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The Integris H 5000 / BH 5000 systems are subject to Federal Performance Standards, defined in 21CFR - part 1000; The Integris H5000 / BH 5000 systems will be manufactured in accordance with voluntary safety standards, such as UL 187 and UL 2601; The information for Users contains comprehensive information to insure safe and effective use; Past experience with substantially equivalent predicate devices has shown our device to be safe and effective when used as directed in the Information for Users.

The provided document is a 510(k) summary for Philips Integris H 5000 and BH 5000 Cardio/Vascular Systems, dated February 25, 1997. It is a pre-market notification to the FDA for medical devices.

This document describes a medical imaging system (Cardio/Vascular Systems), not an AI-powered device or an algorithm. Therefore, it does not contain the specific information requested in the prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, ground truth, or AI-specific performance metrics. These types of details were not typically part of 510(k) submissions in 1997 for non-AI hardware.

The summary focuses on:

• Compliance with Federal Performance Standards (21CFR - part 1000).
• Manufacturing in accordance with voluntary safety standards (UL 187 and UL 2601).
• Comprehensive user information for safe and effective use.
• Past experience with predicate devices for safety and effectiveness.

Therefore, I cannot provide the requested information based on the provided text, as it pertains to a different type of medical device submission and predates the common application of AI in medical imaging at a level requiring such detailed performance evaluation.

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