(88 days)
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.
| Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Functional Equivalence to Predicate: | The device performs the same functions (tympanometry, acoustic reflex, air conduction audiometry) as the predicate (Interacoustics AT22t). |
| - Indication for Use | Identical to the predicate device. |
| - Display Description | Digital (same as predicate). |
| - Probe Tone Frequency: 226Hz ± 3% | Same as predicate. |
| - Probe Tone Intensity: 85dB SPL ± 3dB | Same as predicate. |
| - Compliance Range: 0,1 to 5 ml | Same as predicate. |
| - Transducers | Same as predicate (TDH39, Contralateral Earphone, Probe with Probe Tip). |
| - Patient Response Unit | Same as predicate (Handheld Push Button Switch). |
| - Compatible Windows Software | Same as predicate. |
| - Tests | Same as predicate (Tympanometry, Acoustic Reflex and Air Conduction Audiometry). |
| - Audiometer Calibration: ISO/R 389-1991 | Same as predicate. |
| - Power: 100-120 V or 220-240V | Same as predicate. |
| Compliance with Performance Standards: | The device is in compliance with all listed standards. |
| - Audiometer Standards | ANSI 3.6-1989, IEC 645-1-1992 Type 4 |
| - Impedance Audiometer Standards | ANSI 3.39-1987, IEC 1027-1991 Type 2 |
| Compliance with Safety Standards: | The device is in compliance with the listed safety standard. |
| - Safety Standard | IEC 601-1-1988 |
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.
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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.
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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.
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Adjudication method: Not applicable.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
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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.
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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.
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The sample size for the training set: Not applicable. There is no training set mentioned, as this is not an AI/ML device.
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How the ground truth for the training set was established: Not applicable.
§ 874.1090 Auditory impedance tester.
(a)
Identification. An auditory impedance tester is a device that 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 fluid in the middle ear cavity. The device is also used to measure the acoustic reflex threshold from contractions of the stapedial muscle, to monitor healing of tympanic membrane grafts or stapedectomies, or to monitor followup treatment for inflammation of the middle ear.(b)
Classification. Class II (special controls). The device, when it is a tympanometer or auditory impedance tester that complies with FDA-recognized consensus standard ANSI S3.39, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.