(80 days)
The Range Spinal System is comprised of the Denali Deformity and Mesa spinal systems all of which are cleared for the following indications:
Non-cervical spinal fixation devices intended for posterior, non-pedicle 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.
Non-cervical pedicle screw fixation devices for stabilization as an adjunct to fusion for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures (i.e. scoliosis; and/or lordosis); turnor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the LS-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine ( 1.3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The Mesa Spine System is a top-loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, hooks, and transverse connectors. All of the components are available in a variety of sizes to match more closely the patient's anatomy.
Materials: The devices are manufactured from Ti6Al-4V ELI alloy per ASTM and ISO standards.
Function: The system functions as an adjunct to fusion to provide immobilization of spinal segments of the thoracic, lumbar and / or sacral spine.
The acceptance criteria and study proving the device meets them are described below.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biomechanical performance at least equivalent to predicate systems and other currently marketed systems in ASTM F1717 testing. | The Mesa Spine System "performed equal to or better than these systems in ASTM testing to F1717." |
| Design features and sizing substantially the same as predicate systems. | The design features and sizing of the components were "substantially the same as these systems." |
| Manufactured from the same FDA-recognized materials as predicate systems. | Manufactured from "the same FDA recognized materials." |
| Indicated for the same intended uses as predicate systems. | "Indicated for the same intended uses as these systems." |
| No significant differences from currently marketed Mesa Spinal Systems that would adversely affect product use. | "There are no significant differences between the Mesa Spinal Systems currently being marketed which would adversely affect the use of the product." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "test set" in the context of clinical data for algorithmic performance. Instead, the testing described is biomechanical.
- Sample Size for Biomechanical Testing: Not explicitly stated. The document refers to "the Mesa Spine System" being tested, implying a sample of the manufactured device.
- Data Provenance: The testing was biomechanical (laboratory testing) based on ASTM standards. This is not human data, so "country of origin" and "retrospective/prospective" are not applicable in the typical sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. The study conducted was biomechanical testing against an industry standard (ASTM F1717), not a study involving human experts to establish ground truth for a diagnostic or predictive algorithm.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods are relevant for studies involving human interpretation or clinical data analysis where discrepancies need resolution. The study described is biomechanical testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not applicable to a spinal fixation system that undergoes biomechanical testing.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone (algorithm only) study was not done. This type of study is relevant for AI algorithms. The Mesa Spinal System is a physical medical device.
7. Type of Ground Truth Used
The "ground truth" used for this device's evaluation was an accepted industry standard for biomechanical performance (ASTM F1717). The device's performance was compared against this standard and against predicate devices.
8. Sample Size for the Training Set
This information is not applicable. The device is a physical spinal fixation system, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for a physical device.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.