(54 days)
The Stryker Spine XIA 3 Spinal System is intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation system, the XIA 3 Spinal System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
- 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 Ø5.5 mm titanium and Vitallium rods from the Stryker Spine Radius® Spinal System and Ø6.0 mm Vitallium rods from XIA Spinal System are intended to be used with the other components of XIA® 3 Spinal System.
This 510(k) is intended to introduce an extension to the existing Xia 3 Spinal System. The proposed line extension includes the addition of titanium Uniplanar Screws, titanium Uniplanar Reduction Screws, and use of the Stryker Spine Radius Ø5.5 mm Vitallium® rod with the Xia® 3 Spinal System.
The provided text is for a Special 510(k) Premarket Notification for a spinal system (Xia 3 Spinal System – Line Extension), which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through engineering analysis and performance testing for mechanical properties and biocompatibility, not clinical studies or AI/software performance evaluations.
Therefore, the specific information requested in your prompt (acceptance criteria for a device's performance often related to AI/software, sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance, etc.) is not typically applicable or found in this type of 510(k) submission for a physical medical implant.
The document does state:
- Study performed: "Engineering analysis and testing to demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 were completed for the Stryker Spine Xia 3 Spinal System."
However, it does not provide the specific details about:
- Acceptance criteria and reported device performance (in a table): The document only generally states that testing was completed for compliance.
- Sample sizes used for the test set and data provenance: Not applicable, as this refers to engineering tests, not a clinical data test set.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable.
- Adjudication method for the test set: Not applicable.
- MRMC comparative effectiveness study or effect size of AI improvement: Not applicable, as this is a physical implant, not an AI-assisted diagnostic tool.
- Standalone (algorithm-only) performance: Not applicable.
- Type of ground truth used: Not applicable in the context of clinical expert consensus. For engineering testing, the "ground truth" would be established mechanical properties or design specifications.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document describes a "line extension" for an existing spinal fixation system. The "study" mentioned refers to engineering tests and analysis to ensure the new components meet established mechanical and material safety standards as per FDA guidance for spinal systems. It does not involve performance evaluation in the context of AI or diagnostic accuracy, which is what most of your questions pertain to.
§ 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.