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The Digital Fluoroscopic Imaging Systems are indicated for use in diagnostic and interventional cardiac angiography and optionally, rotational cardiac angiography procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional cardiac angiography procedures. They can be operated in a mobile as well as a fixed site environment.

The Innova 2000 and 2000S (Mobile version) hereafter referred to as Mobile Innova 2000 and Innova 2000S - are composed of the the same components as the predicate device. The principle system components include a Carm, image acquisition, processing and archiving capabilities.

The provided text is a 510(k) summary for the GE Medical Systems Innova 2000 and Innova 2000S (Mobile version). It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, specific device performance metrics, or details of a study designed to prove the device meets these criteria.

The document primarily focuses on establishing substantial equivalence based on:

• The device having the "same components as the predicate device"
• Its compliance with electrical, mechanical, and radiation safety standards.
• The manufacturer's adherence to quality systems (21 CFR 820 and ISO 9001/EN 46001).
• The "same technological characteristics, comparable key safety and effectiveness features, same basic design, construction and materials," and "same intended use as the predicate devices."

Therefore, I cannot fulfill your request for an acceptance criteria table and study details from the provided input. The document states:

• "Summary of Studies: The devices have been evaluated for electrical, mechanical and radiation safety and conform to applicable medical device safety and performance standards." This is a high-level summary and does not provide specific acceptance criteria or performance results.
• It's a "substantial equivalence" submission, meaning the primary goal is to show the device is as safe and effective as a legally marketed predecessor, rather than proving performance against novel acceptance criteria in a detailed clinical study.

To answer your prompt, specific performance data and a detailed study report would be required, which are not present in the provided text.

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