(69 days)
The 4CIS® Spinal System and 4CIS® Low Back System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S I vertebra in skeletally mature patients receiving fusion by the autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the 4CIS® Spinal System and 4CIS® Low Back 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 Spondylolisthesis with the objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).
The 4CIS® Spinal System and 4CIS® Low Back System are a top-loading multiple component, posterior spinal fixation systems which consist of pedicle screws, rods, locking spacer, and a transverse (cross) linking mechanism.
The 4CIS® Spinal System and 4CIS® Low Back System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The 4CIS® Spinal System and 4CIS® Low Back System implant components are supplied in the non-sterile condition for a single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to the ASTM F136. Various sizes of these implants are available. Specialized instruments are also available for the application and removal of the 4CIS® Spinal System and 4CIS® Low Back System.
The provided text is a 510(k) summary for the 4CIS® Spinal System and 4CIS® Low Back System. It describes the device, its intended use, and states that mechanical testing was conducted to demonstrate substantial equivalence to predicate devices. However, this document does not contain information related to an AI/ML device or a study involving acceptance criteria for an AI/ML device's performance metrics.
The document discusses:
- Device Identification: 4CIS® Spinal System and 4CIS® Low Back System (pedicle screw spinal fixation system).
- Predicate Devices: Global Spinal Fixation System (K001668) and OPTIMA™ Spinal System (K031585).
- Device Description: Top-loading multiple component, posterior spinal fixation systems consisting of pedicle screws, rods, locking spacer, and a transverse linking mechanism made from titanium alloy (Ti-6A1-4V ELI).
- Indications for Use: Treatment of severe Spondylolisthesis (Grade 3 and 4) of L5-S1 vertebra and as an adjunct to fusion for various spinal instabilities or deformities (degenerative Spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion).
- Performance Data: States "Mechanical testing as listed in APPENDIX 10 that was conducted in accordance with ASTM F1717 demonstrates the substantial equivalence to the above predicate devices."
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance for an AI/ML device, as the document pertains to a traditional medical device (pedicle screw spinal fixation system) and its mechanical testing for substantial equivalence. The document does not mention any AI/ML components or performance metrics for such a system.
§ 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.