(28 days)
The PadPro radiotransparent external electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patent 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 adult patients. 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 (360 joule maximum).
The electrodes are multifunction because they can be used for defibrillation, pacing, cardioversion, and monitoring. PadPro electrodes can be used on all makes and models of defibrillator, including all of the Bi-Phasic units. Radio transparent. "One Pad System" enables the pads to stay with the patient as they move through departments. PadPro has an electrode for any clinical need or patient situation. The high tack adhesive gel allows PadPro electrodes to be repositioned multiple times. PadPro can provide onsite conversion of current cables to accept the PadPro electrodes. The polymer adhesive gel allows superior contact for uniform current distribution and more effective defibrillation and pacing. PadPro's adapter system simply plugs into the OEM cable. Standardization of products - One connector can be used throughout the institution, no matter what brand or model of defibrillation/pacing unit is being used. All PadPro products are Latex free.
The provided document is a 510(k) summary for the "PadPro" Multifunction Electrodes, seeking substantial equivalence to a predicate device. It does not describe a study to prove acceptance criteria in the manner typically seen for novel medical device performance claims. Instead, it argues for equivalence based on similar design, intended use, and adherence to recognized standards.
Here's an analysis based on the document, addressing your points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the standards the device meets and the comparison to the predicate device. The performance is "reported" by stating it meets these standards and is equivalent to the predicate.
| Acceptance Criteria (Stated/Implied) | Reported Device Performance (PadPro) |
|---|---|
| Indications for Use: For use as disposable electrodes for automatic and manual external defibrillators for monitoring, pacing, cardioversion, and defibrillation (matching predicate device). | SAME |
| Where Used: Hospitals and Paramedic situations (matching predicate device). | SAME |
| Basic Features: Radiotransparent, non-sterile, latex-free, single patient use, self-adhesive, in sealed foil pouch (matching predicate device). | SAME |
| Standard Met: International Electrotechnical Commission (IEC) 601-1: Medical Electrical Equipment 601-1 (1988) Part 1: General requirements for safety Amendment No. 1 (1991) Amendment No. 2 (1995 and Sec.898.12 Performance standard; ANSI/AAMI DF-39 (3.3.19) standard, self adhesive electrodes for monitoring and defibrillation. | SAME / Meets Standards |
The document concludes: "In all respects, the PadPro System Defibrillator Electrodes are substantially equivalent to other electrodes that are legally marketed for this purpose. The device meets the standards referenced above."
This implies that demonstrating conformity to these existing standards and showing functional equivalence to the legally marketed predicate device (Katecho KDP-60A) constitutes the "acceptance criteria" and "device performance" for this 510(k) submission. No specific quantitative performance metrics from a dedicated study are presented.
Regarding specific study details (points 2-9):
The provided 510(k) summary does not describe a clinical performance study with a test set, ground truth, experts, or adjudication methods. Instead, it relies on:
- Comparison to a Predicate Device: The primary argument for safety and effectiveness is that the "PadPro" device is "identical in function" to the Katecho KDP-60A (K002806) and "nearly identical in design."
- Adherence to Recognized Standards: The device states it meets IEC 601-1 and ANSI/AAMI DF-39. Compliance with these standards is often assessed through bench testing and verification, not necessarily large-scale clinical trials in the context of a 510(k) for a well-established device type.
Therefore, many of your questions related to a performance study cannot be answered from this document:
2. Sample size used for the test set and the data provenance: Not applicable; no specific test set or clinical study described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; no specific test set or ground truth established by experts described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable; no test set described.
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 passive medical 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: Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable; no ground truth as typically understood for diagnostic performance studies is described. The "ground truth" here is compliance with established device standards for defibrillator electrodes and functional equivalence to a legally marketed predicate.
8. The sample size for the training set: Not applicable; this is not a machine learning device, so there is no "training set."
9. How the ground truth for the training set was established: Not applicable; no training set.
In summary: This 510(k) submission demonstrates substantial equivalence by comparing the device to an existing predicate and stating compliance with relevant industry standards. It does not present data from a clinical performance study with a test set, experts, or ground truth as typically requested for novel diagnostic or AI-driven devices.
§ 870.5310 Automated external defibrillator system.
(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.