(133 days)
The UNI-T Uni-Thread Spinal System is a pedicle screw system indicated for skeletally mature patients who:
- have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra; .
- receive fusions using autogenous bone graft only; .
- · have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and
- have the device removed after the development of a solid fusion. .
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- Degenerative spondylolisthesis with objective evidence of neurologic impairment .
- fracture ◆
- . dislocation
- scoliosis .
- kyphosis .
- spinal tumor .
- failed previous fusion (pseudoarthrosis) .
The UNI-T Uni-Thread Spinal System instrumentation consists of screws, rods and connectors that can be assembled in a variety of constructs. The instrumentation is combined and placed to treat a variety of spinal disorders, with the constructs varying according to the nature of the spinal pathology. The UNI-T System components are available in titanium alloy, manufactured according to ASTM F136.
The provided text is a 510(k) summary for the UNI-T™ Uni-Thread Spinal System. This document describes a medical device (spinal instrumentation) and its indications for use, and it declares substantial equivalence to existing devices.
The information you are requesting, specifically acceptance criteria and a study proving a device meets acceptance criteria, is typically associated with performance studies for diagnostic devices or those with quantifiable performance metrics that are clinically assessed. For a spinal implant system like this, the "acceptance criteria" and "study" are primarily focused on mechanical testing to demonstrate equivalence and safety, rather than a clinical performance study with specific sensitivity, specificity, or similar metrics.
Based on the provided text, here's an attempt to extract relevant information according to your request, but please note that some of your requested categories are not directly applicable or explicitly detailed for this type of device submission.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalence in design, material, and indications to predicate devices for posterior spinal use. | Components are similar in design, material, and indications to other cleared spinal instrumentation systems. |
| Satisfactory mechanical performance to withstand stresses associated with spinal instrumentation. | "Mechanical testing was performed to demonstrate the equivalence of the construct design to currently marketed spinal systems." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified. "Mechanical testing" typically involves a specific number of constructs tested under various loading conditions, but the exact number of samples is not detailed in this summary.
- Data Provenance: Not specified, but likely refers to laboratory testing data (in-vitro mechanical tests) rather than clinical patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This category is not applicable for this type of device and submission. "Ground truth" established by experts in the context of diagnostic performance (e.g., radiologists interpreting images) is not relevant for a mechanical implant. For mechanical testing, the "ground truth" is defined by established engineering standards and test protocols.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are typically used in clinical studies involving interpretation or outcome assessment by multiple experts, which is not described for this 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
Not applicable. This is not an AI/diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm/diagnostic device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For this device, the "ground truth" for mechanical performance is established through adherence to recognized mechanical testing standards and protocols (e.g., ASTM standards for medical implants). This involves measuring properties like fatigue strength, pull-out strength, and bending stiffness according to predefined methods, and comparing these results to predicate devices or established minimum performance criteria. The text explicitly mentions "Mechanical testing was performed to demonstrate the equivalence."
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not a machine learning or AI device that requires a training set.
Summary of the Study Discussed (Mechanical Testing):
The primary "study" mentioned to support the UNI-T™ Uni-Thread Spinal System's safety and effectiveness is mechanical testing.
- Objective: To demonstrate the equivalence of the construct design to currently marketed spinal systems.
- Methodology (implied): The mechanical testing would have involved subjecting samples of the UNI-T System components (screws, rods, connectors) and assembled constructs to various mechanical loads and conditions (e.g., static and dynamic loading, fatigue testing) as specified by relevant industry standards (e.g., ASTM F1717 for Spinal Implant Constructs, ASTM F1798 for fatigue testing of pedicle screw spinal systems).
- Conclusion: The tests demonstrated the device's equivalence, implying that its mechanical performance characteristics are comparable to the predicate devices (SCS Claris Spinal System, Orthotec, Inc., and CD Horizon Sofamor Danek) which have already been cleared by the FDA. This equivalence in mechanical performance provides the scientific basis for demonstrating the device's safety and effectiveness for its intended use, as it suggests the device can withstand the physiological forces it will encounter in the body.
§ 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.