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The TIGER™ Spine System is intended to provide immobilization 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 (TI Si/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 turnor, and failed previous fusion (pseudarthrosis).

The TIGER™ Spine System is composed of rods, connectors, and pedicle screws. It can be used for single or multiple level fixations.

The purpose of this premarket notification is twofold: 1) the addition of new components to the TIGER™ Spine System, 2) Size range expansion and 3) expand the Indications For Use statement to include Degenerative Disc Disease (DDD) for previously cleared components of the system.

The provided text describes a Special 510(k) Summary for the Tiger™ Spine System, which is a medical device. This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness or safety through extensive clinical trials. Therefore, the information typically requested in your prompt (especially related to AI/algorithm performance, ground truth, and expert consensus for a separate study) is not applicable to this document.

However, I can extract the relevant information regarding the "acceptance criteria" and the "study that proves the device meets the acceptance criteria" as presented in this 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated. The tests were "non-clinical" and likely involved a number of manufactured devices/components for mechanical testing.
• Data Provenance: Not applicable in the context of clinical data. The tests were laboratory-based mechanical performance tests.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This is not applicable. The "ground truth" for mechanical testing is established by the specified ASTM standards and the physical properties of the materials and design. No humans were involved in interpreting data for ground truth in this context.

4. Adjudication Method

Not applicable. Mechanical tests have objective pass/fail criteria based on physical measurements against established standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This document explicitly states, "No clinical studies were performed." and details non-clinical mechanical testing. MRMC studies are for evaluating human reader performance, often with AI assistance, which is not relevant here.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This document describes a physical medical device (pedicle screw system), not an algorithm or AI.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests was established by the ASTM standards (ASTM F1798 and ASTM F1717) which define the test methodologies and acceptance parameters for spinal implant constructs. Equivalence was demonstrated through engineering rationale comparing the test results to the predicate device's performance, as per these standards.

8. Sample Size for the Training Set

Not applicable. This is a physical device, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. (See #8)

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