(84 days)
The Range Spinal System is comprised of the 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 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 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 lordosis); 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, hooks and rod connectors. The purpose of this submission is to add larger Mesa screws, transition rods, hooks, transverse connectors and rod connectors to the system.
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 of the posterior thoracic and lumbar spine.
The provide 510(k) summary does not contain information typically associated with the acceptance criteria and study design for AI/ML devices, such as performance metrics (e.g., sensitivity, specificity, AUC), sample sizes for test/training data, expert qualifications, or details about standalone or MRMC studies.
Instead, this document describes a traditional medical device (Range Spinal System - spinal fixation system components) and its submission for 510(k) clearance based on substantial equivalence to predicate devices. The "performance data" referred to in the document relates to mechanical testing of the components, not clinical performance or AI/ML algorithm performance.
Therefore, I cannot fulfill the request as the provided text does not contain the required information for an AI/ML device.
However, I can extract the information that is present regarding the device's technical performance relative to acceptance criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Testing | In accordance with ASTM F1717 for static compression, static torsion, and dynamic compression. | Worst case components of the modified implants were tested in static compression, static torsion and dynamic compression in accordance with ASTM F1717 and compared with the original Range Spinal System components. The modified implants were determined to be substantially equivalent to the predicate devices. |
| Material | To meet ASTM and ISO standards for Titanium Alloy and Cobalt Chrome. | The devices are manufactured from Titanium Alloy and Cobalt Chrome per ASTM and ISO standards. |
| Design/Sizing | Substantially the same as predicate devices. | 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. |
Study Proving Device Meets Acceptance Criteria:
The study conducted was a mechanical testing study comparing the modified components of the Range Spinal System to its predicate devices and original components.
Information on requested AI/ML specific aspects (Not applicable to this device type based on the provided text):
- Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to physical device components for mechanical testing. No patient data is mentioned for performance evaluation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on standardized tests and measurements, not expert consensus on clinical data.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device.
- If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For mechanical properties, the "ground truth" is derived from the physical properties of the materials and the results of the standardized ASTM F1717 tests.
- The sample size for the training set: Not applicable.
- How the 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.