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The BioFlex® 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 the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, kyphosis, failed previous fusion (pseudoarthrosis).

In addition, the BioFlex® is indicated for use in patients:

• . Who are receiving fusions with autogenous graft only;
• . Who are having the device fixed or attached to the lumbar or sacral spine:
• t Who are having the device removed after the development of a solid fusion mass.

The BioFlex® is comprised spring-like rods and pedicle screws. All components are manufactured from medical grade titanium alloy (Ti6Al4V).

This is a 510(k) premarket notification for a medical device called BioFlex®, a pedicle screw spinal system. This document package does not contain a study with acceptance criteria or performance data as typically seen in AI/ML performance studies. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on design, function, materials, and intended use.

Therefore, many of the requested sections (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training sets) are not applicable to the information provided in this 510(k) submission.

Here's the information that can be extracted or deduced from the provided text:

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

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

• Not Applicable. This submission does not describe a "test set" in the context of an algorithmic performance study. The "testing performed" refers to verification and validation activities (likely mechanical and material testing) to demonstrate substantial equivalence, not a clinical performance validation against a ground truth.

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):

• Not Applicable. No ground truth establishment by experts for a test set is described.

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

• Not Applicable. No test set or adjudication method is described.

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 is a hardware device (pedicle screw system), not an AI/ML diagnostic or assistive device. Therefore, no MRMC study comparing human readers with and without AI assistance was performed or is relevant.

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

• Not Applicable. This is a hardware device.

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

• Not Applicable. For this hardware device submission, "ground truth" isn't established in the context of diagnostic accuracy. Substantial equivalence is established through engineering and material testing, and comparison to legally marketed predicate devices.

8. The sample size for the training set:

• Not Applicable. This is a hardware device, not an AI/ML product requiring a training set.

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

• Not Applicable. This is a hardware device, not an AI/ML product.

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