(199 days)
The VERTICALE® Triangular Fixation System, when used in combination with the VERTICALE® Posterior Spinal Fixation System, is intended for immobilization of the 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® Triangular Fixation System is intended to treat the following conditions: trauma (i.e., fracture or dislocation); tumor, pseudoarthrosis; and failed previous fusion.
The VERTICALE® Triangular Fixation System is intended for iliac fixation and must be attached to the VERTICALE® Posterior Spinal Fixation System to treat the conditions listed above.
Refer to the labeling for the VERTICALE® Posterior Spinal Fixation System for limitations and instructions for use.
The VERTICALE® Triangular Fixation System consists of iliac screws with a UHMWPE lined slot, a polyaxial head as well as related instruments. The VERTICALE® Triangular Fixation System is intended to be used with VERTICALE® Posterior Spinal Fixation System (K171421).
The implants of the VERTICALE Triangular Fixation System are manufactured from titanium alloy conforming to ASTM F136 / ISO 5832-3 and Ultra-High-Molecular-Weight Polyethylene according to ASTM F648 / ISO 5834-1 and -2.
The provided text describes a 510(k) premarket notification for a medical device called the "VERTICALE® Triangular Fixation System." However, the document focuses on regulatory approval based on substantial equivalence to predicate devices through non-clinical testing and engineering rationales, rather than a clinical study evaluating AI software or diagnostic performance against specific acceptance criteria for an AI/ML device.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving a device meets these criteria for an AI/ML product.
The listed aspects in your prompt (e.g., sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance, ground truth types) are typically associated with the rigorous validation of AI/ML-driven medical devices. This document describes a more traditional mechanical device approval process based on non-clinical performance testing (e.g., strength, durability).
To directly answer your prompt, I would need a different type of document, specifically one detailing the clinical or technical validation of an AI/ML medical device.
§ 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.