Search Results

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."

Ask a specific question about this device

The Kodiak Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications; degenerative discase (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 Kodiak Spinal Fixation System implants are indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis. Additionally, the Kodiak Spinal Fixation System is intended to treat pediatic 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 Kodiak Spinal Fixation System is intended to be used with autograft and/or allograft.

The Kodiak 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-6AI-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 Kodiak 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 provided text is a 510(k) summary for the Kodiak Spinal Fixation System, a medical device for orthopedic surgery. It details the device's intended use, regulatory classification, and a comparison to predicate devices, focusing on non-clinical testing.

However, the document explicitly states: "Clinical Information: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."

This means that the 510(k) submission for the Kodiak Spinal Fixation System does not include a study proving the device meets acceptance criteria based on clinical performance or human-in-the-loop AI assistance. The "performance data" section only describes non-clinical mechanical testing (e.g., static and dynamic axial compression testing per ASTM F1717).

Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets those criteria, as no such clinical study data is presented or summarized in this 510(k) document. The device's substantial equivalence determination was based on non-clinical performance and a comparison of technological features to predicate devices.

Ask a specific question about this device

Alphatec Spine Navigated Reusable Instruments are intended to be used during the preparation and placement of Alphatec screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Alphatec Spine Navigated Reusable Instruments are specifically designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, along bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

The Alphatec NAV Instruments are Class II, manual, surgical instruments for use with Medtronic SteathStation Navigation system to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system implants. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems provides the surgeon access to real-time, multi-plane 3D images (and 2D images) providing confirmation of hardware placement.

The provided text describes the Alphatec Navigation Instruments and its 510(k) submission for market clearance. While it outlines the device's intended use, comparison to a predicate device, and general performance data, it does not provide detailed acceptance criteria or a specific study proving the device meets those criteria with the level of detail requested in the prompt.

The document states that "Engineering analysis and performance data demonstrate that the subject Alphatec Spine Navigation Instruments are substantially equivalent to the predicate in compatibility, accuracy, function, and performance." It mentions "Validation testing includes 1:1 accuracy and performance testing of the subject and predicate device in a simulated surgical navigation use environment," but does not provide the quantitative results or specific criteria for acceptance.

Therefore, many of the requested details cannot be extracted from this document.

Here's an attempt to answer based on the available information, with notations where information is missing:

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

Ask a specific question about this device