(26 days)
The TriALTIS™ Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities of the thoracic, lumbar and sacral spine.
The TriALTIS™ Spine System is intended for pedicle fixation of the thoracic, lumbar, and sacral spine (T1-S2) and nonpedicle fixation for the following indications: degenerative disc disease (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, pseudarthrosis; and failed previous fusion in skeletally mature patients.
When used for posterior pedicle screw fixation of the thoracic, lumbar, and sacral spine (T1-S2) in pediatric patients, the TriALTIS™ Spine System is indicated as an adjunct to fusion to treat spinal deformities (i.e, scoliosis, or lordosis) including adolescent idiopathic scoliosis, neuromuscular scoliosis. Additionally, the TriALTIS™ System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. The TriALTIS™ Spine System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
When the TriALTIS™ Spine System fenestrated screws are used in conjunction with CONFIDENCE™ High Viscosity Spinal Cement, the TriALTIS™ Spine System is intended to stabilize the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The TriALTIS™ fenestrated screws augmented with the CONFIDENCE™ High Viscosity Spinal Cement is for use at spinal levels where the structural integrity of the spine is not severely compromised.
The TriALTIS™ Spine System is a posterior spinal fixation system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic lumbar and sacral spine (T1-S2). The system is composed of multiple components to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The system consists of bone anchors (such as screws) for connection by longitudinal components (such as rods) via an interconnection mechanism (e.g., set screws) to link the longitudinal components for additional stability. The TriALTIS™ System implant components are comprised of Titanium alloy conforming to ASTM F136, and Cobalt-Chromium-Molybdenum alloy conforming to ASTM F1537.
The provided FDA 510(k) summary (K233684) for the TriALTIS™ Spine System does not contain information regarding acceptance criteria or a study proving the device meets acceptance criteria in the context of device performance metrics typically reported for AI/ML-enabled devices (e.g., sensitivity, specificity, AUC).
This document is a notification of intent to market a thoracolumbosacral pedicle screw system, which is a physical implant, not an AI/ML software device. The review focuses on substantial equivalence to a predicate device based on intended use, design, materials, and performance characteristics, typically established through non-clinical bench testing and engineering rationale.
Therefore, many of the requested details about acceptance criteria, study design for performance metrics (like sample size for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable to this type of medical device submission.
The relevant information from the document is summarized below:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly defined in terms of specific performance metrics (e.g., sensitivity, specificity) as this is a physical implant, not an AI/ML diagnostic tool. The document implies meeting the safety and effectiveness profile of the predicate device through engineering rationale and non-clinical testing.
- Reported Device Performance:
- Substantial Equivalence: The TriALTIS™ Spine System is substantially equivalent to the predicate (K231479).
- Compatibility: The only changes are labeling updates to include compatibility with existing spine systems (SYMPHONY OCT, EXPEDIUM Spine System titanium alloy, EXPEDIUM VERSE, VIPER 2, VIPER PRIME).
- Safety and Effectiveness: "Evaluation of the subject device performance data as compared to the predicate system has found that the TriALTIS™ System has a substantially equivalent safety and effectiveness profile compared to the predicate system identified above."
2. Sample size used for the test set and the data provenance:
- Not Applicable. This submission is for a physical implant. Performance is evaluated through non-clinical testing and engineering rationale, not by analyzing a "test set" of data in the sense of AI/ML performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth in the context of diagnostic accuracy is not relevant for this device. Safety and effectiveness are established through engineering design, material properties, and mechanical testing, often against standards.
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:
- No. This is not an AI/ML device, so MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is not an algorithmic device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not Applicable in the context of diagnostic accuracy. The "ground truth" for this device's safety and effectiveness focuses on mechanical properties, material biocompatibility, and structural integrity, typically evaluated through engineering tests and adherence to standards.
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.