(100 days)
The LITe® Plate System Universal, Sacral, 2 Screw and 4 Screw Plates are indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the thoracic and thoracolumbar (TI-LS) spine or via an anterior approach below the bifureation of the great vessels in the treatment of lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: Degenerative Disc Discase (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); Pseudoarthrosis; Spondylolysis; Spondylolisthesis; Spinal stenosis; Tumors; Trauma (i.e. Fractures or Dislocation); Deformities (i.e. Scoliosis, Kyphosis or Lordosis); Failed Previous Fusion
The LITe® Plate System Buttress Plate is intended to stabilize the allograft at one level (T1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.
The LITe® Plate System is an anterior/anterolateral/lateral plate system that may be used in the thoracic, lumbar, and sacral spine (T1-S1). The LITe® Plate System consists of plates and screws manufactured from titanium alloy (Ti6Al4V) per ASTM F136 and ISO 5832-3, as well as associated manual general surgical instrumentation. The implants are available in a variety of sizes to accommodate various patient anatomies.
The provided text is a 510(k) summary for a medical device called the LITe® Plate System. It describes the device, its intended use, and its comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving device performance against such criteria in the context of AI/algorithm performance.
The document focuses on demonstrating substantial equivalence to legally marketed predicate devices, a requirement for 510(k) clearance, rather than establishing acceptance criteria and proving performance through a clinical or algorithmic study with specific metrics like sensitivity, specificity, or reader improvement.
Therefore, I cannot fulfill your request for the following information based on the provided text:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or human reader improvement with AI
- If a standalone (algorithm only) performance study was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The sample size for the training set
- How the ground truth for the training set was established
The "Performance Data" section in the K142699 document refers to non-clinical mechanical testing, not a study of an AI/algorithm's diagnostic or predictive performance.
It states:
"Nonclinical testing was performed to demonstrate that the LITe® Plate System is substantially equivalent to its predicate devices. The following testing and analysis was performed:
- Static and dynamic compression testing per ASTM F1717-14
- Static torsion testing per ASTM F1717-14
- Buttress plate expulsion testing"
This type of testing is to ensure the physical integrity and mechanical properties of the orthopedic implant meet established standards for similar devices, not to assess the performance of a diagnostic algorithm or AI system.
§ 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.