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The ICS Chartr EP 200 with VEMP is indicated for auditory evoked potential testing as an aid in assessing hearing loss and lesions in the auditory pathway. The Vestibular Evoked Myogenic Potential is indicated for vestibular evoked potential testing as an aid in assessing vestibular function in adult patients. The device is to be used only by qualified medical personnel with prior knowledge of the medical and scientific facts underlying the procedure.

"Vestibular Evoked Myogenic Potentials (VEMPs) are short latency electromyograms (EMGs) evoked by high level acoustic stimuli recorded from surface electrodes over the tonically contracted sternocleidomastoid (SCM) muscle." Akin FW & Murnane OD (2001).
The ICS Chartr EP 200 with VEMP is used to test the auditory and vestibular functions of children and adults in a hospital, in an Ear, Nose and Throat Clinic or in an Audiology office. The ICS Chartr EP 200 system measures evoked potentials from the patient using repeated auditory stimuli and averaging EEG or EMG activity in order to abstract the response from the noise resulting in an analysis of the auditory/vestibular system functions.

The ICS Chartr EP 200 is a PC-based system, which consists of software modules for installation on a PC, an isolation transformer, a hardware platform, pre-amp, a mains adapter, stimulation devices and recording devices. The stimulation and recording devices are connected to the preamp, which is connected to the hardware platform, which is connected to the PC via a USB cable - no hardware installation inside the PC is required. The PC and hardware platform are powered from the isolation transformer which is powered from the mains.

One added item as compared to the standard EP200 is the VEMP monitor. The Chartr EP (USB) VEMP monitor assesses the level of tonic EMG and displays if the level is adequate or inadequate. The monitor light will display the following based on the EMG level: Low (blue) -EMG level is below the Min value- Good (green) - EMG level is between Min value and the Max value - High (amber) - EMG level is above the Max value

Summary: VEMP is an evoked potential (EP) just like ABR obtained using any commercially available EP system. The unique feature with the ICS Chartr EP 200 is the ability to perform EMG monitoring during VEMP data collection.

The VEMP function of the EP 200 does not make a diagnosis. The diagnosis is made by a medical professional.

The provided text describes a 510(k) premarket notification for the ICS Chartr EP 200 with VEMP, an auditory and vestibular evoked potential testing device. It does not contain information about an AI/ML medical device. Therefore, a comprehensive answer to the user's request for acceptance criteria and study proving an AI/ML device meets them cannot be wholly extracted from the given text.

However, I can extract the information relevant to the device's validation and substantial equivalence, and then address the remaining points by stating the information is not present in the provided document.

Here's an attempt to answer the user's request based only on the provided text, highlighting what is available and what is not:

Based on the provided FDA 510(k) summary for the ICS Chartr EP 200 with VEMP:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly define "acceptance criteria" in a quantitative table format for performance metrics relevant to an AI/ML device (e.g., sensitivity, specificity, AUC). Instead, it focuses on demonstrating the reproducibility of VEMP waveforms and comparing the new device's features and safety/effectiveness to a predicate device.

The closest equivalent to "reported device performance" in the context of this device is the correlation values for VEMP waveform reproducibility.

2. Sample sized used for the test set and the data provenance

• Test Set Sample Size:
  • 60 normal cVEMP subjects
  • 58 pathologic cVEMP subjects
  • 20 normal oVEMP subjects
• Data Provenance: Studies were collected at two different facilities, one in the USA and one in Canada. The document states these were "clinical studies," implying they were prospective, but does not explicitly state "retrospective" or "prospective."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not present in the provided text. The device assesses auditory and vestibular function, and the "ground truth" seems to be the VEMP waveform itself and its reproducibility, rather than a clinical diagnosis established by experts. The diagnosis is stated to be made by a medical professional.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not present in the provided text. The study focuses on correlation and reproducibility of waveforms, not on classification or diagnostic accuracy adjudicated by multiple readers.

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

• MRMC Study: No, an MRMC study was not done. This device is an evoked potential testing system, not an AI-powered diagnostic algorithm assisting human readers.
• Effect Size of AI assistance: Not applicable, as this is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Not applicable in the context of AI/ML. The device's "performance" is its ability to reliably acquire and display VEMP waveforms. The clinical conclusion and diagnosis are explicitly stated to be made by a medical professional. "The VEMP function of the EP 200 does not make a diagnosis. The diagnosis is made by a medical professional."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" implicitly used for the reproducibility study is the VEMP waveform itself and its consistency across repeated measurements. The study aimed to demonstrate that the device could reliably produce these waveforms. For patients with disorders, the "pathologic" status serves as a descriptor for that cohort, with results indicating lower correlation due to the nature of their conditions (absent or abnormal VEMPs).

8. The sample size for the training set

This information is not present in the provided text. This is not an AI/ML device that requires a "training set" in the machine learning sense. Clinical studies presented were to confirm reproducibility, not to train an algorithm.

9. How the ground truth for the training set was established

This information is not present in the provided text, as it is not an AI/ML device with a training set and corresponding ground truth.

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