(244 days)
The Eclipse with VEMP (Vestibular Evoked Myogenic Potential) is intended for vestibular evoked myogenic potential testing to assist in the assessment of vestibular function. The target population for Eclipse with VEMP includes patients aged from 8 years and up.
The device is to be used only by qualified medical personnel with prior knowledge of the medical and scientific facts underlying the procedure.
The Eclipse with VEMP is audiometric equipment intended to perform various Otoacoustic Emissions (OAEs) and Auditory Evoked Potential evaluations. The Eclipse is operated solely from PC based software modules. The Eclipse platform performs the physical measurements. The protocols are created in the software modules. The Eclipse consists of a hardware platform, a preamplifier, stimulation transducers and recording electrodes.
VEMP evaluations are tests of the vestibular portion of the inner ear and acoustic nerve, evoked with an auditory stimulation. The evoked response results in a potential recorded from the sternocleidomastoid (neck) muscles or the inferior oblique (eye) muscles. VEMP is not a test of the neck or eye musculature directly; the clinician is interested in the vestibular anatomy which triggers the response. The cervical Vestibular Evoked Myogenic Potential (cVEMP) is an evoked potential measured from the sternocleidomastiod (SCM) muscle and the ocular VEMP (oVEMP) is an evoked potential measured from the inferior oblique muscle. Both tests are used to assess the otolith organs (saccule and utricle) of the vestibular system and their afferent pathways and assist medical practitioners in the diagnosis of various balance disorders.
Summary: VEMP is Auditory Evoked Potentials like ABR obtained using any commercially available EP system. The addition of the VEMP module to Eclipse will make it possible for clinicians to conduct VEMP tests while using EMG (electromyography) monitoring and scaling. The VEMP function of the Eclipse with VEMP does not make a diagnosis. It only assists the medical professional.
Here's a breakdown of the acceptance criteria and study information for the Interacoustics A/S Eclipse with VEMP, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in terms of predefined numerical thresholds for performance metrics. Instead, it presents the results of internal clinical evaluations (test-retest reliability and reproducibility studies) and compares them to similar reported values in a predicate device. The implicit acceptance criterion is that the device demonstrates comparable or better reliability and reproducibility than the predicate device.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance (Eclipse with VEMP) | Predicate Device (K143670) Performance (for comparison) |
|---|---|---|---|
| cVEMP Test-Retest Reliability: | High correlation between repeated measurements | Mean: 0.9374 | |
| Median: 0.9562 | |||
| IQR: 0.0547 | N/A (No direct predicate comparison for test-retest in this doc) | ||
| oVEMP Test-Retest Reliability: | High correlation between repeated measurements | Mean: 0.9095 | |
| Median: 0.9280 | |||
| IQR: 0.0738 | N/A (No direct predicate comparison for test-retest in this doc) | ||
| cVEMP Reproducibility (Different Days, Testers, Electrode Placements): | High correlation between measurements on different days | Mean: 0.8794 | |
| Median: 0.9235 | |||
| IQR: 0.0955 | Mean: 0.9146 (R) / 0.9162 (L) | ||
| oVEMP Reproducibility (Different Days, Testers, Electrode Placements): | High correlation between measurements on different days | Mean: 0.8923 | |
| Median: 0.9100 | |||
| IQR: 0.1112 | Mean: 0.926 (R) / 0.93 (L) |
Conclusion from document: The mean and median values for both test-retest reliability and reproducibility are high, indicating good performance. For reproducibility, the Eclipse with VEMP's mean correlation values are "similar to or higher than" those reported by the predicate device (GN Otometrics K143670).
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 14 normal adults (for both cVEMP and oVEMP).
- Data Provenance: The studies were conducted at two internal sites: one in Denmark and one in the United States. They appear to be prospective internal evaluations specifically for this device and its VEMP module.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of diagnostic accuracy. The studies evaluated the reliability and reproducibility of the device's measurements, not its diagnostic accuracy against a separate, definitive truth. The VEMP module "does not make a diagnosis" but "only assists the medical professional." Therefore, there isn't a stated ground truth established by experts for these specific studies.
4. Adjudication Method for the Test Set
Not applicable. As noted above, these studies focused on the intrinsic reliability and reproducibility of the device's waveform measurements, not diagnostic outcomes requiring expert adjudication. The analysis involved correlation of waveforms.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study involving human readers with/without AI assistance was not mentioned or performed in the provided document. The device itself is an "Evoked Response Auditory Stimulator," a diagnostic tool that assists medical professionals, rather than an AI-powered diagnostic system that interprets images or data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The studies performed evaluate the device's ability to consistently acquire and output VEMP waveforms. The device itself is a data acquisition system. While it has software for processing signals (e.g., filtering, averaging), the "performance" described is the consistency of the recorded physiological responses, not an algorithm's standalone diagnostic interpretation. The document explicitly states the VEMP module "does not make a diagnosis."
7. The Type of Ground Truth Used
There is no traditional "ground truth" (like pathology or clinical outcomes) used in these studies. The studies aimed to establish the test-retest reliability (consistency of measurements taken repeatedly within a short timeframe) and reproducibility (consistency of measurements taken on different occasions, potentially by different operators with slightly different setups) of the VEMP waveforms produced by the device. The comparison point is the device's own prior measurement or the measurement from a different session.
8. The Sample Size for the Training Set
The document describes internal clinical evaluations, not the training of a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for an AI/ML algorithm mentioned in the document.
§ 882.1900 Evoked response auditory stimulator.
(a)
Identification. An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.(b)
Classification. Class II (performance standards).