(148 days)
The VIPER Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The VIPER Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (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; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients. When used in a posterior percutaneous approach with MIS instrumentation, the VIPER System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (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; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients. With the exception of degenerative disc disease (DDD), the PEEK rods and associated components of the VIPER Spine System may be used for the aforementioned indications in skeletally mature patients.
The EXPEDIUM Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The EXPEDIUM™ Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (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; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients. With the exception of degenerative disc disease (DDD), the PEEK rods and associated components of the EXPEDIUM Spine System may be used for the aforementioned indications in skeletally mature patients.
This submission addresses additional rod components. Rod components are manufactured from medical grade PEEK (polyetheretherketone) polymer both with and without 6% barium sulfate (BaSO4) filler and ASTM F 560 implant grade tantalum wire. Setscrew components are manufactured from ASTM F 136 implant grade titanium alloy.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the VIPER™ and EXPEDIUM™ Spine Systems:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Reported Device Performance (VIPER™ & EXPEDIUM™ Spine Systems) |
|---|---|
| Material Composition | Rod components: Medical-grade PEEK (polyetheretherketone) polymer (with and without 6% barium sulfate (BaSO4) filler) and ASTM F 560 implant grade tantalum wire. Setscrew components: ASTM F 136 implant grade titanium alloy. |
| Mechanical Performance | Performance data per ASTM F 1717 and ASTM F 1798. |
| Biocompatibility | Not explicitly stated as an acceptance criterion or performance measure within the provided text, but implied by the use of "medical grade" materials and general regulatory standards for implants. |
| Sterility | Not explicitly stated as an acceptance criterion or performance measure within the provided text. |
| Shelf Life/Stability | Not explicitly stated as an acceptance criterion or performance measure within the provided text. |
Study Information
Based on the provided text, the submission is a "Traditional 510(k) Submission" for additional rod components for existing spine systems. The regulatory review focuses on substantial equivalence to predicate devices. This type of submission typically relies heavily on performance data from recognized standards rather than extensive clinical studies with human participants.
Here's a breakdown of the study-related information:
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Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable in the context of human data. The performance data provided is for material and mechanical testing using ASTM standards. The sample sizes for these specific tests (e.g., number of rods tested, number of cycles) are not detailed in the provided summary.
- Data Provenance: Not applicable in the context of human data. The performance data is derived from in-vitro mechanical testing according to established ASTM standards. The country of origin for such laboratory testing is not specified but is typically performed by the manufacturer or a certified testing lab. It is a retrospective analysis of device performance against standards.
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Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. The "ground truth" for this device, in terms of its substantial equivalence, is based on its compliance with established mechanical standards (ASTM F 1717 and ASTM F 1798) and material specifications. There is no explicit mention of human experts establishing "ground truth" for a test set in the way one would for diagnostic imaging.
- The "experts" involved are the engineers and material scientists who designed and tested the device, and the regulatory bodies (like FDA) who evaluate compliance with standards.
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Adjudication Method for the Test Set:
- Not applicable. This device relies on objective, quantifiable mechanical and material testing against established standards, not subjective interpretations requiring adjudication.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. The provided documentation does not indicate that a MRMC comparative effectiveness study was done. This type of study is more common for diagnostic devices where human interpretation of data (e.g., medical images) is central. For an orthopedic implant like a spinal rod, the focus is on mechanical integrity and material properties.
- Effect Size: Not applicable, as no such study was conducted.
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Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):
- Yes, in spirit. The performance data submitted is for the device itself (the rods and setscrews) independent of human-in-the-loop performance. Its mechanical properties and material composition are characterized in a "standalone" fashion against engineering standards.
- However, this is not an "algorithm" in the typical sense of AI/software performance. It's the physical device's performance.
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Type of Ground Truth Used:
- Engineering Standards and Material Specifications: The "ground truth" for the device's performance is compliance with established ASTM (American Society for Testing and Materials) standards: ASTM F 1717 ("Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model") and ASTM F 1798 ("Standard Guide for Evaluation of Spinal Intervertebral Body Fusion Devices in vitro"). Additionally, material "ground truth" is based on medical-grade PEEK and titanium alloys meeting specific ASTM F 560 and ASTM F 136 standards.
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Sample Size for the Training Set:
- Not applicable. This submission concerns a physical implant, not a machine learning algorithm that requires a "training set."
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How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for a machine learning model.
§ 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.