(157 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 acoustic reflexes.
The Titan Impedance System measures various acoustic properties of the ear, namely power reflectance, power absorption, transmittance, reflectance group delay, complex acoustic impedance and admittance, and equivalent ear canal volume. These measures allow the evaluation of the functional condition of the middle and outer ear.
The Titan Impedance System is suitable for all populations including new-born infants.
The Titan Impedance System is to be used by trained personnel only such as audiologists, ENT surgeons, doctors, hearing healthcare professionals or personnel with a similar level of education. The device should not be used without the necessary knowledge and training to understand its use and how results should be interpreted.
The instrument is audiometric equipment used for measuring aural acoustic impedance and admittance (According to ANSI S3.39).
The Titan is a platform with multi functions depending of licensing. The license function for this submission is IMP440 (IMP) for measurement of aural acoustic impedance and admittance.
The Titan IMP test 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 IMP test function is already cleared by FDA 510(k) premarket notification K083861 (04/09/2009)
The instrument is a diagnostic/clinical instrument (as defined in IEC60645-5), but provides normative data for guidance.
Titan consists of a handheld unit named Titan, Titan Cradle (cleared by FDA 510(k) premarket notification K083861) and PC software (Titan Suite/IMP440). The measurements are controlled by the handheld unit.
A connection box (shoulder box) enables different types of accessories to be connected to the platform
The Titan platform can connect to PC software via a Bluetooth connection.
The Interacoustics Titan IMP440 WBT is an electroacoustic test instrument intended for diagnostic hearing evaluations and assisting in the diagnosis of otologic disorders. It measures various acoustic properties of the ear, including power reflectance, power absorption, transmittance, reflectance group delay, complex acoustic impedance and admittance, and equivalent ear canal volume.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than detailing specific numeric acceptance criteria for performance metrics. The comparison table (on pages 3-5 of the original document) primarily highlights similarities and differences in technical characteristics and functionalities between the Titan IMP440 WBT and its predicate devices (Titan with IMP440 and MIMOSA HEARID).
Implicit Acceptance Criteria (based on substantial equivalence):
| Feature/Measure | Acceptance Criteria (Substantial Equivalence) | Reported Device Performance (Titan IMP440 WBT) |
|---|---|---|
| Indications for Use | "Same" as predicate devices (Titan IMP440 and MIMOSA HEARID): Conduct diagnostic hearing evaluations, assist in diagnosing otologic disorders, perform tympanometry and acoustic reflexes, measure various acoustic properties of the ear (power reflectance, absorption, transmittance, delay, impedance, admittance, ear canal volume). | Meets: Identical intended use as the previous Titan IMP440, with additional paragraphs matching the predicate MIMOSA HEARID regarding specific acoustic property measurements, suitability for all populations (including newborns), and use by trained personnel. |
| Target Population | "Same" as predicate devices: All populations, including newborn infants. | Meets: Suitable for all populations, including newborn infants. |
| Intended User | "Same" as predicate devices: Trained personnel (audiologists, ENT surgeons, doctors, hearing healthcare professionals). | Meets: To be used by trained personnel only. |
| Safety Standard | Compliance with IEC 60601-1 (assumed for predicate). | Meets: Complies with IEC 60601-1. |
| EMC Standard | Compliance with IEC 60601-1-2 (assumed for predicate). | Meets: Complies with IEC 60601-1-2. |
| Performance Standard | Unknown for MIMOSA HEARID, but expectation of compliance with state-of-the-art standards. | Meets: Complies with IEC 60645-5 / ANSI S3.39 (Type 1 Diagnostic/Clinical). |
| Frequency Range | Functionally equivalent to 200-6000 Hz of MIMOSA HEARID, ensuring no negative impact on safety or effectiveness. | Meets (Substantially Equivalent): 250-8000 Hz. Justified that expanded range (due to better transducers) does not influence safety or effectiveness. |
| Intensity Range | Functionally equivalent to 0-80 dB SPL of MIMOSA HEARID, ensuring no negative impact on safety or effectiveness. | Meets (Substantially Equivalent): 90/94 dB peSPL = 70/74 dB SPL (fixed). Justified that fixed range is within predicate device's variable range and does not impact safety/effectiveness for WBT (wideband tympanometry) as pure tone stimulation is not relevant. |
| Stimuli | Functionally equivalent to Chirp/Pure Tone of MIMOSA HEARID. | Meets (Substantially Equivalent): Chirp (Frequency linearized click). Pure Tone is not relevant for this WBT function. |
| Artefact Rejection | Presence of an artefact rejection system. | Meets (Substantially Equivalent): Present, described as removing responses contaminated with noise or noise artifacts, similar to the predicate's equivalent system. |
| Normative Data | Presence of normative data. | Meets (Substantially Equivalent): Present, used to indicate normal middle ear function in the user interface. Based on referenced studies [1, 2]. |
| Reflectance Area Index | Presence of a system for enhanced diagnosis via reflectance area index. | Meets (Substantially Equivalent): Uses shaded area (10/90 or 5/95 percentiles) indicating normative region. Identical functionality to normative data display. |
| Measurement Protocols | Customizable measurement protocols. | Meets: Users can change the sequence of measurements to fit diagnostic and clinical purposes. |
| Customizable Display Parameters | Customizable display of graphs/parameters. | Meets (Substantially Equivalent): Users can change how many graphs are presented, with the intended purpose being the same as the predicate. |
| Otitis Media Examples | Presence of examples for Otitis Media with Effusion. | Meets (Substantially Equivalent): Sketched examples of curve characteristics based on measurements [4]. |
| Measures (Power Reflectance, Absorption, Transmittance, Acoustic Impedance, Resistance, Reactance, Admittance, Conductance, Susceptance, Equivalent Volume) | Presence of these specific acoustic measurements as defined by ANSI S3.39. | Meets (Substantially Equivalent): All listed measures are present, often explicitly stated as equivalent or directly derived from each other (e.g., reflectance to absorbance), and align with ANSI S3.39 definitions of these quantities. Power absorbance is plotted, noting its identity to power transmittance. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "No clinical tests were performed" (page 9) for the Titan IMP440 WBT device in this 510(k) submission. Therefore, there is no test set sample size mentioned, nor any data provenance (country of origin, retrospective/prospective). The assessment relies on compliance with international standards and comparison to predicate devices' performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given that no clinical tests were performed, no experts were used to establish ground truth for a test set as part of this specific submission.
4. Adjudication Method for the Test Set
Since no clinical tests and no test set were used, there was no adjudication method applied for this submission.
5. Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The submission solely focuses on demonstrating substantial equivalence through technical comparisons and compliance with standards, not on human reader performance improvement with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
No standalone (algorithm only) performance study was conducted that would typically involve a test set. Instead, the device's functional performance was verified through compliance with recognized standards (IEC 60645-5 / ANSI S3.39) and comparison against the technical specifications of predicate devices.
7. Type of Ground Truth Used
For the newly submitted device, no direct ground truth (e.g., pathology, outcomes data) was established for its own performance. The grounds for acceptance criteria are:
- Compliance with international standards: IEC 60601-1, IEC 60601-1-2, IEC 60645-5 / ANSI S3.39.
- Substantial equivalence to predicate devices: The functionality and performance characteristics of the Titan IMP440 WBT were compared to the cleared Titan IMP440 and MIMOSA HEARID. The assumption is that if it is substantially equivalent and meets standards, it is safe and effective.
The normative data included in the device (mentioned as "present" in the comparison table) are based on published research [1, 2], which would inherently have involved clinical studies to establish their "ground truth" (e.g., healthy ear function). However, this is for the normative data itself, not for a direct performance study of the Titan IMP440 WBT in this submission.
8. Sample Size for the Training Set
As the device described is a medical instrument for measurement and diagnosis (not an AI algorithm that "learns" from data in a conventional sense), the concept of a "training set" is not applicable in the way it is for machine learning algorithms. The device's functionality is engineered based on established acoustic principles and standards. The "normative data" could be considered analogous to a statistical reference for interpretation rather than a training set for an algorithm. However, the sample sizes for the studies used to generate these normative data [1, 2] are not provided in this excerpt, though they would have been part of the original research.
9. How the Ground Truth for the Training Set Was Established
Again, the concept of a "training set ground truth" is not directly applicable. If considering the normative data as an analogous reference, its "ground truth" would have been established through the research studies it was based on (e.g., "adults with normal hearing" [1], and "newborn infants" [2]). These studies would have involved clinical assessments to define "normal" (or the specific conditions being studied). However, the details of these ground truth establishments are beyond the scope of this 510(k) summary, referring instead to external academic publications.
§ 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.