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510(k) Data Aggregation
(119 days)
INFANT/CHILD REDUCED ENERGY ELECTRODES
Use the Infant/Child defibrillation electrodes on an infant or child up to 8 years old or up to 25kg (55lbs). Do not delay therapy to determine child's exact age or weight.
These electrodes are to be used only with LIFEPAK CR PLUS defibrillators and biphasic LIFEPAK® 500 AEDs configured with a pink cable connector.
The LIFEPAK CR PLUS and LIFEPAK 500 biphasic defibrillators are indicated for use on patients in cardiopulmonary arrest. The patient must be unconscious, not breathing normally, and showing no signs of circulation (for example, no pulse, and/or no coughing, no movement) before the device is used to analyze the patient's ECG rhythm.
The LIFEPAK CR PLUS and LIFEPAK 500 biphasic defibrillators are intended to be used by personnel who have been trained on the device operation and in basic life support or other physician authorized emergency medical response system.
The attenuating electrode is designed to allow minimally trained responders to safely and effectively defibrillate infants and children under 8 using the LIFEPAK® CR Plus or biphasic LIFEPAK 500 AEDs manufactured after a certain date. (Compatible biphasic LIFEPAK 500 AEDs can be identified by the pink connector on the AED.)
The Infant / Child Reduced Energy Electrode assembly consists of currently marketed Pediatric QUIK-COMBO electrode pads, wires, a connector, and an attenuator. The attenuator is comprised of multiple resistors and a surge protector mounted on a PCB and installed in a flat plastic case.
The attenuator reduces the standard "adult" AED energy at a ratio of about 4 to 1. When used with the Infant / Child Reduced Energy electrodes, an AED set to deliver 200J first shock, 300J second shock, and 360J third shock for adult patients, will instead deliver about 50, 75, and 86J.
Here's a breakdown of the acceptance criteria and study information for the Medtronic Physio-Control Infant/Child Reduced Energy Electrodes, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text focuses on substantial equivalence to predicate devices rather than explicit, quantitative acceptance criteria for all performance metrics. However, it does outline the energy reduction ratio, which is a key performance characteristic.
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| Energy Reduction Ratio (Standard "adult" AED energy to delivered energy) | About 4 to 1 |
| Example: | When an AED is set to deliver 200J (1st shock), 300J (2nd shock), and 360J (3rd shock) for adult patients, the Infant/Child Reduced Energy Electrodes will deliver about 50J, 75J, and 86J respectively. |
| Substantial Equivalence to Predicate Devices (Safety, Effectiveness, Performance) | The 510(k) submission states that the information demonstrates the device is substantially equivalent to the Medtronic Physio-Control Pediatric QUIK-COMBO electrodes (K979301) and the Heartstream Attenuated Defibrillation Pads (K003819) with respect to safety, effectiveness, and performance. This is the overarching acceptance criterion for 510(k) clearance. |
| Clinical testing of algorithm accuracy on pediatric rhythms | Performed (Result: Implies adequate accuracy for pediatric rhythms to support substantial equivalence). Specific numerical acceptance criteria or performance metrics for algorithm accuracy are not provided in the text. |
| Non-Clinical testing of energy dosing | Performed (Result: Implies successful verification of energy dosing in line with specifications and substantial equivalence). Specific numerical acceptance criteria or performance metrics for energy dosing are not provided in the text. |
| Bench testing to verify electrodes meet specifications | Performed (Result: Implies electrodes meet their specifications). Specific numerical acceptance criteria or performance metrics are not provided in the text. |
| Labeling Usability Validation | Performed (Result: Implies favorable usability). Specific acceptance criteria or metrics for usability are not provided in the text. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Clinical testing of algorithm accuracy on pediatric rhythms" and "Non-Clinical testing of energy dosing" but does not specify:
- The exact sample size used for the test set in either category.
- The country of origin of the data.
- Whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document mentions "Clinical testing of algorithm accuracy on pediatric rhythms" but does not specify:
- The number of experts used to establish ground truth.
- The qualifications of those experts.
4. Adjudication Method for the Test Set
The document mentions "Clinical testing of algorithm accuracy on pediatric rhythms" but does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was NOT mentioned or described in the provided text. The submission focuses on the performance of the device itself and its substantial equivalence to predicate devices, rather than measuring the improvement of human readers with AI assistance.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
The document mentions "Clinical testing of algorithm accuracy on pediatric rhythms," which suggests a standalone evaluation of the algorithm's performance in analyzing ECG rhythms. However, further details on how this was conducted (e.g., specific metrics, comparison to human interpretation) are not provided. The primary focus seems to be the algorithm's ability to accurately identify pediatric rhythms for the defribrillator.
7. Type of Ground Truth Used
The document mentions "Clinical testing of algorithm accuracy on pediatric rhythms." For ECG rhythm analysis, the ground truth is typically established by expert consensus of cardiologists or electrophysiologists on the rhythm strips. However, the document does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data).
8. Sample Size for the Training Set
The document does NOT provide any information regarding the sample size used for the training set for the algorithm.
9. How the Ground Truth for the Training Set Was Established
The document does NOT provide any information on how the ground truth for the training set was established.
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