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Meniett 20 is indicated for symptomatic treatment of Menière's disease. The therapeutic effect of Meniett 20 is achieved by applying low frequency, low amplitude pressure pulses to the middle ear whereby inner ear endolymphatic fluids are assumed to be evacuated from the cochlea and thus relieve the patient of the symptoms associated with endolymphatic hydrops.

Meniett 20 is an electronically controlled membrane pump. Meniett 20 generates dynamic pressure and consists of a pump house, electronic hardware, software and encapsulation. In connection with the pump house there is a tube to which an ear cuff is connected and through which air pressure pulses from Meniett 20 are transferred to the patient's ear canal. The construction is encapsulated in a plastic cover designed specially for Meniett 20. There is an opening for replacing the battery. With the help of a pulse shape selector, concealed in the battery compartment, there is a possibility to switch between three different pulse shapes. To start and stop the treatment there is an on/off button on the front panel. On the front panel are four indicators for communication with the patient.

The provided document is a 510(k) summary for the Pascal Medical AB Meniett 20 device, which is a medical device for symptomatic treatment of Meniere's Disease. It does not contain information about acceptance criteria or a detailed study proving the device meets those criteria in the format requested. However, it does describe non-clinical and clinical test results.

Based on the available text, here's what can be extracted and inferred regarding the closest equivalent to acceptance criteria and study details:

Closest Equivalent to Acceptance Criteria and Device Performance:

The document summarizes the device's technical specifications and clinical effect, which serve as the de facto "performance" even if not explicitly stated as "acceptance criteria."

Study Details:

1. Sample size used for the test set and the data provenance:

   • Sample Size (Clinical): 20 patients.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "patients with a definite history and diagnosis of Meniere's disease and active vestibular symptoms." It is an observational study described in a regulatory submission, so it is retrospective in nature from the perspective of the submission, but the patient data would have been collected prospectively during the treatment period.

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

   • This information is not provided in the document. The diagnosis of Meniere's disease would typically be made by medical professionals, but the number and qualifications of those involved in establishing the "ground truth" (i.e., diagnosis and symptom assessment in the context of the study) are not detailed.

3. Adjudication method for the test set:

   • This information is not provided in the document. The text states "The results showed that the use of Meniett 20 gave the intended clinical effect in all the patients except two," implying an assessment of clinical effect, but the method for dispute resolution or consensus among multiple assessors (if any) is not discussed.

4. 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:

   • This was not an MRMC study, nor does it involve AI assistance for human readers. This device is a treatment device, not an diagnostic imaging or AI-assisted diagnostic tool.

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

   • This device is a physical medical device (membrane pump) for treatment, not an algorithm. Therefore, a standalone algorithm-only performance assessment does not apply. The device operates under patient use following medical instruction and surgical intervention (myringotomy).

6. The type of ground truth used:

   • The "ground truth" for the clinical study was based on clinical diagnosis of Meniere's disease and patient-reported symptoms (e.g., attacks of vertigo, balance, functionality), presumably corroborated by medical professionals. The statement "The aim of treatment was to relieve patients from the attacks of vertigo and to improve balance and functionality" indicates subjective and objective clinical assessments.

7. The sample size for the training set:

   • This device is not an AI/ML algorithm that requires a "training set" in the typical sense. The "Clinical Test Results" section describes a clinical study on 20 patients. There is no mention of a separate training set.

8. How the ground truth for the training set was established:

   • As there is no "training set" for an AI/ML algorithm, this question does not apply. If interpreted as how the patients were selected for the clinical study (the "test set"), they were identified as "20 patients with a definite history and diagnosis of Meniere's disease and active vestibular symptoms." This diagnosis would be established by medical experts based on clinical criteria for Meniere's disease.

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