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The SurgiCase system is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance Imaging scanner. It is also intended as pre-operative software for simulating / evaluating implant placement and surgical treatment options.

SurgiCase Connect for iPad is a component of the SurgiCase system and intended to be used as a software interface to assist in pre-operative planning by simulation / evaluation of surgical treatment options.

The Materialise SurgiCase system is a software medical device to transfer and to segment imaging information from a medical scanner such as a CT or MRI scanner. It allows for presurgical simulation and evaluation of implant placement and surgical treatment options.

SurgiCase Connect is a medical device for pre-surgical simulation and evaluation of surgical treatment options. This includes transferring, visualizing and editing medical data. .

Based on a pre-surgical software plan the patient specific templates - SurgiCase Guides can be manufactured to fit a specific patient. SurgiCase Guides are not a part of this premarket notification submission.

The provided text is a 510(k) summary from Materialise N.V. regarding their SurgiCase system, specifically focusing on the new component, SurgiCase Connect for iPad. The core of the submission is to demonstrate substantial equivalence to a predicate device (SurgiCase K073449).

The document explicitly states:

• Clinical testing: Not applicable.

This means that a clinical study with acceptance criteria and reported device performance, as typically understood in a clinical trial context, was not performed for this submission. The device is being cleared based on its substantial equivalence to a predicate device through non-clinical testing.

Therefore, I cannot provide the detailed information requested regarding acceptance criteria and the study proving the device meets them, because such a study (clinical or performance study with defined acceptance criteria and results) is not described in this 510(k) summary.

The submission focuses entirely on demonstrating substantial equivalence through non-clinical testing, primarily asserting that the new component (SurgiCase Connect for iPad) has equivalent intended use, performance characteristics, design, and function to the predicate SurgiCase system.

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