(37 days)
The Golden Isles Pedicle Screw System is intended to help provide immobilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine as follows:
The Golden Isles System is intended for posterior, non-cervical pedicle fixation in skeletally mature patients for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoathrosis; and failed previous fusion.
In addition, when used as a pedicle screw fixation system, the Golden Isles Pedicle Screw System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (1.5-S1) vertebral joint, (b) who are receiving fusions using autogenous bone graft only, (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below), and (d) who are having the device removed after the development of a solid fusion mass.
The Golden Isles Pedicle Screw System is a spinal fixation system consisting of a variety of components including pedicle screws, modular head bodies, and various types and sizes of rods. The components are designed to be rigidly locked into a variety of configurations with each construct being appropriate for the individual patient. The Golden Isles Pedicle Screw System implant components are fabricated from medical grade titanium alloy (Ti-6Al-4V) or cobalt chrome alloy (Co-28Cr-6Mo).
The provided text describes a 510(k) premarket notification for the "Golden Isles Pedicle Screw System". However, it explicitly states that no performance data or studies were required or conducted because the device is "identical to the predicate device" (Preference Elite Pedicle Screw System, K162160).
Therefore, the requested details about acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a study cannot be extracted from this document, as such a study was not performed for the Golden Isles Pedicle Screw System.
Here's what can be stated based on the provided text:
The Golden Isles Pedicle Screw System did not undergo a specific study to demonstrate its performance against acceptance criteria. The FDA cleared its marketability based on its substantial equivalence to a legally marketed predicate device (K162160), asserting that the subject and predicate devices are identical.
Therefore, the following information, relating to a performance study, is not applicable or not provided in this document:
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Table of Acceptance Criteria and Reported Device Performance: Not applicable, as no performance testing was required or conducted for this specific device due to its identical nature to the predicate.
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Sample Size Used for the Test Set and Data Provenance: Not applicable.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications: Not applicable.
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Adjudication Method for the Test Set: Not applicable.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No MRMC study was conducted.
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Standalone Performance Study (algorithm only without human-in-the-loop performance): Not applicable.
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Type of Ground Truth Used: Not applicable.
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Sample Size for the Training Set: Not applicable.
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How the Ground Truth for the Training Set Was Established: Not applicable.
Explanation from the document:
The document explicitly states:
- "The subject and predicate devices are identical and therefore, no performance testing is required: This submission is only transferring the name of a system that has already been cleared under K162160. No testing is required."
- "The Golden Isles Pedicle Screw System and the primary predicate, Preference Elite Pedicle Screw System have the same intended use and identical indications, technological characteristics and principles of operation. There are no technological differences between the Golden Isles Pedicle Screw System and its predicate. Hence the Golden Isles Pedicle Screw System is substantially equivalent to the primary predicate."
§ 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.