(106 days)
The Titan Impedance System is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conduction diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry and acoustics reflex.
Titan IMP440 consists of a handheld unit named Titan, Titan Cradle and PC software (Titan Suite and Titan IMP440 module). The measurements are controlled by the handheld unit. Titan IMP440 is going to be offered as 3 configurations that will support screening, diagnostic and clinic users. A license system makes it possible within each configuration to select which functionality the user wants to be incorporated in the system. Titan IMP440 is an impedance product based on a hardware platform named Titan Platform. It uses a cabinet named Titan but may use any other cabinets as long as it meets the requirement of the platform. Other products will in the future be developed to the Titan platform and submitted as required and thereby become a part of the Titan System Family as Titan IMP440. A connection box named Titan Shoulder Box enables different types of accessories to the hardware platform.
The provided text is a 510(k) summary for the Interacoustics Titan IMP440 device, which is an auditory impedance tester. This type of document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. As such, it focuses on comparing the new device's technological characteristics and performance to an existing, cleared device, rather than conducting a full clinical study with acceptance criteria, sample sizes, and expert validation in the way a novel AI/ML device might.
Therefore, many of the requested categories (e.g., sample size for training/test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, specific acceptance criteria with reported performance, ground truth types) are NOT applicable to this type of regulatory submission as it appears from the provided text.
Based on the information given, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document states: "The performance data indicated that the Titan Impedance System meets all specified requirements, and is substantially equivalent to the predicate device." However, the specific acceptance criteria (e.g., accuracy thresholds, precision ranges) are not detailed in this summary. The "specified requirements" likely refer to internal design specifications and relevant industry standards for auditory impedance testers, but these are not enumerated here.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document. | "meets all specified requirements" and "is substantially equivalent to the predicate device." |
2. Sample size used for the test set and the data provenance
Not applicable. This 510(k) summary does not describe a clinical study with a specific test set, sample size, or data provenance in the context of an AI/ML device. The "performance data" likely refers to engineering tests and comparisons against the predicate device's specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a clinical study involving expert-established ground truth for a test set.
4. Adjudication method for the test set
Not applicable.
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. The Titan IMP440 is an electroacoustic test instrument, not an AI-assisted diagnostic tool that would involve human readers interpreting results with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a diagnostic instrument, not an algorithm, and its performance is inherently standalone in generating measurement data for a clinician to interpret.
7. The type of ground truth used
Not applicable in the typical sense of a clinical study or AI/ML validation. For an impedance system, "ground truth" would be the physically accurate measurement of the auditory system's impedance. The document implies that the device's measurements are accurate enough to be considered substantially equivalent to the predicate device, which is already an accepted method for obtaining such "ground truth" in routine clinical use.
8. The sample size for the training set
Not applicable. This device does not use machine learning, so there is no training set.
9. 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.