(23 days)
The Stryker Spine TRIO® Spinal Fixation System is a pedicle screw system 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: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The Stryker Spine TRIO® Spinal Fixation System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the development of a solid fusion mass.
The Stryker Spine TRIO® Spinal Fixation System is also a sacral/iliac screw fixation system indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, kyphosis and/or lordosis), tumor, pseudoarthrosis and revision of failed fusion attempts.
The Stryker Spine TRIO® Spinal Fixation System is also intended to be used in conjunction with the OSS/Diapason Rods, Opus Spinal System Rods and the Multi-Axis Cross Connectors.
The Stryker Spine TRIO® Spinal Fixation System is comprised of screws, rods, and connectors. The components are available in a variety of lengths in order to accommodate patient anatomy. The implants are provided non-sterile and are fabricated from titanium alloy. This submission is intended to address a line extension to Stryker Spine MAPS System and the system name change. The line extension includes the addition of a new offset connector. The name of the MAPS System is changed to TRIO® Spinal Fixation System.
The provided document describes a 510(k) premarket notification for a line extension to a spinal fixation system, not a device with an AI/ML component or a diagnostic capability requiring clinical studies to establish performance. Therefore, many of the typical acceptance criteria and study design elements requested in the prompt (like sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable in this context.
This submission is for a modification to an existing medical device (Stryker Spine MAPS System, renamed to TRIO® Spinal Fixation System) which includes adding a new offset connector and changing the system name. The primary focus of the submission is to demonstrate substantial equivalence to predicate devices through technological comparison and mechanical testing, rather than through clinical performance metrics of an AI algorithm or diagnostic tool.
Here's a breakdown of the relevant information provided, addressing the prompt where applicable, and noting where information is not available due to the nature of the device and submission type:
Stryker Spine TRIO® Spinal Fixation System (K052971)
1. A table of acceptance criteria and the reported device performance
For this type of device modification (a line extension with a new connector), the "acceptance criteria" are typically related to demonstrating comparable mechanical properties and safety/effectiveness to predicate devices through design and non-clinical testing. The "reported device performance" is the result of these mechanical tests.
| Acceptance Criteria (Implicit from Submission) | Reported Device Performance (Summary) |
|---|---|
| Material Equivalence: Same materials as predicate. | Device uses same materials (titanium alloy) as predicate. |
| Design Equivalence (Basic Concept): Similar design concepts to predicate. | Subject connector shares basic design concepts with predicate device (K032855). |
| Mechanical Properties: Comparable mechanical properties to predicate devices. | Mechanical testing demonstrated comparable mechanical properties to predicate devices (K013823, K012870, K951725). |
| Intended Use Equivalence: Same intended use as predicate devices. | Device shares the same intended use as the predicate device. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: This information is not explicitly stated in the provided summary. For mechanical testing, the "sample size" would refer to the number of test specimens (e.g., connectors) subjected to various mechanical loads.
- Data Provenance: Not applicable in the context of clinical data for an AI/ML device. The data provenance would refer to the conditions and methods of the mechanical testing performed, which are typically conducted in a laboratory setting by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For a spinal fixation system line extension, ground truth is not established by human experts in a clinical context (e.g., radiologists interpreting images). Ground truth for mechanical properties is established by engineering standards and validated testing methodologies.
4. Adjudication method for the test set
Not applicable, as there is no "ground truth" established by human experts requiring adjudication for this type of device modification.
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 is a spinal fixation system, not an AI/ML diagnostic or assistive device. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" (or basis for comparison) for this device modification is established through engineering standards and mechanical testing results compared against predicate devices. The performance target is "comparable mechanical properties" to existing, legally marketed predicate devices.
8. The sample size for the training set
Not applicable. This device does not involve machine learning or a "training set."
9. How the ground truth for the training set was established
Not applicable. This device does not involve machine learning or a "training set."
Summary of the Study (as described in the 510(k) Summary):
The "study" conducted for this 510(k) submission was primarily a non-clinical performance evaluation focused on demonstrating the substantial equivalence of the modified device (new offset connector and renamed system) to its predicate devices.
- Objective: To show that the new Stryker Spine TRIO® Spinal Fixation System, including the added offset connector, is as safe and effective as the predicate devices.
- Methodology: The submission states that the subject connector shares the same intended use, material, and basic design concepts as a predicate device (K032855). Crucially, "Mechanical testing also demonstrated comparable mechanical properties to the predicate device: Xia Spinal System (K013823), Xia Stainless Steel System (K012870) and Osteonics Spinal System (K951725)."
- Conclusion: Based on this technological comparison and mechanical testing, the FDA determined the device to be substantially equivalent to legally marketed predicate devices. This indicates that the device met the implicit acceptance criteria of demonstrating comparable safety and effectiveness through engineering and material properties.
§ 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.