(28 days)
The Xia® Spinal System is intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation 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.
The 6 mm diameter rods from the DIAPASON™ Spinal System and OPUS™ Spinal System are intended to be used with the other components of the Xia® Titanium Spinal System. The Titanium Multi-axial Cross Connectors are intended to be used with the other components of the Xia® Titanium Spinal System.
This submission is intended to address a line extension to Xia® Spinal System. The line extension includes the addition of Xia Stainless Steel Uni-Planar Screws.
This document, K080928, is a Special 510(k) Premarket Notification for a line extension to the Xia® Spinal System, specifically the addition of Stainless Steel Uni-Planar Screws. This type of submission generally focuses on demonstrating substantial equivalence to a predicate device through material, design, and functional equivalence, often relying heavily on mechanical testing rather than clinical study data.
Due to the nature of this submission (a line extension for a spinal fixation system, focusing on new uni-planar screws), the traditional "acceptance criteria" and "device performance" in terms of clinical accuracy (like in AI/diagnostic devices) are not directly applicable in the same way. Instead, acceptance criteria would relate to the mechanical properties and safety of the new components, proving they are comparable to or meet the standards of the predicate device. The "study" would be mechanical testing.
Here's an analysis based on your categories, adapted for this type of medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document explicitly states "Mechanical testing also demonstrated comparable mechanical properties to the predicate device." However, it does not provide specific quantitative acceptance criteria or detailed reported performance values (e.g., stiffness thresholds, fatigue limits, etc.) within the provided text. Such detailed results would typically be found in the full 510(k) submission, not necessarily in the public summary.
| Acceptance Criteria Category (Implied) | Reported Device Performance (as stated in summary) |
|---|---|
| Mechanical Properties Comparability | "demonstrated comparable mechanical properties to the predicate device" |
| Material Equivalence | "share the same ... material" as predicate device (Stainless Steel or Titanium) |
| Design Concepts Equivalence | "share the same ... basic design concepts as that of the predicate device" |
| Intended Use Equivalence | "share the same intended use" as the predicate device |
| Safety and Effectiveness Equivalence | Implied by "comparable mechanical properties" and "intended use" to predicate device |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided text. For mechanical testing of medical devices like spinal screws, "sample size" refers to the number of screws or constructs tested in various mechanical tests (e.g., static compression, fatigue). These are typically bench-top tests, not human subject tests.
- Data Provenance: The data would be generated from prospective bench-top laboratory mechanical testing conducted by the manufacturer (Stryker Spine). There is no mention of country of origin of data, as it's not a clinical study involving patients from specific geographical locations.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This question is not applicable in the context of this device and submission type. Ground truth, typically established by experts (like radiologists for imaging or pathologists for pathology), is relevant for diagnostic or AI-driven devices. For a spinal implant, the "ground truth" for mechanical performance is established by recognized material science and biomechanical engineering standards (e.g., ASTM, ISO standards) and comparison to the predicate device's established performance. The "experts" would be the biomechanical engineers and quality assurance personnel conducting and interpreting the mechanical tests. The document does not specify the number or qualifications of these internal experts.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies or expert consensus processes to resolve disagreements, particularly in diagnostic assessments. Mechanical testing involves objective measurements against predefined criteria or comparison to predicate device performance; there's no "adjudication" in this sense.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This question is not applicable. An MRMC study is relevant for diagnostic devices that involve human interpretation of images or other data, especially in the context of AI assistance. This submission is for a physical orthopedic implant (spinal screws), not a diagnostic or AI device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
For this type of device, the "ground truth" for mechanical testing is established by:
- Industry Standards: Adherence to recognized national and international testing standards for spinal implants (e.g., ASTM F1717 for Spinal Implant Constructs in a Vertebrectomy Model, ASTM F2077 for Mechanical Testing of Spinal Intervertebral Body Fusion Devices, or similar which ensure appropriate stress, fatigue, and torsional testing).
- Predicate Device Performance: The mechanical performance of the legally marketed predicate device (Xia® Spinal System) serves as the benchmark against which the new line extension components are compared. The "ground truth" is that the new device must perform at least as well as or comparably to the predicate device.
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" in the context of mechanical testing for a spinal implant. Training sets are used in machine learning for AI algorithms.
9. How the Ground Truth for the Training Set was Established
This question is not applicable for the same reasons as #8.
§ 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.