(27 days)
The VERTEBRON PSSIM Pedicle Screw System is intended for noncervical, nonpedicte fixation for the following indications: degenerative 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 VERTEBRON PSS™ Pedicle Screw System is intended for non cervical pedicte fixation for the following indications: spondylolisthesis (Grade 3 and 4 at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment); 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 VERTEBRON PSS Pedicle Screw System is comprised of non-sterile, single use, titanium alloy components. The VERTEBRON PSS Pedicle Screw System attaches to the vertebral body by means of screws to the non-cervical spinal and allows a surgeon to build a spinal implant construct. This system's design is intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. The VERTEBRON PSS Pedicle Screw System is made up of rods, multi-axial and standard screws, hooks, locking caps and both adjustable and fixed cross connectors. This submission adds 5.5, 6.5 & 7.5mm Cannulated MA Screws & Buttress Cap.
The VERTEBRON PSS Pedicle Screw System is a medical device and its acceptance is determined by demonstrating "substantial equivalence" to a predicate device already legally marketed. This is a common pathway for medical devices in the US through the 510(k) premarket notification process, rather than a typical "acceptance criteria" study for algorithm performance.
Here's an analysis based on the provided document:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstration of Equivalence) | Reported Device Performance |
|---|---|
| Mechanical Performance (ASTM F1717 Standard) | Demonstrated substantial equivalence through testing in accordance with ASTM F1717. |
| Material Compatibility | Medical grade titanium material that conforms to ASTM F136. |
| Intended Use | Intended uses are consistent with predicate devices and established standards for pedicle screw systems for non-cervical spinal fixation. |
| Safety Profile | Implied to be equivalent to predicate devices based on material and performance testing. |
Study Details
It's important to note that the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence, not typically on extensive clinical trials or independent algorithm performance studies as might be seen for AI/ML devices. Therefore, many of the requested categories (like number of experts, adjudication methods, MRMC studies, standalone performance, ground truth for training) are not applicable in the context of this device and submission type.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a "test set" in the context of clinical trials. The "testing" refers to mechanical testing according to ASTM F1717. The number of samples for this mechanical test is not provided in this summary.
- Data Provenance: Not applicable in the sense of clinical data origin. The testing is laboratory-based mechanical testing of the device components.
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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 expert consensus is not relevant here. The ground truth for mechanical testing is established by engineering standards and measurements.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically for clinical interpretations, not mechanical testing.
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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:
- No, not done. This is a physical medical device (pedicle screw system), not an AI/ML-driven diagnostic or assistive tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, not done. This is a physical medical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Mechanical standards and measurements. The "ground truth" for the device's performance is its ability to meet the specified mechanical properties and performance under the ASTM F1717 standard.
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The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of AI/ML or a clinical trial.
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How the ground truth for the training set was established:
- Not applicable.
Summary of the "Study"
The "study" referenced in the document is the mechanical testing of the device components according to ASTM F1717. This standard evaluates the static and fatigue properties of metallic spinal implant ensembles. By demonstrating that the new components (5.5, 6.5 & 7.5mm Cannulated MA Screws & Buttress Cap) meet the criteria specified by ASTM F1717, the manufacturer showed that these components are substantially equivalent in performance to their previously cleared predicate devices (K033352, K043152 & K051716).
The purpose of this submission (Special 510(k)) is to introduce minor modifications (additional screw sizes and a cap) to an already cleared device, and the method for demonstrating safety and effectiveness for such modifications is primarily through engineering and biocompatibility testing, proving that the changes do not raise new questions of safety and effectiveness and perform comparably to the predicate.
§ 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.