The Grason-Stadler Inc. model GSI SA60 Otoacoustic Emissions/Screening Audiometer is similar to and predicated upon the Grason-Stadler Inc. model GSI 60 Otoacoustic Emissions/Screening Audiometer. The GSI SA60 is to be used as part of an audiometric test battery. The purpose of this device is to assess the status of cochlear function by presenting an acoustic stimulus (i.e. the primary tone pair) to evoke an otoacoustic emission (i.e. the distortion product) which is measured. The GSI 60 and the GSI SA60 utilize a probe containing a microphone and two (2) independent speakers (one for each primary tone) to present the acoustic stimulus and measure for the presence of an evoked otoacoustic emission.

Device Description

The Grason-Stadler Inc. model GSI SA60 Otoacoustic Emissions/Screening Audiometer is similar to and predicated upon the Grason-Stadler Inc. model GS1 60 Otoacoustic Emissions/Screening Audiometer. The GSI SA60 is to be used as part of an audiometric test battery. The purpose of this device is to assess the status of cochlear function by presenting an acoustic stimulus (i.e. the primary tone pair) to evoke an otoacoustic emission (i.e. the distortion product) which is measured. The GSI 60 and the GSI SA60 utilize a probe containing a microphone and two (2) independent speakers (one for each primary tone) to present the acoustic stimulus and measure for the presence of an evoked otoacoustic emission.

AI/ML Overview

Here's an analysis of the provided text regarding the GSI SA60 DPOAE System, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It does not contain detailed information about a comprehensive clinical study to prove the device meets specific performance acceptance criteria in the way a clinical trial report would. Instead, it relies on the predicate device's established effectiveness and similarities between the new and predicate device.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Electrical Safety Standards:	Meets or designed to meet: - IEC 601-1 (medical electrical equipment) - UL2601 (medical electrical equipment) - CSA 601-1-M90 (medical electrical equipment) - Preliminary design review with competent test laboratory indicates design will meet requirements for IEC 601-1 class 1, type B medical instrument.
Information Technology Equipment Safety Standards (for companion notebook computer):	Specified to meet: - IEC 950 - UL1950 - CSA 950 - CE mark
Electromagnetic Compatibility (EMC) Standards:	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 (Conforms with provisions of 89/336/EEC Electromagnetic Compatibility Directive)
Effectiveness (Cochlear Function Assessment):	Equivalent or better in effectiveness compared to the predicate device (Grason-Stadler Inc. model GSI 60 DPOAE system). Rationale: Operates in the same manner as the GSI 60, with the primary difference being enhanced portability due to direct compatibility with a notebook computer without a docking station.
Intended Use:	To be used as part of an audiometric test battery to assess the status of cochlear function by presenting an acoustic stimulus to evoke and measure an otoacoustic emission.

Study Details (Based on the 510(k) Summary)

Given that this is a 510(k) submission, the "study" referred to is primarily the comparison to the predicate device and the demonstration of equivalent performance and safety characteristics. A traditional "study" in the sense of a large-scale clinical trial with acceptance criteria for diagnostic accuracy (e.g., sensitivity, specificity) is not described.

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not explicitly stated as a separate "test set" in the context of a performance study. The evaluation appears to be based on engineering testing for safety and EMC, and a functional comparison demonstrating operational equivalence to the predicate device.
- Data Provenance: Not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for the type of evaluation described. No human expert "ground truth" was established for a clinical performance test set. The effectiveness claim rests on the established performance of the predicate device.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable.
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 MRMC study was done. This device is an Otoacoustic Emissions/Screening Audiometer; it directly measures physiological responses, not an AI-interpreted image or signal that requires human reader adjudication.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The device itself is a measurement instrument. Its performance is inherent to its design and how accurately it can acquire and process the otoacoustic emissions. The "effectiveness" is linked to its ability to perform this measurement, which is directly compared to the predicate device's ability to do the same. So, in a sense, its standalone functional equivalency to the predicate device was evaluated.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the effectiveness claim is the established clinical performance and safety of the predicate device (GSI 60 DPOAE system). The new device is stated to operate "in the same manner" and is thus "equivalent or better in effectiveness." For safety and EMC, the ground truth is adherence to international and national standards.
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set in the conventional sense.
How the ground truth for the training set was established:
- Not applicable.

Summary

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K970324

JUN - 6 1997

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

Submitter's Name & Address:	Grason-Stadler Inc.1 Westchester DriveMilford, N.H. 03055-3056
Contact Person & Telephone:	Norman L. Schultz(603) 672-7303
Date Summary Prepared:	January 22, 1997
Device Name:	Classification Name - AudiometerCommon/Usual Name - Otoacoustic Emissions/ScreeningAudiometerProprietary Name - GSI SA60 DPOAE System
Predicate Device:	Grason-Stadler Inc. model GSI 60 DPOAE system (ref.510(k) #K934658S1).

Device Description, intended Use & Effectiveness:

Technological Characteristics:

See attachment "A" for a comparison of the GSI SA60 to the predicate device.

Safety:

The GSI SA60 system is designed to provide electrical safety to the patient as well as the user. The system is designed to be used with a notebook computer powered either by its internal battery or by the supplied low voltage ungrounded DC power supply. The notebook computer used with

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the system will be specified to meet standards pertaining to the safety of Information Technology Equipment namely: IEC 950, UL1950, CSA 950 and CE mark. The instrument portion of the system may be powered by its internal battery or by the supplied low voltage DC power supply. The instrument enclosure is also connected to protective earth (ground) when powered by the low voltage DC power supply. No other mains powered equipment will be connected to the system during patient testing. The front panel of the instrument will have status indicators that inform the user of the following conditions: 1) Battery charging, 2) low battery voltage, and 3) power applied. The battery charger status will be constantly monitored and the instrument will not collect data when the battery charge is too low to reliably operate the instrument. The system is designed to meet the following standards related to electrical safety: IEC 601-1, UL2601, and CSA 601-1-M90. A preliminary design review was conducted with a competent test laboratory and the design will meet requirements for electrical safety of an IEC 601-1 class 1, type B medical instrument.

The system will also be certified to the following standards:

EMI EN55011	Group 1 Class B requirements (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	Conforms with provisions of 89/336/EEC Electromagnetic Compatibility Directive.

Summary of Effectiveness:

The GSI SA60 is an extension of the current GSI 60 system and operates in the same manner. The GSI SA60 allows the use of the system with a notebook computer without the need for a docking station which is required for the GSI 60 (See attachment "A" Chart of Predicate Device Comparison). The GSI SA60 is therefor more portable than the GSI 60 making it equivalent or better in effectiveness for the testing of cochlear function.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 6 1997

Norman L. Schultz Senior Quality Engineer Grason-Stadler, Inc. 1 Westchester Drive Milford, NH 03055-3056 Re: K970324 Grason-Stadler GSI SA60 DPOAE Otoacoustic Emission (OAE) Test Instrument Dated: March 18, 1997 ... Received: March 19, 1997 Regulatory class: II 21 CFR 874.1050/Procode: 77 ETW

Dear Mr. Schultz: 44

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 (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical 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 misbranion.

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 an be found in the Code of Federal Regulations, Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: · General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 notification does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(x) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication for your device and this, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591 for Radology devices, Nose and Throat devices. Additionally, for questions on the promotion 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 premarket 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,

William Y

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

Enclosure

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510(k) Number (if known): K970324

Device Name: GSI SA60 DPOAE System

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of	Reproductive, Abdominal, ENT,
and Radiologic	Reproductive, Abdominal, ENT,
	Medical Devices
510(k) Number	K970324

Prescription Use	✓	OR	Over-The-Counter Use	__
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(Optional Format 1-2-96)

Regulation Number and Section

§ 874.3310 Hearing aid calibrator and analysis system.

(a)
Identification. A hearing aid calibrator and analysis system is an electronic reference device intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid, master hearing aid, group hearing aid or group auditory trainer. The device consists of an acoustic complex of known cavity volume, a sound level meter, a microphone, oscillators, frequency counters, microphone amplifiers, a distoration analyzer, a chart recorder, and a hearing aid test box.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.