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The UNiTi ACDF Implant System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients as part of an anterior cervical fusion procedure for the indications listed below. The intended levels for treatment range from C3 to C7.

Indications are limited to patients with degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), at one level, with radiculopathy and/or myelopathy with herniated disc producing symptomatic nerve root and or spinal compression confirmed by radiographic studies and/or with osteophyte formation on the posterior vertebral endplates producing symptomatic nerve root and or spinal compression confirmed by radiographic studies.

The UNiTi ACDF Implant System is limited to one level fusion. A single UNiTi Implant must be implanted per functional segment unit fused. It MUST be used with a cervical interbody fusion device filled with autograft.

Warning: This device is not approved for attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The UNiTi ACDF Implant System consists of plate-like staple implants offered in various sizes to match the various patient anatomies. To accommodate different patient anatomies, the implant sizes are offered in bridge length from 14mm to 20mm and with a leg lengths of 12mm and 14mm. The UNiTi ACDF Implant is manufactured from pseudo-elastic (super-elastic) Nitinol with superelastic properties at room temperature and at in vivo temperatures. The implant is retained in an active open position with its legs held parallel by the insertion device. Upon release from the insertion device, the active compression from the implant is transferred to the bones at the fusion site. In its implant position, the UNiTi ACDF Implant is intended to provide active compression and maintain stability across the fusion site at the desired cervical level (C3-C7).

This document describes the UNiTi ACDF Implant System, a spinal intervertebral body fixation orthosis. However, it does not contain the information required to answer your questions about acceptance criteria and study details as it primarily focuses on the device description, indications for use, technological characteristics, and a broad statement about performance and substantial equivalence to predicate devices.

Specifically, the document does NOT provide:

• A table of acceptance criteria and reported device performance. While it lists types of performance tests (Static compression bending, Static torsion, Dynamic compression bending, Corrosion, Cadaveric implantation and range of motion, Pullout), it does not present specific criteria (e.g., maximum deflection, number of cycles survived, corrosion rate limits) or the actual results obtained from these tests.
• Sample size for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size.
• Results of a standalone (algorithm only) performance study.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How the ground truth for the training set was established.

The document concludes with a general statement that "The results of this non-clinical testing show that the strength of the UNiTi ACDF Implant System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." This is a summary statement that doesn't provide the detailed data requested.

Therefore, for this particular device, the provided text does not allow for a detailed response to your specific questions regarding acceptance criteria and study data.

Ask a specific question about this device