(15 days)
The DA-2006/DA-2006P are used to determine that defibrillators and transcutaneous pacemakers are performing within their performance specifications through the measurement of energy output. The DA-2006 tests defibrillators while the DA-2006P additionally tests transcutaneous pacemakers.
The BC Group International DA-2006 Defibrillator Tester is a precision instrument for testing defibrillators, and for ensuring that defibrillators comply with specified requirements.
The DA-2006 is a microprocessor-based instrument that is used in the testing of defibrillators. It measures the energy output and provides information about the pulse. It is used on manual, semi-automatic and automatic defibrillators with monophasic or biphasic outputs.
The DA-2006P model additionally provides a Transcutaneous Pacemaker analysis function. It measures and displays pacer pulse information as well as performing Refractory Period, Sensitivity and Immunity testing,
All models have a built in 50 ohm human body simulation load as well as 12 lead ECG with arrhythmias and performance waveforms. Additionally, they have a centronics printer port, a serial port, oscilloscope output, high level ECG output, as well as provision for a batterv eliminator.
The DA-2006P makes viewing and selecting the desired waveforms and test data quick and intuitive, with all operational information being available on the 240 by 64 pixel graphic display, allowing for easy maneuvering through parameters and scrolling through available options.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the DA-2006P Defibrillator Tester:
Device: DA-2006P Defibrillator Tester
Indications for Use: To determine that defibrillators and transcutaneous pacemakers are performing within their performance specifications through the measurement of energy output.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the acceptance criteria are primarily defined by compliance with specific international standards for electromagnetic compatibility and electrical safety, and the successful execution of internal validation and verification tests. The reported device performance is simply that the device "Pass"ed all these tests.
| Test / Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| International Standards Compliance: | |
| EN61326: Electrical equipment for measurement, control, and laboratory use - EMC Requirements | Pass |
| EN61000-3-2: Electromagnetic Compatibility (EMC) Part 3-2 Limits - Limits for Harmonic Current Emissions | Pass |
| EN61000-3-3: Electromagnetic Compatibility (EMC) – Part 3: Limits - Section 3: Limitation of Voltage Changes, Voltage Fluctuations and Flicker in Public Low-Voltage Supply Systems | Pass |
| IEC61010-1: Safety requirements for electrical equipment for measurement, control, and laboratory use Part 1: General Requirements | Pass |
| Internal Testing & Functionality: | |
| Debugger Validation: Evaluate device operation under conditions not available under normal use | Pass |
| Device Validation: Validate device function of each hardware and software specification | Pass |
| Device Verification: Ensure device function during assembly | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for any "test set" in the context of clinical or performance data from actual defibrillator/pacemaker measurements. The testing described is for the device itself (DA-2006P), not for the performance of defibrillators/pacemakers measured by the DA-2006P.
- Sample Size: Not applicable/Not specified for a "test set" related to clinical performance. The tests are on the device itself.
- Data Provenance: Not applicable in the sense of clinical data origin. The testing involves engineering and safety standards verification, likely performed in a controlled laboratory environment. There is no mention of country of origin for data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the document. The "tests" described are against international engineering and safety standards (EN, IEC), and internal device validation/verification. These are typically assessed by qualified engineers and technicians, not clinical "experts" establishing a "ground truth" for medical imaging or diagnosis.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable in the context of the described engineering and safety tests. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies where human interpretation of medical data is involved and discrepancies need to be resolved. The "Pass" results indicate direct compliance with predefined technical specifications or standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic AI devices where human readers' performance with and without AI assistance is compared. The DA-2006P is a test instrument, not a diagnostic AI device intended for human interpretation of medical cases.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
The concept of "standalone" performance without human-in-the-loop is typically applied to software algorithms that make independent assessments. The DA-2006P is a physical hardware device with embedded software. The described "Device Validation" and "Device Verification" could be considered "standalone" in the sense that they are testing the device's inherent functionality against its specifications, independent of a specific human operator's diagnostic interpretation. However, it's not "standalone" in the context of an AI algorithm making a clinical decision. The device is designed to be operated by a "trained service technician" to measure and display data.
7. The Type of Ground Truth Used
The "ground truth" for the tests performed on the DA-2006P is based on:
- International Engineering and Safety Standards: The requirements and limits defined in EN61326, EN61000-3-2, EN61000-3-3, and IEC61010-1.
- Manufacturer's Internal Specifications: The defined hardware and software specifications and operational parameters of the DA-2006P itself, used for "Device Validation" and "Device Verification."
There is no mention of expert consensus, pathology, or outcomes data, as these are not relevant for the type of device and testing described.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The DA-2006P is not an AI/ML device that requires a "training set" in the conventional sense. It's a measurement instrument.
9. How the Ground Truth for the Training Set was Established
This information is not applicable and not provided for the same reasons as point 8.
§ 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).