(59 days)
The UniPulse 400 Defibrillator/Pacemaker Analyzer is used to determine that a defibrillator equipped with transcutaneous pacemaker capability are performing within their performance specifications through the measurement of energy output. The UniPulse 400 is intended to be used in the laboratory environment, outside of the patient care vicinity and is not intended to be used on patients or to test devices while connected to patients.
The Rigel Medical UniPulse 400 is a portable, rechargeable battery operated (with AC Adapter) defibrillator tester used to determine that a defibrillator and a defibrillator with a transcutaneous pacemaker function perform to their published performance specifications. The UniPulse 400 is connected to a defibrillator output and is used to measure the output energy delivered from the device into a standard resistive test load. It also provides waveform information on its integrated display. For pacemaker testing, a variable load from 50 to 1600 ohms is available in 50-ohm steps. Defibrillator paddles are connected directly to the UniPulse 400 for hands free operation, or to contact plates if using the paddles. When the defibrillator is discharged, the UniPulse 400 will display the energy delivered. Included in the UniPulse 400 is an ECG simulator with normal sinus rhythm and arrhythmia simulation to trigger automated defibrillation.
UniPulse 400 is used by biomedical and/or clinical engineers to verify performance of defibrillators used in their hospital. The UniPulse 400 provides statistical data measured from the device and can communicate to an external Bluetooth printer and a PC / Laptop via Bluetooth and USB.
The provided text describes the UniPulse 400 Defibrillator/Pacemaker Analyzer, a device used to verify the performance of defibrillators. However, it does not include detailed acceptance criteria or a study proving the device meets those criteria in a format directly addressing typical AI/ML device study parameters.
The document discusses performance testing, but focuses on compliance with general safety and EMC standards rather than specific analytical performance metrics and their acceptance thresholds. It also states the device is not an AI/ML product, and thus many of the requested criteria (like ground truth, expert adjudication, MRMC studies) are not applicable.
Here's a breakdown based on the provided text, and where gaps exist because the device is not an AI/ML diagnostic tool:
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions that the device was tested to comply with its specifications, but it does not explicitly list quantitative performance acceptance criteria for measuring energy output or pacemaker analysis, nor does it report specific numerical performance results against such criteria. The "Summary of Performance Testing" refers to compliance with safety (Electrical Safety, Electromagnetic Compatibility) and software development standards, not analytical performance accuracy or precision with defined thresholds relevant to a diagnostic AI/ML device.
2. Sample Size for Test Set and Data Provenance
This information is not applicable/provided in the context of an AI/ML test set. The UniPulse 400 is an analyzer for other medical devices, not a diagnostic tool that processes patient data. Performance testing appears to involve laboratory bench testing against standards, not a patient-based test set.
3. Number of Experts for Ground Truth and Qualifications
This is not applicable as the device is not an AI/ML diagnostic device requiring expert interpretation for ground truth. Its performance evaluation would involve comparing its measurements against known, calibrated inputs or reference devices, not expert consensus on medical images or signals.
4. Adjudication Method for Test Set
This is not applicable for the same reasons as (3).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This is not applicable. The UniPulse 400 is a measurement device for defibrillators, not an AI-assisted diagnostic tool that aids human readers in interpreting clinical cases. Therefore, there's no "human readers improve with AI vs without AI assistance" effect size to report.
6. Standalone (Algorithm Only) Performance Study
While the device's "performance testing" assesses its standalone function, it's not a standalone algorithm in the sense of an AI/ML diagnostic tool. The document states its performance was tested against its predetermined specifications, indicating standalone functionality, but does not provide details of this testing beyond compliance.
7. Type of Ground Truth Used
The concept of "ground truth" as typically applied to AI/ML diagnostic devices (e.g., pathology, outcomes data) is not applicable here. For the UniPulse 400, "ground truth" would likely involve highly accurate and calibrated reference measurements from specialized lab equipment or known, precise outputs from simulated defibrillator discharges. The document does not specify how the accuracy of these reference measurements was established.
8. Sample Size for Training Set
This is not applicable. The UniPulse 400 is a hardware and software device following traditional engineering principles, not an AI/ML algorithm that is 'trained' on a dataset.
9. How Ground Truth for Training Set was Established
This is not applicable for the same reasons as (8).
Conclusion from the document:
The K182905 510(k) summary for the UniPulse 400 primarily focuses on demonstrating substantial equivalence to a predicate device (Fluke Biomedical Impulse 7000dp Defibrillator Analyzer) by showing similar technological characteristics and compliance with general safety and electromagnetic compatibility (EMC) standards. The "Performance Testing - Bench" section states that the device was tested according to "predetermined specifications" and that the results show compliance, but it does not elaborate on what these specific performance specifications are (e.g., accuracy, precision of energy measurement), nor does it present the numerical results of these tests.
The document is a regulatory clearance for a physical measurement device, not an AI/ML diagnostic algorithm, hence the lack of information pertinent to AI/ML specific study requirements.
§ 870.5325 Defibrillator tester.
(a)
Identification. A defibrillator tester is a device that is connected to the output of a defibrillator and is used to measure the energy delivered by the defibrillator into a standard resistive load. Some testers also provide waveform information.(b)
Classification. Class II (performance standards).