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The Interacoustics AT235 Impedance Audiometer is an electroacoustic test instrument 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. It features tympanometry, acoustic reflex and air conduction audiometry.

The Interacoustics AT235 Impedence Audiometer is an electroacoustic test instrument 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. It features tympanometry, acoustic reflex and air conduction audiometry.

Here's a breakdown of the acceptance criteria and study information for the Interacoustics AT235 Impedance Audiometer, based on the provided text:

Acceptance Criteria and Reported Device Performance

The submission does not explicitly state "acceptance criteria" in the form of specific performance metrics with numerical thresholds (e.g., "accuracy must be > 90%"). Instead, the basis for clearance is substantial equivalence to a predicate device and compliance with relevant performance and safety standards. The "reported device performance" is implicitly that it meets these standards and functions similarly to the predicate.

Differences noted vs. Predicate:

• Available Frequencies: AT235 includes 125 Hz, while AT22t does not.
• Pressure Range: AT235: +300 to -600daPa; AT22t: +200 to -300daPa.
• Impedance Calibration: AT235 lists ANSI S 3.39-1987, IEC 1027-1991; AT22t lists none (assumed to be covered by the AT235's more detailed listing for calibration standards).
• Size and Weight: AT235: 14" x 10" x 4"; 6 lbs.; AT22t: 14" x 16" x 6"; 15.5 lbs.

Study Information

The provided text describes a comparison of the new device (Interacoustics AT235) to a predicate device (Interacoustics AT22t). This is a common approach for 510(k) submissions to demonstrate substantial equivalence, rather than a clinical study in the typical sense with patient cohorts and statistical outcomes.

1. Sample size used for the test set and the data provenance: Not applicable. This submission relies on a comparison of device specifications and compliance with recognized standards. There is no mention of a "test set" of patient data or clinical samples.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in a clinical context, is not established for this type of submission. The "ground truth" here is adherence to engineering and performance standards, and comparison to an established predicate device.

3. Adjudication method: Not applicable.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No. This is a medical device, not an algorithm. The device itself performs the measurements.

6. The type of ground truth used: Not applicable in a clinical sense. The "ground truth" for this submission are the established industry performance and safety standards (e.g., ANSI, IEC) and the specifications of the legally marketed predicate device.

7. The sample size for the training set: Not applicable. There is no training set mentioned, as this is not an AI/ML device.

8. How the ground truth for the training set was established: Not applicable.

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