(126 days)
The LnK Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization and stabilization of the spine as an adjunct to fusions in patients with:
- · degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
- · spondylolisthesis,
- · trauma (i.e. fractures or dislocations),
- · tumors,
- · deformity (defined as kyphosis, lordosis, or scoliosis),
- · pseudoarthrosis.
- · failed previous fusion,
- · spinal stenosis.
The LnK Anterior Cervical Plate System is composed of plates and screws which are made from titanium alloy Ti-6A1-4V ELI (ASTM F136). These plates attach to the anterior cervical spine with a minimum of four screws per plate. The plates are offered in one-level, two-level, three-level and four-level fusion configurations (13~97mm). The plate screws are 3.5mm and 4.0mm diameter head screws. They are self-tapping and selfdrilling threaded. All implants are provided non-sterile.
The provided document is a 510(k) summary for the LnK Anterior Cervical Plate System. It describes the device, its intended use, and claims substantial equivalence to a predicate device based on performance data.
However, this document does not contain the specific information required to answer your request about acceptance criteria and a study proving a device meets acceptance criteria.
Specifically, it lacks:
- A table of acceptance criteria and reported device performance: While it mentions static compression bending, tension, torsion, and dynamic compression bending were performed according to ASTM F1717, it does not provide specific numerical acceptance criteria (e.g., "must withstand X N of force") nor the measured device performance against those criteria. It only states "These data demonstrate substantial equivalence in terms of performance bench testing."
- Sample size used for the test set and data provenance: No information about sample sizes or data origin is provided.
- Number of experts used to establish ground truth and qualifications: This type of information is not relevant for a mechanical device like an anterior cervical plate. "Ground truth" typically refers to diagnostic accuracy studies, which are not applicable here.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this device is a physical implant, not an AI or diagnostic tool.
- Standalone (algorithm-only) performance: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable (no "training set" for a mechanical device).
- How the ground truth for the training set was established: Not applicable.
In summary, the document states that the device's performance was evaluated through bench testing according to ASTM F1717 standards, and these data were deemed sufficient to demonstrate substantial equivalence to a predicate device. However, it does not disclose the specific numerical acceptance criteria or the quantitative results of these tests.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.