FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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

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.