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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.

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The C-JAWS cervical compressive staple 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 C-JAWS cervical compressive staple is limited to one level fusion. A single C-JAWS staple must be implanted per functional segment unit fused. It MUST be used with a cervical interbody fusion device filled with autograft.

WARNING: The C-JAWS cervical compressive staple is not intended for attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

The C-JAWS cervical compressive staple device is a single component system. The device is shaped to conform to the anatomy of the anterior spine. It features two ridged extension legs, which engage the vertebral bodies and allow secure anchorage of the device and antiback-out using a locking mechanism.

Materials: The C-JAWS cervical compressive staple device is manufactured from CP Titanium (T40. ASTM F-67). The complete C-JAWS cervical compressive staple device contains Class I instruments and non-implantable devices manufactured from stainless steel.

The provided text describes a 510(k) submission for the Medicrea C-JAWS Compressive Cervical Staple, not an AI/ML device. Therefore, it does not contain the information requested about acceptance criteria and studies related to AI/ML device performance.

The document discusses:

• Mechanical Testing: Non-clinical tests were conducted following ASTM F1717 standards (Static Compression, Static Torsion, Dynamic Compression) to demonstrate the device's capability. The document states "Mechanical testing indicates that the C-JAWS cervical compressive staple device is capable of performing in accordance with its intended use." However, specific numerical acceptance criteria and reported performance metrics from these tests are not provided.
• Clinical Study: A clinical study involving 118 patients established an "overall fusion rate of 95.8% and a safety profile directly comparable to standard of care fusion."

Since the request is specifically about AI/ML device performance, and this document describes a physical medical device (cervical staple), a direct answer to the requested table and study details for an AI/ML device cannot be extracted from this text.

Ask a specific question about this device