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.

Device Description

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.

AI/ML Overview

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.

Summary

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MAR 2 1 1997

Image /page/0/Picture/1 description: The image shows a logo with a black triangle at the top. Below the triangle is the word "ANDROMEDA" in capital letters. Underneath the word is the alphanumeric code "K964522" in a handwritten style font. The logo appears to be for a company or organization named Andromeda.

SUMMARY OF SAFETY AND EFFECTIVENESS

MANUFACTURER IDENTIFICATION:

ANDROMBIDA medizinische Systeme GmbH Wallbergstrassc 5 D-22024 Taufkirchen / Potzham Germany

SPONSOR IDENTIFICATION:

KSTABLISHMENT KEGISTRATION NUMBER:

OFFICIAL CONTACT PERSON:

DATE OF PREPARATION OF THIS SUMMARY:

TRADE NAME:

COMMON NAME:

CLASSIFICATION NAME:

REFERENCE:

PROPOSED REGULATORY CLASS:

|DEVICE PRODUCT CODE:

PANEL CODE:

. .

In process (Submitted Nov. 5, 1996)

Norman F. Estrin, Ph.D., RAC President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac , MD 20854

Tcl. : (301) 279 -2899 Fax : (301) 294-0126

March 21, 1997

Ellipse AM

Same

Urodynamic System

Urodynamic Measuring System

(2) CPR Section 876.1620)

Class II

FAP

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DESCRIPTION OF DEVICE:	The Ellipse 4™ is a small, compact devicethat can register pressures, uroflow andEMG from the patient. The signals are ADconverted and displayed on a LCD screen,printed on a thermal printer and stored inmemory. After the recording, the data canbe copied on a printer or downloaded to aPC using a network.The Ellipse 4™ uses microp catheters(MTC's) for recording the pressures, andsurface electrodes.
INTENDED USE:	The Ellipse 4™ is intended to assist in thediagnosis of incontinence and/or voidingdisorders.
INDICATIONS FOR USE:	The Ellipse 4™ is a Urodynamic System. Itcan perform the following tests: Flowmetry,Cystometry, Pressure Flow, UrethralPressure Profile and EMG.
PREDICATE DEVICE:	The Ellipse 4™ is substantially equivalentto the MERKUR™ 4000, manufactured byF. M. Wiest Medizintechnik (K920575)andto the SPACE TM 7500 manufactured by F.M. Wiest (K 912071).
COMPARISON OFTECHNOLOGICALCHARACTERISTICS:	Both the Ellipse 4™ and the MERKUR™4000 have the same intended use and are ofvery similar design. They both have acoated aluminum housing and are poweredsimilarly. Neither deliver energy to thepatient. The Ellipse 4™ is also capable ofcarrying out CC-EMG investigations.

SUMMARY OF STUDIES:

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

Clinical experience in use of the Ellipse 4M has confirmed its safety and effectiveness. Over 10,000 Urodynamic investigations have been performed using the Ellipse 4TM with excellent results and an absence of complications.

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Regulation Number and Section

§ 876.1620 Urodynamics measurement system.

(a)
Identification. A urodynamics measurement system is a device used to measure volume and pressure in the urinary bladder when it is filled through a catheter with carbon dioxide or water. The device controls the supply of carbon dioxide or water and may also record the electrical activity of the muscles associated with urination. The device system may include transducers, electronic signal conditioning and display equipment, a catheter withdrawal device to enable a urethral pressure profile to be obtained, and special catheters for urethral profilometry and electrodes for electromyography. This generic type of device includes the cystometric gas (carbon dioxide) device, the cystometric hydrualic device, and the electrical recording cystometer, but excludes any device that uses air to fill the bladder.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.