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The TriALTIS™ System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities 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 fusions 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, and congenital 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 and connectors) to link the longitudinal components for additional stability. The subject TriALTIS™ System implants are comprised of Titanium alloy conforming to ASTM F136 and Nitinol conforming to ASTM F2063.

The provided FDA 510(k) clearance letter and summary for the TriALTIS™ Spine System do not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the context of an AI/algorithm-driven medical device.

The document describes a spinal fixation system, which is a physical implant, not a software or AI-driven diagnostic or treatment device. The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section on page 5 explicitly states:

• "The TriALTIS® Spine System was evaluated against the predicate system, EXPEDIUM connectors on a component level using ASTM F1798 'Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants', specifically axial and torsional grip testing and flexion-extension testing."
• "Clinical testing is not applicable."

Therefore, the requested information regarding acceptance criteria, reported device performance (in terms of AI metrics), sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as typically found for AI/software devices, is not present in this document. This submission pertains to a traditional physical medical device.

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The TriALTIS™ System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities 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, and congenital 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 TriALTIST™ 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 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 and connectors) to link the longitudinal components for addity. The subject TriALTIS™ Spine System implant components are comprised of Titanium alloy conforming to ASTM F136.

The provided document is a 510(k) premarket notification clearance letter for the TriALTIS™ Spine System. This document does not describe acceptance criteria or a study that proves the device meets acceptance criteria in the context of a software or AI/ML-enabled medical device.

The document pertains to a physical medical device (Thoracolumbosacral Pedicle Screw System) and its mechanical properties. The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section explicitly states:

• "The TriALTIS™ System was evaluated against the predicate system, EXPEDIUM connectors on a component level using ASTM F1798 'Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants', specifically axial and torsional grip testing."
• "Clinical testing is not applicable."

Therefore, the requested details about acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set information are not present in the provided text, as they are not relevant to the type of device and regulatory submission discussed.

Ask a specific question about this device

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.

Ask a specific question about this device

The TriALTIS™ Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities 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): spondvlolisthesis: 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 metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The TriALTIS™ Spine System is intended to be used with autograft and/or allograft. Pediatric screw fixation is limited to a posterior approach.

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 progressive spinal deformities (i.e., scoliosis, or lordosis) including adolescent idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the TriALTIS™ Spine 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 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 addity. The TriALTS System implant components are comprised of Titanium alloy conforming to ASTM F136, and Cobalt-Chromium-Molybdenum alloy conforming to ASTM F1537.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets acceptance criteria. The document is an FDA 510(k) clearance letter for the TriALTIS Spine System, which outlines the device's indications for use, its substantial equivalence to predicate devices, and the non-clinical testing performed.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

Ask a specific question about this device