(253 days)
The AccelFix Spinal Fixation System is intended for use as a posterior pedicle screw system (T1-S2/ilium), or as an anterolateral fixation system (T8-L5), to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc 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).
AccelFix Spinal Fixation System consists of screws, rods, crosslinks, set screws, connectors and hooks. The components of this system are manufactured of Titanium Alloy (Titanium-6Aluminum-4Vanadium ELI, per ASTM F136) or CoCrMo alloy (Cobalt-28Chromium-6Molybdenum, per ASTM F1537). The AccelFix Spinal Fixation System is comprised of five different groupings; AccelFix-S, AccelFix-DS, AccelFix-SS, AccelFix-MIS, and Accessory.
The provided text is a 510(k) summary for the "AccelFix Spinal Fixation System," a medical device. It focuses on demonstrating substantial equivalence to existing predicate devices, primarily through mechanical and material performance testing, not through clinical or AI-driven diagnostic accuracy studies.
Therefore, the information required to answer your prompt about AI device acceptance criteria, study design, expert ground truth, etc., is not present in this document. This typically applies to devices like AI-powered diagnostic software, not spinal implants.
The document describes:
- Device Type: A spinal fixation system (pedicle screws, rods, etc.).
- Indications for Use: Stabilization of spinal segments, fixation for various spinal conditions.
- Materials: Titanium Alloy and CoCrMo alloy.
- Performance Data: Lists ASTM standards for various mechanical tests (static compression, torsion, fatigue, cantilever, pullout, axial grip force).
- Conclusion: The device is substantially equivalent to predicates based on similar design, materials, performance characteristics, and intended use.
In summary, this document does not contain any information about:
- Acceptance criteria for an AI-driven or diagnostic device.
- "Reported device performance" in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC).
- Sample sizes for AI test sets.
- Data provenance for clinical imagery.
- Number/qualifications of experts for ground truth.
- Adjudication methods.
- MRMC studies or human reader improvement with AI.
- Standalone algorithm performance.
- Types of ground truth (beyond mechanical testing per ASTM standards).
- Training set details for an AI model.
The "study" mentioned refers to engineering and biocompatibility testing required for a mechanical orthopedic implant, not a clinical trial for an AI diagnostic tool.
§ 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.