The Amplaid 171S is a clinical diagnostic audiometer which can perform all audiometric tests normally performed in a clinical situation. It is intended for use by a qualified/trained audio!ogist on both adult and pediatric subjects for measurement and diagnosis of various types of hearing losses.

Device Description

The Amplaid 171S is a one channel clinical diagnostic audiometer which can perform all audiometric tests normally performed in a clinical situation. It provides testing capability for basic evaluation, cochlear versus retrocochlear dysfunction, central dysfunction and non-organic hearing loss. Other diagnostic audiometric tests are: pure tone, and speech.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Amplaid 171S Clinical Audiometer, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria for the Amplaid 171S are primarily based on its equivalence to a predicate device, the Amplaid 308 Clinical Audiometer. The study demonstrated that the new device is "as safe and effective as the predicate device," and the acceptance criteria are met by showing comparable performance, function, and adherence to relevant standards.

Table of Acceptance Criteria and Reported Device Performance:

Characteristic	Acceptance Criteria (Predicate Device: Amplaid 308)	Reported Device Performance (New Device: Amplaid 171S)	Meets Criteria?
Indications for Use	Clinical diagnostic audiometric applications for measurement and diagnosis of various types of hearing losses by a qualified/trained audiologist on both adult and pediatric subjects.	Clinical diagnostic audiometric applications for measurement and diagnosis of various types of hearing losses by a qualified/trained audiologist on both adult and pediatric subjects (stated as "Same" and "no new indications for use").	Yes
Audiometric Standards	ISO 389-1975, ANSI S3.6-1969, ANSI S3.13-1972, IEC 645	ISO 389-1989, ANSI S3.6-1989, IEC 645-1,-2, -4 (Stated as "Same, standards have been updated.")	Yes (meets updated standards)
Electrical Safety Standards	UL-544, IEC 601	UL-544, IEC 601 (Stated as "Same")	Yes
Energy Source	115/230 Vac, ± 10%, 50-60 Hz	115/230 Vac, ± 10%, 50-60 Hz (Stated as "Same")	Yes
Hardcopy Output	Possible via computer interface	Possible via computer interface (Stated as "Same")	Yes
Safety and Effectiveness	As safe and effective as the Amplaid 308.	Stated as "as safe and effective as the predicate device."	Yes
Technological Differences	No significant technological differences that would impact safety or effectiveness.	Stated as having "few technological differences" and "no new indications for use," implying differences are minor and do not affect equivalence for safety and effectiveness.	Yes

Study Information

Sample size used for the test set and the data provenance:
- The document states that "bench and user testing" were performed. However, it does not provide a specific sample size for the test set (number of subjects or assessments).
- The data provenance (country of origin, retrospective/prospective) is not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document mentions "user testing," which implies involvement of qualified users (audiologists, as per indications for use).
- However, it does not specify the number of experts or their qualifications regarding ground truth establishment for the test set.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not describe an adjudication method for the test set results.
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, an MRMC comparative effectiveness study was not done. This report is for a medical device (audiometer), not an AI-assisted diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, this is not applicable. The device is a clinical diagnostic audiometer, a human-operated instrument, not an algorithm. Performance is inherently "with human-in-the-loop" (the audiologist).
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Based on "bench and user testing," the ground truth for performance comparison likely involved measurements against established audiometric standards and potentially clinical assessments by audiologists comparing the output/functionality to expected clinical results for diagnosing hearing loss. The document does not explicitly state "expert consensus," but "user testing" implies clinical validation.
The sample size for the training set:
- Not applicable. This device is a hardware instrument, not a machine learning model, so there is no "training set."
How the ground truth for the training set was established:
- Not applicable. No training set for an algorithm.

Summary

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5972862

EXHIBIT 2 Amplifon S.p.A. Via Ripamonti, 133 20141 Milan, ITALY Tel ++39-2-57472.482 Fax ++39-2-57409427 Contact: Giovanni Rollier, President

OCT 31 1007

August 1, 1997

510(k) Summary of Safety and Effectiveness

1. Identification of the Device: Proprietary-Trade Name: Amplaid 171S Classification Name: Audiometer 77EWO Ocentro .. L. Name: Clinical Dingnostic Aveller
  ﺎ .
1. Equivalent legally marketed devices This product is similar in design and function to the Amplaid 308 Clinical Audiometer (K891988)
1. Indications for Use (intended use) The Amplaid 171S is a clinical diagnostic audiometer which can perform all audiometric tests normally performed in a clinical situation. It is intended for use by a qualified/trained audio!ogist on both adult and pediatric subjects for measurement and diagnosis of various types of hearing losses.
1. Description of the Device: The Amplaid 171S is a one channel clinical diagnostic audiometer which can perform all audiometric tests normally performed in a clinical situation. It provides testing capability for basic evaluation, cochlear versus retrocochlear dysfunction, central dysfunction and non-organic hearing loss. Other diagnostic audiometric tests are: pure tone, and speech,
5 Safety and Effectiveness, comparison to predicate device. The results of bench and user testing indicates that the new device is as safe and effective as the predicate 'evia e

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Characteristic	Predicate device:Amplaid 308Clinical diagnostic audiometricapplications	New device:Amplaid 171S(Same)
Physical characteristics:Size/weight	17.3" W x 19.3" D x 7" H.28 lbs.	11 3/8" W x 12"D x 4 3/4" H6.6 lbs.
Energy Source:	115/230 Vac, ± 10%, 50-60 Hz	(Same)
Hardcopy Output:	Possible via computer interface	(Same)
Standards and Safetycharacteristics:Audiometric:	ISO 389-1975, ANSI S3.6-1969,ANSI S3.13-1972, IEC 645	ISO 389-1989, ANSI S3.6-1989,IEC 645-1,-2, -4 (Same,standards have been updated)
Electrical safety:	UL-544, IEC 601	(Same)

6. Substantial Equivalence Chart

Conclusion 7.

After analyzing both bench and effective as the predicate device, has few
that the Amplaid 171S is as safe and effective as the predicate device, has few that the Amplaid 1715 is as sale and chective as the productions for use, thus rendering it
technological differences, and has no new indications for use, thus rendering it technological differenter, and the predicate Device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH" are arranged vertically along the left side of the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 31 1997

Daniel Kamm, P.E c/o Kamm & Associates PO Box 7007 Deerfield, IL 60015 USA Re: K972862.

Amplaid 171S Clinical Audiometer Dated: August 1, 1997 Received: August 4, 1997 Regulatory class: II 21 CFR 874.1050/Procode: 77 EWO

Dear Mr. Kamm:

We have reviewed your Section 5100x) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the intentions for use stated in the enclosure) to 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). 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 II (Special Controls) or 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 Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply 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 submission does 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 marketed 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 801 and additionally 809.10 for in vitro 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 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

hĩ liau Yu

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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i) Indications for Use

510(k) Number 11973862

Device Name: Amplaid 171S Clinical Audiometer

Indications for Use: The Amplaid 171S is a one channel clinical diagnostic audiometer which can perform all audiometric tests normally performed in a clinical situation. It is which our perform an audiologist on both adult and pediatric subjects for measurement and diagnosis of various types of hearing losses.

Concurrence of CDRH, Office of Device Evaluation (JDz)

Prescription Use

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ਾਲ

Over the Counter Use (Per 21 CFR 801.109)

Jamil A. Segran

(Division Sign-Off) Division of Reproductive, Abdominal, El and Radiological Devic 510(k) Number J

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.