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The ELI PC Electrocardiograph is a non-invasive prescription device

• The proposed Mortara ELI-PC Electrocardiograph is indicated for use to acquire, analyze, display and print electrocardiograms.
• The device is indicated for use for patients of any age, diseased or non-diseased.
• The device Is Indicated for use to provide interpretation of the data for consideration by a physician.
• The interpretations of ECG offered by the device are only significant when used in conjunction with a physician over-read as well as consideration of all other relevant patient data.
• The device is indicated for use in a clinical setting, by qualified medical professionals, properly trained for ECG monitoring and use of the system. The personnel must be experienced in cardiovascular problematic situations and emergency procedures or pathologies related to cardiac involvements. It is not intended as a sole means of diagnosis.
• The device is not intended to be used as a vital signs physiological monitor.
• It is not designed for out of hospital transport.
• It is not designed for use in highly invasive environments, such as an operating theatre.
• The cardiac data and analysis provided is reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns.

The proposed Mortara Instrument ELI PC utilizes previously approved predicate Mortara legacy technology and design features from the Mortara electrocardiograph device family, together with other currently touring technologies, to achieve a highly reliable electrocardiograph. The ELI PC is a standard 12-lead internretive electrocardiograph system that is indicated for use by qualified medical professionals in a clinical solting. The ELI PC combines proprietary hardware and an off-the-shelf personal computer. The concept behind the LI PC is to provide the user with an acquisition module that can transfer the acquired ECG record to a minut the he processing, display, printing and storage. The device may be used in medical clinics and offices of or urlier, to include Clinical Research Organizations.

The system will be based on two major components:

• A wireless acquisition module with memory (WAM PC) and USB-transceiver key (UTK) combination that will allow the acquisition of a 12-lead ECG that will be stored on the module and subsequently wires you transmitted to a PC Station. The Wireless Acquisition Module system will operate at 2.4GHz,
• A software Application (MEPA) that will receive the ECG from the WAM PC and will communicate bi-directionally to the Clinical Server (CTS) and gather/transmit information about the patient's demographics, visit information as well as acquired ECG data. The application controls user access and cutherning top, submits the resulting ECG and demographic and visit information to the Clinical Server and allowing the user to select the appropriate visit protocol and enter patient's demographic and visit data.

The wireless acquisition module with memory (WAM PC) and USB-transceiver key (UTK) combination will be able to acquire multi-lead ECG signals, store the record on the module in an internal non-volation many and subsequently wirelessly transmit the record to a PC Station. The PC side of the system will recoverner your her yeard and will process it. The received ECG data will be first analyzed to determined the quality of the ECG, then the record will be analyzed using the Mortara Resting Interpretation (adults and pediatric). The proprietary software configuration incorporates Mortara's VERITAS™ interpretive algorithms. The analyzed ECG will be displayed on the PC screen and will include all the measurements performed by the interpretation algorithm and he text of the automatic analysis. The user will have the possibility to edit the patient demographic data and, in some versions of the product, also the interpretation text.

The acquisition module (WAM or ELI series) can be offered in various models, with or without internal printer. depending on the market and the customers' requirements. The WAM PC acquisition module requirers unne of a supplied Mortara proprietary 10-wire ECG patient cable for patient connection. The cable is unique to the WAM PC and is distributed as a device component with the WAM PC.

The UTK will interface to the PC host via a USB 2.0 compliant interface and a USB type-A connector. The USB connection will transfer data from the UTK to the PC host. The user will be able to store the record on the local hard disk or on a networked server. In addition, printouts will be possible as well as file export in several formals (DICOM, UNIPRO32, XML, FDA-XML). The ELI PC is capable of being interfaced with Hospital Information i Systems (or similar) in order to receive patient demographics.

The provided text is a 510(k) premarket notification for the Mortara ELI PC Electrocardiograph. It describes the device's intended use, indications for use, and claims substantial equivalence to predicate devices. However, the document does not contain the specific details you requested regarding acceptance criteria, a study proving the device meets those criteria, or information about sample size, expert ground truth, adjudication, MRMC studies, standalone performance, or training set details.

The document primarily focuses on the regulatory submission process for a Class II medical device (electrocardiograph) and its substantial equivalence to previously marketed devices. It details the device's technical description, components, and how it functions, but it does not present a performance study with quantitative acceptance criteria and results.

Therefore, I cannot populate the table or answer the specific questions based solely on the provided text. To answer your questions, you would need access to the actual performance study report that would have been submitted to the FDA as part of their review process, which is not part of this 510(k) summary document.

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