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The Ellipse 4™ is intended to assist in the diagnosis of incontinence and/or voiding disorders.
The Ellipse 4™ is a Urodynamic System. It can perform the following tests: Flowmetry, Cystometry, Pressure Flow, Urethral Pressure Profile and EMG.

The Ellipse 4™ is a small, compact device that can register pressures, uroflow and EMG from the patient. The signals are AD converted and displayed on a LCD screen, printed on a thermal printer and stored in memory. After the recording, the data can be copied on a printer or downloaded to a PC using a network.
The Ellipse 4™ uses microp catheters (MTC's) for recording the pressures, and surface electrodes.

The provided text does not contain detailed acceptance criteria or a specific study that proves the device (Ellipse 4™) meets said criteria in the format requested. The document describes the device, its intended use, and briefly mentions "bench testing" and "clinical experience." However, it lacks the specificity required for the detailed table and information points.

Here's a breakdown of what can be extracted and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not available in the provided text.
The document states:

• "Bench testing was performed to confirm accuracy of the basic parameters measured by the Ellipse 4™."
• "Tests were performed in the following areas: transducer, pump, EMG, pressure, pressure flow and urethral pressure profile."
• "Satisfactory results were achieved."

However, it does not specify what "satisfactory results" entail (i.e., the acceptance criteria) or the quantitative performance metrics achieved for each parameter.

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

• Sample Size for Test Set: Not explicitly stated as a "test set" in the context of a controlled study.
• Data Provenance: The document mentions "Clinical experience in use of the Ellipse 4™ has confirmed its safety and effectiveness. Over 10,000 Urodynamic investigations have been performed using the Ellipse 4™". This suggests retrospective collection of real-world usage data. The country of origin is not specified for these investigations, but the manufacturer is based in Germany.

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

This information is not available in the provided text. The document refers to "clinical experience" and "excellent results and an absence of complications," implying evaluation by medical professionals, but does not detail the process of establishing ground truth or the qualifications of evaluators.

4. Adjudication method for the test set

This information is not available in the provided text.

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

The Ellipse 4™ is described as an "Urodynamic System" that registers pressures, uroflow, and EMG. This is a diagnostic measurement device, not an AI-assisted interpretation system. Therefore, an MRMC study comparing human readers with AI assistance is not applicable and not mentioned.

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

The device is a measurement system; its performance is inherent to its sensors and processing. The concept of an "algorithm only" performance study in the context of AI is not applicable as it's not an AI diagnostic tool. The "bench testing" mentioned might be considered a standalone performance evaluation of the hardware and integrated software for measurement accuracy.

7. The type of ground truth used

For the "clinical experience," the implied ground truth would be the clinical outcomes and the absence of complications as determined by medical professionals in a real-world setting. For the "bench testing," the ground truth would be known physical parameters against which the device's measurements were compared for accuracy.

8. The sample size for the training set

This information is not available in the provided text. As the device is a measurement system and not an AI model requiring a training phase, the concept of a "training set" in the context of machine learning is not directly applicable.

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

This information is not available and not applicable for the reasons mentioned in point 8.

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