(29 days)
Properly used, the LAURAIN DEWALD™ Anterior Fixation System is intended to provide stabilization during the development of a solid spinal fusion. The specific indications are: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) pseudoarthrosis, (3) spondylolysis, (4) spinal deformation such as kyphosis and lordosis, (5) fracture, (6) unsuccessful previous attempts at spinal surgery, (7) tumor resection, (8) correction of severe instability and/or deformity when used in addition to a posterior spinal instrumentation system, (9) neoplastic disease, and/or (10) deformity associated with deficient posterior elements, such as laminectomy, spina bifida, or myelomeningocele.
The LAURAIN DEWALD Anterior Fixation System consists of a variety of shapes and sizes of plates, screws, nuts, spacers and staples, as well as ancillary products and instrument sets. The components can be locked into a variety of configurations, with each construct tailor-made for the individual case. The purpose of this submission is to include additional plates, screws and staples to the LAURAIN DEWALD Anterior Fixation System.
This document is a 510(k) summary for the LAURAIN DEWALD Anterior Fixation System, which is a spinal implant. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as it's a submission for substantial equivalence to a predicate device, not a performance study.
Therefore, I cannot provide the requested information based on the given document. The document explicitly states:
- "Documentation was provided which demonstrated the LAURAIN DEWALD Anterior Fixation System to be substantially equivalent to itself." This indicates that the device is being compared to an already marketed version of itself or a very similar predicate device, rather than undergoing a new clinical or performance study with defined acceptance criteria.
- The FDA letter confirms the device is substantially equivalent to "legally marketed predicate devices".
A 510(k) submission primarily focuses on demonstrating that a new device is "substantially equivalent" to an already legally marketed device (the predicate device) in terms of intended use, technological characteristics, and safety and effectiveness. It typically does not involve new clinical trials or performance studies with acceptance criteria in the way a PMA (Pre-Market Approval) or a de novo submission might.
To directly answer your request based on the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present in the document.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set or data provenance is mentioned as part of a performance study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as no ground truth for a test set is mentioned.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is a physical spinal fixation system, not an AI or imaging device involving human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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.