(30 days)
The VIPER Systems are 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 Systems metallic components are intended for noncervical pedicle fixation and nonpedicle fixation for fusion 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 Systems metallic components are intended for noncervical pedicle fixation and nonpedicle fixation for fusion 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.
The VIPER PEEK rods are only indicated for fusion procedures for spinal stenosis with instability (no greater than Grade I spondylolisthesis) from L1-S1 in skeletally mature patients.
The VIPER Systems are 5.5mm rod systems offered in both titanium and stainless steel materials. The systems consist of monoaxial screws, polyaxial screws, uni-planar screws, and extended tab implants. They are available in various geometries and sizes to accommodate patient anatomy. The VIPER Systems 8mm to 12mm diameter favored angle polyaxial screws are not intended to be used with the VIPER PEEK rods.
The provided text outlines the 510(k) premarket notification for the DePuy Spine VIPER Systems, focusing on its substantial equivalence to predicate devices and performance data. It does not describe an AI medical device or a study involving acceptance criteria with sensitivity, specificity, or human reader performance. Instead, it describes a medical device (Pedicle Screw Spinal System) and its mechanical performance testing.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance related to AI, sample sizes for test sets or training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not addressed in the provided document.
The document describes Performance Data for the VIPER Systems, which are mechanical tests rather than clinical or AI performance evaluations:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance (ASTM F 1798) | The device must demonstrate mechanical properties (static and dynamic cantilever bending, axial pull-out, torsion, and static axial slip) that are substantially equivalent or superior to the identified predicate devices, ensuring it can withstand the expected mechanical loads in vivo without failure or compromise to its intended function. The specific quantitative criteria (e.g., stiffness thresholds, fatigue limits, pull-out force minimums) are not explicitly detailed in the summary but would be defined in the full test protocol. | The performance data submitted "characterize the subject VIPER Systems components." The Conclusion states: "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." This implies the tests met the established criteria for substantial equivalence to the predicate devices. |
| Biocompatibility | Biocompatibility requirements per ISO 10993 (or equivalent) for implantable devices. | While not explicitly detailed as "reported performance" in this summary, the use of "ASTM F 138 implant grade stainless steel, ASTM F 139 implant grade stainless steel, and ASTM F 136 implant grade titanium alloy" for manufacturing indicates compliance with accepted biocompatibility standards for these materials. |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified in the provided text. Mechanical testing typically involves a set number of samples per configuration (e.g., 5-10 samples per test condition) to satisfy statistical requirements for device qualification.
- Data provenance: The performance data was generated through "Performance data per ASTM F 1798" and submitted by DePuy Spine, Inc. This indicates laboratory testing of physical device components, not clinical data from patients or data from specific countries.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable. The "ground truth" for mechanical testing is based on the physical properties and performance of the device components as measured by test equipment, not on expert interpretation of results in the way clinical diagnostic accuracy studies require.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable. Adjudication methods are used in studies involving human interpretation or clinical outcomes, not for standard mechanical testing results.
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 document describes a medical device (spinal pedicle screw system) and its mechanical performance, not an AI medical device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable as the device is a physical pedicle screw system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for mechanical testing is based on objective, quantifiable measurements (e.g., load at failure, displacement, fatigue cycles) obtained from laboratory test equipment, adhering to ASTM F 1798 standards. There is no expert consensus, pathology, or outcomes data used to establish ground truth for this type of performance evaluation.
8. The sample size for the training set:
- This is not applicable as the document describes a physical medical device and its mechanical testing, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- This is not applicable.
§ 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.