(197 days)
The RELIANCE Spinal Screw System is a pedicle screw systems 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The RELIANCE Spinal Screw System is also indicated for pedicle screw fixation 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.
When used posteriorly, the RELIANCE Spinal Screw System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for, spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.
The RELIANCE Spinal Screw System when used with staples and two rods as an anterior thoracic/lumbar screw fixation system, is indicated for spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).
When used in a percutaneous, posterior approach with MIS Instrumentation, the RELIANCE Spinal Screw System components are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications:spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
The Posterior RELIANCE Spinal Screw System consists of longitudinal rods, monoaxial screws, polyaxial screws, reduction screws, cannulated poly axial screws, cannulated reduction screws, hooks, reduction hooks, set screws, transverse connectors.
The Anterior RELIANCE Spinal Screw System consists of two spinal rods, monoaxial screws, staples, and set screws. The Anterior RELIANCE staples and screws are intended to the lateral aspect of the vertebral bodies from T5 to L4, and SHOULD NOT be attached to the anterior aspect. Furthermore, only Titanium components should be used anteriorly. (See Precautions section.) The RELIANCE Spinal Screw System components are available in titanium alloy conforming to ASTM F-136 specifications as well as stainless steel conforming to ASTM F-138 specifications. Furthermore, various rods of the RELIANCE Spinal Screw System are available in Cobalt Chrome conforming to ASTM F-75 specifications. Components of the differing diameter rod systems are NOT interchangeable. The components of one material should not be used with components of another material, with the exception that the Cobalt Chrome rods may be used with titanium alloy implants. The extension tabs on the reduction screw and hook components are intended to be removed intraoperatively.
The provided text describes a medical device, the Reliance Spinal Screw System, and its acceptance criteria are based on non-clinical testing for substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Set by ASTM F1717) | Reported Device Performance |
|---|---|
| Static Compressive Strength | System underwent testing in accordance with ASTM F1717 and demonstrated substantial equivalence to predicate devices. |
| Static Torsion Strength | System underwent testing in accordance with ASTM F1717 and demonstrated substantial equivalence to predicate devices. |
| Dynamic Compressive Strength | System underwent testing in accordance with ASTM F1717 and demonstrated substantial equivalence to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical data or human subjects. The testing described is non-clinical testing (mechanical testing) conducted in accordance with ASTM F1717. Therefore, information about sample size for a test set of data, data provenance (country of origin, retrospective/prospective), or human subject-related data is not applicable. The samples would be physical components of the spinal screw system.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Not applicable. The ground truth for this device's acceptance is based on the mechanical performance against established ASTM standards (F1717) and an engineering comparison for "substantial equivalence" to predicate devices, not on expert clinical evaluation of a test set of data.
4. Adjudication Method for the Test Set
Not applicable, as this refers to non-clinical mechanical testing, not a study involving human subjects or clinical data requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states "Non-Clinical Testing." There is no mention of a clinical study, human readers, or assessment of human improvement with AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical spinal implant system, not an AI algorithm.
7. Type of Ground Truth Used
The ground truth used for proving the device meets acceptance criteria is based on:
- Mechanical performance standards: Compliance with ASTM F1717 for Static Compressive, Static Torsion, and Dynamic Compressive strengths.
- Engineering comparison: A detailed engineering comparison to predicate devices to demonstrate "substantial equivalence" in terms of material, intended use, levels of attachment, size range, and strength.
8. Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device does not involve a "training set" or AI, and therefore no ground truth was established for such.
§ 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.