(57 days)
The LOCK-IN Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications: 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; pseudarthrosis; and/or failed previous fusion.
The LOCK-IN Spinal Fixation System is intended to be used with autograft and/or allograft.
The LOCK-IN Spinal Fixation System is a spinal pedicle fixation system consisting of polyaxial pedicle screws (expandable and non-expandable; cannulated and non-cannulated), rods (straight and curved), rod lockers, and crosslinks. All components are manufactured from Ti-6Al-4V ELI titanium alloy. All screws are available with either standard or spondylolisthesis head configurations. Fixation is provided via a posterior approach.
The LOCK-IN Spinal Fixation System expandable pedicle screws increase screw pullout strength when compared to similarly sized conventional screws. These screws are recommended for cases when increased fixation strength is desired.
The LOCK-IN Spinal Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion in the non-cervical spine, including the thoracic, lumbar and/or sacral spine (T1- S5). The LOCK-IN Spinal Fixation System consists of a variety of shapes and sizes of rods, screws, cross connectors that provide internal fixation and stabilization during bone graft healing and /or fusion mass development.
This document pertains to the clearance of a mechanical spinal fixation system, not an AI/software-based medical device. Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment, which are typical for AI/ML device evaluations, is not applicable or present in this context.
Specifically, the document describes the LOCK-IN Spinal Fixation System, which is a physical device composed of pedicle screws, rods, rod lockers, and crosslinks made from titanium alloy. The performance testing detailed focuses on the mechanical properties of these components (e.g., pull-out strength, bending, torsion), not on a software algorithm's diagnostic or predictive capabilities.
Therefore, I cannot provide details such as:
- Table of acceptance criteria and reported device performance (for an AI/software device): The Acceptance Criteria section applies to the mechanical properties of the device, not the AI/software performance.
- Sample size for test set and data provenance: No software "test set" in the AI/ML sense is mentioned.
- Number of experts and qualifications: Experts are not mentioned in the context of establishing ground truth for an AI algorithm.
- Adjudication method for test set: Not applicable to a mechanical device.
- MRMC comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: Not applicable to an AI algorithm. The "ground truth" for this device would relate to its mechanical integrity and biological compatibility, demonstrated through physical testing and material science, not clinical consensus from images.
- Sample size for training set: Not applicable for a mechanical device.
- How ground truth for training set was established: Not applicable.
The document states:
- "Non-clinical testing was performed to demonstrate the LOCK-IN Spinal Fixation System is substantially equivalent to the listed predicate devices in accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", issued May 3, 2004." This indicates the evaluation was based on engineering and biomechanical testing demonstrating equivalence to already cleared devices, rather than a clinical study involving human readers or AI performance metrics.
- The tests performed are primarily ASTM (American Society for Testing and Materials) standards like F543 (Pedicle Screw Pull-Out, Driving Torque, Torsional Testing), F1717 (Static/Compressive Bending and Torsional Testing), F2193 (Static and Dynamic Cantilever Bending Testing), and F1798 (Tulip Disassociation Testing). These are all mechanical and material property tests for physical implants.
- "Expandable Screw Cadaver Pullout Comparative Performance Study" is mentioned, which is a biomechanical study, not a study of AI performance.
In summary, the provided text describes the clearance of a Class II mechanical spinal implant, not an AI/ML-driven device. As such, the requested information about AI acceptance criteria and study methodologies is not present in the document.
§ 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.