(30 days)
The TRIO® and TRIO®+ Spinal Systems are pedicle screw systems 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, dislocations, scoliosis, spinal tumor and failed previous fusion (pseudarthrosis).
The TRIO® and TRIO®+ Spinal Systems are also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) at the LS-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 TRIO® and TRIO®+ Spinal Systems are sacral/iliac screw fixation systems 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 review of failed fusion attempts.
The TRIO® Spinal System is intended to be used in conjunction with the OSS Diapason Rods, Opus Spinal System Rods, and the Multi-Axis Cross Connectors.
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 TRIO® and TRIO®+ Spinal Systems are pedicle screw systems 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. The TRIO® and TRIO®+ Spinal Systems are sacral/iliac screw fixation systems indicated for degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, deformities, tumor, pseudoarthrosis and review of failed fusion attempts. The TRIO® and TRIO®+ Spinal Systems are comprised of bone screws, rods, and connectors. The components are available in a variety of lengths in order to accommodate patient anatomy and are fabricated from titanium alloy.
This 510(k) premarket notification for the TRIO®+ Spinal System is for a line extension to an existing device, the TRIO® Spinal System. As such, the submission primarily relies on demonstrating substantial equivalence to predicate devices through material, design, and intended use comparisons, along with mechanical testing. It is not a submission for an AI/ML powered device, nor does it describe a clinical study of the type that would typically involve acceptance criteria, ground truth establishment, or human reader performance comparisons.
Therefore, many of the requested details are not applicable or cannot be extracted from the provided text for this specific type of medical device submission.
Here's an attempt to answer the questions based on the provided document, noting where the information is not present or relevant:
Acceptance Criteria and Device Performance Study for TRIO®+ Spinal System
This submission pertains to a line extension (TRIO®+ Spinal System) to an existing spinal fixation system. The primary method for demonstrating device performance and meeting acceptance criteria is through mechanical testing to confirm comparable mechanical properties to predicate devices, and through demonstrating substantial equivalence in materials, design, and intended use. The document does not specify quantitative acceptance criteria in terms of clinical outcomes or performance metrics typically seen for diagnostic AI/ML devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (as implied by submission type) | Reported Device Performance (as implied by submission type) |
|---|---|---|
| Mechanical Properties | Comparable strength, fatigue life, and other relevant mechanical characteristics to predicate devices (e.g., TRIO®, Xia® Spinal Systems). | "Mechanical testing also demonstrated comparable mechanical properties to the predicate devices..." (Details of specific tests and numerical results are not provided in this summary, but would have been in the full submission). |
| Material Composition | Use of the same material (Titanium alloy) as predicate devices. | "The subject system consists of Titanium alloy bone screws, rods, and connectors..." |
| Basic Design Concepts | Shares basic design concepts with predicate devices. | "The subject components share the same intended use, material, and basic design concepts as that of the predicate device..." |
| Intended Use | Same intended use as predicate devices. | "The subject components share the same intended use..." (Indications for use are explicitly listed and are consistent with predicate devices). |
2. Sample Size for Test Set and Data Provenance
- Sample Size (Test Set): Not applicable in the context of this device and submission type. The "test set" for this device would refer to the samples used in mechanical testing, not a clinical data set. The document does not specify the number of implants/components tested.
- Data Provenance: Not applicable in the context of clinical data for this device. Mechanical testing data would typically be generated in a laboratory setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. This device is a mechanical implant, not a diagnostic tool requiring expert interpretation for ground truth establishment on a test set.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods are relevant for clinical studies involving expert disagreement, which is not described for this device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of diagnostic or AI-assisted tools on human reader performance, which is not applicable to a spinal implant line extension.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No, a standalone study of an algorithm was not done. This device is a physical medical implant, not an algorithm.
7. Type of Ground Truth Used
- Not applicable in the clinical sense. For mechanical testing, the "ground truth" would be established by validated test methods and engineering standards.
8. Sample Size for the Training Set
- Not applicable. This is not an AI/ML device requiring a 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.