(80 days)
The Range Spinal System is comprised of the DENALI, DENALI DEFORMITY, and MESA Spinal Systems and the ARI Anterior Vertebral Body Staples, all of which are cleared for the following indications:
Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to firstien for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the L5-S I vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine ( L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
Non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumbar screw stabilization as an adjunct to fusion for the following indications: degenerative disc disease (DDD ) (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, kyphosis; and/or tordosis); tumor; pseudoarthrosis; and failed previous fusion.
The Range Spinal System is a top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation system which consists of pedicle screws, rods, locking set screws, and hooks.
Here's the analysis of the provided text regarding the Range Spinal System:
This document is a 510(k) summary for component modifications to an existing device, the Range Spinal System. It does not describe a clinical study in the traditional sense, but rather a mechanical testing comparison to establish substantial equivalence with predicate devices. Therefore, many of the requested categories related to clinical studies and expert review will not be applicable.
Acceptance Criteria and Study Details
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | The modified components of the Range Spinal System must perform equally to or better than the predicate devices in static compression, static torsion, and dynamic compression. This testing is to be conducted in accordance with ASTM F1717. (This is inferred from "The modifications to the Range Spinal System were mechanically tested and compared to predicate devices. The modified component performed equally to or better than these systems in static compression, static torsion and dynamic compression in accordance with ASTM F1717.") | The modified component performed equally to or better than the predicate systems in static compression, static torsion, and dynamic compression. |
| Substantial Equivalence | Design Features: Similar to predicate devices. (Inferred from "The design features and sizing of the components were compared to predicate devices and the Range Spinal System was found to be substantially the same as these systems.") | |
| Function: Similar to predicate devices. (Inferred from "There are no significant differences between the Range Spinal Systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.") | ||
| Material: Similar to predicate devices. (Inferred from "There are no significant differences between the Range Spinal Systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.") | ||
| Intended Use: Similar to predicate devices. (Inferred from "There are no significant differences between the Range Spinal Systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.") | The Range Spinal System's design features and sizing were found to be substantially the same as predicate systems. | |
| The device maintains substantial equivalence to other devices in design, function, material, and intended use. | ||
| There are no significant differences that would adversely affect product use. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. This was a mechanical engineering test on components, not a clinical study on human subjects or clinical data. The "sample" would be the number of test articles (modified components) subjected to mechanical loads, which is not specified but would follow ASTM F1717 guidelines.
- Data Provenance: Not applicable in terms of country of origin or retrospective/prospective. The data comes from mechanical laboratory testing of device components.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. Ground truth for mechanical performance tests is established by adhering to standardized testing protocols (e.g., ASTM F1717) and engineering measurements, not by expert clinical consensus.
4. Adjudication Method for the Test Set
- Not applicable. This was a mechanical test, not a subjective assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not applicable. This is not a clinical study involving human readers or assessment of AI performance.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- Not applicable. This is not an AI/algorithm-based device.
7. Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Ground Truth: For mechanical testing, the "ground truth" is defined by the objective, quantifiable measurements of force, displacement, cycles to failure, and other mechanical properties obtained through standardized testing methods (ASTM F1717). The performance of the predicate devices under these same conditions serves as the benchmark.
8. Sample Size for the Training Set
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This is not an AI/machine learning 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.