(251 days)
CardioServ is intended to be used for the emergency resuscitation of cardiac arrest victims and clinical cardiac dysrhythmia.
CardioServ is intended to be used by trained operators
CardioServ is designed for external and internal defibrillation (including cardioversion)
CardioServ is capable of monitoring the heart rate with adjustable alarm limits.
CardioServ is designed for external pacing with adjustable current and frequency.
The intended use of CardioServ is identical to the intended use of the predicate devices.
CardioServ is a portable defibrillator with ECG monitor, built-in recorder, and the capability of external pacing with adjustable current and frequency.
The provided text describes a medical device, the CardioServ P, and its equivalence to predicate devices, but it does not contain the specific information requested about acceptance criteria and a study proving those criteria are met for AI/algorithm performance.
The document is a 510(k) summary from 1997, focusing on the safety and effectiveness of a defibrillator/pacemaker. The "Technology" section mentions compliance with voluntary standards (e.g., ANSI/AAMI, IEC) and quality assurance measures like "software and hardware testing," "safety testing," and "final validation testing by an independent test group." However, these are general development and testing processes for a hardware medical device, not a study evaluating an AI algorithm's performance against specific acceptance criteria.
Therefore, I cannot provide the requested information. The document focuses on the equivalence of the CardioServ P to predicate devices based on its intended use, technological similarity, and adherence to established electrical and medical device standards. There is no mention of an AI component, performance metrics like sensitivity/specificity, or a study design suitable for evaluating such a component.
To fulfill your request, I would need a document detailing the performance evaluation of an AI or algorithm, including specific acceptance criteria and the results of a study designed to demonstrate compliance.
§ 870.5550 External transcutaneous cardiac pacemaker (noninvasive).
(a)
Identification. An external transcutaneous cardiac pacemaker (noninvasive) is a device used to supply a periodic electrical pulse intended to pace the heart. The pulse from the device is usually applied to the surface of the chest through electrodes such as defibrillator paddles.(b)
Classification. Class II. The special controls for this device are:(1) “American National Standards Institute/American Association for Medical Instrumentation's DF-21 ‘Cardiac Defibrillator Devices’ ” 2d ed., 1996, and
(2) “The maximum pulse amplitude should not exceed 200 milliamperes. The maximum pulse duration should not exceed 50 milliseconds.”