(94 days)
The Kalitec Direct InSePtion™ MIS Fixation System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1 – S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The Kalitec Direct InSePtion™ MIS Fixation System is not intended for standalone use, and is intended for use with autograft or allograft.
The Kalitec Direct InSePtion110 MIS Fixation System implant is a posterior non-pedicle supplemental fixation device utilized to achieve supplemental fusion in the non-cervical spine. The system is made of titanium alloy and includes eight color coded sizes, ranging from 8 mm to 18 mm.
The provided text is a 510(k) summary for the Kalitec Direct InSePtion™ MIS Fixation System, a medical device for spinal fixation. It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices.
However, the document does NOT contain any information about: studies proving device performance against acceptance criteria, sample sizes for test or training sets, data provenance, expert qualifications or numbers, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth was established beyond referencing "radiographic studies" for disc degeneration.
The "Performance Testing" section states: "Testing performed on this device indicates that the Kalitec Direct InSePtionTM MIS Fixation System is substantially equivalent to predicate devices. ASTM F1717 performance standards were adhered to and all applicable requirements were met. This testing included static compression bending, static torsion, dynamic compression bending, and disassociation testing in UHMWPE test blocks. Finite Element Analysis was also performed to characterize device performance."
This indicates mechanical/physical performance testing against engineering standards (ASTM F1717), not clinical or algorithmic performance against diagnostic or clinical utility criteria. The tests mentioned are mechanical integrity tests for spinal implants.
Therefore, I cannot provide the requested information for a study on "device meets acceptance criteria" as it pertains to AI/algorithm performance or clinical diagnostic accuracy, because this document describes a mechanical implant and its mechanical performance testing for substantial equivalence, not a diagnostic device involving AI or expert interpretation of medical images.
Based on the provided text, the device is a physical spinal implant, not an AI/software medical device.
Thus, I cannot fill out the requested table or answer the questions related to AI studies, ground truth, expert consensus, MRMC studies, or training/test sets for an algorithm. The acceptance criteria here would relate to the mechanical properties and safety of the implant itself, not its diagnostic accuracy or utility with human readers.
§ 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.