(157 days)
The CBT Screw Fixation System is a posterior, noncervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine:
- Spondylolisthesis
- Degenerative spondylolisthesis with objective evidence of neurological impairment
- Trauma (i.e., fracture or dislocation)
- Spinal stenosis
- Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- Tumor
- Pseudoarthrosis
- Failed previous fusion
The Cortical Bone Trajectory(CBT) Screw Fixation System(hereinafter referred to as "CBT Screw Fixation System") is manufactured by U&I corporation. The Cortical Bone Trajectory(CBT) Screw Fixation System is modular, with the screw assembled intraoperatively, posterior spinal fixation system and less invasive surgery. The CBT Screw Fixation System allows surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The CBT Screw Fixation System components are supplied non-sterile, single use and are fabricated from medical grade titanium alloy (ASTM F136) and medical grade cobalt-chromium-molybdenum alloy (ASTM F1537). All bone screws have self-tapping function in CBT Screw Fixation System. The double lead thread is applied to the all bone screws to shorten the operation time. CBT Screw Fixation System with CoCr rods may be used to provide immobilization and stabilization of spinal segment when the rigid system is need. (Recommendation: trauma or deformities)
The provided text describes a 510(k) premarket notification for a medical device called the "CBT Screw Fixation System." This document primarily focuses on demonstrating substantial equivalence to a predicate device through mechanical performance testing.
Therefore, the information required to answer your specific questions about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/algorithm-based medical device is not present in the provided text. The device being reviewed here is a physical orthopedic implant (a pedicle screw system), not an AI-powered diagnostic or therapeutic tool.
The document does not contain:
- A table of acceptance criteria and reported device performance related to AI/algorithm performance. The "performance" discussed is purely mechanical.
- Sample size used for a test set for an AI algorithm.
- Data provenance for an AI test set.
- Number of experts used to establish ground truth for an AI test set.
- Adjudication method for an AI test set.
- MRMC comparative effectiveness study related to AI assistance.
- Standalone (algorithm only) performance data.
- Type of ground truth used for an AI system.
- Sample size for the training set for an AI algorithm.
- How the ground truth for the training set was established for an AI algorithm.
What the document does describe in terms of "acceptance criteria" and "study":
For the CBT Screw Fixation System (a physical medical device):
- Acceptance Criteria & Performance: The document states, "The mechanical performance of the CBT Screw Fixation System met the acceptance criteria which have been established from the predicate devices." It also says, "All tests met all acceptance criteria and that verifies performance of the CBT Screw Fixation System is substantially equivalent to predicate devices." Specific numerical acceptance values are not provided in this summary.
- Study Type: Non-clinical (bench testing) was performed.
- Tests Conducted:
- Static compression bending test according to ASTM F1717-15
- Static torsion test according to ASTM F1717-15
- Compression bending fatigue test according to ASTM F1717-15
- Dissociation test
- Purpose of Studies: To assess that "no new safety and efficiency issues were raised with this device" and to demonstrate substantial equivalence to predicate devices in mechanical 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.