(306 days)
The Spectrum SPINOUS PROCESS DEVICE is a posterior, non-pedicle supplemental fixation device, intended for use at a single-level in the non-cervical spine (T1-S1 inclusive). It is intended for plate fixation and attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain or discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation), and/or tumor. The Spectrum Spine SPINOUS PROCESS DEVICE is intended for use with bone graft, and is not intended for standalone use.
The Spectrum Spine Spinous Process Device is a permanent implant device with plates and rods made from Titanium Alloy per ASTM F136 and Commercially Pure Titanium per ASTM F67 and cages made from polyetheretherketone (Zeniva PEEK 500 per ASTM F2026-10, PEEK Polymer for surgical implant applications). It is a posterior, non-pedicle supplemental fixation device. The device provides plates, cages and connecting rods of various shapes and sizes to provide supplemental stabilization of the spinous process to support fusion.
The provided text describes the Spectrum Spine SPINOUS PROCESS DEVICE and its 510(k) summary for FDA clearance. However, it does not include information about acceptance criteria or a study that specifically proves the device meets such criteria in terms of diagnostic performance or clinical outcomes.
The "Performance Data" section solely refers to mechanical testing of the device: "Performance data for the Spectrum Spine SPINOUS PROCESS DEVICE included static and dynamic compression bend, static torsion, locking screw torque strength, axial push off strength from simulated bone and rod dissociation strength. Most testing was completed per ASTM 1717-12 and ASTM F1798-97."
This type of testing is to ensure the device's structural integrity and physical properties meet established standards for medical implants, not to evaluate diagnostic accuracy or compare its performance against a ground truth.
Therefore, I cannot populate the requested table or answer the questions related to acceptance criteria for diagnostic performance, sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details from the provided text.
The document indicates that the device was deemed "substantially equivalent" to predicate devices based on:
- Indications for Use
- Materials
- Means of fixation
This implies that the lack of new performance studies concerning diagnostic accuracy or extensive clinical outcomes was acceptable because the device was not presenting a novel diagnostic function or significantly different mechanism of action that would necessitate such studies for substantial equivalence.
§ 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.