(85 days)
The Stryker Spine Trio® Plate System is intended for posterior, noncervical (T10-S1) pedical and nonpedical fixation of the spine 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 Stryker Spine Trio® Spinal Fixation System is intended for posterior, noncervical pedicle and non-pedicle fixation of the spine. The Stryker Spine Trio® Spinal Fixation System is indicated for: 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 Trio® Spinal Fixation System is 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 System is intended for posterior, noncervical pedicle and non-pedicle fixation of the spine. The Stryker SpineTrio®+ Spinal System is indicated for: 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 Trio + Spinal System is intended to be used in conjunction with the OSS Diapason Rods, Opus Spinal System Rods, Xia " Pre-bent Rods, and the Multi-Axis Cross Connectors.
The Stryker Spine Trio® Plate System is comprised of spinal screws, plates and locking components, fabricated from Titanium alloy.
The Stryker Spine Trio® Spinal Fixation System is comprised of spinal screws, rods, and offset connectors, fabricated from Titanium alloy.
The Stryker Spine Trio®+ Spinal System contains spinal screws, rods, and connectors, fabricated from Titanium alloy.
The provided submission does not include information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically found for AI/ML-based medical devices.
This document describes a 510(k) premarket notification for the Stryker Spine Trio® Plate System, Trio® Spinal Fixation System, and Trio®+ Spinal System. This is a traditional medical device (spinal fixation system) and not an AI/ML-based device. The "study" mentioned refers to mechanical testing in compliance with FDA's Guidance for Spinal System 510(k)s, not a clinical study involving human or AI performance evaluation.
Therefore, the requested information elements related to AI/ML device performance (like sample sizes for test/training sets, experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not applicable to this submission.
Here's a breakdown based on the characteristics of this traditional medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria Category | Acceptance Criteria (N/A for AI/ML) | Reported Device Performance (N/A for AI/ML) |
|---|---|---|
| Material Properties | Compatibility with Titanium alloy standards, mechanical strength, fatigue resistance. | Implied: Passed mechanical testing, demonstrating sufficient strength and durability as per FDA guidance for spinal systems. The device is fabricated from Titanium alloy. |
| Biocompatibility | Biocompatibility with human tissue. | Implied: Met biocompatibility standards for implantable devices made of Titanium alloy, as it's a predicate-based submission. |
| Sterilization | Ability to be sterilized. | Implied: Sterilization methods are suitable for the device as an implantable medical device. |
| Functional Equivalence | Equivalent mechanical performance to predicate devices. | Stated: "Testing in compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 was performed... and was presented in their respective predicate 510(k)s." |
| Indications for Use | Expanded Class III indications (NKB) are appropriate and consistent with predicate devices and FDA guidance. | Stated: The submission "addresses the additional Class III indications associated with product code NKB." The expanded indications were "modeled on the suggested indications for use statement for posterior thoracolumbar systems... suggested by FDA in FDA's 'Guidance for Industry and FDA Staff: Spinal System 510(k)s,' dated May 3, 2004." |
Explanation: For this type of traditional spinal implant, the "acceptance criteria" are primarily established through bench testing (mechanical, material, biocompatibility) to demonstrate substantial equivalence to predicate devices and adherence to relevant FDA guidance and recognized standards. The submission highlights that no new components are being introduced; rather, it is seeking approval for additional Class III indications based on existing predicate device testing and FDA guidance. There is no performance reported in terms of diagnostic accuracy or clinical outcomes of the device itself beyond its mechanical integrity and intended use alignment.
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 submission is for a traditional spinal fixation system, not an AI/ML device that would have a "test set" of data in the AI/ML context. The testing referenced is bench/mechanical testing to demonstrate substantial equivalence.
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. See point 2.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. See point 2.
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 not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the AI/ML sense. For this device, the "ground truth" for demonstrating safety and effectiveness relies on established engineering principles, material science, and the functional performance of predicate devices in accordance with FDA guidance for spinal systems. It's about meeting mechanical and material performance specifications rather than diagnostic truth.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
§ 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.