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The Diamondback™ Spinal System is designed to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion in skeletally mature patients. The system is intended for posterior, pedicle fixation for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra. In addition, when used as a pedicle screw fixation system of the non-cervical posterior spine (T1 to S2) the system is intended for the treatment of the following acute and chronic instabilities or deformities: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion.

The Diamondback™ Spinal System consists of rods, monoaxial and polyaxial screws with caps, and cross connectors with lock screws. Rods are available either straight or pre-contoured in a variety of lengths. Monoaxial and polyaxial screws are available in a variety of diameter-length combinations.

The Diamondback™ Spinal System is a spinal implant system with acceptance criteria and performance data as follows:

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: The document refers to "worst case Diamondback™ Spinal System construct" for mechanical testing, implying a specific configuration or small set of configurations for testing. A numerical sample size for individual tests (e.g., number of constructs tested) is not explicitly provided in the excerpt.
• Data Provenance: The testing was "performed according to ASTM F1717," indicating laboratory-based mechanical testing. The country of origin for the data is not specified, but the submission is to the US FDA. The nature of the data is retrospective as it refers to performance of the device rather than a clinical trial.

3. Number of Experts and Qualifications

This document describes a premarket notification (510(k)) for a medical device (spinal implant), not an AI/software device. Therefore, the concept of "experts used to establish the ground truth for the test set" in the context of clinical interpretation or image analysis does not apply here. The "experts" involved would be mechanical engineers or testing professionals who conduct and analyze the ASTM F1717 tests. Their qualifications are not explicitly stated.

4. Adjudication Method

Not applicable. This is a mechanical device submission, not a study requiring adjudication of clinical or imaging data.

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

Not applicable. This is a mechanical device, not an AI or software-assisted diagnostic tool for which MRMC studies would be relevant.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a mechanical device, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established by demonstrating mechanical equivalence or superiority to predicate devices as measured by standardized mechanical testing (ASTM F1717) and by technical characteristics (design, materials, sizes). The predicate devices are legally marketed devices that have a history of safe and effective use.

8. Sample Size for the Training Set

Not applicable. This is a mechanical device, not an AI system that requires a training set.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a mechanical device.

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