(49 days)
The Republic Spine Dark Star Spinal System is intended for posterior, non-cervical pedicle rigid fixation of the spine to provide immobilization 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 (T1-S1):
- · Degenerative Disc Disease (DDD);
- · Spondylolisthesis;
- · Trauma (i.e. fracture or dislocation);
- · Spinal stenosis;
- · Curvatures (i.e. scoliosis, kyphosis, and/or lordosis);
- · Tumor;
- · Pseudoarthrosis; and
- · Failed previous fusion
The Republic Spine Dark Star Spinal System is a multi-component posterior spinal fixation system which consists of pedicle screws, rods, locking spacers, and cross-linking mechanism. The system is contains non-sterile single use titanium alloy (Ti-6AI-4V ELI) implantable components that comply with ASTM F136. Various sizes of these implants are available. Instrumentation is available for the delivery and removal of the Republic Spine Dark Star Spinal System. The system allows the surgeon to build a spinal implant construct to stabilize and promote spinal fusion.
The provided document is a 510(k) premarket notification for the "Republic Spine Dark Star Spinal System," which is a spinal implant. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting new clinical studies to establish acceptance criteria for device performance as would be done for a novel device.
Therefore, the document does not contain information about acceptance criteria and a study proving the device meets those criteria in the traditional sense of a clinical trial for a new medical device. Instead, it relies on demonstrating that the modified device is substantially equivalent to a previously cleared predicate device based on non-clinical performance data and design similarities.
Here's a breakdown of why the requested information cannot be fully provided from this document:
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A table of acceptance criteria and the reported device performance:
The document does not explicitly state acceptance criteria for a new clinical study. Instead, it relies on previously tested performance of the predicate device against specific ASTM standards for mechanical strength. -
Sample sized used for the test set and the data provenance:
No clinical test set with human or animal subjects is mentioned for the subject device. The non-clinical performance data refers to testing done on the predicate device against engineering standards (ASTM F1717, ASTM F1798-97). Therefore, there is no sample size in terms of test subjects or data provenance from a new study. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as there is no clinical test set in the context of this 510(k) submission. -
Adjudication method for the test set:
This is not applicable for the same reason as above. -
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 entirely not applicable. The device is a spinal implant (pedicle screw system), not an AI-powered diagnostic tool. -
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 spinal implant, not an algorithm or AI system. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical performance data of the predicate device, the "ground truth" would be the engineering specifications and performance requirements outlined in the ASTM standards. -
The sample size for the training set:
Not applicable, as this device does not involve machine learning or AI models with training sets. -
How the ground truth for the training set was established:
Not applicable, for the same reason as above.
Summary based on the provided document:
The device (Republic Spine Dark Star Spinal System) is seeking 510(k) clearance, which means it aims to demonstrate substantial equivalence to a predicate device.
Key points from the document regarding "acceptance criteria" and "study":
- The document explicitly states: "Clinical performance data is not required to demonstrate substantial equivalence to the predicate."
- The "study" referenced is non-clinical performance data previously conducted on the predicate device (Republic Spine Dark Star Spinal System, K150283).
- These predicate tests were against established ASTM standards for mechanical strength:
- Static compression bending per ASTM F1717
- Static torsion per ASTM F1717
- Dynamic compression bending per ASTM F1717
- Torsional, Axial and Flexural Grip ASTM F1798-97
- The subject device (modified Republic Spine Dark Star Spinal System) did not undergo new performance testing because the modifications "do not introduce a new, worst-case compared to the predicate devices tested per the standards identified above."
- The conclusion is that the subject device's mechanical strength is "equivalent or better" than the predicate based on these prior tests.
In essence, the "acceptance criteria" were the performance requirements of the ASTM standards, and the "study" was the non-clinical testing of the predicate device against these standards. The subject device's modifications were deemed not to negatively impact this established performance.
§ 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.