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 decay test.

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

Device Description

The Amplaid A724 and A728 ADMITTANCE METERS perform plane and compensated tympanometry; Programmed and manual stimuli for ipsilateral and contralateral acoustic reflex; Automatic reflex threshold; and Decay measurements.

AI/ML Overview

The given text describes the Amplaid A724 and A728 Clinical Automatic Programmable Admittance Meters, which are intended to evaluate middle ear functions and perform acoustic reflex tests. The submission claims substantial equivalence to the predicate device, Amplaid 770 Admittance Meter (K903066).

Here's the breakdown of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The core of the "acceptance criteria" presented in this 510(k) summary is based on demonstrating substantial equivalence to a predicate device, the Amplaid 770 (K903066). The acceptance criteria are implicitly that the new device performs "as safe and effective as the predicate device" and has no new indications for use.

Characteristic	Acceptance Criteria (Predicate Device Performance - Amplaid 770 per K903066)	Reported Device Performance (Amplaid A724 - A728)
Intended Use	Clinical auditory impedance testing applications	Same (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 decay test.)
Computer interface	RS232 Transmit only	RS232 Bi-directional
Display	Built-in liquid crystal	Same
Control interface	Built-in keyboard	Same
Size/weight	17.3" W x 19.3" D x 7" H, 28 lbs.	19.6"w x 16"d x 8"h, 18.8 lbs.
Energy Source	115/230 Vac, ± 10%, 50-60 Hz	Same
Hardcopy Output	Built-in Thermal printer	Same
Audiometric Standards	ANSI 3.6, 1969, ISO 1975 for contralateral, 2 cm3 cavity for ipsilateral, IEC 61027	Same or better: Standards updated and added: IEC 61027 (1993); Instruments for the measurement of aural acoustic impedance/admittance; ANSI S3.39(1987): Specifications for Instruments to Measure Aural Acoustic Impedance and Admittance (Aural Acoustic Immittance); IEC 60645-1: Audiometers - Part 1: Pure-tone audiometers; ANSI S3.6 (1996): Specification for audiometers; EN ISO 389 (1995): Acoustics - Standard reference zero for the calibration of pure-tone air conduction audiometers
Electrical Safety Standards	UL-544, IEC 601	Updated/Expanded: 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)

Study Information:

The provided document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence rather than presenting extensive clinical study data as would be found in a PMA.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document states "results of bench and user testing." It does not provide specific details on the sample size of subjects or cases used for "user testing" or the data provenance (country of origin, retrospective/prospective).
- Bench testing would involve testing the device's adherence to technical specifications and standards, not human subjects.
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):
- The document implies "user testing" was performed, but it does not specify the number or qualifications of "users" (audiologists) involved, nor how ground truth might have been established if clinical performance was assessed this way. Given the nature of a 510(k) for an impedance meter, the primary "ground truth" would be the accurate measurement of audiological parameters, likely validated against established calibration standards and potentially against a predicate device.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned. The document does not describe adjudication for a test set in the context of diagnostic interpretation. The evaluation is likely focused on the device's ability to accurately perform its specified measurements.
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 comparative effectiveness study was done. This type of study is not relevant for an auditory impedance meter, which is a measurement device, not an AI-assisted diagnostic interpretation tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device described is an "Amplaid A724 and A728 Clinical Automatic Programmable Admittance Meters." It is a measurement device operated by a "qualified/trained audiologist." Therefore, it inherently involves a human-in-the-loop for operation and interpretation. The performance evaluation would be of the device itself and its interaction with the user, not a standalone AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this device, the "ground truth" for demonstrating safety and effectiveness would primarily be:
  - Adherence to recognized industry standards: ANSI, ISO, IEC, EN standards for audiometric and electrical safety.
  - Comparison to the predicate device: The new device must perform "as safe and effective as the predicate device," implying performance metrics that align with or are better than the predicate's established performance. This suggests comparative testing against the predicate to ensure equivalent measurement accuracy and functionality.
  - Bench testing: Verifying technical specifications of the device itself.
The sample size for the training set:
- Not applicable/Not mentioned. This device is not an AI/ML product that undergoes a "training phase." Its functionality is based on established audiological measurement principles and hardware/software design.
How the ground truth for the training set was established:
- Not applicable. As noted above, there is no "training set" in the context of an AI/ML algorithm.

Summary

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K912370

SEP 2 0 1999

EXHIBIT 2 Amplifon S.p.A. Via Ripamonti, 133 20141 Milan, ITALY Tel ++39-02-57472482 Fax ++39-02-57409427 Contact: Giovanni Rollier, President

July 13, 1999

510(k) Summary of Safety and Effectiveness

1. Identification of the Device: Proprietary-Trade Name: Amplaid A724 and A728 Classification Name: Auditory Impedance Tester 77ETY Common/Usual Name: Clinical Admittance Meter
1. Equivalent legally marketed devices This product is similar in design and function to the Amplaid 770 Admittance Meter (K903066)
1. Indications for Use (intended use) The Amplaid A724 A728 are Programmable Admittance Meters which 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 decay test. .

It is intended for use by a qualified/trained audiologist on both adult and pediatric subjects for measurement and diagnosis of various types of hearing losses.

1. Description of the Device: The Amplaid A724 and A728 ADMITTANCE METERS perform 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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Characteristic	Predicate device:	New device:
	Amplaid 770 Per K903066	Amplaid A724 -A728
Intended Use:	Clinical auditory impedancetesting applications	(Same)
Technical characteristics
Physical characteristics:
Computer interface	RS232 Transmit only	RS232 Bi-directional
Display	Built-in liquid crystal	(Same)
Control interface	Built-in keyboard	(Same)
Size/weight	17.3" W x 19.3" D x 7" H,28 lbs.	19.6"w x 16"d x 8"h18.8 lbs.
Energy Source:	115/230 Vac, ± 10%, 50-60 Hz	(Same)
Hardcopy Output:	Built-in Thermal printer	(Same)
Standards and Safetycharacteristics:
Audiometric:	ANSI 3.6, 1969, ISO 1975 forcontralateral, 2 cm3 cavity foripsilateral, IEC 61027	(Same or better) Standardsupdated and added:IEC 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
Electrical safety:	UL-544, IEC 601	Safety: EN 60601-1 Class I TypeBF (1990); EN 60601-1/A1(1993);EN 60601-1/A2 (1995); EN60601-1/A13 (1996)EMC: EN 60601-1-2 (1993)

6. Substantial Equivalence Chart

7. Conclusion

After analyzing both bench and user testing data, it is the conclusion of Amplifon S.p.A. that the Amplaid A724 and A728 are as 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 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" around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three curved lines above three wavy lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 0 1999

Mr. Daniel Kamm, P.E. Kamm & Associates PO Box 7007 Deerfield IL 60015 USA

Re: K992370

Trade Name: Amplaid A724 and A728 Clinical Automatic Programmable Admittance Meters Regulatory Class: II Product Code: 77 ETY Dated: July 13, 1999 Received: July 15, 1999

Dear Mr. Kamm:

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 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 requirements, 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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations .

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Page 2 - Mr. Daniel Kamm, P.E.

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

If you desire specific advice for your devices 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 questions on the promotion and advertising of your devices, 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 tollfree number (800) 638-2041 or at (301) 443-6597.

Sincerely yours,

Alvarez Rosenthal

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

Enclosure

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j) Indications for Use

510(k) Number K9923 70

Device Name: Amplaid A724 and A728 Clinical Automatic Programmable Admittance Meters

Indications for Use: The Amplaid A724 and A728 are Programmable Admittance Meters which can

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.

They 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)

Ray J. Lankester

Prescription Use /

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.