(144 days)
The CENTERPIECE™ Plate Fixation System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The CENTERPIECE™ Plate Fixation System is used to hold the graft material in place in order to prevent the graft material from expulsion, or impinging the spinal cord.
The CENTERPIECE™ Plate Fixation System consists of a variety of sizes of plates and screws. The CENTERPIECE™ Plate Fixation System components are made of from medical grade titanium or titanium alloy.
The provided document is a 510(k) premarket notification for a medical device called the CENTERPIECE™ Plate Fixation System. This type of regulatory submission is for demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through a clinical study with performance metrics.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets them. Specifically:
- No table of acceptance criteria and reported device performance: The document only describes the device, its intended use, and states that "Mechanical testing was performed on the CENTERPIECE™ Plate Fixation System and was included in this submission." It does not provide specific performance metrics or acceptance criteria for this testing.
- No sample size for the test set or data provenance: No clinical or test set data is provided.
- No number of experts or their qualifications: Not applicable as no ground truth or expert review process is described.
- No adjudication method: Not applicable.
- No multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- No standalone algorithm performance: The device is a physical implant, not an algorithm.
- No type of ground truth used: Not applicable.
- No sample size for the training set: Not applicable.
- No description of how ground truth for the training set was established: Not applicable.
The submission focuses on establishing substantial equivalence to a previously cleared device (Kirschner Orthopedic Wire, K850631) based on shared indications for use and general safety/functionality. It doesn't present a study designed to meet pre-defined performance acceptance criteria with a test set, ground truth, or expert review.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.