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The Inertia™ MIS Pedicle Screw System 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 (T1 to S2): severe spondylolisthesis (grades 3 and 4) of the L5-SI vertebra: degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; spinal stenosis; scoliosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Inertia™ MIS Pedicle Screw System consists of rods, polyaxial screws and set screws. Rods are available in either straight or pre-contoured (curved) forms and in a variety of lengths. Polyaxial screws are available in a variety of diameter-length combinations. Set screws are used to fasten the rod and polyaxial screw. The purpose of this 510(k) is to add cannulated pedicle screws to the Inertia™ MIS Pedicle Screw System.

The provided 510(k) summary for the Inertia™ MIS Pedicle Screw System describes a mechanical testing study to demonstrate substantial equivalence to a predicate device. This study focuses on engineering performance, not AI/ML-driven diagnostic or assistive capabilities. Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, sample size for training set, etc.) are not applicable to this type of device and study.

Here's a breakdown of the available information:

Acceptance Criteria and Reported Device Performance

Details of the study that proves the device meets the acceptance criteria:

1. Sample size used for the test set and the data provenance: Not applicable. This was mechanical testing, not a study involving patient data. The "test set" would refer to the physical devices tested.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established by engineering standards (ASTM F1717) and measurement, not expert consensus.
3. Adjudication method for the test set: Not applicable. This was mechanical testing against predefined engineering standards.
4. 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: No. This device is a pedicle screw system, a physical implant. It does not involve AI or human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This is a physical medical device, not an algorithm.
6. The type of ground truth used: Mechanical testing data compared against the performance requirements outlined in the ASTM F1717 standard and the company's "Design Control Activities Summary."
7. The sample size for the training set: Not applicable. There is no "training set" as this is not an AI/ML device.
8. How the ground truth for the training set was established: Not applicable.

Summary of the Study:

The study was a mechanical testing study conducted according to ASTM F1717. It involved testing the "worst case" subject Inertia™ MIS Pedicle Screw System and comparing its performance to the predicate Inertia™ Pedicle Screw System. The tests performed were:

• Static compression bending
• Dynamic compression bending
• Static torsion

The results of these tests were reported to have met the acceptance criteria defined in the Design Control Activities Summary. This demonstrates the substantial equivalence of the new cannulated pedicle screws to the predicate device in terms of mechanical performance.

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