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The TIGER™ Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral/iliac spine (T1 - S1/Ileum): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies). degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The TIGER™ Spine System is comprised of polyaxial pedicle screws, rods and crosslinks. The TIGER The System can be used for single or multiple level fixations. The pedicle screws are available in various lengths and diameters. The rods are available in straight and pre-lordosed (curved) configurations. The system has variable length cross connectors. The implants are manufactured from Ti6Al4V alloy.

This 510(k) summary describes a spinal implant system, not an AI/ML device, therefore, the requested information regarding acceptance criteria, study details, and ground truth establishment, which are specific to AI/ML device evaluations, cannot be provided.

The TIGER™ Spine System is a pedicle screw spinal system used for spinal immobilization and stabilization. The submission is for an expansion of its Indications For Use to include Degenerative Disc Disease (DDD).

The device's performance was evaluated through mechanical testing and comparison to predicate devices, not through a study involving AI/ML performance metrics.

Here's the relevant information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not applicable as this is a mechanical medical device, not an AI/ML device that uses a test set of data. The "testing" refers to mechanical integrity and performance as per ASTM standards for spinal implants.

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 information is not applicable. The device's "ground truth" is defined by its mechanical properties and performance against established ASTM standards for spinal implants, not by expert interpretation of data.

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

This information is not applicable. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, not for mechanical testing of hardware.

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 information is not applicable. This is a spinal implant system, not an AI-assisted diagnostic or clinical decision-making tool.

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

This information is not applicable. This is a physical medical device (spinal implant), not an algorithm.

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

The "ground truth" for this device's performance is established by adherence to mechanical testing standards (ASTM F1717), not expert consensus, pathology, or outcomes data in the context of an AI/ML model. The comparison is against previously cleared devices and their established performance and safety profiles.

8. The sample size for the training set

This information is not applicable as this is a mechanical medical device, not an AI/ML device that uses a training set.

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

This information is not applicable as this is a mechanical medical device, not an AI/ML device.

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