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Tiger® Occipital-Cervical-Thoracic Spinal Fixation System is intended to promote fusion of the cervical spine and the occipito-cervico-thoracic junction (occiput-T3). The system is intended to be used in skeletally mature patients as an adjunct to fusion using autograft and allograft for the following conditions: degenerative disc disease (DDD): defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies; spondylolisthesis; spinal stenosis; fracture/dislocation; atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumor.

The occipital bone screws are limited to occipital fixation only. Hook components are indicated for use from C1-C7. The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3). They are not intended to be placed in the cervical spine.

The Tiger® Occipital-Cervical-Thoracic Spinal Fixation System can be connected to the Tiger® Spine System using the side by side and end to end rod to rod connectors.

The CoreLink Tiger® OCT System consists of occipital plates, occipital bone screws, cervical hooks, upper thoracic pedicle screws, rods in both titanium and cobalt chrome, transverse connectors, and other various connectors. These components are manufactured from Ti-6Al-4V ELI in accordance with ASTM F136.

The provided text describes a 510(k) summary for the Tiger® OCT System, a spinal fixation system. It details the device's indications for use, description, predicate devices, and performance standards. However, it does not contain information regarding an AI/ML device or a study comparing device performance against acceptance criteria in the way typically expected for an AI/ML diagnostic or assistive tool.

The "Performance Standards" section refers to mechanical testing of the implantable device against ASTM F2706 standards, not a clinical performance study with human subjects, ground truth, or expert readers.

Therefore, many of the requested categories for AI/ML device evaluation are not applicable or cannot be extracted from this document.

Here's a breakdown of the information that can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

• Static Compression Bending
• Static Torsion
• Dynamic Torsion
• Dynamic Compression Bending | "ASTM F2706 performance standards were adhered to and all applicable requirements were met." (Specific numerical values or pass/fail thresholds are not provided in this summary.) |

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

• Not Applicable. This document describes mechanical testing of an implantable device, not a performance study on a test set of data (e.g., medical images) to evaluate an AI/ML algorithm.

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

• Not Applicable. No human experts were involved in establishing ground truth for mechanical device testing.

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

• Not Applicable. No adjudication method is relevant for mechanical device testing.

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:

• No. This is not an AI/ML device. No MRMC study was performed.

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

• Not Applicable. This is not an AI/ML device. No standalone algorithm performance was assessed.

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

• For the mechanical performance testing, the "ground truth" would be the engineering specifications and requirements outlined in ASTM F2706.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device. No training set was used.

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

• Not Applicable. This is not an AI/ML device. No training set ground truth was established.

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