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The Cervical Implant is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are intended via an open, anterior approach and packed with autogenous bone graft. The Cervical Implant is intended to be used with supplemental fixation system.

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The provided document is an FDA 510(k) clearance letter for the Sapphire Cervical Implant System. This letter is for a medical device (an implant), not an AI/Software as a Medical Device (SaMD) product. Therefore, the questions related to AI/SaMD performance, such as acceptance criteria based on metrics like sensitivity/specificity, sample sizes for training/test sets, expert adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to this document.

The document confirms that the Sapphire Cervical Implant System is substantially equivalent to legally marketed predicate devices. The "Indications for Use" section (page 2) describes its intended purpose and target patient population.

Therefore, I cannot provide the requested information as the document does not contain data or information related to the acceptance criteria and study proving performance for an AI/SaMD product.

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