(77 days)
The Interacoustics AZ26 Clinical 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.
Our device, the Model AZ26 Clinical 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 Model AZ26 Clinical Impedance Audiometer (K990652) is deemed substantially equivalent to the Interacoustics Clinical Impedance Audiometer Model AZ26 (predicate device) and thus meets its acceptance criteria by complying with relevant performance and safety standards.
Here's a breakdown of the information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the device's compliance with established performance and safety standards, and its similarity to the predicate device. The performance is reported through comparison with the predicate device and explicit statements of compliance with standards.
| Acceptance Criteria (Implied by Predicate & Standards) | Reported Device Performance (Interacoustics Model AZ26) |
|---|---|
| Display Description | Digital |
| Available Frequencies | 250 Hz, 500 Hz, 1kHz, 2kHz, 3kHz, 4kHz, 6kHz, and 8kHz |
| Probe Tone Frequency | 226Hz ± 1% |
| Probe Tone Intensity | 85dB SPL ± 1.5dB |
| Harmonic Distortion | Less than 5% |
| Pressure Range | -600 to +300 daPa |
| Transducers | TDH39 Single Contralateral Earphone, Probe with Probe Tip |
| Patient response unit | Handheld Push Button Switch |
| Compatible Windows Software | IABase95, Printview, IA-NOAH-IMP Module |
| Tests Offered | Tympanometry, Acoustic Reflex, Eustachian Tube Test (Williams and Toynbee), Air Conduction Audiometry, and Gelle Test |
| Impedance Calibration Standard | ANSI S 3.39-1987, IEC 1027-1991 |
| Audiometer Calibration Standard | ISO/R 389-1991 |
| Pressure Release | Pressure Release Function |
| Size and Weight | 19" x 16" x 6"; 21 lbs. |
| Power | 100-120 V or 220-240V |
| Optional External Keyboard | Yes |
| Safety Standard (Audiometer) | ANSI S 3.6-1996 IEC 645-1-1992, Type 4 |
| Safety Standard (Impedance) | ANSI S 3.39-1987 IEC 1027-1991, Type 1 |
| General Safety Standard | IEC 601-1-1988 |
2. Sample size used for the test set and the data provenance
The document specifies the device is "in compliance with the following performance and safety standards" (listed above) and provides a "Comparison of the Interacoustics Model AZ26 Clinical Impedance Audiometer and the Interacoustics Clinical Impedance Audiometer Model AZ26". This suggests that the "testing" for acceptance was based on device specifications and adherence to recognized industry standards, rather than a clinical trial with a specific "test set" of patients or data.
Therefore, there is no explicit sample size or data provenance (country of origin, retrospective/prospective) for a clinical test set mentioned in this 510(k) summary, as it is a predicate-based submission relying on technical equivalence and compliance with standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
There is no mention of experts establishing ground truth for a test set, as the submission appears to rely on technical specifications and adherence to established industry standards for audiometric and impedance devices rather than a clinical ground truth established by experts.
4. Adjudication method for the test set
As there is no identified "test set" or clinical study described in the provided document, there is no adjudication method mentioned.
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
The document does not describe an MRMC comparative effectiveness study, nor does it involve AI assistance. This device is a measurement instrument (audiometer), not an AI-powered diagnostic aid for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a clinical impedance audiometer, not an algorithm. Its performance is inherent to its design and calibration, not a standalone algorithmic output.
7. The type of ground truth used
The "ground truth" for this device's acceptance is its compliance with established international and national performance and safety standards (e.g., ANSI S 3.6-1996, IEC 645-1-1992 for audiometers; ANSI S 3.39-1987, IEC 1027-1991 for impedance; IEC 601-1-1988 for general safety). Additionally, the device demonstrated substantial equivalence to a legally marketed predicate device based on feature comparison. The performance parameters detailed in the comparison table essentially serve as the "ground truth" for its technical specifications matching or exceeding the predicate.
8. The sample size for the training set
This question is not applicable. The device is an electroacoustic test instrument, not a machine learning model. Therefore, there is no concept of a "training set" for its development or validation.
9. How the ground truth for the training set was established
This question is not applicable as there is no training set for this type of device.
§ 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.