(240 days)
The VERTICALE® System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities of the thoracic, lumbar and sacral spine. The VERTICALE® System is intended for non-cervical pedicle fixation and nonpedicle fixation for the following indications: 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); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.
When used in a posterior percutaneous approach with MIS instrumentation, the VERTICALE® MIS System is intended for non-cervical pedicle fixation and nonpedicle fixation for the following indications: 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); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the VERTICALE® MIS metallic implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The subject device is intended to be used with autograft and/or allograft. Pedicle screw fixation is limited to a posterior approach.
The VERTICALE® System is a posterior fixation system for stabilizing the thoracic, lumbar and sacral spine. The VERTICALE® System is a modular, versatile fixation system consisting of pedicle screws, iliac screws, revision screws, hooks and rods for the fusion of treated spinal segments.
The pedicle screws are available in a range of sizes, and in solid, cannulated and fenestrated designs, which when used in combination with the rods, can be used for a range of indications. The pedicle screws and hooks are manufactured from titanium alloy and the rods, from titanium alloy or cobalt chrome alloy.
The VERTICALE® System comprises modular ergonomically designed, bi-functional two-in-one (2 in 1) instruments with modular handle options. The VERTICALE® System also offers a set of minimal invasive instrumentation (MIS) to facilitate minimally invasive implantation of the components.
The VERTICALE® System is color coded by diameter for ease of identification.
The VERTICALE® implants are manufactured from Ti6Al4V ELI conforming to ASTM F136 and CoCrMo conforming to ASTM F1537. The VERTICALE® System specific instruments are manufactured from materials conforming to ISO 16061 and ASTM F899.
The safety and effectiveness of this device has not been established when used in conjunction with bone cement or for use in patients with poor bone quality (e.q., osteoporosis, osteopenia). This device is intended only to be used with saline or radiopaque dye.
I am sorry, but the provided text is a 510(k) summary for a medical device (spinal fixation system) and does not contain information about acceptance criteria or a study proving that an AI/ML powered device meets those criteria.
The document focuses on demonstrating substantial equivalence of the VERTICALE® Posterior Spinal Fixation System to legally marketed predicate devices through:
- Indications for Use: Matching the predicate devices.
- Technological Characteristics: Similar materials, design, and function.
- Non-Clinical Performance Data: Mechanical testing (ASTM F1717-15, ASTM F1798-13), biocompatibility (ISO 10993-1), and validation activities for cleaning, sterilization, packaging, shelf life, and transport.
- Absence of Clinical Data Requirement: Stating that due to established safety and efficacy of similar predicate devices, clinical testing was not required.
Therefore, I cannot provide the requested table or answer the specific questions about an AI/ML powered device's acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment based on the given text.
§ 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.