(52 days)
The EXPEDIUM and VIPER Spine Systems are intended to provide immobilization 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 and VIPER Spine 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.
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); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM and VIPER Spine System metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The EXPEDIUM and VIPER Spine Systems are intended to be used with autograft. Pediatric pediatric pedicle screw fixation is limited to a posterior approach.
The VIPER System (including VIPER2) is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
The system is composed of components offered in a range of sizes to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The system consists of bone anchors including screws, longitudinal members including rods and interconnection mechanisms including set screws. The system is compatible with transverse connectors, like the SFX cross connector from the EXPEDIUM Spine System. The system components are implanted using class I premarket notification exempt manual surgical instruments.
The purpose of this premarket notification is to add new screws to the VIPER System. The VIPER PRIME screws are designed to facilitate a posterior percutaneous approach with minimally invasive surgery (MIS) instrumentation. The VIPER PRIME screws are intended for use with existing components of the VIPER System to generate a posterior construct to provide immobilization and stabilization of spinal segments as an adjunct to fusion.
Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance:
Assessment: The provided document is an FDA 510(k) clearance letter for a medical device (VIPER PRIME™ additions to the VIPER® System). While it discusses the device's intended use and technological characteristics, it does not contain the detailed clinical study information typically required to describe acceptance criteria, device performance metrics, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/Software as a Medical Device (SaMD) product.
This document describes a traditional medical device (pedicle screw spinal system) and its mechanical testing for substantial equivalence, not a machine learning or AI-driven diagnostic/prognostic device. Therefore, many of the requested points are not applicable or cannot be extracted from this specific text.
However, I can extract the information that is present and explain why other requested information is not available.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Mechanical Testing) | Reported Device Performance |
|---|---|
| Static compression bending | Evaluated (consistent with predicate devices) |
| Static torsion | Evaluated (consistent with predicate devices) |
| Dynamic compression bending | Evaluated (consistent with predicate devices) |
| Note: Criteria are based on demonstrating "substantial equivalence" to predicate devices, not specific performance thresholds against a disease state or clinical outcome. The testing was performed in accordance with ASTM F1717-15. | Note: The document states that the technological characteristics (including design, materials, and performance) of the VIPER PRIME screws are consistent with those of the predicate devices. Specific numerical performance values or pass/fail thresholds for these tests are not provided in this summary. The goal was to show equivalence, not superiority or a specific standalone performance metric. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. This document refers to mechanical bench testing, not clinical data or a "test set" in the context of an AI/SaMD. The tests were performed on device components.
- Data Provenance: Not applicable in the context of clinical data. The performance data is from laboratory mechanical testing of the device components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth, in the context of clinical diagnosis or outcomes, is not established for this type of mechanical testing. The "ground truth" here would be the physical properties and performance of the device components under defined load conditions, measured by technicians according to ASTM standards.
4. Adjudication method for the test set
- Not applicable. Adjudication methods (like 2+1, 3+1) are for human interpretation of clinical data, which is not present here. The mechanical tests are objective measurements.
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
- Not applicable. This is not an AI/SaMD device. No MRMC study was conducted or is relevant for a pedicle screw spinal system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/SaMD device. No standalone algorithm performance was assessed.
7. The type of ground truth used
- Ground Truth Type: Not applicable in the context of clinical outcomes or pathology. For mechanical testing, the "ground truth" is established by the specified test conditions and measurement instruments used to evaluate the physical properties and load-bearing capacity of the screws and system components according to ASTM F1717-15.
8. The sample size for the training set
- Not applicable. This is not an AI/SaMD device. No training set for an algorithm was used.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/SaMD 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.