(39 days)
The Xia® Spinal System and Xia® 4.5 Spinal System are 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, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The 6 mm diameter rods from the DIAPASONTM 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.
The Stryker Spine Xia Spinal System consists of Ø6mm rods, Monoaxial and Polyaxial screws, Hooks, Blockers, and Monoaxial and Polyaxial Cross Connectors. The Xia® 4.5 Spinal System is comprised of Ø 4.5 mm rods, Polyaxial and Monoaxial bone screws, Blockers, Hooks, Dual Staples, and Connectors. The components of both systems are available in a variety of diameters and lengths in order to accommodate patient anatomy and are fabricated from titanium alloy. The implants are provided non-sterile and are used for either posterior or anterior/anteral non-cervical spinal fixation.
This submission is intended to address a line extension to both the Xia® Titanium and Xia® 4.5 Spinal Systems (K060361). The line extension for the Xia® Titanium Spinal System includes:
- . A new Ø6mm spinal rod fabricated from Cobalt-Chromium-Molybdenum Alloy (Vitallium®).
The line extension for the Xia® 4.5 Spinal System includes: - New Ø4mm monoaxial titanium alloy screw in lengths of 20mm to 40mm in five 미 millimeter increments,
- 트 New Ø4mm polyaxial titanium alloy screw in lengths of 20mm to 40mm in five millimeter increments, and
- New Ø 4.5mm spinal rod fabricated from Cobalt-Chromium-Molybdenum Alloy . (Vitallium®).
The provided text describes a 510(k) submission for a line extension to the Xia® Titanium Spinal System and Xia® 4.5 Spinal System. It does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of typical AI/ML device performance studies (e.g., sensitivity, specificity, AUC, etc.).
Instead, this submission is for a medical device (spinal system components), and the "study" mentioned refers to mechanical testing to demonstrate comparable mechanical properties to predicate devices. The acceptance criteria for such a device would typically involve satisfying specific mechanical and material properties as stipulated by relevant ISO standards or FDA guidance for spinal implants.
Based on the provided text, here's what can be extracted:
- A table of acceptance criteria and the reported device performance:
The document states: "Mechanical testing also demonstrated comparable mechanical properties to the predicate devices." This implies that the acceptance criterion was "comparable mechanical properties" to the predicate devices, and the reported performance was that this comparison was met. However, no specific quantitative criteria (e.g., minimum bending strength, fatigue life, etc.) or specific performance values are provided in this summary.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Comparable mechanical properties to predicate devices | Mechanical testing demonstrated comparable mechanical properties. |
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not available in the provided text. Mechanical testing typically involves material samples or prototypes, not patient-derived data. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This information is not applicable and not available in the provided text. "Ground truth" in the context of this device's mechanical testing refers to established engineering standards and material science principles, not expert clinical interpretation. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable and not available in the provided text, as it pertains to clinical data adjudication, not mechanical testing. -
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 information is not applicable and not available in the provided text. This device is a physical spinal implant, not an AI/ML-assisted diagnostic or therapeutic tool. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable and not available in the provided text. This device is a physical spinal implant, not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For mechanical testing, the "ground truth" is typically defined by established engineering standards and material specifications for spinal implants. The submission implies that the mechanical properties of the new components were compared against those of the predicate devices, which are presumed to meet such standards. -
The sample size for the training set:
This information is not applicable and not available in the provided text. "Training set" is relevant for AI/ML models, not for mechanical testing of physical implants. -
How the ground truth for the training set was established:
This information is not applicable and not available in the provided text. See point 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.