(257 days)
The LnK Posterior Cervical Fixation System is indicated for the following:
- DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- Spondylolisthesis
- Spinal stenosis
- Fracture/dislocation
- Failed previous fusion
- Tumors
The implants are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following the reduction of fractures/dislocations or trauma in the spine.
Hooks and rods are also intended to provide stabilization following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (CI-T3) spine.
The pedicle screws are limited to placement in T1-T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.
The LnK Posterior Cervical Fixation System is a top-loading, multiple component, posterior (cervical-thoracic) spinal fixation system which consists of polyscrew, Reduction poly screw, partially screw, semi-reduction partially screw, straight rod, curved rod, transitional rod, set screw and hooks that can be used via an open surgical approach.
This document is a 510(k) premarket notification for the "LnK Posterior Cervical Fixation System", seeking clearance for device modifications (adding sizes and additional components) rather than the introduction of a new AI/software-based medical device. Therefore, the questions related to AI performance, ground truth, expert adjudication, and training/test sets are not applicable to the content provided.
The document focuses on demonstrating substantial equivalence to a legally marketed predicate device (K120879) primarily through material and mechanical performance testing for spinal implants.
Here's an analysis of the available information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance | Study Protocol/Standard |
|---|---|---|
| Mechanical Performance | Demonstrated equivalent or superior performance to predicate device | Static compression bending testing per ASTM F1717 |
| Biocompatibility | Materials (Ti-6Al-4V ELI and CoCrMo alloy) meet recognized standards for implantable devices | Implicit through material specifications (ASTM F136, ASTM F1537) and substantial equivalence to predicate with the same materials. |
| Sterilization | Not explicitly detailed in the provided text, but assumed to meet standards for implantable medical devices. | Not explicitly detailed. |
| Labeling | Indications for Use are clearly stated and consistent with the predicate device. | Explicitly stated in the "Indications for Use" section. |
| Substantial Equivalence | Device is similar in design, material, and indications for use to the predicate device. | Comparison table and overall 510(k) submission. |
Study Proving Device Meets Acceptance Criteria:
The primary study cited to demonstrate the device's performance is Static Compression Bending Testing per ASTM F1717. This standard is used to evaluate the mechanical properties of metallic spinal implant constructs. While the specific numerical results of the testing (e.g., stiffness, yield strength, ultimate strength) are not provided in this summary, the document states:
"Static compression bending testing was performed per ASTM F1717."
And concludes:
"The LnK Posterior Cervical Fixation System is substantially equivalent to legally marketed predicates."
This implies that the results of the ASTM F1717 testing demonstrated performance comparable or superior to the predicate device, thus meeting the mechanical performance acceptance criteria for spinal fixation systems.
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as the study is a mechanical performance test on physical devices, not a study evaluating an AI algorithm with a test set of data. The "sample size" would refer to the number of physical implants tested. This information is not provided in the summary but would typically be detailed in the full test report.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not an AI/software device requiring expert ground truth for data.
4. Adjudication Method for the Test Set
Not applicable. This is not an AI/software device requiring expert adjudication.
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 is a physical spinal implant system, not an AI-assisted diagnostic or therapeutic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical spinal implant system, not a standalone algorithm.
7. The Type of Ground Truth Used
For the mechanical performance testing, the "ground truth" would be the established engineering standards and specifications outlined in ASTM F1717, which define acceptable mechanical properties for spinal implants. The physical measurements (e.g., load at failure, deflection) collected from the tested devices are compared against these engineering "truths."
8. The Sample Size for the Training Set
Not applicable. There is no training set as this is a physical medical device, not an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for a physical medical device.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.