI 70 AudioPath™ Screener
Predicate Device:	Grason-Stadler Inc. model GSI 60 DPOAE system (ref. 510(k) #K934658S1) GSI 37 Auto Tymp (ref. 510(k) #K911095 ), and theGSI 17 Screening Audiometer (ref. 510(k) #K902540).

Device Description, intended Use & Effectiveness:

Technological Characteristics:

See attachment "A" for a comparison of the GSI 70 AudioPath™ Screener to the predicate device.

Safety:

The GSI 70 AudioPath™ Screener is designed to provide electrical safety to the patient as well as the user. The system is designed to meet the following standards related to electrical safety: IEC 601-1, UL2601, and CSA 601-1-M90. To prevent excessive tone levels within the ear the system is designed with watchdog timers that monitor the system and disable the tone generation when disparity is detected. Also, the speakers that are used within the probes are

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incapable of producing enough decibels to permanently damage the ear. The pump for the tympanometry function has been designed such that the volume of the pump is incapable of producing a pressure that would exceed the safe level as specified within ANSI S3.39.

The system will also be certified to the following standards:

EMI EN55011	Group 1 Class B requirements (medical equipment, conducted and radiatedemissions).
IEC801-2	ESD Susceptibility.
IEC801-3	Radiated Electromagnetic Field Susceptibility.
IEC801-4	Conducted Susceptibility to Line Transients.
CE Mark	Conforms with provisions of European Council Directive 93/42/EEC concerningmedical devices.

Summary of Effectiveness:

The GSI 70 AudioPath™ Screener is a consolidation of three current audiological products into one portable instrument making it equivalent or better in effectiveness for the detection and tracking of hearing loss and abnormal middle ear conditions in all ages of patients (from premature infants through adults).

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Attachment A Chart of Predicate Device Comparison

TechnologicalSpecification	GSI 17	GSI 37	GSI 60	GSI 70
Power Source	Powered by a lowvoltage DC wallmounted power supply.	Powered by a lowvoltage DC wallmounted power supply.	Powered by battery ora low voltage DC wallmounted powersupply.	Powered by re-chargeable battery.
Battery LowIndication.	None	None	LED lights on front ofinstrument.	Battery low indicator ondisplay.
SafetyCompliance.	IEC 601-1 and UL544	IEC 601-1 and UL544	IEC 601-1 andUL2601-1	IEC 601-1 and UL2601-1
Computer Interface	RS232	None	DSP Board pluggedinto printer interface.	IRDA communications
Audiometry	Technology used isspeaker headset thatpresent tones to patientwhich if perceived isindicated by a patientresponse switch. Tonequality and frequencyspecified per ANSI S3.6.	N/A	N/A	Tones are presented bya minature speakerwithin the probe which ifperceived is indicatedby the patient using aresponse switch. Tonequality and frequencyspecified per ANSI S3.6.
Tympanometry	N/A	Tones are presentedduring a pressurizationof the ear by aminature pump andresponse is recordedby a microphone. Tonequality and frequencycontrolled by ANSIS3.39.	N/A	Same as GSI 37
OAE Probe Design	N/A	N/A	Two speakers and amicrophone presentand record responsefrom cochlea of ear.	Same as GSI 60
DSP Software forOAE Function			GSI 60 DSP Software	Same
Supporting softwarefor OAE Function			Windows basedsoftware that graphsDP result, allowschanges to protocall,export of data, andchanges to patient ID.	Windows basedsoftware that showsresult, allows export ofdata, and updating ofpatient ID.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN..." is arranged in a circular fashion around the left side of the emblem, partially obscured.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 0 1998

Norman L. Schultz Senior Quality Engineer Grason-Stadler, Inc. 1 Westchester Drive Milford, New Hampshire 03055-3056 Re:

K974237 GSI 70 AudioPath TM Hearing Screener Dated: November 7, 1997 Received: November 12, 1997 Regulatory class: II Procode: 77 EWO, 21 CFR 874.1050 77 ETY, 21 CFR 874.1090

Dear Mr. Schultz:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the ensement 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). 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.

If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Portugions, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Onality System Regulation (OS) for Medical Devices: General regulation (21/CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marked predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 80) and additionally 809.10 for in vity diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and " advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premailed notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

Lillian Yin, Ph.D.

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

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510(k) Number (if known): イタフ 4 237

Device Name: GSI 70 AudioPath™ Hearing Screener

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David L. Simpson

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

Prescription Use

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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.