(187 days)
Netech Corporation Delta 3300 Defibrillator/Pacemaker Analyzer is used to determine that defibrillators and transcutaneous pacemakers are performing within their performance specifications through the measurement of energy output.
Netech Corporation Delta 3300 Defibrillator/Pacemaker Analyzer is used to determine that defibrillators and transcutaneous pacemakers are performing within their performance specifications through the measurement of energy output.
The portable battery-powered device is intended for use by trained service technicians. Delta 3300 is a waveform analyzer that determines the characteristics of an electrical discharge signal produced by a defibrillator and transcutaneous pacemaker.
It provides a basis for verifying the energy output of a defibrillator, including energy, peak current, and peak voltage. The device incorporates a simulation function of ECG and arrhythmia waveforms for verifying the performance of defibrillator monitors.
Delta 3300 also verifies transcutaneous pacemaker parameters such as pulse rate, width, amplitude, and energy as well as refractory and sensitivity measurement.
This document is a 510(k) premarket notification for the Delta 3300 Defibrillator/Pacemaker Analyzer. The information provided focuses on demonstrating substantial equivalence to a predicate device, the BC Group International, Inc. DA-2006.
Here's an analysis based on your requested criteria:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" for the Delta 3300's performance in the typical sense of a diagnostic device (e.g., sensitivity, specificity, accuracy). Instead, it demonstrates performance by comparing its technical specifications and test results to those of the predicate device, aiming to show it is equivalent or better. The acceptance criteria are implicitly met by demonstrating that the Delta 3300's performance specifications are comparable to or improved over the predicate, and that it passed relevant safety and EMC standards.
| Characteristic | Acceptance Criteria (Predicate DA-2006) | Reported Device Performance (Delta 3300) | Comparison |
|---|---|---|---|
| Maximum Voltage | 5000V | 5000V | Same |
| Maximum Continuous Power | 12W, 10 defib pulses at 360J every 5 min | 10W, 10 defib pulses at 360J every 5 min | Power dissipation factor increased by 2W (Predicate is higher) |
| Inductance | 10, 100 | 0.01 resolution 10 -99.9 (Delta 3300 offers higher resolution in lower ranges) | |
| Elec Spec: Load Settings | 50 Ω, +/- 1% | 50 Ω, +/- 1% | Same |
| Elec Spec: Accuracy (50 Ω) | +/- 2% of reading; +/- 2 Joules | Auto Ranging: +/- 1% of reading for 100 Joules | +/- 1% of reading for 100 Joules (Delta 3300 offers better accuracy in lower ranges) |
| Operating Temp | 15 to 40 °C | 15 to 40 °C | Same |
| Storage Temp | -20 to +60 °C | -20 to +60 °C | Same |
| Electrical Safety | Met IEC 61010-1:2010 | Passed IEC 61010-1:2010 (Third Edition) | Compliance with safety standard |
| EMC | Met EN 61000-3-2; EN 61000-3-3 | Passed EN 61000-3-2; EN 61000-3-3 | Compliance with EMC standards |
| Software Verification | Implied by predicate clearance | Passed IEC 61508 - Embedded software verification and validation | Compliance with software standard |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This device is a defibrillator/pacemaker analyzer, a test and measurement instrument, not a diagnostic device that processes patient data. Therefore, the concept of a "test set" with patient data or provenance does not apply. The performance evaluation was based on non-clinical bench tests. The document does not specify a "sample size" in terms of number of patient cases.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. As a test and measurement device, ground truth is established by the known physical properties and outputs of the equipment being tested (e.g., a defibrillator's energy output), calibrated standards, and compliance with engineering standards. There is no mention of human expert consensus for establishing ground truth as there would be for an AI-powered diagnostic tool.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human readers or interpretation of results that would require an adjudication method.
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
Not applicable. This device is a standalone analyzer, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in a sense. The "performance testing" described involved non-clinical bench tests of the device itself (electrical safety, EMC, embedded software verification). The device operates as a standalone instrument for measuring parameters of other medical devices (defibrillators and transcutaneous pacemakers) without human-in-the-loop interpretation of its internal functioning. Its performance is evaluated against engineering specifications and standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the performance testing of the Delta 3300 is based on:
- Engineering specifications and standards: e.g., the specified voltage/current/energy output of a defibrillator for measurement, the requirements of IEC 61010-1 for electrical safety, EN 61000 series for EMC, and IEC 61508 for software.
- Known, calibrated inputs/simulations: The device measures electrical signals; these signals would be generated by calibrated sources or actual medical devices with known performance characteristics to verify the analyzer's accuracy.
8. The sample size for the training set
Not applicable. This is a hardware device with embedded software, not a machine learning model that requires a training set in the AI sense. The embedded software was verified and validated according to IEC 61508, which involves testing against requirements, but not a "training set" of data.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of this device. The phrase "ground truth" for embedded software might refer to the functional requirements and intended behavior established during the design and development phases, against which the software's performance is tested.
§ 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).