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The ELI 350 is intended to be a high-performance, up to 15-lead, multifunctional electrocardiograph. As a resting electrocardiograph, ELI 350 simultaneously acquires data from each lead. Once the data is acquired, it can be analyzed, reviewed and/or stored, and/or printed. It is a device primarily intended for use in hospitals, but may be used in medical clinics and offices of any size.

The stress exercise option is a diagnostic tool intended to acquire, process, and store ECG data of patients undergoing stress exercise testing. The software records ECG, heart rate, and ST data; creates summary tables, trends and a final report regarding a variety of cardiac data indices. The cardiac data provided is reviewed, confirmed, and used by trained medical personnel to assist in the diagnosis of the electrocardiographic data reflecting the patient's physiological condition during stress exercise testing.

The late potential, signal-averaged ECG (SAECG) option allows for the acquisition, analysis, and printout of signal-averaged ECGs in order to detect ventricular late potentials for consideration by a physician.

Indications for Use:

• The device is indicated for use to acquire, analyze, display and print electrocardiograms.
• The device is indicated for use to provide interpretation of the data for consideration by a physician.
• The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis.
• 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 on adult and pediatric populations.
• The device is not intended to be used as a vital signs physiological monitor.
• The device is indicated for use to acquire, analyze, display and print signal-averaged ECGs to detect ventricular late potentials for consideration by a physician.
• The device is indicated for use to acquire, process, record, archive, analyze, display and print ECG data of patients undergoing physiologic stress exercise testing.

The electrocardiogram (ECG) is a graphic description of the electrical activity of the heart. This activity is recorded from the body surface by a group of electrodes positioned at predefined places to reflect the activity from different perspectives. The cardiac data acquired and provided by the ELI 350 is used by trained medical personnel to assist in the diagnosis of symptomatic patients with various rhythm patterns.

The ELI 350 is a multi-channel, high-end resting interpretation electrocardiograph utilizing a 17" SXGA (1280x1024 pixel) color LCD for display of ECG waveforms, menu options and status information. The LCD provides a preview of the record for the clinician to assess the quality of the acquired ECG. The overall design of the ELI 350 is a "clamshell" style where the LCD screen can be closed over the printer when the unit is shipped or not in use.

A full size keyboard is part of the ELI 350 design and allows patient data entry as well as control of the functions and options available for the unit. The keyboard includes alphabetic, numeric, symbol, cursor control and special function keys. The ELI 350 is designed to be installed on a transport cart.

The ELI 350 is able to acquire data from up to 15-leads, analyze, display, and/or print electrocardiograms acquired via direct or wireless patient connection. The ELI 350 also offers storage capability in order to retrieve or transmit stored records. Transmission can be achieved using one of the optional communication media designed in the unit: RS 232, LAN, WLAN, USB port, or GSM module.

The ELI 350 incorporates a full size thermal writer (8.5" x 11") that allows printouts using several formats available to the user, from the 6+6 channels to the Cabrera formats. The writer is also used by the unit for real time, continuous rhythm printouts.

The ELI 350 offers, adult and pediatric interpretation capability to assist the physician over-read of the electrocardiogram, review the electrocardiogram to identify the best 10 second sample based on noise, and will offer the options to conduct late potential analysis and allow connection to a treadmill or ergometer for exercise stress testing.

Stress Exercise Option: The ELI 350 Stress Exercise test option is a software module that can be loaded onto the ELI 350 platform. The Stress Exercise option allows the ELI 350 to function as a diagnostic tool to analyze, edit, review, report and store acquired ECG data of patients that have undergone stress exercise testing. The stress exercise software displays the electrocardiographic (ECG) waveforms, exercise time, ST measurements, and other data useful during testing utilizing stress test protocols for ergometer and treadmill.

Late Potential (Signal-averaged ECGs) Option: The Late Potential (Signal-averaged ECGs) option allows for the acquisition, analysis and printout of signal-averaged ECGs in order to detect ventricular late potentials are low amplitude, relatively high-frequency bioelectric signals which can be detected at the end of the QRS. When acquiring late potentials, orthogonal leads (X, Y, and Z leads are most commonly used).

The provided text describes the ELI 350 Electrocardiograph and its modifications, including a stress exercise option and a late potential option. However, it does not contain information regarding a specific study with acceptance criteria and device performance evaluation. The document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed study results for performance validation.

Therefore, I cannot populate most of the requested fields because the information is not present in the provided document.

Here's what I can extract and what is explicitly missing:

Missing Information:

1. Sample Size Used for Test Set & Data Provenance: Not mentioned. The document focuses on demonstrating substantial equivalence.
2. Number of Experts & Qualifications for Ground Truth: Not mentioned.
3. Adjudication Method for Test Set: Not mentioned.
4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not mentioned.
5. Standalone Performance Study: Not mentioned. This document is about a device modification and substantial equivalence, not a new algorithm's standalone performance.
6. Type of Ground Truth Used: Not mentioned.
7. Sample Size for Training Set: Not mentioned.
8. How Ground Truth for Training Set was Established: Not mentioned.

The document primarily describes the device's features, intended use, and indications for use, stating its substantial equivalence to predicate devices. It outlines what the device does (e.g., acquires ECG data, provides interpretation, offers stress exercise and late potential options) but not the specific performance metrics or the studies that would typically prove these capabilities against defined acceptance criteria.

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The ELI 350 is intended to be a high-performance, 15-lead, multifunctional electrocardiograph. As a resting electrocardiograph, ELI 350 simultaneously acquires data from 15 leads. Once the data is acquired, it can be reviewed and/or stored, and/or printed. It will be a device primarily intended for use in hospitals, but may be used in medical clinics and offices of any size.

Indications for Use:

• The device is indicated for use to acquire, analyze, display and print electrocardiograms.
• The device is indicated for use to provide interpretation of the data for consideration by a physician.
• The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis.
• 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 on adult and pediatric populations.
• The device is not intended to be used as a vital signs physiological monitor.

The ELI 350 is a multi-channel, high-end resting interpretation electrocardiograph. The ELI 350 simultaneously acquires data from up to 15 leads. Once the data is acquired, it can be reviewed, and/or stored, and/or printed. The electrocardiogram (ECG) is a graphic description of the electrical activity of the heart. This activity is recorded from the body surface by a group of electrodes positioned at predefined places to reflect the activity from different perspectives. The cardiac data acquired and provided by the ELI 350 is used by trained medical personnel to assist in the diagnosis of symptomatic patients with various rhythm patterns. The ELI 350 is designed to be installed on a transport cart. Its design is a "clam-shell" style, with a 17" color LCD screen that can be closed over the printer when the unit is shipped or not in use. The ELI 350 is able to acquire, analyze, display and print electrocardiograms acquired through its internal Mortara front-end amplifier. The size of the screen will allow a full size preview of the record for the technician to assess the quality of the acquired ECG. The ELI 350 uses a 17" SXGA (1280 x 1024 pixel) color LCD for display of ECG waveforms, menu options and status information. A full size keyboard is part of the ELI 350 design and allows patient data entry as well as control of the functions available for the unit. The ELI 350 custom keyboard will include alphabetic, numeric, symbol, cursor control and special function keys. The ELI 350 incorporates a full size thermal writer (8.5" x 11") that allows printouts using several formats available to the user, from the 6+6 channels to the Cabrera formats. The writer is also used by the unit for real time, continuous rhythm printout. The ELI 350 will offer storage capability in order to retrieve or transmit stored records. Transmission can be achieved using one of the optional communication media designed in the unit: RS 232, LAN, WLAN, USB port, GSM module.

The provided document describes a 510(k) submission for a device modification (K082946: ELI 350 Electrocardiograph). This is a traditional 510(k) for a hardware device (electrocardiograph) and does not involve AI or a software algorithm requiring detailed performance studies with acceptance criteria in the manner requested. The document does not contain information on acceptance criteria for algorithm performance, study design, sample sizes, expert qualifications, or ground truth establishment relevant to AI/algorithm performance.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on the device description, intended use, indications for use, and regulatory classification within the context of a 510(k) submission for a hardware device modification to an existing predicate.

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• The device is indicated for use to acquire, analyze, display and print electrocardiograms.
• The device is indicated for use to provide interpretation of the data for consideration by a physician. .
• The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting . on the orders of a licensed physician. It is not intended as a sole means of diagnosis.
• . 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 on adult populations.
• The device is indicated for use on pediatric populations for acquisition, display, and printing of multi-. channel ECGs.
• The device is not intended to be used as a vital signs physiological monitor. .

The ELI 350 is a multi-channel, high-end interpretive electrocardiograph. The ELI 350 provides simultaneous multi-channel acquisition and is designed to be installed on a transport car. Its design is a "clam-shell" style, with a 17" color LCD screen that can be closed over the printer when the unit is shipped or not used. The ELI 350 is able to acquire, analyze, display and print electrocardiograms acquired through its internal Mortara front-end amplifier. The size of the screen will size preview of the record for the technician to assess the quality of the acquired ECG.

The ELI 350 will use a 17" SXGA (1280 x 1024 pixel) color LCD for display of ECG waveforms, menu options and status information. A full size keyboard is part of the ELI 350 design and allows patient data entry as well as control of the functions available for the unit. The ELI 350 custom keyboard will include alphabetic, numeric, symbol, cursor control and special function keys. The ELI 350 incorporates a full size thermal writer (8.5" x 11") that allows printouts using several formats available to the user, from the 6+6 channels to the Cabrera formats. The writer is also used by the unit for real time, continuous rhythm printout.

The ELI 350 will offer storage capability in order to retrieve or transmit stored records. Transmission can be achieved using one of the optional communication media designed in the unit: RS 232, LAN, WLAN, USB port, GSM module.

This document describes a 510(k) submission for the Mortara ELI 350 Electrocardiograph, a device for acquiring, analyzing, displaying, and printing electrocardiograms. However, the provided text does not contain any information regarding specific acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement.

The document primarily focuses on:

• Device Description: Features and capabilities of the ELI 350.
• Intended Use: The general purpose of the device.
• Indications for Use: Specific clinical applications approved by the FDA.
• Predicate Device: The ELI 300, to which substantial equivalence is claimed.
• FDA 510(k) Clearance Letter: Confirming the device's substantial equivalence.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study that proves the device meets them because that information is not present in the provided text. The document is for a "Special 510(k): Device Modification," which often means the core safety and effectiveness studies were conducted for the predicate device, and the current submission focuses on demonstrating that the modifications do not negatively impact those aspects.

To answer your questions, I would need a different document (e.g., the test report, clinical study protocol, or detailed specifications) that outlines the performance evaluation of the ELI 350.

Ask a specific question about this device