CCA-200 by BENSON MEDICAL INSTRUMENTS CO.

The CCA-200 Computer Controlled Audiometer is an air conduction audiometer designed to provide automatic hearing testing. A series of tones is presented by the CCA-200 through a TDH-39 headset to the test subject. The test subject then presses a hand switch to indicate Lo the CCA-200 that the tone bas been heard. The CCA-200 proceeds with the hearing test using the Modified Hughson-Westlake method of hearing testing, and records the subject's responses, The resultant data are available to print on an external printer connected to the control computer or to store in the computer.

The CCA-200 can perform its function only on command from a control computer. The computer monitor displays the setup and control screens that are used to perform the Lest functions. An IRM compatible computer with a 486DX2-50 or proceessor, running Windows 95 or Windows NT, is required. Control of the CCA-200 is handled through the RS232 serial port. The computer is not included with the CCA-200.

The CCA-200 is designed for use in test environments where multiple automatic hearing tests are controlled from a single computer. The CCA-200 has a range of options for both computer interfacing and automatic testing, such as multilingual voice instructions. These options are selected using a setup screen on the computer.

Device Description

AI/ML Overview

I'm facing a few limitations that prevent me from fully addressing your request:

Missing Study Information: The provided documents (FDA Premarket Notification and Indications for Use) are regulatory filings. They confirm the device's substantial equivalence to a predicate device but do not contain the detailed study information you're asking for, such as acceptance criteria, reported performance, sample sizes for test and training sets, expert qualifications, adjudication methods, or MRMC study results. This type of information is typically found in a separate clinical study report or a more comprehensive technical submission, neither of which is present here.
Nature of the Device (CCA-200 Audiometer): The CCA-200 is a "Computer Controlled Audiometer" designed for "automatic hearing testing" using the "Modified Hughson-Westlake method." This device is a measurement tool that automates a standard clinical procedure. Its performance is primarily assessed by its accuracy and reliability in measuring hearing thresholds, not by its ability to provide a diagnostic interpretation or assist a human in making a diagnosis in the same way an AI-powered diagnostic tool would.

Given these limitations, I cannot extract the specific details you've requested regarding acceptance criteria and the study proving device performance because that information simply isn't in the provided text.

Specifically:

Acceptance Criteria and Reported Device Performance: This document does not specify quantitative acceptance criteria or report on device performance metrics (e.g., sensitivity, specificity, accuracy) from a study against such criteria. The FDA letter primarily confirms substantial equivalence to a legally marketed predicate.
Sample Size for Test Set and Data Provenance: No information about a test set, its sample size, or data provenance is available.
Number of Experts and Qualifications: The concept of "experts establishing ground truth" as it applies to AI/diagnostic imaging is not relevant here, as this is an automated audiometer.
Adjudication Method: Not applicable for this type of device and the information provided.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. An audiometer automates a test; it doesn't "assist" a human in interpreting an image or making a diagnosis in the way MRMC studies usually evaluate.
Standalone Performance: While the device operates standalone in terms of conducting the test, the FDA letter confirms substantial equivalence, implying its performance is comparable to existing audiometers. There isn't a detailed "standalone performance study" report in these documents.
Type of Ground Truth Used: For an audiometer, the "ground truth" would implicitly be the actual hearing threshold of an individual, established through a gold standard measurement or a consensus of multiple audiologists. This document doesn't detail how this was established for any validation.
Sample Size for Training Set & How Ground Truth was Established for Training Set: Since this is an audiometer automating a standard protocol, it's not an AI model that "learns" from a training set in the conventional sense. Its "training" would be its programming to accurately implement the Modified Hughson-Westlake method.

In summary, the provided FDA communication and indications for use describe regulatory clearance and the intended use of a medical device (an audiometer), but they do not contain the details of a performance study with acceptance criteria as one would find for a modern AI/diagnostic device.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES · USA

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 5 1998

David P. Mayou Vice-President Benson Medical Instruments Company 2344 Nicollet Avenue, Suite 150 Minneapolis, MN 55404

Re:

K981439 CCA-200 (Computer Controlled Audiometer Dated: March 19, 1998 Received: April 21, 1998 Regulatory class: II 21 CFR 874.1050/Procode: 77 EWO

Dear Mr. Mayou:

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 Rederal 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 equivaliation assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) 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 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitto 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/odrh/dsmaldsmam.html".

Sincerely yours,

Lillian Yin, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductiv Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device I ame:_ CCA-200

Indicatic is For Use:

(PLE VSE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NERDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

	(Division Sign-Off)
	Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number	K981439
	OR	Over-The-Counter Use

Prescript on Use (Pet 21 ( FR 801.109)

The former the may be the many of the may be the may be the

Over-The-Counter Use

(Optional Format 1-2-96)

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.