(70 days)
The COLONNADE Posterior Screw Fixation System is intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and/or allograft for the following indications: degenerative disc disease (DDD) (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. Fenestrated screws are not intended for use with cement.
The COLONNADE Posterior Screw Fixation System pedicle screw is an internal fixation device for spinal surgery. Various forms and sizes of these implants are available so that constructions can be utilized to account for the unique pathology and anatomy of each patient. The subject pedicle screws and set screw of COLONNADE Posterior Screw Fixation System are manufactured from Ti-6Al-4V ELI as per ASTM F136, and are anodized The subject rods are manufactured from Ti-6Al-4V ELI as per ASTM F136 and Co-28Cr-6Mo as per ASTM F1537.
This document, an FDA 510(k) clearance letter for the "COLONNADE Posterior Screw Fixation System," details the regulatory approval of a medical device intended for spinal surgery. However, it does not contain information about a study proving that an AI/software device meets acceptance criteria.
The 510(k) letter explicitly states, "Clinical Testing: Not Applicable" in the "Non-Clinical and/or Clinical Tests Summary & Conclusions" section on page 6. This indicates that no human clinical study was performed to assess the device's performance in a clinical setting against acceptance criteria for diagnostic or AI-driven tasks.
Instead, the provided text emphasizes the substantial equivalence of the "COLONNADE Posterior Screw Fixation System" to predicate devices based on:
- Identical Indications for Use: The intended applications of the new device are the same as previously cleared devices.
- Similar Technological Characteristics: The design, materials (Ti-6Al-4V ELI, Co-28Cr-6Mo), function, and fundamental technologies are comparable to predicates, with only "slight differences between the length and diameter of screws, and rod length."
- Non-Clinical Testing: Performance was evaluated through mechanical testing standards (ASTM F1717) related to spinal implant constructs (Static Compression Bending, Static Torsion, Dynamic Compression Bending).
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/software device meets them, as this information is not present in the provided FDA 510(k) clearance letter.
The letter pertains to a hardware device (a spinal fixation system), not a software or AI device for which performance metrics like those typically associated with diagnostic AI (e.g., sensitivity, specificity, AUC, human reader improvement) would be established and tested in a clinical trial.
§ 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.