(124 days)
The Fixpine II System is a posterior pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 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.
In addition, the Fixpine II System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in 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, spinal tumor and failed previous fusion (pseudarthrosis).
The Fixpine II System is a top-loading multiple component, posterior spinal fixation system which consists fixation system which consists of pedicle screws, connectors, and a transverse (cross) linking mechanism.
The Fixpine II System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The DIO Spinal System implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available.
The Fixpine II System is a pedicle screw spinal fixation system. Its acceptance criteria and performance are established through mechanical bench testing.
1. Acceptance Criteria and Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| * Meets ASTM F1717-04 Standard Test Method requirements for Spinal Implant Constructs in a Vertebrectomy Model (static and dynamic axial compression bending test and static torsion test). | * Bench testing (static and dynamic axial compression bending test and static torsion test of the worst-case Fixpine II system structure) was performed in accordance with ASTM F 1717-04. |
| * Substantially equivalent in design, materials, indications and intended use, packaging, and performance to predicate devices (4CIS® Vane Spine System (K060702) and GSS Pedicle Screw System (K053573)). | * Testing and other comparisons established substantial equivalence to predicate devices. |
2. Sample Size and Data Provenance for the Test Set:
- Sample Size: The document does not explicitly state the sample size used for the bench tests. It refers to "worst-case Fixpine II system structure" testing but does not provide specific numbers of units tested.
- Data Provenance: The data is generated from mechanical bench testing conducted by the manufacturer, DIO Medical Co., Ltd. The country of origin for the data is implicitly South Korea, where the manufacturer is located. The study is prospective in the sense that the tests were performed specifically to support this 510(k) submission.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable. This device's performance evaluation is based on mechanical bench testing against established ASTM standards and comparison to predicate devices, not on expert-established ground truth from clinical images or patient data.
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical studies involving interpretation of data by multiple experts. The Fixpine II System's evaluation relies on objective mechanical testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. MRMC studies are used to evaluate the impact of a device (often AI-assisted) on human reader performance in interpreting medical images or data. The Fixpine II System is a spinal implant, and its evaluation does not involve such human-in-the-loop performance assessment.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. This device is a physical spinal implant, not an algorithm or software. A standalone performance study as described would apply to AI/ML software.
7. Type of Ground Truth Used:
The "ground truth" for this device's performance is based on established engineering and biomechanical standards, specifically:
- ASTM F1717-04: Standard Test Method for Spinal Implant Constructs in a Vertebrectomy Model. This standard defines the methodologies and expected performance characteristics for such devices.
- Predicate Device Performance: Performance of legally marketed devices (4CIS® Vane Spine System and GSS Pedicle Screw System) which the subject device aims to be substantially equivalent to.
8. Sample Size for the Training Set:
Not applicable. The Fixpine II System is a physical medical device, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for a physical 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.