(168 days)
The Conklusion Pedicle Screw System, including hooks, is 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 instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to S1) with removal of the implants after the attainment of a solid fusion.
The ConKlusion Pedicle Screw System is a spinal system that consists of a variety of hooks, screws, rods, connectors, and associated instruments. Fixation is provided by bone (pedicular) screws inserted into the vertebral body of the spine using posterior approach.
The provided text describes a 510(k) premarket notification for the ConKlusion Pedicle Screw System. The acceptance criteria and the study proving the device meets them are focused on mechanical and functional safety for an orthopedic implant, rather than the performance of an AI or diagnostic device.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Type) | Standard Met | Reported Device Performance |
|---|---|---|
| Static Compression Bending | ASTM F1717 | Performed as designed and met, or exceeded, product specifications. |
| Static Tensile Bending | ASTM F1717 | Performed as designed and met, or exceeded, product specifications. |
| Static Torsion | ASTM F1717 | Performed as designed and met, or exceeded, product specifications. |
| Dynamic Compression Bending Fatigue | ASTM F1717 | Performed as designed and met, or exceeded, product specifications. |
Note: The text indicates that "All testing was conducted in accordance with ASTM F1717." While it states the device met or exceeded "all product specifications," the specific quantitative acceptance thresholds for each test (e.g., minimum load to failure, maximum deflection, number of cycles survived) are not detailed in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The sample size for each functional and mechanical test (compression bending, tensile bending, torsion, and compression bending fatigue) is not specified in the provided document. The document only states "Functional and Mechanical testing of the subject device consisted of three static mechanical tests and one dynamic test to evaluate the spinal implant assemblies."
- Data Provenance: The data provenance is implied to be from the manufacturer's internal testing as part of their 510(k) submission. No country of origin for the data is explicitly mentioned, but the submitter is SIGNUS Medical, LLC, based in Chanhassen, MN, USA, and the FDA is the reviewing body, suggesting a US-based context for the testing. The testing is retrospective in the sense that it was completed prior to the submission for market clearance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This question is not applicable to this type of device and study. The "ground truth" for mechanical testing is established by the specifications and standards (ASTM F1717) and the physical measurements of the device's performance under stress, pressure, and fatigue, not by expert human interpretation.
4. Adjudication Method
- This question is not applicable to this type of device and study. Adjudication methods like 2+1 or 3+1 typically apply to studies where human interpretation (e.g., medical imaging reads) requires consensus or tie-breaking mechanisms. In mechanical testing, results are objectively measured against predefined engineering specifications.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. This type of study assesses the performance of human readers, sometimes with and without AI assistance, on a set of cases. The ConKlusion Pedicle Screw System is a physical orthopedic implant, and its performance is evaluated through mechanical testing, not through human reader interpretation of cases.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This question pertains to AI algorithms. The device described is a physical pedicle screw system, not an algorithm. Its "standalone performance" refers to its mechanical integrity and function as tested in a lab.
7. The Type of Ground Truth Used
- The ground truth used for the device's performance evaluation is based on defined engineering specifications and compliance with recognized industry standards (ASTM F1717). These standards dictate specific test parameters and success criteria for spinal implant assemblies. The "ground truth" is that the device must meet or exceed these physical, measurable requirements.
8. The Sample Size for the Training Set
- This question is not applicable as the described study is for a physical medical device and its mechanical properties, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this type of device and study.
§ 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.