(90 days)
The uCentum™ comprehensive posterior system is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and sacral spine (T1-S2). When used as a posterior spine thoracic/lumbar system, the uCentum is intended for the following indications: degenerative disc disease (as defined by back pain of discogenic with degeneration of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., degenerative scoliosis, kyphosis, and/or lordosis), fracture, spinal tumor, pseudarthrosis and failed previous fusion.
The uCentum™ comprehensive posterior system consists of rods, polyaxial pedicle screws and crosslinks with locking set screws. The components are available in various sizes to accommodate differing patient anatomy. Rods are available straight and curved in a variety of lengths. Polyaxial screws are available in a variety of diameterlength combinations. Crosslinks are offered in five lengths. The system can be implanted in open or minimally invasive procedures. The uCentum™ system components are manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136.
Here's an analysis of the provided text regarding the acceptance criteria and study for the uCentum™ comprehensive posterior system:
The provided text is a 510(k) summary for a medical device (spinal system). It outlines the rationale for substantial equivalence to predicate devices, primarily based on design and mechanical performance, rather than clinical performance data with specific acceptance criteria that would typically be seen in a study evaluating diagnostic accuracy or a new therapeutic efficacy.
Therefore, there isn't a traditional "study" in the sense of a clinical trial with human subjects proving performance against specific acceptance criteria for diagnostic accuracy or clinical outcomes. Instead, the "study" referred to is a mechanical testing comparison to establish substantial equivalence.
Here's the breakdown of the requested information based on the provided document:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Substantially equivalent to predicate devices based on ASTM F1717 for |
- Static compression bending
- Dynamic compression bending
- Static torsion | The mechanical test results demonstrated that uCentum™ performance is substantially equivalent to the predicate devices. |
Study Details
-
Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable in the context of a human test set. The "test set" refers to the mechanical constructs of the uCentum™ system. The document does not specify the number of constructs tested, only that "worst case uCentum™ constructs" were included.
- Data Provenance: Not applicable in the context of human data. The data is generated from laboratory mechanical testing.
-
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. The "ground truth" for mechanical testing is based on established engineering principles and standards (ASTM F1717), not expert human interpretation.
-
Adjudication Method for the Test Set:
- Not applicable. Adjudication is typically used for human-reviewed data, not mechanical test results.
-
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. An MRMC study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not pertinent to the mechanical testing of a spinal implant.
-
If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical implant, not an algorithm.
-
The Type of Ground Truth Used:
- The "ground truth" for the mechanical performance comparison is the established performance characteristics of the predicate devices as defined by ASTM F1717 testing. The uCentum™ system is compared against these benchmarks to demonstrate substantial equivalence.
-
The Sample Size for the Training Set:
- Not applicable. There is no "training set" in the context of mechanical testing for substantial equivalence of a physical device. This concept is typically associated with machine learning algorithms.
-
How the Ground Truth for the Training Set was Established:
- Not applicable, as no training set was used.
§ 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.