(28 days)
The Xia Stainless Steel 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, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
This 510(k) is intended to introduce a new Stainless Steel material grade for the previously cleared Xia long arm Monoaxial and Polyaxial screws (K061854). The Xia® Stainless Steel 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 provided document, K063428, is a Special 510(k) Premarket Notification for a device modification to the Xia® Stainless Steel Spinal System. It focuses on changing the material grade of previously cleared Xia long arm monoaxial and polyaxial screws. As such, the document primarily addresses substantial equivalence based on material, design, and intended use, rather than presenting a clinical study with acceptance criteria for device performance in the way a diagnostic AI device would.
Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance are not applicable or cannot be extracted from this type of regulatory submission. This document describes a modification to an existing device, and the demonstration of substantial equivalence relies on engineering analysis and testing to ensure the new material grade performs comparably to the predicate device, not on a clinical effectiveness study measuring human improvement with AI or ground truth established by experts.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: The document implies acceptance criteria through discussions of:
- Compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004.
- No new types of safety or effectiveness problems raised by the material change.
- Demonstration of substantial equivalence to predicate devices in terms of material, design, and indications for use.
- Comparison of design features, materials, intended use, and performance characteristics.
The specific quantitative pass/fail values for material properties (e.g., tensile strength, fatigue life) are not provided in this summary but would be part of the underlying engineering analysis.
- Reported Device Performance: The document states that "Engineering analysis and testing... was completed for the Stryker Spine Xia® Stainless Steel modified long arm screws." However, the results (i.e., specific performance metrics against quantitative criteria) are not reported in this summary. It only states that the testing was completed to demonstrate compliance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with FDA's Guidance for Spinal System 510(k)'s 2004 | "Engineering analysis and testing to demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 was completed..." (Specific results not detailed in this summary). |
| No new types of safety or effectiveness problems | "...the device has been demonstrated through a comparison of design features, materials, intended use, and performance characteristics, to be substantially equivalent to existing Xia® Stainless Steel Spinal System screw and hook components." |
| Substantial equivalence to predicate devices | "Documentation is provided which demonstrates the new long arm screws... to be substantially equivalent to its predicate devices in terms of its material, design, and indications for use." "The device modification... raises no new types of safety or effectiveness problems..." (Specific comparative results not detailed in this summary, but the conclusion is affirmative). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable. This document describes a modification to an existing mechanical device (spinal screws), not a diagnostic device involving a "test set" of patient data in the typical sense. The "testing" mentioned refers to engineering and laboratory analysis of the device's material and mechanical properties, not a clinical study on human subjects or a dataset for an AI algorithm.
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)
- Not Applicable. As mentioned above, there is no "test set" requiring expert ground truth in the context of this device modification. Expert input might be involved in defining material specifications or testing protocols, but not in a manner consistent with an AI/diagnostic device evaluation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable.
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
- Not Applicable. This document is for a spinal implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This document is for a mechanical spinal implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable (in the context of AI/diagnostic devices). The "ground truth" for this device modification would relate to established material science properties, mechanical testing standards, and predicate device performance characteristics. For example, material composition would be verified against industrial standards, and mechanical strength would be measured against specific thresholds derived from biomechanical requirements.
8. The sample size for the training set
- Not Applicable. As this is not an AI/diagnostic device, there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable.
§ 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.