(64 days)
The Rod-To-Rod Coupler is intended to form a transverse connection between spinal rods in a spinal construct in order to increase the torsional stiffness of the construct.
A construct with screws attached to the pedicles of the lumbar and sacral spine (L3 to S1) and autogenous bone graft may be used only for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint (see warnings below). The device is intended to be implanted using a posterior surgical approach and removed after the development of a solid fusion mass.
When not used as a pedicle screw fixation system, various combinations of the Versalok Posterior Spinal Fixation System components are also indicated to provide temporary stability of the thoracic, thoracolumbar, or lumbar spine (T1 to S1) during bony fusion healing secondary to:
-
- Unstable spinal fractures (such as fracture dislocations) or instability secondary to spinal tumors;
-
- Degenerative disk diseases of the spine (defined as back pain of diskogenic origin with degeneration of the disk confirmed by history and radiographic studies);
-
- Spinal curvatures (such as idiopathic scoliosis, neuromuscular scoliosis/kyphoscoliosis with associated paralysis or spasticity, and secondary to spinal fractures) which are:
- . Progressive, despite other forms of treatment,
- . Detrimental to cardiopulmonary function,
- . Interfering with spinal mechanics or causing severe back pain, or
- . Cosmetically unacceptable, progressive, and painful.
The system is intended to provide temporary maintenance and support of the correction during the time normally needed for the fusion mass to mature. Use of spinal fixation instrumentation in children has been reported. Children should have adequate bony and soft tissue maturity to undergo implantation but need not have reached skeletal maturity.
The coupler is designed to form a transverse connection between spinal construct in order to increase the torsional stiffness of the construct.
The provided text describes a 510(k) premarket notification for a medical device, the Rod-To-Rod Coupler, which is part of the Versalok Posterior Spinal Fixation System. However, it does not contain explicit acceptance criteria or detailed study results in the format usually associated with a scientific study proving device performance against such criteria.
The "Testing Summary" section states: "Submitted testing demonstrates that the Rod-To-Rod Coupler fatigue performance is comparable to a predicate device and adequate for its intended use." This is a high-level summary, not a detailed report of acceptance criteria and performance data.
Therefore, many of the requested details cannot be extracted from the provided text. I will answer based on the information that is available.
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Fatigue Performance | Not explicitly stated (implied to be comparable to predicate device for intended use) | "Comparable to a predicate device and adequate for its intended use." |
2. Sample Size Used for the Test Set and Data Provenance
Not available in the provided text. The document states "Submitted testing demonstrates...", suggesting a test was conducted, but details on sample size and data provenance are absent.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. The testing described is mechanical fatigue performance, not a clinical study requiring expert ground truth for interpretation of cases.
4. Adjudication Method
Not applicable, as it's a mechanical test, not a subjective clinical assessment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The testing described is mechanical (fatigue performance).
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
Not applicable. This is a physical medical device, not an AI algorithm. The performance testing would be of the device itself.
7. Type of Ground Truth Used
The "ground truth" for the mechanical fatigue testing would be the physical properties and performance of the device under specific test conditions, likely compared against a predicate device's known performance standards or established engineering benchmarks for spinal implants. The document implies a comparison to a "predicate device."
8. Sample Size for the Training Set
Not applicable. This is not an AI/machine learning study that would have a training set.
9. How Ground Truth for the Training Set Was Established
Not applicable.
§ 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.