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Maxilim is indicated 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. It is also indicated for use as a planning and simulation software for surgical treatment, specifically maxillofacial procedures.

The device is a software device (minor level of concern) with minimal risk to the patient. The device does not make contact with the patient. The device is used to assist physicians in the planning of surgical treatments, but is not meant to replace the professional judgment of the physician.

The provided FDA document (K052424) for the Maxilim device describes its intended use and classification but does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

The document primarily focuses on:

• Contact Information: Submitter and applicant details.
• Device Information: Trade name (Maxilim), common name (Image Processing System), and classification.
• Predicate Devices: Identifies Simplant System (K033849) as the predicate, stating similarities in indications for use, technology, and 3-D CT image utilization.
• Intended Use: Maxilim is indicated as a software interface and image segmentation system for transferring imaging information from medical scanners (like CT) and as planning/simulation software for maxillofacial surgical treatment.
• Technological Characteristics: Described as a software device with minimal patient risk, not making contact with the patient, assisting physicians in planning but not replacing professional judgment.
• Conclusion: States the differences from the predicate are minor and the device is considered as safe and effective.
• FDA Communication: A letter from the FDA confirming substantial equivalence to legally marketed predicate devices, allowing the device to be marketed under general controls provisions.

Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets them because this information is not present in the provided text.

The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria in the manner you've outlined. For such details, one would usually need to consult the complete 510(k) submission or associated scientific literature if studies were published.

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