(290 days)
The 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System are a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bon 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® SOLAR Spine System and 4CIS® APOLLON Spine 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 objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudarthrosis).
The 4C15® SOLAR Spine System and 4CIS® APOLLON Spine System are a toploading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, nuts, and a transverse (cross) linking mechanism.
The 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System implant components are supplied non-sterile are single use and are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available. Specialized instruments are available for the application and removal of the 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System.
The provided text describes a medical device, the "4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System," which is a pedicle screw spinal fixation system. However, the document does not contain any information regarding acceptance criteria, device performance metrics, or a study that specifically addresses these points as typically expected for software or AI-based devices.
The core of the document is a 510(k) summary for a spinal implant system, focusing on its substantial equivalence to predicate devices based on mechanical testing. It does not involve AI or software performance metrics that would require the detailed study information you've requested.
Therefore, I cannot populate the requested sections because the information is not present in the provided text. The document discusses:
- Device Identification: Trade name, common name, classification.
- Substantially Equivalent Predicate Devices: Identification of similar devices already on the market.
- Device Description: What the device is made of and its components.
- Indications for Use: What the device is intended to treat and where it can be used in the spine.
- Performance Data and Test Method: This section explicitly states: "Mechanical testing has been carried out as listed in APPENDIX 10 which includes the static compression test and static torsion test as well as the dynamic compressive fatigue testing in accordance with ASTM F1717 demonstrates equivalence to the above predicate devices." This refers to physical, mechanical tests of the implant's strength and durability, not performance criteria for a diagnostic/AI tool.
The question's structure (acceptance criteria, sample size, ground truth, expert opinions, MRMC studies, standalone performance, training set) is typically relevant for evaluating AI/machine learning algorithms or diagnostic devices. Since this document describes a physical surgical implant, these types of details are not applicable as presented.
In conclusion, the input text does not contain the information requested regarding the acceptance criteria and the study that proves the device meets those criteria, as understood in the context of device performance metrics for AI/software/diagnostic tools.
§ 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.