(103 days)
The Stryker Spine XIA® III 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®III 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 Ø5.5mm 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® III Spinal System.
The Stryker Spine Xia® III Spinal System is comprised of monoaxial & polyaxial bone screws, blocker (as a locking mechanism), rods, hooks, and connectors. The implants are manufactured from Ti6Al4V alloy, and CPTi. The subject system also offers MoCoCr alloy (Vitallium) rods.
The Stryker Spine Xia® III Spinal System is a spinal fixation system. The provided text indicates that its performance was assessed through testing in compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004. This testing demonstrated substantial equivalent performance characteristics to the predicate device systems.
However, the provided document does not contain detailed information regarding specific acceptance criteria, reported device performance metrics, sample sizes, data provenance, expert ground truth establishment, adjudication methods, or specific study types (MRMC or standalone AI studies).
Therefore, I can only provide the information that is explicitly stated or can be inferred from the text.
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of acceptance criteria with numerical values or detailed reported device performance. It generally states:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device systems based on FDA Guidance for Spinal System 510(k)'s May 3, 2004. | Demonstrated substantial equivalent performance characteristics. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document.
3. 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 provided in the document. It's important to note that this is a spinal implant, and "ground truth" may not be established by medical experts in the same way it would be for an AI diagnostic device. Instead, performance is typically assessed through mechanical and biocompatibility testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done, nor would it be applicable for this type of medical device (a spinal implant). MRMC studies are typically performed for diagnostic imaging devices where human interpretation is involved, often with AI assistance. This device is an implant for surgical use.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a spinal implant, not an algorithm or AI system. Its performance is assessed through various engineering and biocompatibility tests, not algorithmic output.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Given that this is a spinal implant, the "ground truth" for its performance would likely be based on engineering standards, materials testing results (e.g., strength, fatigue, biocompatibility), and potentially pre-clinical data on mechanical stability and integration. The document mentions "testing in compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004," which would involve these types of evaluations. Expert consensus, pathology, or outcomes data are not explicitly mentioned as the primary ground truth for its performance in this 510(k) summary for substantial equivalence.
8. The sample size for the training set
This information is not provided and is not applicable as this is not an AI or machine learning device requiring a training set.
9. How the ground truth for the training set was established
This information is not provided and is not applicable as this is not an AI or machine learning device requiring a training set.
§ 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.