(358 days)
The Finn Rod to Rod Connector is used as part of the Rogozinski Spinal Rod System. The Rod to Rod Connector is designed to attach two 1/4" Rogozinski Spinal Rods to provide temporary stability to the lumbosacral spine during the development of a solid spinal fusion. The Finn Rod to Rod Connectors are designed to be part of a construct that consists of Rogozinski rods anached to the spine with hooks, bolls and/or screws. The Finn Rod to Rod Connectors when used in constructs with spinal screws or bolls placed in he pedicles are intended only for patients: (a) having severe spondy. Olistinsis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. Otherwise, the Finn Rod to Rod Connectors when used in constructs with spinal screws or bolts are intended for sacral iliac anachment only in the treatment of degencrative disc disease of the lumbar spine, pseudoarthrosis, spinal stenosis, scoliosis, spondylolisthesis, fracture, failed back syndrome/unsuccessful previous at spinal fusion, or tumor resection. Degenerative disc disease of the lumbar spine is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
The Rogozinski System is limited to noncervical spine use. The levels of pedicle screw / bolt use for this system are limited to L3-SI or iliac screw fixation.
The Rod to Rod Connector is manufactured of ASTM F 133 sainless steel. The device of a set screw, a hex nut, a crossbar clamp, an extended clamp, and an eyebolt. The eyebolt is adjustable with the hex nut to provide varying offsets from rod to rod. The Rod to Rod Connector is intended to connect two contralatoral 1/4" Rogozinski Spinal System rods.
The provided text does not describe acceptance criteria for a device or a study proving that the device meets those criteria. Instead, it is a 510(k) Summary for a "Rod to Rod Connector" and focuses on establishing substantial equivalence to predicate devices, intended use, and information bearing on safety and effectiveness (mostly through literature reviews and meta-analyses of spinal fusion procedures).
The "Rod to Rod Connector" is a mechanical medical device, and its safety and effectiveness are supported by clinical outcomes in spinal fusion, rather than by performance metrics like accuracy, sensitivity, or specificity that would be typical for an AI/digital health device.
Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, device performance, sample sizes for test/training sets, expert involvement, or AI-specific study types (MRMC, standalone algorithm performance).
The information provided is centered around:
- Substantial Equivalence: Listing predicate devices.
- Intended Use: Specifying its role in spinal fusion with the Rogozinski Spinal Rod System.
- Safety and Effectiveness: Citing published literature (meta-analyses, cohort studies, randomized studies) to support the benefits of spinal fusion with instrumentation (including pedicle screws, which this device is designed to interact with) compared to non-instrumented fusions, particularly for degenerative spondylolisthesis. This literature highlights fusion rates, patient satisfaction, and complication rates, but not specific performance metrics for the "Rod to Rod Connector" itself.
§ 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.