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510(k) Data Aggregation
(46 days)
The DA-2006-VL is used to determine that defibrillators are performing within their performance specifications by providing multiple loads of 25, 50, 75, 100, 125, 150, 175 and 200 Ohms. The DA-2006-VL is used in conjunction with the DA-2006/DA-2006P.
The BC Group International DA-2006-VL Variable Load is a precision instrument for testing defibrillators, and for ensuring that defibrillators comply with international standards IEC 60601-2-4 and AAMI DF80.
The DA-2006-VL is a non-powered, selectable resistive load bank. Through various series and parallel resistor combinations. the DA-2006-VL allows a user to select 25, 50, 75, 100, 125, 150, 175, and 200 Ohm loads.
The DA-2006-VL is used in conjunction with the DA-2006/DA-2006P Defibrillator Analyzer.
The provided text describes a medical device, the DA-2006-VL Defibrillator Analyzer Variable Load, and its equivalency to a predicate device, the Fluke Impulse 7010 Defibrillator Selectable Loads. However, the document does not contain information about an AI-powered device or a study involving human readers or AI assistance. Therefore, most of the requested information cannot be extracted from this document.
Here's the information that can be extracted and a note on what is not available:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from Predicate/DA-2006-VL Specifications) | Reported Device Performance (DA-2006-VL) |
|---|---|
| Maximum voltage: 5000 V | 5000 V |
| Maximum Continuous Power: 12 W, 10 defib pulses of 360 J every 5 minutes | 12 W, 10 defib pulses of 360 J every 5 minutes |
| Inductance: 100 Joules, ± 1 J for ≤100 Joules | High Range: ± 2 % of reading for >100 Joules, ± 2 Joules for ≤100 Joules |
| Accuracy (50 Ω) Low Range: Not explicitly stated for predicate in table, but implied by DA-2006-VL description | Low Range: ± 2 % of reading for >20 Joules, ± 0.4 Joules for ≤20 Joules |
| Accuracy (25 Ω, 75-200 Ω) High Range: ± 2% of reading + 0.1 J for >100 Joules, ± 2 J for ≤100 Joules | High Range: ± 3 % of reading for >100 Joules, ± 3 Joules for ≤100 Joules |
| Accuracy (25 Ω, 75-200 Ω) Low Range: Not explicitly stated for predicate in table, but implied by DA-2006-VL description | Low Range: ± 3 % of reading for >20 Joules, ± 0.6 Joules for ≤20 Joules |
| Dimensions: 138.7 mm x 154 mm x 272 mm | 248.9 mm x 205.7 mm x 120.7 mm |
| Weight: 1.54 kg | 2.27 kg |
| Operating Temperature: 10 to 40 C | 15 to 40 C |
| Storage Temperature: -20 to +60 C | -20 to +65 C |
The device was also tested to a standard:
- IEC61010-1: Safety requirements for electrical equipment for measurement, control, and laboratory use Part 1: General Requirements. Result: Pass
2. Sample size used for the test set and the data provenance: Not applicable. This document describes a physical medical device (defibrillator analyzer), not a software or AI algorithm that would typically have a "test set" in the context of data. The testing performed was related to device function and electrical safety. The data provenance is also not applicable for this type of device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI algorithms (e.g., expert labels on images) is not relevant for this device. The "ground truth" for this device's functionality would be established by engineering specifications and measurements using calibrated reference equipment.
4. Adjudication method for the test set: Not applicable.
5. 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. This document is not about an AI-powered device or a study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This is not an AI algorithm.
7. The type of ground truth used: For the functional performance, the "ground truth" would be established by calibrated measurement standards and the device's design specifications. For the IEC standard, the ground truth is adherence to the standard's requirements.
8. The sample size for the training set: Not applicable. This is not an AI algorithm.
9. How the ground truth for the training set was established: Not applicable. This is not an AI algorithm.
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(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.
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