(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.
§ 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.