1 . Evaluate middle ear functions such as otitis media, glue ear, eardrum scar tissues, perform myringotomy status, ossicular chain discontinuity ear canal volume, otosclerosis, stapes fixation.
1. Perform Acoustic reflex test.
1. Determine acoustic reflex threshold
1. Perform reflex decay test.

The unit is intended for use by a qualified/trained audiologist on both adult and pediatric subjects for measurement of acoustic impedance.

Device Description

The Amplaid A756 Screening ADMITTANCE METER performs plane and compensated tympanometry; Programmed and manual stimuli for ipsilateral and contralateral acoustic reflex; Automatic reflex threshold; and Decay measurements.

AI/ML Overview

The Amplaid A756 Screening Admittance Meter was determined to be substantially equivalent to the predicate device (Amplaid A724 – A728 ADMITTANCE METERS, K992370) based on bench and user testing. The provided document does not contain explicit acceptance criteria thresholds or detailed study results beyond a general statement of safety and effectiveness.

Here's the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the A756 device is "as safe and effective as the predicate device" after analyzing "bench and user testing data." No specific quantitative acceptance criteria or detailed performance metrics are given in the provided text. The comparison focuses on technical and safety characteristics.

Characteristic	Acceptance Criteria (Implicit: Equivalence to Predicate)	Reported Device Performance (Amplaid A756)
Intended Use	Similar to predicate: Clinical auditory impedance testing applications	Screening audiometry impedance testing applications (subset of predicate's use)
Computer Interface	RS232 Bi-directional	SAME (RS232 Bi-directional)
Display	Built-in liquid crystal	SAME (Built-in liquid crystal)
Control Interface	Built-in keyboard	SAME (Built-in keyboard)
Hardcopy Output	Built-in Thermal printer	SAME (Built-in Thermal printer)
Audiometric Standards	Compliance with IEC 61027, ANSI S3.39, IEC 60645-1, ANSI S3.6, EN ISO 389	SAME (Compliance with listed standards)
Electrical Safety Standards	Compliance with EN 60601-1 Class I Type BF (1990) and amendments, EMC: EN 60601-1-2 (1993)	EN 60601-1 Class I Type B (1990) and amendments, EMC: EN 60601-1-2 (1993) (Note: Type B vs Type BF, but considered substantially equivalent)
Overall Safety & Effectiveness	As safe and effective as predicate	"as safe and effective as the predicate device"

2. Sample size used for the test set and the data provenance

The document mentions "bench and user testing" but does not specify the sample size for the test set. It also does not detail the data provenance (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document.

4. Adjudication method for the test set

This information is not provided in the document.

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

An MRMC study was not conducted as this device is an Auditory Impedance Tester, not an AI-powered diagnostic tool. The comparison is between two medical devices, not AI assistance for human readers.

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

The device is an Auditory Impedance Tester, which is a physical medical device and not an algorithm or AI system. Therefore, a "standalone algorithm-only" performance study is not applicable. The device's performance is inherently standalone in its function, but results are interpreted by a "qualified/trained audiologist."

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

The document does not specify the type of ground truth used for validating the "user testing" or "bench testing." It can be inferred that for an auditory impedance tester, validation would typically involve comparing measurements against established audiometric standards or clinical diagnoses, but this is not explicitly stated.

8. The sample size for the training set

This information is not applicable as the device is not an AI/machine learning model that typically requires a training set.

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

This information is not applicable as the device is not an AI/machine learning model.

Summary

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KO31978

JUL 2 1 2003

EXHIBIT 2 Amplaid -Biomedical division of Amplimedical S.p.A. (Amplifon Group) Via Donizetti. 12 - 20090 Assago - Milan (Italy) Tel. +39 02 45790303 +39 02 45790340 Fax. Contact: Giovanni Rollier, CEO June 24, 2003

510(k) Summary of Safety and Effectiveness

1. Identification of the Device: Proprietarv-Trade Name: Amplaid A756 Classification Name: Auditory Impedance Tester 77ETY Common/Usual Name: Admittance Meter
1. Equivalent legally marketed devices This product is similar in design and function to the AMPLAID A724 and A728 ADMITTANCE METERS (K992370)
1. Indications for Use (intended use) The Amplaid A756 Screening Admittance Meter can
Evaluate middle ear functions such as otitis media, glue ear, eardrum scar tissues, perform . myringotomy status, ossicular chain discontinuity ear canal volume, otosclerosis, stapes fixation.
Perform Acoustic reflex test. .
. Determine acoustic reflex threshold
Perform reflex decav test. .

The unit is intended for use by a qualified/trained audiologist on both adult and pediatric subjects for measurement of acoustic impedance.

1. Description of the Device: The Amplaid A756 Screening ADMITTANCE METER performs plane and compensated tympanometry; Programmed and manual stimuli for ipsilateral and contralateral acoustic reflex; Automatic reflex threshold; and Decay measurements.
1. 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 device.

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6. Substantial Equivalence Chart

Characteristic	Predicate K992370Amplaid A724 –A728	Amplaid A756
Intended Use:	Clinical auditory impedancetesting applications	Screening audiometry impedancetesting applications
Technical characteristics
Physical characteristics:
Computer interface	RS232 Bi-directional	SAME
Display	Built-in liquid crystal	SAME
Control interface	Built-in keyboard	SAME
Size/weight	19.6"w x 16"d x 8"h18.8 lbs.	14' x 11" x 7"7.7 lbs.
Energy Source:	115/230 Vac, ± 10%, 50-60 Hz(100 va)	SAME (40 va)
Hardcopy Output:	Built-in Thermal printer	SAME
Standards and Safety characteristics:
Audiometric:	Performance StandardsIEC 61027 (1993); Instrumentsfor the measurement of auralacoustic impedance/admittanceANSI S3.39(1987): Specificationsfor Instruments to Measure AuralAcoustic Impedance andAdmittance (Aural AcousticImmittance);IEC 60645-1: Audiometers - Part1: Pure-tone audiometersANSI S3.6 (1996): Specificationfor audiometers;EN ISO 389 (1995): Acoustics –Standard reference zero for thecalibration of pure-tone airconduction audiometers	SAME
Electrical safety:	EN 60601-1 Class I Type BF(1990);EN 60601-1/A1 (1993);EN 60601-1/A2 (1995);EN 60601-1/A13 (1996)EMC: EN 60601-1-2 (1993)	EN 60601-1 Class I Type B(1990);EN 60601-1/A1 (1993);EN 60601-1/A2 (1995);EN 60601-1/A13 (1996)EMC: EN 60601-1-2 (1993)

7. Conclusion

After analyzing both bench and user testing data, it is the conclusion of Amplaid. that the Amplaid A756 is safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the border. Inside the circle is a symbol that resembles an eagle with three lines representing its wings. The seal appears to be a logo or emblem for the U.S. Department of Health and Human Services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 1 2003

Amplaid c/o Daniel Kamm, P.E. Regulatory Engineer P.O. Box 7007 Deerfield. IL 60015

Re: K031978

Trade/Device Name: Amplaid A756 Screening Admittance Meter Regulation Number: 21 CFR 874.1090 Regulation Name: Auditory impedance tester Regulatory Class: Class II Product Code: ETY Dated: June 24, 2003 Received: June 26, 2003

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, 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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); 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.

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Page 2 - Daniel Kamm, P.E.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Alegi Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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j) Indications for Use

510(k) Number_ KO 31978

Device Name: Amplaid A756 Screening Admittance Meter

Indications for Use: The Amplaid A756 Screening Admittance Meter can

I . Evaluate middle ear functions such as otitis media, glue ear, eardrum scar tissues, perform myringotomy status, ossicular chain discontinuity ear canal volume, otosclerosis, stapes fixation.
1. Perform Acoustic reflex test.
1. Determine acoustic reflex threshold
1. Perform reflex decay test.

The unit is intended for use by a qualified/trained audiologist on both adult and pediatric subjects for measurement of acoustic impedance.

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Ophthalmic Ear,

Nose and Throat Devises

510(k) Number	K031975
---------------	---------

Prescription Use		OR	Over the Counter Use
			(Per 21 CFR 801.109)

Regulation Number and Section

§ 874.1090 Auditory impedance tester.

(a)
Identification. An auditory impedance tester is a device that is intended to change the air pressure in the external auditory canal and measure and graph the mobility characteristics of the tympanic membrane to evaluate the functional condition of the middle ear. The device is used to determine abnormalities in the mobility of the tympanic membrane due to stiffness, flaccidity, or the presence of fluid in the middle ear cavity. The device is also used to measure the acoustic reflex threshold from contractions of the stapedial muscle, to monitor healing of tympanic membrane grafts or stapedectomies, or to monitor followup treatment for inflammation of the middle ear.(b)
Classification. Class II (special controls). The device, when it is a tympanometer or auditory impedance tester that complies with FDA-recognized consensus standard ANSI S3.39, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.