(149 days)
LnK Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation system T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use: degenerative dis disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); deformities or curvatures (i.e., scoliosis, kyphosis); tumor, stenosis; and failed previous fusion (pseudoarthrosis).
The LnK Spinal Fixation System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 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 sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the LnK Spinal Fixation System is intended 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 spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
This system is comprised of screws, set screws, rods, crosslink, Hook and connectors. The components of this system are manufactured by Titanium alloy (Titanium-6Aluminum-4Vanadium ELI, per ASTM F136) and CoCrMo alloy (Cobalt-28Chromium-6Molybdenum, per ASTM F1537). The screws are available from 4.0 to 8.5mm diameters with lengths ranging from 20-150mm. The purpose of this submission is to add Hooks to this system.
The provided document describes a 510(k) premarket notification for the "Lnk Spinal Fixation System" and focuses on demonstrating its substantial equivalence to predicate devices, rather than a study on a new AI/software device that requires acceptance criteria and performance data in the typical sense of a diagnostic or assistive AI.
The "acceptance criteria" and "device performance" in this context refer to the mechanical and material properties of the spinal fixation system, compared against established standards and predicate devices.
Here's the information extracted and interpreted based on the content:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Bench Test Standard) | Reported Device Performance (L&K Spinal Fixation System) |
|---|---|
| Static Compression Bending (ASTM F1717-10) | Performs equivalently to predicates |
| Static Tension | Performs equivalently to predicates |
| Static Torsion | Performs equivalently to predicates |
| Dynamic Compression Bending (ASTM F1717-10) | Performs equivalently to predicates |
| Gripping-Push Down (ASTM F1798) | Performs equivalently to predicates |
| Material Composition | Titanium alloy (ASTM F136) and CoCrMo alloy (ASTM F1537) |
| Sterility | Non-sterile |
2. Sample sized used for the test set and the data provenance
The document does not specify the exact sample sizes (number of fixation devices tested) for each bench test. The provenance is "Bench testing," meaning laboratory-controlled mechanical tests, not human or patient data. Details on the specific lab or country of origin for these tests are not provided, other than the manufacturer being based in the Republic of Korea. These are non-clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a mechanical device, and "ground truth" is established by adherence to ASTM standards and comparison to predicate devices, not by expert consensus on clinical data.
4. Adjudication method for the test set
Not applicable, as this involves mechanical bench testing against established standards, not human expert adjudication of clinical outcomes or interpretations.
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 spinal fixation system, not an AI/software device, and therefore no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a spinal fixation system, not an AI/software device.
7. The type of ground truth used
The "ground truth" for the performance claims is defined by established ASTM standards for spinal implant testing (e.g., ASTM F1717-10, ASTM F1798) and the performance characteristics of legally marketed predicate devices. The goal is to demonstrate "substantial equivalence" in mechanical performance.
8. The sample size for the training set
Not applicable. This is not an AI/software device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/software device that requires a training set or its associated ground truth establishment.
Summary of the Study:
The study described is a non-clinical bench testing study designed to demonstrate the mechanical and material substantial equivalence of the "Lnk Spinal Fixation System" to predicate devices. The study involved subjecting the device components (screws, rods, hooks, connectors) to various mechanical tests, including static compression bending, static tension, static torsion, dynamic compression bending, and gripping-push down, in accordance with recognized ASTM standards (F1717-10 and F1798). The performance was then compared to that of the predicate devices. The conclusion was that the Lnk Spinal Fixation System performs equivalently to the predicates, sharing similar design, materials, and performance characteristics, thus supporting its substantial equivalence for the stated indications for use. No clinical data or AI performance studies were involved or required for this 510(k) submission.
§ 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.