(83 days)
The Interacoustics AT22t Automatic 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 AT22t Automatic 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 provided text describes a 510(k) premarket notification for the Interacoustics AT22t Automatic Impedance Audiometer. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a de novo study to prove safety and effectiveness against specific acceptance criteria.
Therefore, the information you requested regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not available in the provided document.
The document primarily provides:
- Device Description: The Interacoustics AT22t Automatic Impedance Audiometer is an electroacoustic test instrument for diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders, featuring tympanometry, acoustic reflex, and air conduction audiometry.
- Predicate Device: Interacoustics Automatic Impedance Audiometer.
- Comparison Table: A comparison showcasing the similarities and differences between the new device (AT22t) and the predicate device, emphasizing identical indications for use and similar technical specifications.
- Safety and Effectiveness: A statement that the device complies with specific performance and safety standards (Audiometer: ANSI 3.6-1989 IEC 645-1-1992 Type 4; Impedance: ANSI 3.39-1987 IEC 1027-1991 Type 2; Safety: IEC 601-1-1988). This compliance indicates that the device meets established industry standards, which serve as a form of acceptance criteria in regulated environments, but it's not data from a specific study to prove novel performance.
Here's a breakdown of why each requested point cannot be addressed from the given text:
- Table of acceptance criteria and reported device performance: The document lists compliance with standards (e.g., ANSI, IEC) as the basis for safety and effectiveness. It does not present a table of specific measurable acceptance criteria with corresponding performance statistics from a study.
- Sample size used for the test set and data provenance: No information on a test set, sample size, or data provenance is provided.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no such test set or ground truth establishment is described.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted or reported. The device is a diagnostic instrument, not an AI-assisted diagnostic tool, so such a study would not be relevant in this context.
- Standalone (algorithm-only) performance: Not applicable, as this is a physical audiometer, not an algorithm.
- Type of ground truth used: Not applicable, as no study requiring ground truth is described.
- Sample size for the training set: Not applicable, as the device is not an AI/ML model that undergoes a training phase.
- How the ground truth for the training set was established: Not applicable.
In essence, the 510(k) pathway demonstrates equivalence, not novel performance, and therefore does not typically include detailed clinical study data of the kind requested for an AI/ML device. The "proof" of the device meeting "acceptance criteria" here is its adherence to existing, recognized performance and safety standards for impedance audiometers.
§ 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.