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Nobel Biocare's Zirconia Implants are root-form endosseous dental implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's Zirconia Implants are indicated for single or multiple unit restorations in splinted applications. Nobel Biocare Zirconia Implant may be placed immediately and put into immediate function providing that the initial stability requirements detailed in the surgical manual are satisfied.

Nobel Biocare Zirconia Implants are threaded, root-form dental implants intended for use in the upper and/or lower jaw to support prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function to partially or fully edentulous patients. The Zirconia implant is manufactured from Y20 stabilized zirconium oxide. The Zirconia Implant has an integrated abutment that eliminates the need for attaching an abutment.

The provided text is a 510(k) summary for a Zirconia Implant and does not contain information about the acceptance criteria or a study proving that a device meets such criteria. It describes the device, its indications for use, and a letter from the FDA confirming substantial equivalence to legally marketed predicate devices.

Therefore, I cannot provide a response to your request based on the input text. The information requested (acceptance criteria table, sample size, ground truth, MRMC study, standalone performance, training set details) is not present in the provided document.

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