(180 days)
The Impulse 6000D/7000DP is used to determine that defibrillators and transcutancous pacemekers are performing within their performance specifications through the measurement of energy output.
The Impulse 600013/7000DP is a portable, rechargeable, battery-operated defibrillator tester. The Impulse 7000DP also functions as a transcutaneous pacemaker tester. The device's defibrillator input is connected to the output of a defibrillator under test which provides a 50-Ohm test load, approximately the impedance of the human body. The Impulse 6000D/7000DP simulates patient electrocardiogram signals to trigger automated defibrillation when a ventricular fibrillation waveform is presented, and the device tests that the automated defibrillator does not advise shock when a normal sinus rhythm electrocardiogram is presented. The energy output delivered by the defibrillator under test is measured. The Impulse 7000DP also tests transcutaneous pacemaker outputs by presenting a low level electrocardiogram at various pulse rates and measures the response of the pacemaker under testing rate and amplitude. For pacemaker testing, the device incorporates inputs of 50 to 1500 Ohm impedance test loads. The Impulse 6000D is a defibrillator tester only without the pacemaker test option. Both models have 10 electrocardiogram outputs to simulate patient milli-volt level electrocardiogram signals to test combination patient monitors/defibrillators/pacemakers.
The Impulse 7000DP has a USB type "B" interface to a PC to allow data download to a PC. It is electrically isolated from the measurement circuitry and allows remote control of the test from a PC. A BNC type connector on the rear panel also allows an oscilloscope to record the waveform output from the defibrillator under test, attenuated to a lower voltage level, and also electrically isolated from the measurement circuitry. Another BNC connector outputs a higher level signal (greater amplitude) to view the electrocardiogram signal on a second oscilloscope channel.
The accessories for the Impulse 6000D/7000DP include an external power supply to operate and re-charge the internal battery. Optional adapters to connect defibrillators marketed by different manufacturers to the standard 4 mm banana style input jacks are available.
Waveform analysis determines the characteristics of a defibrillator discharge pulse. Peak voltage amplitude, current, timing, overall energy and the refractory period of a pacemaker are recorded. Measurement is done by attenuating the high voltage signal to a lower voltage level, which is then input into an analog to digital converter. A digital signal processor calculates the measurements and corrects hardware error sources with mathematical calibration constants for any offset and gain errors.
The provided text describes a medical device, the Impulse 6000D/7000DP Defibrillator Tester, and its FDA 510(k) clearance (K072114). However, it does not contain the specific details required to fully address your request.
The document is a 510(k) summary and the FDA's clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results with acceptance criteria.
Therefore, I cannot provide a complete answer to your request. Here's specifically what is missing or cannot be inferred from the provided text:
- Acceptance Criteria Table: No explicit acceptance criteria are mentioned for the device's performance. The document only states the device "is used to determine that defibrillators and transcutaneous pacemakers are performing within their performance specifications." These "performance specifications" are not detailed.
- Study That Proves the Device Meets Acceptance Criteria: While a 510(k) submission requires performance data, the provided summary does not include the actual study design, results, or comparison to specific acceptance criteria. It mentions "waveform analysis determines the characteristics of a defibrillator discharge pulse," and "digital signal processor calculates the measurements and corrects hardware error sources," but doesn't elaborate on the studies or their outcomes.
Here's what can be extracted/inferred from the provided text, acknowledging the significant gaps:
Analysis of Acceptance Criteria and Performance Study:
The provided document (a 510(k) summary and FDA clearance letter) does not detail specific acceptance criteria or a comprehensive study that proves the device meets those criteria. Instead, it focuses on establishing substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in the document. The device's purpose is to determine if defibrillators and pacemakers are performing "within their performance specifications." These specifications themselves are not provided.
- Reported Device Performance: The document describes the device's functions (e.g., measuring energy output, simulating ECG signals, testing pacemaker outputs), but it does not provide quantitative performance metrics or results against any defined criteria.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no such expert-based ground truth establishment is described for a performance study in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) 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:
- Not applicable. This device is a defibrillator and pacemaker tester, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The device itself is a standalone tester. The document describes its functional capabilities (e.g., "Measurement is done by attenuating the high voltage signal to a lower voltage level, which is then input into an analog to digital converter. A digital signal processor calculates the measurements and corrects hardware error sources..."). This implies the device provides objective measurements independently. However, no specific details on standalone performance studies (e.g., accuracy, precision tests) are provided in this summary.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For a device like this, the "ground truth" would likely be established through reference standards (e.g., highly accurate and calibrated physical measurement equipment, or known electrical signals) to which the device's measurements are compared. However, the document does not specify the ground truth methodology used for its internal validation or for its 510(k) submission package.
8. The sample size for the training set:
- Not applicable. This device is a measurement instrument, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable (as above).
In summary, the provided 510(k) documents focus on device description, intended use, and substantial equivalence to a predicate device, rather than detailed performance study reports with acceptance criteria, sample sizes, or ground truth methodologies. To obtain such information, one would typically need to review the full 510(k) submission package, which is not provided here.
§ 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).