(125 days)
The intended use of the OtoStat DPOAE Measurement is to determine the presence of cochlear function.
The intended use of the OtoStat MEPA Middle Ear Power Analyzer is to characterize the middle ear status and to assist in diagnosing middle ear pathologies.
The intended use of the OtoStat DPOAE+MEPA is to determine the presence of cochlear and middle ear functions and to assist in differential diagnosis between cochlear and middle ear dysfunctions.
The OtoStat MEPA system measures various acoustic properties of the ear, namely power reflectance, power absorbance, transmittance, wideband immittance, and equivalent ear canal volume. These measures allow the evaluation of the functional condition of the middle and outer ear.
The OtoStat is a small portable handheld audiometric measurement device for measuring either DPOAE (distortion product otoacoustic emission), MEPA (middle ear power analysis), or both, where DPOAE is for evaluating cochlear function and MEPA for middle and outer ear status. Both MEPA and DPOAE measurements present acoustic stimulus into the ear canal via the loudspeakers in the acoustic ear probe, then record the complex pressure frequency responses via the microphone in the same acoustic ear probe. The responses are then analyzed and displayed against relevant normative data with recommended pass/refer indication for the trained user to determine the cochlear and middle ear status and for differential diagnosis.
Here's a breakdown of the acceptance criteria and study information for the Mimosa Acoustics OtoStat DPOAE+MEPA, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices: | The nonclinical performance evaluations demonstrated substantial equivalence in effectiveness to the predicate devices (CUB®DIS-DPOAE Measurement System (K981460) and HearID Wideband Middle Ear Power Analyzer (MEPA3) (K053216)). |
| Same or Identical Technology: | The OtoStat DPOAE+MEPA uses the same or identical technology as the predicate devices. |
| Same Intended Use: | The OtoStat DPOAE+MEPA has the same intended use as the cited predicate devices. |
| Safety and Effectiveness: | The nonclinical performance evaluations demonstrated the device is as safe and effective as the original and predicate devices. |
| Compliance with Recognized Consensus Standards (IEC 60601-1): | The OtoStat has been demonstrated to comply with Medical Electrical Equipment, Part 1: General Requirements for Safety (IEC 60601-1). |
| DPOAE Specific Performance (Implied from predicate comparison): | Provides stimuli for rapid clinical measurement and evaluation of odd-order distortion product tones. Measures 4, 6, or 12 audiometric octave frequencies (or other frequencies) between 500-8000 Hz. Low system-noise floor, high signal-to-noise ratio. |
| MEPA Specific Performance (Implied from predicate comparison): | Measures and plots reflectance (power reflectance) and other related acoustic characteristics over a wide frequency range. Employs computer-generated stimuli, automated data monitoring, and advanced signal processing for noise and artifact rejection. |
2. Sample Size and Data Provenance
The provided 510(k) summary does not specify sample sizes for test sets or data provenance (e.g., country of origin, retrospective/prospective). The evaluations were primarily nonclinical performance evaluations and benchmarking against predicate devices.
3. Number of Experts and Qualifications
The document does not mention the use of experts to establish ground truth for any test set. The evaluation relied on direct comparison against predicate devices and compliance with technical standards.
4. Adjudication Method
No adjudication method is described, as the evaluation was not based on expert review of diagnostic classifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The submission focuses on direct technical equivalence to predicate devices and adherence to safety standards, not on improvement in human reader performance with AI assistance. This device is an audiometric measurement device, not an AI-powered diagnostic tool requiring human interpretation.
6. Standalone Performance Study
The evaluation described is essentially a standalone performance assessment in the context of comparing its functionality against predicate devices and demonstrating compliance with safety standards. However, it's not a "standalone performance study" in the sense of evaluating a novel AI algorithm's diagnostic accuracy. The study aims to show that the OtoStat's measurements are consistent with and comparable to the predicate devices.
7. Type of Ground Truth Used
The "ground truth" for this submission appears to be the performance and specifications of the predicate devices and adherence to recognized consensus standards (like IEC 60601-1 for safety). The nonclinical performance evaluations were conducted by "comparing their functionality against CUB®DIS-DIS-DPOAE and HearID MEPA Measurement Systems."
8. Sample Size for the Training Set
No information is provided regarding a "training set" as this device does not appear to utilize machine learning or AI in a way that requires a separate training phase. The device measures acoustic responses and analyzes them based on established physiological principles and normative data.
9. How Ground Truth for the Training Set Was Established
As no training set is indicated, no ground truth establishment for a training set is described.
§ 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.