(238 days)
The Republic Spine Dark Deformity Pedicle Screw System is intended for posterior, non-cervical pedicle 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:
- Degenerative Disc Disease (DDD) (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
- Curvature (i.e. scoliosis, kyphosis, and/or lordosis)
- Tumor
- Pseudoarthrosis
- . Failed previous fusion
When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Dark Star Deformity Pedicle Screw System implants are indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Dark Star Deformity Pedicle Screw System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/ or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The Republic Spine Dark Star Deformity Pedicle Screw System (previously cleared as Dark Star Spinal System) is a multi-component posterior spinal fixation system which consists of pedicle screws, set screws, rods, hooks, connectors, and crosslinks. The system contains non-sterile single use components manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) and Cobalt Chromium (CoCr per ASTM F1537). Various sizes of these implants are available. Instrumentation is available for the delivery and removal of the Republic Spine Dark Star Deformity Pedicle Screw System. The system allows the surgeon to build a spinal implant construct to stabilize and promote spinal fusion.
The scope of the Republic Spine Dark Star Deformity Pedicle Screw System is being extended with this submission via a line extension to offer new implant options including connectors, prebent rods, crosslinks, and hooks and to offer implant design modifications to the uniplanar screws, to the connectors, and to the hooks. New instrumentation will also be introduced to aid in the implantation of the new and existing implants. The indications for use are being expanded to include pediatric applications.
This document does not describe an AI/ML medical device, therefore the requested information for AI/ML performance acceptance criteria and study data is not available. This document is a 510(k) premarket notification for a medical device called the "Dark Star Deformity Pedicle Screw System," which is a spinal implant system.
Instead, the document focuses on the mechanical performance (verification testing) of the spinal implant system to demonstrate its substantial equivalence to a predicate device.
Here's a breakdown of the performance data presented, related to the physical device:
1. Acceptance Criteria and Reported Device Performance (Implied from the study):
The document doesn't explicitly state "acceptance criteria" in a table format with specific numerical targets. However, the performance data section indicates that the device was subjected to specific ASTM standards, and the conclusion states that the device is "substantially equivalent" to the predicate device based on this data. This implies that the device's performance results met the thresholds or comparable performance to the predicate device as defined by these ASTM standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance according to ASTM F1717 for Static Axial Compression Bending | Subjected to testing, leading to substantial equivalence conclusion with predicate devices |
| Performance according to ASTM F1717 for Dynamic Axial Compression Bending | Subjected to testing, leading to substantial equivalence conclusion with predicate devices |
| Performance according to ASTM F1717 for Static Torsion | Subjected to testing, leading to substantial equivalence conclusion with predicate devices |
| Performance according to ASTM F1798 for Axial Grip | Subjected to testing, leading to substantial equivalence conclusion with predicate devices |
| Performance according to ASTM F1798 for Torsion Grip | Subjected to testing, leading to substantial equivalence conclusion with predicate devices |
2. Sample Size and Data Provenance for Test Set:
- This is not applicable as the study involves mechanical testing of physical device components, not a "test set" of clinical data for an AI/ML model. The "samples" would be the physical implants tested under laboratory conditions. The document does not specify the number of implants used for each test.
- Data Provenance: The tests are conducted in a laboratory setting, not with human patient data or from a specific country of origin in the context of clinical data.
3. Number of Experts and Qualifications for Ground Truth:
- This is not applicable to a mechanical testing study of a physical device. Ground truth, in the AI/ML context, refers to a verified label or outcome for a data point, typically established by human experts.
4. Adjudication Method:
- Not applicable for mechanical testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not applicable. This is a study on the mechanical properties of a physical medical device, not on the performance of human readers with or without AI assistance.
6. Standalone Performance Study:
- The "performance data" section (ASTM tests) can be considered a standalone performance study for the mechanical properties of the device components. It assesses the device's ability to withstand various forces and stresses independently. However, this is for the physical device, not an algorithm.
7. Type of Ground Truth Used:
- For mechanical testing, the "ground truth" is implicitly the physical properties and behavior of the materials and design under controlled laboratory conditions, as measured against established scientific and engineering standards (ASTM). The "truth" is the physical reality of how the device performs under specific loads, rather than a clinical label or outcome.
8. Sample Size for Training Set:
- Not applicable as this is not an AI/ML device.
9. How Ground Truth for Training Set was Established:
- Not applicable as this is not an AI/ML device.
§ 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.