(294 days)
The Cardio Med Pediatric Radiotranslucent Multifunction Electrodes, Various Models are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on pediatric patients whose weight is less than 10 kg (22 lbs). When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (30 joule maximum).
These are single use, non-sterile, self stick defibrillator electrodes packaged in pairs. Effective electrode area = 46.43 cm² (7.1967 in²) They are radiotranslucent. They come in various connector styles to match the specific defibrillator. (See intended use statement below.) The construction and materials employed are identical to the predicate. The patient contact material is a conductive adhesive hydrogel identical to the material used in the predicate devices. These pads meet the AAMI Standard ANSI/AAMI DF80:2003 and the connectors meet the FDA performance standard for touch proof ECG connectors.
The provided text describes a 510(k) premarket notification for Cardio Med Pediatric Radiotranslucent Multifunction Electrodes. This document focuses on demonstrating substantial equivalence to a predicate device through nonclinical bench testing. It does not contain information typically found in studies for AI/machine learning medical devices, such as those related to reader performance, clinical outcomes, or large-scale data analysis for algorithm development.
Therefore, many of the requested categories related to AI device studies (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance) cannot be addressed from the given text.
Here's a summary based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with ANSI/AAMI DF80:2003 for DC offset, offset instability, AC small signal impedance, AC large signal impedance, defibrillator overload | All units passed these tests both initially and after 42-month accelerated aging. |
| Compliance with FDA performance standard for touch-proof ECG connectors | Verified by inspection of the connectors. |
| Biocompatibility of patient contact material (hydrogel) | Material passed biocompatibility testing. |
| Post-pacing characteristics | All units passed these tests. |
| Shelf Life (Accelerated Aging) | All units passed tests after 42-month accelerated age shelf life. |
2. Sample size used for the test set and the data provenance
- Sample Size: "Various different lots containing multiple samples each" were subjected to AAMI tests. The exact number of samples or lots is not specified.
- Data Provenance: Not applicable in the context of this device. The testing was nonclinical bench testing, not involving human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This was bench testing against engineering standards, not diagnostic device validation requiring expert-established ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. This was bench testing against engineering standards. Results would be pass/fail based on direct measurement and comparison to thresholds rather than expert adjudication.
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, an MRMC comparative effectiveness study was not done. This device is a passive electrode, not an AI or diagnostic imaging device that would involve human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the bench testing was defined by the quantitative limits specified in the AAMI Standard ANSI/AAMI DF80:2003 and the FDA performance standard for touch-proof ECG connectors. Biocompatibility was assessed against standard biological safety test protocols.
8. The sample size for the training set
- Not applicable. This device does not involve a training set for an algorithm.
9. How the ground truth for the training set was established
- Not applicable. There is no training set for an algorithm.
§ 870.5300 DC-defibrillator (including paddles).
(a)
Low-energy DC-defibrillator —(1)Identification. A low-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy defibrillators with a maximum electrical output of less than 360 joules of energy that are used in pediatric defibrillation or in cardiac surgery. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.(2)
Classification. Class II (performance standards).(b)
High-energy DC-defibrillator —(1)Identification. A high-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of greater than 360 joules of energy used for defibrillating the atria or ventricles of the heart or to terminate other cardiac arrhythmias. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976. Any other DC-defibrillator (including paddles) described in paragraph (b)(1) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.