(83 days)
The Republic Spine Dark Star Spinal System is intended for posterior, non-cervical pedicle fixation of the spine 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 (T1-S1): · Severe Spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra
- · Degenerative spondylolisthesis with objective evidence of neurologic impairment
- · Trauma (i.e. fracture or dislocation)
- · Spinal stenosis
- · Curvature (i.e. scoliosis, kyphosis, and/or lordosis)
- Tumor
- · Pseudoarthrosis (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 contains non-sterile single use titanium alloy (Ti-6Al-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 a medical device called the "Republic Spine Dark Star Spinal System." This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria for a novel AI/software medical device.
Therefore, the information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment typically requested for an AI/software device is not applicable to this document.
However, I can extract the information that is present concerning the device's performance evaluation, which is focused on mechanical testing for substantial equivalence:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, etc., as would be expected for an AI/software device. Instead, it states that the device's mechanical strength was evaluated against established standards and found to be "equivalent or better" than the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical strength relative to predicate devices. | "Testing in accordance with ASTM 1717-13, ASTM F543-07, and ASTM F1798-97 shows the mechanical strength of the subject device to be equivalent or better than the predicate devices." |
| "All testing met or exceeded the requirements as established by the test protocols and applicable standards." | |
| "A review of the mechanical data indicates that the components of the Subject device are capable of withstanding expected loads without failure." | |
| Hazard evaluation and control through Risk Management Plan. | "The potential hazards have been evaluated and controlled through a Risk Management Plan." |
| Compliance with specified ASTM standards for mechanical testing. | "ASTM 1717 Static Compression Bending", "ASTM 1717 Dynamic Compression Bending", "ASTM 1717 Static Torsion", "ASTM F543-07: Static Torque to Failure", "ASTM F543-07: Axial Pullout", "ASTM F1798-97: Torsional, Axial and Flexural Grip" were all performed and met or exceeded requirements. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The testing described is mechanical, not involving human data or clinical study subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The "ground truth" for mechanical testing is derived from controlled laboratory conditions and adherence to ASTM standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this refers to a method for establishing clinical ground truth, which was not part of this submission.
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 device is a spinal implant system, not an AI/software medical device requiring human reader interaction or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical medical implant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the performance evaluation in this context refers to the specified requirements and methodologies outlined in the referenced ASTM standards (ASTM 1717-13, ASTM F543-07, and ASTM F1798-97). These standards define the acceptable mechanical properties and testing procedures for spinal implants.
8. The sample size for the training set
Not applicable. This device undergoes mechanical testing, not machine learning model training.
9. How the ground truth for the training set was established
Not applicable. This device undergoes mechanical testing, not machine learning model training.
§ 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.