(30 days)
The VIPER 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 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.
When used in a percutaneous approach with MIS Instrumentation, the VIPER Systems are 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.
The VIPER® Systems consist of rods and cannulated screws used in a percutaneous approach and are available in various geometries and sizes. The proposed Viper® 4.35mm diameter cannulated screws maintain the identical cannulation through the center of the screw shank as the previously cleared Viper® pedicle screws. The screw shank component of the proposed screws will have the same dual lead thread form, tapered distal tip, and same flutes as the previously cleared Viper® screws and are available in polyaxial or uniplanar configurations.
This is a 510(k) summary for a medical device, the Viper™ Spinal System, which falls under the category of spinal implants. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study on a device's performance against set acceptance criteria in the context of AI or diagnostic accuracy.
Therefore, many of the requested categories regarding acceptance criteria and study details (especially those related to AI, human readers, ground truth establishment, sample sizes for training/test sets, and expert qualifications) are not applicable to this type of regulatory submission. This document describes a traditional medical device (spinal system components), not an AI/ML-driven diagnostic or assistive device.
Here's an analysis of the provided text, addressing the closest relevant information and explicitly stating when a category is not applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Specifications: Manufactured from implant grade stainless steel (ASTM F 138) and titanium alloy (ASTM F 136). | Material Conformance: "Manufactured from ASTM F 138 implant grade stainless steel and ASTM F 136 implant grade titanium alloy." |
| Mechanical Performance: Meet static and fatigue requirements relevant to spinal fixation systems (e.g., per ASTM F 1717). | Mechanical Performance: "Performance data per ASTM F 1717 were submitted to characterize the subject VIPER System components... This testing was compromised of static and fatigue testing on the proposed device. Specifically, static and dynamic compression testing as well as static torsion and cantilever beam testing were performed." |
| Design Equivalence: Maintain identical design principles (cannulation, thread form, tip, flutes) to previously cleared Viper® pedicle screws. | Design Equivalence: "The proposed Viper® 4.35mm diameter cannulated screws maintain the identical cannulation through the center of the screw shank as the previously cleared Viper® pedicle screws. The screw shank component of the proposed screws will have the same dual lead thread form, tapered distal tip, and same flutes as the previously cleared Viper® screws." "The design, materials, and technology remain identical to the predicate system." |
| Intended Use Equivalence: Similar indications for use as predicate devices. | Intended Use Equivalence: The stated "Intended Use" (Section F) is consistent with the predicate devices and the device seeks to demonstrate substantial equivalence based on this. |
| Safety and Effectiveness: Demonstrate device is as safe, as effective, and performs as well as the predicate device. | Conclusion: "Both the Performance Testing and Substantial Equivalence Justification demonstrate that the device is as safe, as effective, and performs as well as the predicate device." |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not provided in the summary. For mechanical testing, "sample size" typically refers to the number of test articles (screws, rods) subjected to various loads. The document states "Performance data per ASTM F 1717 were submitted," which is a standard for spinal implant testing, but it does not specify the number of samples tested or the exact conditions of data provenance beyond being submitted for regulatory review. This is not a clinical study involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This is not applicable. This submission is for a physical medical device (spinal implant), not a diagnostic device requiring expert interpretation or ground truth establishment based on clinical data. The "ground truth" for this device's performance is derived from standardized mechanical testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This is not applicable. Adjudication methods are typically used in clinical studies, especially for evaluating diagnostic outputs. This submission is for a physical medical device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This is not applicable. This is not an AI-driven device, and therefore, no MRMC study or assessment of human reader improvement with AI assistance would be conducted or relevant for this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable. This is not an algorithm or software device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For this type of device, the "ground truth" for performance is established through objective, standardized mechanical testing (e.g., tensile strength, fatigue life, torsional resistance) as defined by standards like ASTM F 1717. This is not clinical ground truth derived from patient observations or expert consensus.
8. The sample size for the training set
- This is not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- This is not applicable. As it's not an AI/ML device, there is no training set or associated ground truth to establish in that context.
§ 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.