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To replace missing tooth roots for single tooth, partial tooth, and fully edentulous patients. ENDURE endosseous implants are designed to become an Osseointegrated prosthesis allowing the attachment of a partial or a complete prosthodontic appliance in the mandible or maxilla.

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The provided text is a heavily redacted FDA 510(k) clearance letter for the "ENDURE Implant System." This document does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone performance), or training set information as requested in the prompt.

The document states that the "device is substantially equivalent... to legally marketed predicate devices." This substantial equivalence determination means that the FDA did not require new clinical studies demonstrating safety and effectiveness for this device, but rather assessed its similarity to existing, legally marketed devices.

Therefore, I cannot fulfill your request for the specific details about acceptance criteria and study data because this information is not present in the provided text.

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