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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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