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The Dyflex-II is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the Dyflex-II 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 the thoracic, lumbar and sacral spine: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudarthrosis).

The Dyflex-II is a non-cervical pedicle screw and rod system intended to facilitate the surgical correction of spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The Dyflex-II of screws, rods, cross-link connectors, and bolts that can be implanted via percutaneous surgical approach. The components are available in a variety of diameters and lengths in order to accommodate patient anatomy and are fabricated from titanium alloy (ASTM F 136). The implants will be provided non-sterile and the user need to sterilize them before use.

This is a 510(k) premarket notification for the Dyflex-II, a thoracolumbosacral pedicle screw system. The submission aims to demonstrate substantial equivalence to a predicate device, the 4STM Spinal System (K063708).

Here's an analysis of the provided information concerning acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a pedicle screw system, and its "performance" is primarily assessed through mechanical testing to ensure structural integrity and equivalence to the predicate device.

• Static Torsion Test
• Static Compression Bending Test
• Dynamic Compressive Fatigue Test | Tests performed according to ASTM F 1717 for all listed items. Results supported substantial equivalence despite minor exterior design differences. Met. |
  | Screw Size Range (Diameters) | Diameters: 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0mm (Predicate) | Diameters: 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0mm (Dyflex-II) |
  | Screw Size Range (Lengths) | Lengths: 30 to 55mm (Predicate) | Lengths: 30 to 50mm (Dyflex-II) |
  | Rod Size Range (Diameters) | Diameters: 5.5, 6.0mm (Predicate) | Diameters: 5.5, 6.0mm (Dyflex-II) |
  | Rod Size Range (Lengths) | Lengths: 30 to 200mm (Predicate) | Lengths: 30 to 200mm (Dyflex-II) |

Overall Conclusion: The Dyflex-II is deemed substantially equivalent to the predicate device based on similar indications for use, technological characteristics, material, principles of operation, and successful mechanical testing according to industry standards. The size range of the subject device is covered by or very similar to the predicate device.

The document provided is a 510(k) submission for a mechanical medical device (pedicle screw system), not an AI/software as a medical device (SaMD). Therefore, many of the requested items (e.g., test set sample size, provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set) are not applicable to this type of device submission.

Here's why and what information is pertinent to this submission:

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

• Not Applicable. This is a mechanical device. The "test set" refers to physical samples of the device components that undergo mechanical stress testing. The document does not specify the exact number of samples for each mechanical test (e.g., number of screws tested for static torsion). Data provenance is not typically described in terms of geographical origin for mechanical test results; rather, it refers to the conditions and methods under which the tests were conducted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. Mechanical test results for a pedicle screw system do not rely on expert interpretation to establish ground truth in the way medical images or clinical outcomes do. The "ground truth" is determined by objective physical measurements against established engineering standards (ASTM F 1717).

4. Adjudication method for the test set:

• Not Applicable. Since there's no expert interpretation or subjective assessment creating a "ground truth," no adjudication method is needed or 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. MRMC studies are relevant for devices involving human interpretation (e.g., radiologists reading images) where AI might assist. This is a mechanical implant.

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

• Not Applicable. This is not an AI algorithm.

7. The type of ground truth used:

• Engineering Standards / Objective Measurements. For mechanical devices, the "ground truth" is defined by compliance with established engineering standards (e.g., ASTM F 1717) and objective measurements of mechanical properties (e.g., static torsion, compressive fatigue limits).

8. The sample size for the training set:

• Not Applicable. This device does not involve a "training set" in the context of machine learning.

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

• Not Applicable. No training set is involved.

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