(80 days)
RANGE /DENALI/MESA, SMALL STATURE and ARI are cleared for the following indications:
Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to fusion 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-S1 vertebra in skelcially mature patients reveiving fusion by autogenous bone graft having implants attached to the lumbar and sucral spine ( L3 10 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, 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 history and radiographic studies ); spondylolisthesis; trauma ( i.c. fracture or dislocation); spinal stenosis; curvatures ( i.c. scoliosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
Except for the ARI staples, the Range Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior noncervical lixation in pediatric patients. The Runge Spinal System for pediatric use is intended to be used with autografi. Pediatric pediale screw fixation is limited to a posterior approach.
The Range Spinal System is a top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation system which consists of pedicle screws, rods, hooks and rod connectors. The purpose of this submission is to add modified rods and hooks and to incorporate previously cleared implants that were not included in the pediatric submission.
Materials: The devices are manufactured from Titanium Alloy and Cobalt Chrome per ASTM and ISO standards.
Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of the posterior thoracic and lumbar spine.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What they tested for) | Reported Device Performance (How the device performed) |
|---|---|
| Static/dynamic compression bending and static torsion (worst-case constructs) | Constructs representing the worst case components were previously tested in static/dynamic compression bending and static torsion in accordance with ASTM F1717 and were determined to be substantially equivalent to predicate devices. The modified implants were determined to not represent a new worst case. |
| Substantial Equivalence to Predicate Devices | Substantially equivalent in design, function, material, and intended use to predicate devices and other devices currently marketed. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document refers to "Constructs representing the worst case components." It does not specify a numerical sample size but implies a selection of representative configurations rather than a large statistical sample of individual implants.
- Data Provenance: The study was a comparison to previously tested predicate devices. The document does not explicitly state the country of origin or whether the data for the Range Spinal System was retrospective or prospective, but it's implied to be data generated to support the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This document describes a mechanical performance study, not a clinical study involving ground truth established by medical experts for a test set. Therefore, this section is not applicable to this submission. The "ground truth" here is the performance according to ASTM standards and comparison to predicate devices.
4. Adjudication Method for the Test Set
- This document describes a mechanical performance study, not a clinical study requiring adjudication of expert interpretations. Therefore, this section is not applicable to this submission. The results were likely validated by engineers and testing personnel.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This is a submission for a spinal fixation system, and the studies described are mechanical performance tests comparing the device to predicates, not clinical studies evaluating human reader performance with or without AI assistance.
6. Standalone Performance Study (Algorithm only without Human-in-the-loop performance)
- This question is not applicable. The device is a physical spinal implant system, not an algorithm or AI software. The performance studies conducted were mechanical strength and durability.
7. Type of Ground Truth Used
- The "ground truth" for this submission is based on engineering standards (ASTM F1717) and direct comparative mechanical testing against predicate devices. The performance of the Range Spinal System was measured against established benchmarks for spinal fixation devices.
8. Sample Size for the Training Set
- This question is not applicable. This is not an AI/machine learning device that requires a training set. The "training" for such a device is the engineering design and manufacturing process to meet specified standards.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable. As stated above, 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.