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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.

AT235 is an auditory impedance analyser. The device 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 middle ear pathologies. The device is also used to measure the acoustic reflex threshold which occurs due to contractions of the stapedial muscle following exposure to a strong stimulus. This test allow to assess between central and peripheral pathologies and to identify where the patients uncomfortable loudness level may reside. The uncomfortable loudness level is useful when providing rehabilitative amplification methods and determining the correct management process for the patient. The AT235 also includes basic audiometry functions. The instrument is software controlled. The software controls the probe (tone and pressure) stimuli, measures the result and presents the result on a built in display. All functions are set and interpreted by the operator (There are no interpretations of results in the device). The technological characteristics are substantially equivalent with predicate device. All technological characteristics are in compliance with the consensus standard ANSI S3.39 for auditory impedance testers

The provided document is a 510(k) summary for the Interacoustics AT235 Impedance Audiometer. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study proving device performance against those criteria in a typical AI/software-as-a-medical-device (SaMD) context.

Therefore, many of the requested points related to acceptance criteria, specific performance metrics, ground truth establishment, training sets, and MRMC studies are not applicable to this type of regulatory submission. The submission relies on demonstrating that the new AT235 maintains the same safety and effectiveness as its previously cleared version (K994254).

Here's a breakdown based on the available information:

1. A table of acceptance criteria and the reported device performance:

This information is not explicitly stated in the document in the format of specific acceptance criteria and performance results (e.g., sensitivity, specificity, accuracy). The document states that the device was found in compliance with current standards and demonstrated substantial equivalence with the predicate device.

The technological characteristics are stated to be in compliance with the consensus standard ANSI S3.39 for auditory impedance testers. This implicitly means the device meets the performance requirements outlined in that standard, but the specific metrics and targets are not detailed in this summary.

2. Sample sized used for the test set and the data provenance:

• Test set sample size: Not applicable. This document refers to device verification and validation activities, not a study involving a test set of patient data with a defined sample size for performance evaluation in the way an AI/SaMD would.
• Data provenance: Not applicable for performance evaluation against a specific test set. The validation activities are described as "following the design control procedure."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth establishment for a patient-level test set is not described as part of this submission. The device is an electroacoustic test instrument; its performance is validated against physical and instrument standards, not typically against expert-labeled patient data in this context.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. There is no mention of an adjudication process for a test set of patient data.

5. 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 applicable. This device is an audiometer, an electroacoustic test instrument, not an AI-powered diagnostic imaging tool that would typically involve human readers interpreting results.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a measurement instrument. Its "performance" is its ability to accurately measure and present electroacoustic data, not to interpret or diagnose. The document explicitly states: "All functions are set and interpreted by the operator (There are no interpretations of results in the device)."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The ground truth for this type of device would primarily be instrument calibration standards, physical measurements, and compliance with recognized industry standards (e.g., ANSI S3.39 for auditory impedance testers). The document states: "The device was found in compliance with current standards and demonstrated substantial equivalence with the predicate device."

8. The sample size for the training set:

Not applicable. This device does not use machine learning or AI that requires a training set of data.

9. How the ground truth for the training set was established:

Not applicable. As there is no training set for an AI/ML algorithm, there is no ground truth establishment for such a set.

Summary of what the document does state regarding verification and validation:

The "Nonclinical tests summary" section on page 4-5 clearly states:

• "Following the design control procedure the design verification and validation were performed according to current standards for medical device safety and EMC and performance of impedance tester."
• "The device was found in compliance with current standards and demonstrated substantial equivalence with the predicate device."
• "Clinical tests None applicable"

The "Conclusion" further reiterates:

• "The AT235 as a modification to the predicate device (the previous cleared revision of AT235) uses the same or identical technology and has the same intended use as the predicate device."
• "We trust that the verification and validation activities show substantial equivalence with the predicate device and that the modified AT235 is as safe and effective as the predicate device for its claimed purpose."

In essence, the "study" proving the device meets its acceptance criteria is the comprehensive design verification and validation process against relevant medical device standards (including safety, EMC, and the ANSI S3.39 performance standard) to demonstrate substantial equivalence to its predicate. The specifics of these tests (e.g., specific measurement ranges, accuracy tolerances, etc.) are not detailed in this summary document but would be part of the full 510(k) submission.

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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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