(25 days)
The CorticaLINK Spinal Fusion Platform is intended for non-cervical pedicle fixation as an adjunct to fusion for the following acute and chronic instabilities or deformities for the T1-S1 vertebrae in skeletally mature patients:
· degenerative disc disease (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
- · curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- tumor
- · pseudoarthrosis
- · and failed previous fusion
The CorticaLINK Spinal Fusion Platform is a comprehensive suite of fixation implants which can be used to stabilize the spine as an adjunct to fusion following surgical decompression. The platform is comprised of screws, rods and locking caps, with the screws being offered in several different lengths, diameters, and thread pitches to accommodate varying anatomies, pathologies, and surgeon preferences.
The systems components are manufactured using standard manufacturing processes. The tulips, screw shafts, and one family of rods are of medical grade Titanium alloy (Ti6Al4V) that complies with ASTM F136 - Standard Specifications for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Allov for Surgical Implant Applications. The push plate is of Commercially Pure Grade4 Titanium (CP Ti) per ASTM F67 - Standard Specifications for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, R50400, R50500 & R50700). The other family of rods are of Cobalt Chromium (CoCr) per ASTM F75 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075).
The implant components are provided clean and non-sterile. These devices are supplied in a rigid sterilization tray and are to be sterilized by a healthcare professional using a Steam Autoclave in accordance with the instructions for use provided by Spine Smith Holdings. LLC, as well as the instructions provided by the Autoclave manufacturer.
The provided text is a 510(k) summary for the CorticaLINK Spinal Fusion Platform, a medical device for spinal fixation. It describes the device's intended use, materials, and equivalence to a predicate device. However, it does not contain information regarding the acceptance criteria, specific device performance metrics, or study details (like sample size, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies) typically associated with software or AI device clearances.
The document primarily discusses mechanical performance testing against a predicate device, as per ASTM F1717, which is standard for orthopedic implants.
Therefore, many of the requested categories cannot be populated from the provided text.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Not Explicitly Stated for the Device) | Reported Device Performance |
|---|---|
| Implicit: Substantial equivalence in mechanical performance to predicate device per ASTM F1717 for static and dynamic compression bending and static torsion. | The worst-case subject device was tested according to ASTM F1717 in static and dynamic compression bending as well as static torsion. Results demonstrate substantially equivalent mechanical performance as compared to the predicate(s). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not specified. The document refers to "the worst-case subject device" being tested, implying a single or limited number of devices for mechanical testing, not a data sample.
- Data Provenance: Not applicable, as this refers to mechanical testing of physical orthopedic implants, not data analysis for software/AI.
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. Ground truth and expert review are typically associated with performance studies for diagnostic or AI-driven devices, not mechanical testing of implants.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This refers to adjudication of expert opinions for ground truth establishment, which is not relevant to mechanical testing.
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
- No, an MRMC study was not done. This device is an orthopedic implant, not an AI or diagnostic tool that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an orthopedic implant, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. For mechanical testing, the "ground truth" is defined by the physical properties and performance benchmarks specified in the ASTM standard.
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" as it is not a machine learning or AI-driven device.
9. How the ground truth for the training set was established
- Not applicable. This device does not involve a "training set."
Summary of the Study that Proves the Device Meets the Acceptance Criteria:
The device's acceptability is proven through performance testing conducted in accordance with ASTM F1717. This standard evaluates the mechanical performance of spinal implant systems. The testing included static and dynamic compression bending, as well as static torsion. The conclusion states that "Results of the testing demonstrate substantially equivalent mechanical performance as compared to the predicate(s)." This means the CorticaLINK Spinal Fusion Platform met the implicit acceptance criterion of performing mechanically equivalently to legally marketed predicate devices.
§ 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.