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Synthes Antegra System is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels.

Synthes Antegra System is indicated in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of the following:
Fracture (including dislocation and subluxation), Tumor, Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), Pseudoarthrosis, Spondylolysis, Spondylolisthesis, Scoliosis, Lordotic deformities of the spine, Spinal stenosis, and Failed previous spine surgery.

Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The Synthes Antegra System consists of lumbar and sacral plates (one-level and two-level) and cancellous screws with locking heads. The plate attaches to the anterior portion of the lumbar and lumbosacral spine (L1-S1).
The screw heads and screw holes in the plates have matching conical profiles and are threaded. The screw head locks to the plate and is nominally flush with the plate surface when properly seated. The screws have a dual-core design.
The plates and screws are manufactured from Titanium Aluminum Niobium (Ti-6Al-7Nb) ASTM F1295, the same as the predicate device.

The Synthes Antegra System, a lumbosacral plate fixation system, did not require a clinical study to prove its acceptance criteria. Its acceptance was based on a non-clinical bench testing comparison to a predicate device, the Synthes Anterior Tension Band (ATB) System (K022791).

Here's a breakdown of the information as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable. The study was non-clinical bench testing.
• Data Provenance: Not applicable. The study involved laboratory bench testing of physical devices, not patient data.

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

• Number of Experts: Not applicable. Ground truth for non-clinical bench testing is typically established by engineering standards and validated testing protocols.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The evaluation was based on objective measurements and comparison to established engineering standards and the predicate device's performance.

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

• MRMC Study: No. This was a non-clinical evaluation of a surgical implant, not an AI-assisted diagnostic device.

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

• Standalone Study: No. This was a non-clinical evaluation of a surgical implant, not an algorithm.

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

• Type of Ground Truth: The ground truth was established through engineering and biomechanical testing standards and by comparison to the performance characteristics of the legally marketed predicate device (Synthes Anterior Tension Band System - K022791). This involved objective measurements of mechanical properties such as strength, stiffness, and fatigue resistance.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This was a non-clinical study comparing physical devices, not an AI model requiring a training set.

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

• How Ground Truth for Training Set was Established: Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The acceptance of the Synthes Antegra System was established through non-clinical bench testing. This testing successfully demonstrated that the Synthes Antegra System is substantially equivalent to its predicate device, the Synthes Anterior Tension Band (ATB) System (K022791), in terms of its design, function, materials, and mechanical performance. The FDA determined that clinical data and conclusions were not needed for this device due to this strong non-clinical equivalency. The device's materials (Titanium Aluminum Niobium (Ti-6Al-7Nb) ASTM F1295) are identical to the predicate device. The changes were identified as design modifications to the predicate, and the regulatory filing emphasized that these modifications did not raise new questions of safety or effectiveness.

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