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The Invictus™ OsseoScrew® System (for use with the Invictus™ Spinal Fixation System and the transition rods from the Invictus™ CT Spinal Fixation System) is 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 OsseoScrew is a pedicle screw system that consists of pedicle screws and associated general instruments. Implant components are available in a variety of sizes to suit the individual pathology and anatomical conditions of the patient. The subject cannulated polyaxial pedicle screws are in diameters of 6.5 mm and 7.5 mm with lengths ranging from 40 to 55 mm. The Invictus OsseoScrew is designed to be compatible with the Invictus Spinal Fixation System screws, hooks, rods, connectors, and cross-connectors for the thoracolumbar spine and Invictus CT Spinal Fixation System for the cervical (C1 to C7) to thoracic (T1-T3) spine. The Alphatec Spine Invictus OsseoScrew System is an implantable pedicle screw device whose core is manufactured from titanium alloy (Ti-6A1-4V ELI) conforming to ASTM F136 and the expandable screw shank is manufactured from CP2 Titanium conforming to ASTM F67 which are both industry recognized standards.

The device described is the Invictus™ OsseoScrew® System, a pedicle screw system. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting comprehensive clinical study data for device performance against specific acceptance criteria for AI/ML.

Based on the provided text, there is no information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered device. The document pertains to a medical implant and its mechanical performance.

Therefore, many of the requested fields cannot be filled based on the provided text.

Here's an analysis of the information that can be extracted or inferred from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable. The document discusses nonclinical testing for mechanical properties of the implant, not performance criteria for an AI/ML powered device. The "performance data" section lists mechanical tests according to ASTM standards for spinal implant systems. The "results demonstrate that the subject device is substantially equivalent to other predicate devices for nonclinical testing," implying that the performance met regulatory expectations for substantial equivalence based on these mechanical tests.

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

Not applicable. This information is relevant for AI/ML studies, not for the mechanical testing of a pedicle screw system described here.

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

Not applicable. This information is relevant for AI/ML studies, not for the mechanical testing of a pedicle screw system described here.

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

Not applicable. This information is relevant for AI/ML studies, not for the mechanical testing of a pedicle screw system described here.

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 information is relevant for AI/ML studies, not for the mechanical testing of a pedicle screw system described here.

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

Not applicable. The device is a physical pedicle screw system, not an algorithm.

7. The type of ground truth used:

Not applicable. For the mechanical testing mentioned, the "ground truth" would be established by the physical properties and failure points observed during the ASTM standard tests, compared against industry standards and predicate device performance. It's not a concept of "ground truth" as used in AI/ML validation.

8. The sample size for the training set:

Not applicable. This information is relevant for AI/ML studies, not for the mechanical testing of a pedicle screw system described here.

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

Not applicable. This information is relevant for AI/ML studies, not for the mechanical testing of a pedicle screw system described here.

In summary, the provided document does not contain information related to the acceptance criteria or study design for an AI/ML powered medical device. It details a 510(k) submission for a physical medical implant (pedicle screw system) and its nonclinical mechanical testing for substantial equivalence.

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