(90 days)
The Titan with TEOAE440 is intended for use in the audiologic evaluation and documentation of ear disorders using Transient Evoked Otoacoustic Emissions. The target population for Titan with TEOAE440 includes all ages.
The instrument is multi platform audiometric equipment used for various testing of middle ear, inner ear and brainstem abnormalities. This submission is only about OAE measurements of otoacoustic emissions in the human inner ear evoked by acoustic probe pulses. (TEOAE in accordance with IEC60645-6:2009)
The Titan also has a measurement function of otoacoustic emissions in the human inner ear evoked by acoustic probe tones (DPOAE). This functionality is already cleared by FDA 510(k) premarket notification K103760 (05/05/2011)
The Titan OAE test generates an acoustic stimulus in the ear canal at a moderate intensity level. The stimulus vibrates a thin membrane in the cochlear, and activates the outer hair cells located on the membrane. This activation is propagated back through the middle ear as sound into the ear canal. Microphone(s) detects OAErelated sound. Principles are identical for both tone and pulse stimuli.
The instrument has screening and diagnostic functionality of TEOAE (according to IEC 60645-6), which is license dependent. For screening purpose a protocol with Pass-Refer criteria can be set up by the user.
Titan consists of a handheld unit named Titan, Titan Cradle and PC software (Titan Suite, Titan modules/ Titan Applications). The measurements are controlled by the handheld unit. A license system makes it possible within each configuration to select which functionality the user wants to be incorporated in the system.
A connection box (shoulder box) enables different types of accessories to be connected to the platform (depending on the module)
For measuring Transient Evoked OtoAcoustic Emissions (TEOAEs) a probe is placed into the ear canal. A stimulus of short duration (broad band click) is presented into the ear (typically with at intensity of 80dB peSPL). Within a normal functioning cochlea the outer hair cells will become active and produce low intensity tones that travel back out of the ear. The emissions that can be recorded appear in the same frequency range and are recorded following each presentation of the transient stimulation. Being able to measure a significant amount of TEOAEs indicates a normal or close to normal outer hair cell function and is mostly used as a screening for hearing impairment. When no TEOAEs are measured, a priori no conclusion can be made and further diagnostics would be recommended.
The instrument meets the requirements from the international standard for OAE measurements IEC 60645-6.
The provided document is a 510(k) Summary for the Interacoustics Titan with TEOAE440, an otoacoustic emission device. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria through clinical trials.
Based on the available information, here's an analysis of the requested points:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in the way a clinical study report would. Instead, it relies on demonstrating compliance with international standards and substantial equivalence to predicate devices. The "performance" is implicitly deemed acceptable by meeting the requirements of IEC 60645-6 and exhibiting similar or improved technical characteristics compared to the predicates.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary from Submission) |
|---|---|
| Compliance with IEC 60645-6:2009 (OAE measurements) | "The instrument meets the requirements from the international standard for OAE measurements IEC 60645-6." |
| Functional Equivalence to Predicate Titan with DPOAE440 (K103760) | "Based on the comparison between the two versions of Titan with OAE capability we appraised they are fully substantial equivalent." |
| Functional Equivalence to Predicate Eclipse with TEOAE25 (K052562) | "we trust that the two devices are substantial equivalence based on the comparison above." |
| Technical Characteristics similar to or improved over Eclipse with TEOAE25 | Frequency Range: Titan TEOAE440: 500 to 5500Hz (vs. Eclipse TEOAE25: 400 to 4000 Hz) - "Both fulfils the requirements from IEC 60645-6" |
| Level: Titan TEOAE440: 30 to 90 dB peSPL (vs. Eclipse TEOAE25: 50 to 90 dB SPL) - "The level range (30-90) is a requirement From IEC60645-6 clause 5.1.4.2 for type 1 instruments" | |
| A/D Resolution: Titan TEOAE440: 24 bit (vs. Eclipse TEOAE25: 16 bit) - "The TEOAE440 offers newer technology with higher resolution (24bit)" | |
| Artifact Reject: Titan TEOAE440: 0 -> +60 dB SPL or off (vs. Eclipse TEOAE25: +25 -> +55 dB SPL or off) - "The TEOAE440 offers newer technology and has increased the artifact setting range." | |
| Safety and Effectiveness | "trust the device is safe and effective without further clinical tests." (Based on international standards and predicate comparison) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "No clinical tests were performed". Therefore, there is no test set, sample size, or data provenance from clinical data to report. The evaluation was based on design verification and validation against international standards and comparison to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Since no clinical tests were performed, there was no test set requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable as no clinical tests were performed.
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 device is a diagnostic instrument (OAE device), not an AI-assisted interpretation system for human readers. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is an otoacoustic emission device, which is inherently a standalone diagnostic measurement tool. Its "performance" refers to its ability to accurately measure TEOAEs according to physical and audiological standards. The nonclinical tests ("Design verification and validation were performed according to current standards for OAE ... to assure Titan with TEOAE440 meets its performance specifications") serve as the standalone performance evaluation, confirming the device's technical capabilities in measuring OAEs.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the nonclinical tests, the "ground truth" was compliance with the technical specifications and requirements outlined in the international standard IEC 60645-6 for otoacoustic emission devices. The principle of the device is based on known physiological responses (outer hair cell function), and its accuracy is validated against established physical and audiological measurement standards, not medical "ground truth" like pathology in a clinical study.
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning algorithm requiring a training set in the conventional sense. Its functionality is based on established physical principles and signal processing, not learned patterns from a large dataset.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of medical device submission.
§ 874.1050 Audiometer.
(a)
Identification. An audiometer or automated audiometer is an electroacoustic device 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.(b)
Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.