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The ConMed Linvatec HD Digital Camera System is intended for use in a variety of endoscopic surgical procedures including but not limited to orthopedic, laparoscopic, urologic, sinuscopic, plastic and as an accessory for microscopic surgery.

The ConMed Linvatec HD Digital Camera System consists of a camera control unit and a camera head that is used in conjunction with an endoscope to allow for high definition visualization during minimally invasive surgical procedures. Like the unmodified device, sterilization of the camera head and cable is required before use. Additionally, the camera heads may be sterilized using steam sterilization like the unmodified device. The ConMed Linvatec HD Digital Camera System will be capable of interfacing with the ConMed I.S. Operating Room Control System with no impact on normal camera system operation.

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for a medical device (HD Digital Camera System) seeking substantial equivalence to a predicate device. It primarily focuses on the device description, intended use, and substantial equivalence claim, rather than performance studies with specific criteria.

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