(65 days)
The pedirpadz™ Radiolucent MFE's are intended to be used on pediatric patients, 0-8 years of age at
The pediepadz™ Radiolucent Pediatric Multi-Function Electrodes consist of a pair of liquid gel electrodes with permanently attached lead wires that join together at a proprietary ZOLL connector. The connector interfaces with ZOLL the Pacemaker/Defibrillator multifunction cable.
The provided document is a 510(k) Premarket Notification for the pedi•padz™ Radiolucent Pediatric Multi-Function Electrode. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific, novel acceptance criteria through a clinical study. Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria in the context of an algorithm or AI.
The document discusses the technological characteristics of the device and its compliance with standards, which are a type of acceptance criteria for medical devices (e.g., IEC 60601-2-4 Medical Electrical Equipment, ANSI/AAMI DF-2: 1996, Cardiac Defibrillator Devices). However, these are general engineering and safety standards, not performance metrics based on data analysis from a study as would be relevant for an AI/algorithm.
Here's why the requested information cannot be extracted from this document:
- Device Type: The pedi•padz™ is a physical medical electrode, not a digital algorithm, AI, or software-as-a-medical-device (SaMD).
- Regulatory Pathway: A 510(k) submission primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive de novo clinical performance studies for efficacy or diagnostic accuracy.
- Focus of the Document: The document focuses on the device's description, intended use, and compliance with existing electrical and safety standards, and its equivalence to predicate physical electrodes. There is no mention of an "algorithm" or "AI."
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert adjudication, or MRMC studies for an AI/algorithm, because this information is not present in the provided text.
§ 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.