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510(k) Data Aggregation
(58 days)
Invictus**®** Spinal Fixation System
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 discogenc origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis (i.e., scoliosis, kyphosis); 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 pediatic patients diagnosed with the following conditions: 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.
Invictus SI.CORE Screws are intended for sacroiliac joint fusion for the following conditions:
· Sacroliac joint dysfunction that is a direct result of sacrolliac joint disruption and degenerative sacroilitis. This includes conditions whose symptoms began during pregnancy or in the period and have persisted postpartum for more than 6 months.
· To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patropelvic fixation as part of a lumbar or thoracolumbar fusion.
· Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.
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 SI.CORE bone screws are intended to provide sacroiliac joint fusion in sacral alar iliac (SAI) trajectories. Invictus Core and Invictus SI.Core Screws are not intended for use with cement; all other fenestrated screws may be with Invictus Bone Cement, a self-hardening and ready to use used polymethylmethacrylate (PMMA) bone cement with a high amount of radiopaque agent for percutaneous vertebroplasty.
The Invictus Patient Specific Rods are used to connect pedicle screws, hooks, and connectors across different levels of vertebral bodies to create a rigid construct. They are intended to be used with standard Invictus instrumentation. The Invictus Patient Specific Rods are available in 05.5 mm and 6.0 mm diameters and will be provided in lengths between 20 - 600 mm. Equivalent to cleared Invictus rod materials, the rods are made from five different materials: Commercially Pure Titanium (CP Ti Grade 4), Titanium Alloy (Ti-6Al-4V ELI), and three different formulations of Cobalt Chromium (Co-28Cr-6Mo). All Invictus Patient Specific Rods are provided pre-contoured to the surgeon's plan based on the patient's anatomy by means of an industrial bending process prior to distribution for surgery. There is no need for additional bending during surgery.
The purpose of this submission is to expand indications for use of Invictus SI.CORE screws as sacroiliac joint fusion devices, and to add a range of Invictus Patient-Specific Rods to the Invictus Spinal Fixation System.
The provided text is a 510(k) premarket notification letter and summary for the Invictus® Spinal Fixation System. It focuses on establishing substantial equivalence to previously cleared predicate devices through engineering analysis and rationale, primarily for the expansion of indications for use for Invictus SI.CORE screws and the addition of Invictus Patient-Specific Rods.
This document explicitly states: "Clinical Information: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."
Therefore, the information requested in the prompt regarding acceptance criteria, study details, sample sizes, expert involvement, ground truth establishment, or multi-reader multi-case studies cannot be found within this document. This 510(k) submission relied on non-clinical data (engineering analysis and rationale) to demonstrate substantial equivalence.
To answer your prompt, I would need a different type of document, such as a clinical study report or a different section of a regulatory submission that details performance testing against specific acceptance criteria.
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(103 days)
Invictus**®** Spinal Fixation System
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, 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: spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. 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 screw offerings to the Invictus Spinal Fixation System.
The provided document is a 510(k) premarket notification letter from the FDA for the Invictus® Spinal Fixation System. This document describes a medical device, specifically a thoracolumbosacral pedicle screw system, and its substantial equivalence to previously marketed devices.
Crucially, this document does not describe an AI/ML device or any software-based device that would have acceptance criteria related to algorithmic performance (e.g., sensitivity, specificity, AUC). The performance data presented (Section VII) refers to non-clinical mechanical testing of the physical spinal fixation system components according to ASTM standards for static and dynamic loading.
Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML or software performance cannot be extracted from this document.
The document specifically states under "Clinical Information" (Section VIII) that: "Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." This further supports that there are no clinical studies or algorithm performance evaluations being described here.
However, to directly answer the structure of your request based on the absence of AI/ML performance data:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Non-Clinical (Mechanical Testing) | Static and dynamic flexion-extension moment (My) per ASTM F1798: Equivalent to predicate devices. | Results demonstrated substantial equivalence to other predicate devices for nonclinical testing. |
| Static tulip pull-off (Fx) per ASTM F1798: Equivalent to predicate devices. | Results demonstrated substantial equivalence to other predicate devices for nonclinical testing. | |
| Static torsion and driving torque per ASTM F543: Equivalent to predicate devices. | Results demonstrated substantial equivalence to other predicate devices for nonclinical testing. | |
| Static and dynamic cantilever bending per ASTM F2193: Equivalent to predicate devices. | Results demonstrated substantial equivalence to other predicate devices for nonclinical testing. | |
| Clinical Performance (AI/ML) | Not applicable. | Not applicable (determination of substantial equivalence is not based on an assessment of clinical performance data for this device). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No AI/ML test set or clinical data is mentioned. The testing involves mechanical components of a physical medical device.
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. No ground truth establishment for a diagnostic or prognostic algorithm is relevant to the mechanical testing described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication for a test set of algorithmic performance is mentioned.
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. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. No algorithm or software performance is mentioned.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for the mechanical tests would be the measured physical properties of the device components, compared against established ASTM standards and predicate device performance.
8. The sample size for the training set
Not applicable. No training set for an AI/ML model is mentioned.
9. How the ground truth for the training set was established
Not applicable. No training set for an AI/ML model is mentioned.
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