A. General Indications: The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)): Severity: 2. Mild X, 3. Moderate X, 4. Severe X. Configuration: 1. High Frequency - Precipitously Sloping X, 2. Gradually Sloping X, 4. Flat X, 5. Other: steeply sloping X. Other: 1. Low Tolerance to Loudness X.

Device Description

Programmable OnQue for HS, CCA, and CAMEO Models

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA for a hearing aid device, not a study report. Therefore, it does not contain the detailed information about acceptance criteria or a study proving device performance as requested.

The document primarily focuses on establishing "substantial equivalence" to a predicate device, which is a regulatory pathway for certain medical devices. It confirms that the device, "Programmable OnQue for HS, CCA, and CAMEO Models," is substantially equivalent to devices marketed prior to May 28, 1976.

While it mentions "indications for use" and lists categories of hearing loss the device is intended for, it does not provide acceptance criteria, performance metrics, study details, or data provenance normally found in a clinical study report.

Therefore, I cannot populate the requested tables and information based on the provided text.

Here's a breakdown of why each point cannot be addressed:

A table of acceptance criteria and the reported device performance: Not present. The document focuses on regulatory equivalence, not performance metrics like accuracy, sensitivity, or specificity.
Sample size used for the test set and the data provenance: Not present. No test set or clinical study data is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No ground truth or expert review is detailed.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not present. No adjudication process is described.
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: Not present. This document predates common AI applications in medical devices and there is no mention of such a study. The device is a hearing aid, not an AI-powered diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. The device is a hearing aid, which works with a human (the wearer). No standalone algorithm performance is discussed.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not present.
The sample size for the training set: Not present. No training data is mentioned.
How the ground truth for the training set was established: Not present.

The document is a regulatory approval letter, not a scientific or clinical study report.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the left side of the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 20 1998

Ronald A. Scicluna R & D Director Argosy® Electronics, Inc. 10300 West 70th Street Eden Prairie, MN 55344

Re:

K974242

Programmable OnQue for HS, CCA, and CAMEO Models Dated: November 10, 1997 Received: November 12, 1997 Regulatory class: I 21 CFR 874.3300/Procode: 77 ESD

Dear Mr. Scicluna:

We have reviewed your Section 510(k) notification of intent to market the device 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 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 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 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(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.

While your device has been deemed substantially equivalent to other legally marketed hearing aids, please be advised that electromagnetic interference from digital cellular telephones, as well as from other sources is increasingly becoming a concern. Typically, this interference takes the form of a buzzing sound that can range from annoying to very loud and may render a hearing aid temporarily ineffective for the wearer. Because electromagnetic interference may affect, your device, you may be asked to test for electromagnetic compatibility in the future. In this interim period, we encourage you to modify your device labeling to inform practitioners and users of the potential for electromagnetic interference. Please be aware that a 510(k) submission is required for any claims that infer that your device is compatible with potential sources of electromagnetic interference, such as "compatible with digital cellular telephones", and that data supporting such claims is necessary.

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in yitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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,

holliam Yi

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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Page 1 of 1

510(k) Number (if known): K974242

Device Name: Programmable On Que for HS, CCA, and CAME

Indications For Use:

A. General Indications:

The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)):

Severity:		Configuration:		Other:
1. Slight		1. High Frequency - Precipitously Sloping	X	1. Low Tolerance to Loudness	X
2. Mild	X	2. Gradually Sloping	X	2.
3. Moderate	X	3. Reverse Slope		3.
4. Severe	X	4. Flat	X
5. Profound		5. Other: steeply sloping	X

B. Specific Indications (Only if appropriate.):
(Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Restricted device (per 21 CFR 801.420 & 21 CFR 801.421)

Ullad L. Kymm

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

Regulation Number and Section

§ 874.3300 Air-conduction hearing aid.

(a)
Identification. An air-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. An air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. The air-conduction hearing aid generic type excludes the group hearing aid or group auditory trainer, master hearing aid, and the tinnitus masker, regulated under §§ 874.3320, 874.3330, and 874.3400, respectively.(b)
Classification. Class I (general controls). This device is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 874.9.