(178 days)
The intended use of the Prucka Engineering, Inc. CardioLab EP 4.2 System is to acquire, filter, digitize, amplify, display, and record electrical signals obtained during electrophysiological studies and related procedures conducted in an electrophysiological laboratory. Signal types acquired include ECG signals, direct cardiac signals, and pressure recordings. Physiological parameters such as diastolic, systolic, and mean blood pressure, heart rate, and cycle length may be derived from the signal data, displayed and recorded. The system allows the user to monitor the acquisition of data, review the data, store the data, perform elementary caliper-type measurements of the data, and generate reports on the data. Additionally, the system may acquire, amplify, display, and record data received from other medical devices typically used during these procedures, such as imaging devices and RF generators.
The CardioLab EP system does not control the delivery of energy, administer drugs, perform any life-supporting or life-sustaining functions, or analyze physiological data or other data acquired during an EP procedure. It does not transmit alarms or arrhythmias, and does not have arrhythmia detection capabilities.
The CardioLab EP System is a microprocessor based data acquisition system used during electrophysiology procedures to accquire ECG, intracardiac, pressure, and digital data from other devices such as RF generators and fluoro video systems. The ECG, intracardiac and pressure data are acquired by an amplifier that is connected to the patient by third-party devices such as ECG leadwires and catheters. The amplifier filters, amplifies, digitizes and transmits the data to the computer. The computer stores the data on optical disks, displays the data on the video monitors, allows the user to perform basic signal measurements, and prints out waveforms on a laser printer or continuous paper recorder. The software has three major functions: data acquisition and display, data storage, and reporting of data. The system is able to acquire signal data in the presence of pacing pulses. In addition to signal waveform display and basic caliper-type measurement, the system allows the user to create isopotential and isochronal activation maps of waveform timing information. The system can also be used to accept video input from a fluoroscopy system for either single frame capture or full motion video display. The system can also acquire data from an RF generator via standard computer RS-232 serial port. The CardioLab EP system does not control the delivery of energy, administer drugs, perform any life-supporting or life-sustaining functions, or analyze physiological data or other data acquired during an EP procedure. It does not transmit alarms or arrhythmias, and does not have arrhythmia detection capabilities.
Here's an analysis of the provided text regarding the Prucka Engineering, Inc. CardioLab EP System's performance testing:
The document does not describe acceptance criteria for the device's performance in analyzing physiological data or detecting arrhythmias, as the device explicitly states it "does not analyze physiological data or other data acquired during an EP procedure. It does not transmit alarms or arrhythmias, and does not have arrhythmia detection capabilities."
Instead, the non-clinical tests described focus on electrical safety, EMC (Electromagnetic compatibility), and basic functional validation of the system's ability to acquire, filter, digitize, amplify, display, and record various physiological signals and data from other medical devices.
Therefore, the table for "acceptance criteria and the reported device performance" will focus on these aspects related to the system's operational integrity and safety, rather than diagnostic performance on a specific medical condition.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical Safety Standards Compliance | The device is certified to meet IEC 601-1, IEC 601-1-1, IEC 601-1-2, IEC 601-2-27, and IEC 601-2-34 standards by SEMKO (an Inchcape Testing Services Company), and ETL Testing Laboratories performed tests conforming to FDA Reviewer Guidance for Premarket Notification Submissions, November 1993. This means the device's electrical design, construction, and operation comply with internationally recognized safety requirements for medical electrical equipment, including general safety, collateral standards (e.g., safety requirements for medical electrical systems), electromagnetic compatibility, particular requirements for electrocardiographs, and particular requirements for medical record imaging devices. |
| Functional Aspect Validation | An in-house validation was performed on the system. The results met acceptance criteria, confirming the safety and efficacy of each functional aspect of the system. This indicates that functions such as signal acquisition, filtering, digitization, amplification, display, recording, data storage, basic measurement (caliper-type), and report generation operate as intended and safely. The system's ability to acquire signal data in the presence of pacing pulses, create isopotential/isochronal maps, and integrate with external devices (e.g., fluoroscopy, RF generators, cardiac stimulators) were implicitly validated. |
| Substantial Equivalence | The device was determined by the FDA to be substantially equivalent to legally marketed predicate devices, meaning its safety and efficacy profile is comparable. This acts as an overarching acceptance criterion met through the combination of technical characteristics and non-clinical testing. |
Study Information
-
Sample size used for the test set and the data provenance:
- The document does not specify a sample size for a test set in the context of physiological signal analysis or diagnostic performance.
- The tests described are primarily non-clinical (electrical safety, EMC, and functional validation).
- The data provenance is not relevant in the typical sense (e.g., country of origin of patient data) as these are engineering and safety tests on the device itself. The tests were performed by SEMKO and ETL Testing Laboratories, and in-house validation.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the study concerns technical and safety compliance, not diagnostic performance requiring expert interpretation of medical images or signals. The "ground truth" for electrical safety tests are the defined limits and parameters in the international standards (IEC 601 series) and FDA guidance, as assessed by accredited testing laboratories and internal engineering teams.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as the tests are objective measures against technical standards (e.g., leakage current, resistance to interference) and functional checks, not subjective interpretations requiring adjudication.
-
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:
- No MRMC study was done. The device explicitly states it "does not control the delivery of energy, administer drugs, perform any life-supporting or life-sustaining functions, or analyze physiological data or other data acquired during an EP procedure. It does not transmit alarms or arrhythmias, and does not have arrhythmia detection capabilities." Therefore, there is no AI component or diagnostic assistance for human readers to evaluate.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm-only performance study was conducted. As stated above, the device does not perform analysis or detection, thus no algorithm for such tasks exists in this device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the non-clinical tests is based on engineering specifications, international electrical safety and EMC standards (IEC 601 series), and FDA guidance. For the in-house functional validation, the ground truth would be the expected operational parameters and outputs of the system according to its design specifications.
-
The sample size for the training set:
- Not applicable. This device does not use machine learning or AI that would require a training set.
-
How the ground truth for the training set was established:
- Not applicable, as there is no training set mentioned or implied by the device's capabilities.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).