(28 days)
The CorticaLINK Fusion System is intended for noncervical 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 of medical grade Titanium alloy (Ti6Al4V) that complies with ASTM F136 - Standard Specifications for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, Commercially Pure Grade4 Titanium (CP Ti) per ASTM F67 - Standard Specifications for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, R50400, R50500 & R50700) and Cobalt Chromium (CrCo) 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 LinkSPINE, Inc., as well as the instructions provided by the Autoclave manufacturer.
This document is a 510(k) premarket notification for a medical device called the "CorticaLINK Spinal Fusion Platform." It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing details of a study that proves the device meets specific acceptance criteria through a performance study.
Therefore, many of the requested sections about acceptance criteria, detailed study design, sample sizes, expert involvement, and ground truth establishment cannot be fully addressed from the provided text because these elements are not present in a 510(k) for a device like this, which relies on substantial equivalence to a previously cleared predicate.
Here's an attempt to answer the questions based only on the provided text, highlighting where information is absent:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or detailed performance metrics from a clinical study. Instead, it relies on demonstrating substantial equivalence to a predicate device. The "performance" assessment focuses on the modifications substantially meeting established criteria for the cleared parent device.
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance (Summary from text) |
|---|---|
| N/A (Not explicitly stated as quantitative acceptance criteria for a performance study) | "substantially meets the performance criteria established for the cleared parent device" |
| "The modified device is used to treat the same indications for use, utilizes the same scientific and operational principles, and is manufactured using the same manufacturing practices from identical materials as the parent device." |
2. Sample size used for the test set and the data provenance
The document describes a submission for demonstrating substantial equivalence, not a clinical trial with a "test set" of patients or data in the typical sense. Therefore:
- Sample size for test set: Not applicable (no test set of clinical data described).
- Data provenance: Not applicable (no specific clinical data provenance mentioned for a new study). The comparison is primarily based on device characteristics and the predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As there's no described clinical "test set" requiring ground truth establishment by experts for performance evaluation, this information is not provided. The submission focuses on engineering and material equivalence.
4. Adjudication method for the test set
Not applicable. There is no described test set of clinical cases or data requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or described in this document. This is a 510(k) for a spinal fusion platform, which typically demonstrates substantial equivalence through mechanical testing and comparison of design/materials, not through MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical implant (spinal fusion platform), not an algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm is not relevant.
7. The type of ground truth used
Not applicable. There is no described clinical study or algorithm where "ground truth" (e.g., pathology, outcomes data) would need to be established for performance evaluation. The "ground truth" in this context refers to the characteristics and performance of the predicate device to which the new device is being compared for substantial equivalence.
8. The sample size for the training set
Not applicable. This is a physical implant, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is a physical implant and does not involve AI/ML or a training set.
§ 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.