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The PadPro pediatric electrodes are indicated for use in external pacing, defibiliation and monitoring applications as a non-sterne, disposable device for single pediatric use only. The PadPro 2603 electrodes provide ine conductive meetiatic patient's skin. The electrode is intended for use on < pediatric patients whose weight is less than 10kg (22 lbs).
When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied when a patient requires defibrination, carents . This. device is intended for use on defibrillators whose of specifical fea to the patient and collined to the unstrum. The 2017 pediatric electrodes are designed for, ~ output is can be ininted to bio-control, Zoll, and Hewlett Packard defibrillators.

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 of defibrillation/pacing unit is being used. All PadPro products are Latex free.

The provided documentation is a 510(k) premarket notification for a medical device (PadPro 2603 Pediatric Multifunction Electrodes). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and performance data for a new, innovative device with a complex algorithm.

Therefore, much of the requested information about acceptance criteria, study design, expert involvement, and ground truth establishment, which are typical for studies involving AI algorithms or novel diagnostics, is not applicable to this document. The document's purpose is to establish that the new device is as safe and effective as a previously approved device.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: The primary "acceptance criteria" here is substantial equivalence to the predicate device (PadPro 2602 Pediatric Electrode K002280). This isn't a quantitative performance metric in the typical sense but rather a comparison of indications for use, technological characteristics, and safety/effectiveness. The document states that the device "meets the standards referenced above." The referenced standards are 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.
• Reported Device Performance: The document doesn't provide specific numerical performance metrics for the PadPro 2603. Instead, it asserts its performance is "SAME" or improved (e.g., "Slightly larger than 2602" for size, and features like "polymer adhesive gel allows superior contact for uniform current distribution and more effective defibrillation and pacing").

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not applicable. This is not a clinical study involving a test set of data in the way an AI algorithm study would. It's a device comparison for regulatory approval.
• Data Provenance: Not applicable. No clinical data or test set data presented.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not applicable. No ground truth established in the context of this 510(k). The regulatory review itself involves FDA experts.
• Qualifications: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No test set was used for this type of regulatory submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• MRMC Study: No. This document does not describe an MRMC study. It's a technical and functional comparison to a predicate device.
• Effect Size of Human Readers with/without AI: Not applicable, as no AI component is described or evaluated.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

• Standalone Performance: Not applicable. There is no algorithm described or evaluated in this submission. This is a physical medical device (electrodes).

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable. No ground truth data (e.g., pathology, outcomes) was used for performance validation in this 510(k). The "ground truth" for a 510(k) is the established safety and effectiveness of the predicate device.

8. The Sample Size for the Training Set

• Sample Size (Training Set): Not applicable. This submission doesn't involve training any algorithms.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth Establishment (Training Set): Not applicable. No training set is described.

In summary: The provided document is a 510(k) premarket notification that demonstrates substantial equivalence for a physical medical device (electrodes) to an existing predicate. It does not involve a clinical study with acceptance criteria, ground truth, or expert review in the manner usually associated with AI/algorithm performance studies. The "acceptance criteria" are compliance with regulatory standards and functional equivalence to a predicate, which are directly addressed by the comparative table provided.

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