(170 days)
The 12-lead ECG Analysis is useful in the diagnosis and treatment of patients with acute myocardial infarction (AMI). 12-lead ECG Analysis is also useful in the interpretation and documentation of other transient cardiac arrhythmias that may occur. When used in the prehospital setting, the 12-lead analysis results can be of assistance in diagnosis and treatment decisions once the patient has arrived in the hospital emergency department.
Not Found
The provided document is a 510(k) clearance letter for the ZOLL M Series 12SL™ Analysis Option. This document confirms the device's substantial equivalence to a predicate device and outlines its indications for use. However, it does not contain the detailed study information, acceptance criteria, or performance data that would allow for a comprehensive answer to your request.
Specifically, the letter does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test or training sets.
- Data provenance, expert qualifications, or adjudication methods.
- Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone performance.
- Details on how ground truth was established for either test or training sets.
To provide a complete answer, I would need access to the actual 510(k) submission document (or a summary thereof) which would typically contain the study design, methodologies, and results used to demonstrate substantial equivalence.
Therefore, I cannot fully answer your request based solely on 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.