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The Invictus™ OCT Spinal Fixation System is intended to provide immobilization of spinal segments as an adjunct into fusion for the following acute and chronic instabilities of the craniccervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability of deformity; failed previous fusions (e.g.,pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Invictus OCT Spinal is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advance stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the Invictus OCT Spinal Fixation System may be connected to the components in the Arsenal® Spinal Fixation System or the Invictus™ System offered by Alphates Spine using various rod-to-rod connectors and/or transitional rods.

The purpose of this submission is to add occipital components to the previously cleared Invictus™ CT Spinal Fixation System (K200936). The Invictus™ OCT Spinal Fixation System is a posterior approach system designed to stabilize the cervico-thoracic spine and/or occiput with or without fusion. The Invictus OCT system is intended to be compatible with Arsenal® Spinal Fixation System or the Invictus™ Spinal Fixation System offered by Alphatec Spine using various rod-to-rod connectors and/or transitional rods.

The Invictus OCT implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136, and cobalt chromium (Co-28Cr-6Mo) alloy per ASTM F1537. The Invictus OCT System consists of a variety of shapes and sizes of plates, screws, rods, cross connectors, rod-to-rod connectors and general surgical instruments that provide internal fixation and stabilization during bone graft healing and/or fusion mass development.

The Invictus OCT implants are provided non-sterile to be steam sterilized by the end user. The instruments are made of stainless steel and other materials, and are provided nonsterile to be cleaned and sterilized by the end user.

This is not a medical device that uses AI. This is a spinal fixation system. As such, information regarding acceptance criteria, study details, and AI-specific performance metrics (like sample size for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance for AI) are not applicable or found in the provided document.

The document discusses the regulatory review of a physical medical device. It confirms the device, the Invictus™ OCT Spinal Fixation System, is substantially equivalent to legally marketed predicate devices based on its intended use, indications for use, design, technology, and nonclinical performance data.

Here's the relevant information that is provided:

1. Acceptance Criteria and Reported Device Performance (Nonclinical Testing):

2. Sample size used for the test set and the data provenance: Not applicable for this type of nonclinical, physical device testing. The "test set" would refer to the physical devices themselves and the conditions under which they were tested according to ASTM standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical device mechanical testing is based on established engineering standards and measurements, not expert consensus on diagnostic images.

4. Adjudication method for the test set: Not applicable for this type of nonclinical testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This device is not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical spinal fixation system, not an algorithm.

7. The type of ground truth used: For the nonclinical performance data, the "ground truth" is defined by the objective physical measurements and engineering criteria outlined in the ASTM standards (F2706 and F1798).

8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

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The Momentum™ Posterior Spinal Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracolumbar and sacroiliac spine. When used as a posterior spine system, Momentum is intended for the following indications: degenerative disc disease, spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, and/ or lordosis), trauma (i.e., fracture or dislocation), tumor, pseudoarthrosis and failed previous fusion.

In order to achieve additional levels of fixation, the Momentum Posterior System can also be connected to the neon3® universal OCT spinal stabilization system via transition rods or connectors. Please refer to the neon3 Instructions for Use for a list of indications for use.

The Momentum™ Posterior Spinal Fixation System consists of longitudinal members (rods), anchors (screws), connectors (rod/rod and rod/anchor) and fasteners in a variety of sizes to accommodate differing anatomic requirements.

This document is a 510(k) summary for the Momentum™ Posterior Spinal Fixation System. It describes the device, its intended use, and its substantial equivalence to predicate devices, primarily based on mechanical testing. It does not describe an AI/ML-based medical device. Therefore, the questions related to acceptance criteria and studies proving the device meets those criteria, specifically concerning AI/ML performance metrics, ground truth, expert involvement, and sample sizes for AI model training/testing, are not applicable to the provided document.

The document focuses on the mechanical performance of a spinal fixation system. Below is the relevant information from the document related to its performance as a physical medical device, structured as closely as possible to the request, while noting the non-applicability of AI/ML specific criteria.

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• The document mentions "Mechanical testing of worst case Momentum™ System constructs." However, it does not specify the sample size (number of constructs tested) used for these mechanical tests.
• Data Provenance: Not specified, but generally, mechanical testing for medical devices is conducted in a laboratory setting, not typically described by country of origin or retrospective/prospective data.

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)

• This question is not applicable as the device is a mechanical spinal fixation system, not an AI/ML diagnostic or prognostic tool. "Ground truth" in this context would refer to the physical and mechanical properties measured in a lab, not expert interpretations of medical images or data.

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

• This question is not applicable. Mechanical testing typically involves predefined test methods and measurements, not adjudication by human experts.

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

• This question is not applicable as the device is a mechanical spinal fixation system and does not involve human readers or AI assistance.

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

• This question is not applicable as the device is a mechanical spinal fixation system and does not involve algorithms or AI.

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

• The "ground truth" for this device would be its measured mechanical properties (e.g., strength, stiffness, resistance to pull-off) determined experimentally and compared against established industry standards (ASTM F1717) and the performance of predicate devices. This is not "expert consensus," "pathology," or "outcomes data" in the medical sense.

8. The sample size for the training set

• This question is not applicable as the device is a mechanical spinal fixation system and does not involve AI/ML models with training sets.

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

• This question is not applicable for the same reason mentioned in point 8.

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