(160 days)
The Spinal Elements Lotus Posterior Cervical/Thoracic Spinal System is intended for posterior fixation of the cervical and thoracic spine (C1-T3) for the following conditions: degenerative disc disease (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies): spondylolisthesis; spinal stenosis; trauma (fracture/dislocation); failed previous fusion; tumors. The Spinal Elements Lotus Posterior Cervical/Thoracic Spinal System may be used in conjunction with the Spinal Elements Mercury system for transition at T1 - T3.
The use of polyaxial pedicle screws is limited to placement in TI-T3 for treating thoracic conditions only. The screws are not intended to be placed in the cervical spine.
The Spinal Elements Lotus Posterior Cervical/Thoracic System consists of a variety of fixation devices that are attached to the spine by means of screws and hooks placed in/or on the pedicles or posterior elements of the various vertebrae, rods that span the distance between the screws/hooks. Screws are intended for attachment to the thoracic (T1-T3) spine only. The system achieves fixation by the mechanical joining of the rods, screws, and hooks. A variety of constructs may be assembled to suit the individual pathology and anatomy of the patient.
Connectors are offered in a variety of sizes and configurations and are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F 1472 and / or F 136. The following connectors are being added to the system:
- Offset connector .
- Round offset connector .
- Axial rod to rod connector .
- 03.5mm Axial rod to rod connector o
- 0 5.5mm Axial rod to rod connector .
- Parallel rod to rod connector .
- . 0 3.5mm Parallel rod to rod connector
- 0 5.5mm Parallel rod to rod connector ●
- Transition rods .
The provided text describes a medical device, the Spinal Elements Lotus® Posterior Cervical/Thoracic Spinal System, and its clearance through a 510(k) premarket notification. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered device. Instead, the document outlines the device's description, intended use, and the performance testing conducted to demonstrate substantial equivalence to a previously cleared device.
Therefore, I cannot fulfill the request as it asks for information not present in the provided text regarding acceptance criteria, device performance, AI/ML study details, and data provenance. The document is a 510(k) summary for a traditional medical device (spinal fixation system), not an AI/ML powered device.
§ 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.