(43 days)
Xpine Spinal Fixation System is 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:
- · 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
- · failed previous fusion
The Xpine Spinal Fixation System, Internal Fixation Device for Spinal Surgery, is comprised of: Pedicle Screw, Set Screw. Rod. and Cross Link. Various forms and sizes of these implants are available to consider the unique pathology of individual patients for purposes of stabilization, or corrective action through the application of force. Components are made of Ti6Al4V ELI, a titanium-based alloy, which complies with ASTM F136.
I am sorry, but the provided text does not contain the information needed to answer your request. The document is a 510(k) premarket notification for a medical device called the "Xpine Spinal Fixation System," which is a Thoracolumbosacral Pedicle Screw System.
This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through:
- Indications for Use Comparison: Showing that the new device has similar intended uses.
- Technological Comparison: Demonstrating that the materials, design, and other technological characteristics are substantially similar and do not raise new questions of safety or effectiveness.
- Bench Testing: Performing mechanical tests to ensure the device meets relevant ASTM standards and performs comparably to the predicate device.
The document explicitly states: "Clinical data is not applicable." This means there was no clinical study, human-in-the-loop study, or a study involving human readers and AI assistance performed for this device as part of this 510(k) submission.
Therefore, I cannot provide details on:
- Acceptance criteria and reported device performance (in the context of AI/diagnostic accuracy). The acceptance criteria mentioned refer to mechanical bench test results (e.g., meeting or exceeding values from reference literature for spinal implant constructs), not diagnostic performance metrics like sensitivity or specificity.
- Sample size, data provenance, ground truth establishment, or expert involvement for a diagnostic test set.
- Adjudication method.
- MRMC study and effect size.
- Standalone (algorithm-only) performance.
- Type of ground truth (beyond mechanical test standards).
- Training set sample size or ground truth establishment for a training set.
The document is about a mechanical spinal fixation system, not a diagnostic AI/software device.
§ 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.