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The Invictus Spinal Fixation System is intended for non-cervical posterior and anterolateral fixation in skeletally mature patients as an adjunct to fusion 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, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Invictus Spinal Fixation System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Invictus Spinal Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis / spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatric pedicle screw fixation is limited to a posterior approach.

The Invictus Spinal Fixation System is intended to be used with autograft and/or allograft.

Invictus Core and Invictus SI.Core Screws are not intended for use with cement; all other fenestrated screws may be used with Invictus Bone Cement. When used in conjunction with Invictus Bone Cement, the Invictus Fenestrated Screws are intended to restore the integrity of 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 Invictus Fenestrated Screws augmented with Invictus Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

The Invictus Spinal Fixation System is thoracolumbosacral spinal fixation system designed to be implanted through a non-cervical posterior or anterolateral surgical approach. The implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136, commercially pure titanium (CP Ti Grade 2) per ASTM F67 and cobalt chromium (Co-28Cr-6Mo) alloy per ASTM F1537. The Invictus System consists of a variety of shapes and sizes of screws, hooks, rods, connectors, and cross-connectors to create a rigid construct as an adjunct to fusion for temporary internal fixation and stabilization of the thoracic, lumbar and sacral spine.

Invictus Bone Cement is a self-hardening and ready to use polymethylmethacrylate (PMMA) bone cement with a high amount of radiopaque agent for percutaneous vertebroplasty. The cement is made of two sterile components: the polymer in powder and the liquid monomer. The liquid component is mainly composed of methacrylate. The major powder components are polymethylmethacrylate, methyl methacrylate, and zirconium dioxide. Benzoyl peroxide, which initiates polymerization, is included in the polymer powder. The powder and liquid monomer are in a double sterile packaging. Each unit contains a sterile ampoule of liquid within a blister pack and a powder within a double peelable pouch, the whole being packaged in a box.

The purpose of this submission is to expand indications for use of Invictus fenestrated screws with Invictus Bone Cement, add new fixed fenestrated pedicle screws to the Invictus Spinal Fixation System, and to expand indications of the Invictus Spinal Fixation System for non-cervical anterolateral fixation.

The provided text is a 510(k) summary for a medical device (Invictus® Bone Cement, Invictus Spinal Fixation System). It focuses on establishing substantial equivalence to legally marketed predicate devices based on non-clinical performance data.

Crucially, this document explicitly states: "Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."

Therefore, the information required to answer your request regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, ground truth types for test/training sets, training set size, and ground truth establishment for training set) is not present in the provided text.

The document indicates that substantial equivalence was determined through nonclinical testing, specifically:

• Axial Pullout Strength testing per ASTM F543
• Screw Torque Removal testing per ASTM F543
• Cadaveric testing to evaluate cement flow and bolus formation

These tests are typically related to the mechanical and physical performance of the device rather than diagnostic or prognostic accuracy requirements that would necessitate human expert input and clinical study designs.

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The Invictus Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion 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/or failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatic patients, the Invictus Spinal Fixation System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Invictus Spinal Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis / spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatic pedicle screw fixation is limited to a posterior approach.

The Invictus Spinal Fixation System is intended to be used with autograft and/or allograft.

The Invictus Spinal Fixation System is a thoracolumbosacral pedicle screw system designed to be implanted through a posterior surgical approach. The implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136, commercially pure titanium (CP Ti Grade 2) per ASTM F67 and cobalt chromium (Co-28Cr-6Mo) alloy per ASTM F1537. The Invictus System consists of a variety of shapes and sizes of screws, hooks, rods, connectors, and cross-connectors to create a rigid construct as an adjunct to fusion for temporary internal fixation and stabilization of the thoracic, lumbar and sacral spine.

The purpose of this submission is to add new fenestrated screws to the Invictus Spinal Fixation System. The safety and effectiveness of this device has not been established when used in conjunction with bone cement or for use in patients with poor bone quality (e.g., osteoporosis, osteopenia). This device is intended only to be used with saline or radiopaque dye.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that a device (specifically an AI-powered device) meets acceptance criteria.

The document is an FDA 510(k) clearance letter for the Invictus Spinal Fixation System, which is a medical device described as a "thoracolumbosacral pedicle screw system." This is a purely mechanical implant used for spinal fixation, not a digital health or AI-powered device.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training sets, or ground truth establishment for a study proving an AI device meets acceptance criteria. The document simply doesn't contain that type of information.

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The Invictus Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion 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/or failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Invictus Spinal Fixation System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Invictus Spinal Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis / spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatric pedicle screw fixation is limited to a posterior approach.

The Invictus Spinal Fixation System is intended to be used with autograft and/or allograft.

The Invictus Spinal Fixation System is a thoracolumbosacral pedicle screw system designed to be implanted through a posterior surgical approach. The implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136, commercially pure titanium (CP Ti Grade 2) per ASTM F67 and cobalt chromium (Co-28Cr-6Mo) alloy per ASTM F1537. The Invictus System consists of a variety of shapes and sizes of screws, hooks, rods, connectors, and cross-connectors to create a rigid construct as an adjunct to fusion for temporary internal fixation and stabilization of the thoracic, lumbar and sacral spine.

The purpose of this submission is to add new components to the Invictus Spinal Fixation System.

The provided text describes the 510(k) premarket notification for the Invictus™ Spinal Fixation System. This document is a regulatory submission for a medical device that does not involve Artificial Intelligence (AI). It focuses on demonstrating substantial equivalence to existing predicate devices based on mechanical and material properties, rather than an AI algorithm's performance.

Therefore, the information required to answer your request (acceptance criteria, study details for AI performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, etc.) is not present in this document. The document explicitly states:

"Clinical Information: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."

This clarifies that no clinical performance study (which would be the context for AI model evaluation) was conducted for this submission. The "acceptance criteria" discussed are related to the mechanical performance of the spinal fixation system (e.g., ASTM F1717 Dynamic Compression Bending, ASTM F1798 Static Flexion-Extension Moment), not the output of an AI algorithm.

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The Invictus Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion 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/or failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Invictus Spinal Fixation System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, lyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Invictus Spinal Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis / spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatic pedicle screw fixation is limited to a posterior approach.

The Invictus Spinal Fixation System is intended to be used with autograft and/or allograft.

The Invictus Spinal Fixation System is a thoracolumbosacral pedicle screw system designed to be implanted through a posterior surgical approach. The implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136, commercially pure titanium (CP Ti Grade 2) per ASTM F67 and cobalt chromium (Co-28Cr-6Mo) alloy per ASTM F1537. The Invictus System consists of a variety of shapes and sizes of screws, hooks, rods, connectors, and cross-connectors to create a rigid construct as an adjunct to fusion for temporary internal fixation and stabilization of the thoracic. Iumbar and sacral spine.

The purpose of this submission is to add modular pedicle screws and rod connectors to the Invictus Spinal Fixation System.

The provided text describes a 510(k) premarket notification for the Invictus™ Spinal Fixation System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance data, rather than clinical performance studies typically associated with AI/software devices. Therefore, the information requested regarding acceptance criteria, study design for proving it, sample sizes, expert ground truth, MRMC studies, standalone performance, and training data for AI/software is not applicable to this specific document.

The document pertains to a Class II medical device, specifically a thoracolumbosacral pedicle screw system, which is a physical implant. The approval is based on demonstrating the device's substantial equivalence to existing legally marketed predicate devices through material testing and mechanical performance, not through clinical or AI-based performance metrics.

Specifically addressing your numbered points based on the provided text:

1. A table of acceptance criteria and the reported device performance

   • Acceptance Criteria: The acceptance criteria are implicitly based on demonstrating performance comparable to the predicate devices as per industry standards for spinal fixation systems. The relevant ASTM (American Society for Testing and Materials) standards provide the framework for these criteria.
   • Reported Device Performance:

     Test Type	Standard	Reported Performance
     Static and dynamic axial compression	ASTM F1717	"The results demonstrate that the subject Invictus Spinal Fixation System is substantially equivalent to other predicate devices for nonclinical testing."
     Static torsion	ASTM F1717	"The results demonstrate that the subject Invictus Spinal Fixation System is substantially equivalent to other predicate devices for nonclinical testing."
     Static tulip pull-off (Fx)	ASTM F1798	"The results demonstrate that the subject Invictus Spinal Fixation System is substantially equivalent to other predicate devices for nonclinical testing."

   Note: The document does not provide specific numerical results of these tests, but rather states that the results demonstrate substantial equivalence.

2. Sample size used for the test set and the data provenance

   • Sample Size: Not specified in the document. For mechanical testing, sample sizes are typically determined by the relevant ASTM standard and statistical requirements for demonstrating equivalence, but not explicitly stated here.
   • Data Provenance: The data is generated from non-clinical laboratory testing of the physical device components. Not applicable to country of origin in the way it would be for patient data, nor is it retrospective or prospective in the clinical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

   • Not applicable. Ground truth as typically understood in AI/software evaluation (e.g., expert consensus on medical images) is not relevant for this type of mechanical device testing. The "ground truth" for these tests are the established scientific principles of material strength and mechanical integrity as defined by the ASTM standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

   • Not applicable. This is not a clinical study involving human judgment.

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 non-clinical submission for a physical medical device, not an AI or software device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • Not applicable. This is a non-clinical submission for a physical medical device, not an AI or software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

   • For this mechanical device, the "ground truth" is defined by the physical properties and mechanical performance requirements as per the relevant ASTM standards (F1717, F1798) to demonstrate safety and effectiveness comparable to predicate devices. There is no expert consensus on clinical data, pathology, or outcomes data used for the substantial equivalence determination for this device's performance.

8. The sample size for the training set

   • Not applicable. This is a physical medical device, not an AI/software device that requires a "training set."

9. How the ground truth for the training set was established

   • Not applicable. This is a physical medical device, not an AI/software device that requires a "training set."

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