Search Results
Found 1 results
510(k) Data Aggregation
(77 days)
When used with the ProMIS Fixation System, the ProMIS Extension Rod System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion, for the following acute and chronic instabilities or deformities of the lumbar, and sacral spine: 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; deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The ProMIS Extension Rod System is compatible with Premia Spine's Slender Tulip Polyaxial Pedicle Screws for extending the ProMIS Fixation System to a single adjacent level.
The ProMIS Extension Rod System (also referred to as PER System) is composed of a fusion rod (Turret™ Rod) with a spherical head at one end and a rod on the other end. The Turret™ Rod's end is connected to a pedicle screw at the adjacent vertebrae to be fused, while the spherical head attaches to the Tulip's head of Premia Spine's pedicle screw of the existing fusion system using a designated Set Screw and a Ring Nut.
The spherical head of the ProMIS Extension Rod System is designed to be positioned on Premia Spines' Slender Tulip Polyaxial Pedicle Screws. The Rod is available in two lengths 60 and 75 mm in a diameter of 6 mm.
All components of the ProMIS Extension Rod System are made of Titanium alloy (Ti-6Al-4V ELI per ASTM F136).
The FDA 510(k) summary for the ProMIS Extension Rod System describes the device's mechanical performance testing.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Static Torsion (per ASTM F1717) | Not explicitly stated, but implied to be "substantially equivalent mechanical performance compared to predicate devices." | "All devices functioned and have substantially equivalent mechanical performance compared to predicate devices." |
| Dynamic Compression (per ASTM F1717) | Not explicitly stated, but implied to be "substantially equivalent mechanical performance compared to predicate devices." | "All devices functioned and have substantially equivalent mechanical performance compared to predicate devices." |
2. Sample Size and Data Provenance for Test Set:
- Sample Size: Not specified in the provided document. The document states that "All devices functioned," implying that the tested devices represent the system.
- Data Provenance: The testing was performed on the ProMIS Extension Rod System, which is manufactured by Premia Spine Ltd. in Netanya, Israel. The study is a prospective bench test study, as it describes the performance of the device itself.
3. Number of Experts and their Qualifications for Ground Truth:
Not applicable. This device is a mechanical implant, and its performance is evaluated through objective physical testing (bench testing) rather than expert interpretation of data like images or patient outcomes. Therefore, "ground truth" established by human experts is not relevant in this context.
4. Adjudication Method for Test Set:
Not applicable, as the evaluation is based on objective mechanical testing, not human interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is a medical device, specifically an orthopedic implant, where performance is assessed through mechanical bench testing. MRMC studies are typically used for diagnostic or screening devices that involve human interpretation of results (e.g., radiology AI).
6. Standalone (Algorithm Only) Performance Study:
Not applicable. This is a physical medical device, not a software algorithm. Its performance is inherent to its mechanical properties.
7. Type of Ground Truth Used:
Mechanical properties and performance standards as defined by ASTM F1717. The "ground truth" is the objective physical behavior of the device under specific loads and conditions, measured against established engineering standards or in comparison to predicate devices.
8. Sample Size for Training Set:
Not applicable. This is a physical medical device, not an AI or machine learning system that requires a training set.
9. How Ground Truth for Training Set Was Established:
Not applicable. There is no training set for this type of medical device.
Ask a specific question about this device
Page 1 of 1