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The angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures. The OR table is suitable for interventional and surgical procedures.

The basis for this submission is a modification of the common platform of a family of legally marketed devices to expand its indications for use to include image-guided surgical procedures and open surgery procedures. The currently cleared devices are indicated for use for interventional and minimally invasive procedures. The subject modification is intended to introduce a new configuration (OR configuration) that will enable the Innova Systems to be additionally indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures. The modifications mainly consist of introduction of new configuration called OR configuration. The OR configuration of the product is designed in accordance with the operating table standard (IEC 60601-2-46) with deviation for clause 36.101*, it corresponds to the Innova 4100-IQ, 3100-IQ, 2100- IQ product equipped with • OR table (OR table is the Innova-IQ table with specific covers with an "OR" branding) • IPX4Table side user interface • Mandatory UPS • Mandatory surgical accessories • Dedicated surgery protocols *Electromagnetic Compatibility tested to cover high power surgical tool up to 300W and as per the Requirements of the IEC 60601-2-46 Edition 2, refer details in section 9.3.1 standards data forms 3654. To maintain compliance with the operating table safety standard, not all controls are allowed to be mounted on the table rails. The following controls only are allowed: • IPX4 Table Side Status Control (TSSC) • IPX4 Smart Box (Smart Box) • IPX4 Table Panning Device (TPD) • IPX4 Innova Central touch screen • IVUS PIM A table side cart is provided to place any other control (3D mouse, IVUS console and joystick) Table mounted injectors are not allowed with the OR configuration.

The provided text is a 510(k) Premarket Notification Submission for GE Healthcare's Innova Systems - OR configuration. This document outlines the modifications made to an existing device family to expand its indications for use to include image-guided surgical procedures. As such, this submission focuses on the safety and effectiveness of the modified system in its new configuration and does not involve a study of a medical device's performance against specific acceptance criteria in the way an AI/ML algorithm or diagnostic device typically would.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment is not applicable to this S10(k) submission.

This submission asserts substantial equivalence to predicate devices based on:

• Non-Clinical Tests: The document states that the Innova Systems-OR configuration complies with voluntary standards and lists quality assurance measures such as Risk Analysis, Requirements Reviews, Design Reviews, unit-level testing, integration testing, performance testing, safety testing, and simulated use testing.
• Clinical Tests: The submission explicitly states: "The subject of this premarket submission, Innova Systems -OR configuration, did not require clinical studies to support substantial equivalence."

In summary, the document does not contain the information requested because the device in question is an angiographic X-ray system being modified for expanded use, and its substantial equivalence was determined through non-clinical testing and comparison to predicate devices, rather than a performance study against specific acceptance criteria for a diagnostic output.

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