(16 days)
The PROTEX™ Stabilization System, when used as a posterior pedicle screw system, is 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 disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.
In addition, the PROTEX™ Stabilization System is intended for 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 lumbosacral spine and/or illum with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.
When used as a posterior non-pedicle screw fixation system, the PROTEX™ Stabilization System is intended for the treatment of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann's disease), fracture, pseudarthrosis, tumor resection, and/or failed previous fusion. Overall levels of fixation are T1-sacrum/ilium.
When used as an anterolateral thoracolumbar system, the PROTEX™ Stabilization System is intended for anterolateral screw (with or without staple) fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5.
The PROTEX™ Stabilization System consists of a variety of shapes and sizes of rods, hooks, monoaxial screws, polyaxial screws, locking caps, tconnectors, staples, and associated manual surgical instruments. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. Polyaxial screws, hooks, and tconnectors are intended for posterior use only. AccuRods are intended for posterior use with polyaxial and monoaxial screws only. Staples are intended for anterior use only. Rods and monoaxial screws may be used anteriorly or posteriorly. Locking caps are used to connect screws or hooks to the rod.
The implants are composed of titanium alloy as specified in ASTM F136 and F1295.
The PROTEX™ Stabilization System is a medical device designed to provide immobilization and stabilization of spinal segments. The provided text indicates that the device's performance was evaluated through mechanical testing.
Here's an analysis 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 it needed to meet) | Reported Device Performance (How it met the criteria) |
|---|---|
| Mechanical performance in accordance with ASTM F1717 standard requirements | Mechanical testing in accordance with ASTM F1717 was conducted. |
| Substantial equivalence to predicate device PROTEX™ (K040442) components | The additional components are similar to the predicate PROTEX™ (K040442) components with respect to technical characteristics and performance. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes mechanical testing as the performance data.
- Sample Size for the Test Set: Not explicitly mentioned for the mechanical testing. ASTM F1717 specifies various tests (e.g., static and fatigue compression bending, static torsion, fatigue torsion, static cantilever bending). The sample size for each test would typically be defined within the ASTM standard or by the manufacturer based on statistical validity requirements, but this information is not provided in the summary.
- Data Provenance: Not explicitly stated. Mechanical testing is typically conducted in a laboratory setting, so it is prospective data focused on material and design performance. The country of origin for the testing itself is not mentioned, but the manufacturer is based in Phoenixville, PA, USA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to mechanical testing performed for device performance. Mechanical testing relies on established engineering standards (like ASTM F1717) and objective measurements, not expert human interpretation for "ground truth."
4. Adjudication Method for the Test Set
This is not applicable to the mechanical testing described. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation or subjective criteria, which is not the case for material property and structural integrity testing of a medical device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No, an MRMC comparative effectiveness study was not conducted. The performance data presented focuses on mechanical testing of the device itself, not on human reader performance with or without AI assistance. This device is a surgical implant, not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not conducted. This device is a physical medical implant, not a software algorithm.
7. The Type of Ground Truth Used
The ground truth used for performance validation was adherence to established mechanical testing standards (ASTM F1717). This standard defines objective criteria for mechanical properties, strength, and fatigue life for spinal implant assemblies. The "ground truth" is whether the device can withstand the specified forces and cycles without failure, as defined by the standard.
8. The Sample Size for the Training Set
This information is not applicable. Mechanical testing for medical devices does not typically involve a "training set" in the context of machine learning or AI. The design and manufacturing processes are validated through engineering principles and testing against established standards.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated in point 8.
§ 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.