(148 days)
The 4CIS® Chiron Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); deformities or curvatures (i.e., scoliosis, and/or lordosis); tumor; stenosis; and failed previous fusion (pseudoarthrosis).
The Spinal Fixation System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, nuts, transverse (cross) link and associated instruments. Rigid fixation is provided by pedicle screws inserted into the vertebral body through pedicle of the lumbar spine via posterior approach. This system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion through open surgery or minimally invasive surgery. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the mature patient. The implant components are supplied non-sterile single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to ASTM F 136 and CoCr Alloy per ASTM F1537. Also, Specialized instruments are available for the application and removal of the Spinal Fixation System.
The provided text is a 510(k) Summary for a medical device called the "4CIS® Chiron Spinal Fixation System." It details the device's purpose, components, indications for use, and a comparison to predicate devices, including performance data. However, this document does not describe the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-driven medical device.
The "Performance Data" section explicitly states:
"Mechanical testing (static and dynamic compression bending, static tension bending, static torsion) was conducted in accordance with ASTM F1717. Above non-clinical performance data in the form of a comprehensive literature review was provided in support of substantial equivalence of the subject device to the predicate devices."
This indicates that the performance data for this spinal fixation system is based on mechanical testing to ensure its structural integrity and equivalence to existing devices, not on the performance of an AI model in interpreting or diagnosing medical images or other data.
Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device's performance, as the provided document pertains to a physical medical implant and its mechanical properties.
To answer your request, I would need a document related to the regulatory submission of an AI/ML-driven medical device, which would typically involve clinical performance studies assessing the algorithm's accuracy, sensitivity, specificity, and potentially its impact on human reader performance.
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.