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The Explant® Osteonecrosis Intervention Implant Removal Kit is intended for removal of a Trabecular Metal™ Osteonecrosis Intervention Implant.

The instruments are supplied sterile in a preassembled kit. Two size kits are available; a 10mm ID kit and a 14mm ID kit. The 10mm kit cannot be used alone and must be used in combination with the 14mm kit. The instrument come preassembled to Zimmer Hudson Fitting Adaptors, allowing the Tubes to be driven via a Zimmer T-Handle or a Zimmer Power Driver. The Hudson fittings can be removed to expose a through-hole at the end of the tube to allow for removal of a specimen that remains in the coring tube. All components of these kits are single use only.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the Explant™ Osteonecrosis Intervention Implant Removal Kit, focusing on its substantial equivalence to predicate devices, indications for use, and regulatory classification. It does not contain details about performance studies, acceptance criteria, or specific metrics like sample sizes, expert qualifications, or ground truth establishment.

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