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When used as a pedicle screw fixation system in the non-cervical posterior spine (T1-S1) in skeletally mature patients, the R&D Innovation 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: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, deformities or curvatures (i.e., scoliosis, and/or lordosis), (5) spinal stenosis, (6) curvatures (i.e., scoliosis, kyphosis, and/or lordosis, (7) tumor, (8) failed previous fusion (i.e. pseudarthrosis).

The R&D Innovation Pedicle Screw System is a polyaxial pedicle screw system with straight or precontoured crosslink to provide optimal supporting structure for the spinal bodies. The pedicle screw system is a surgically implantable device which is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine.

The R&D Innovation Pedicle Screw System is a spinal implant for immobilization and stabilization of spinal segments. The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices primarily through non-clinical performance testing.

1. Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: Not applicable. The primary evidence presented for substantial equivalence consists of mechanical and material testing, not a clinical test set with human subjects.
• Data Provenance: Not applicable. The data provenance is from laboratory testing of the device and its materials against specified ASTM and ANSI/AAMI standards. It is not from human clinical data or real-world usage.

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

• Not applicable. Ground truth for a clinical test set is not relevant here as the study is based on non-clinical engineering and material standards. The "ground truth" is adherence to established engineering and material specifications.

4. Adjudication method for the test set:

• Not applicable. There was no clinical test set requiring adjudication.

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 medical device (pedicle screw system), not an AI-powered diagnostic or assistive tool. No MRMC study was conducted.

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

• Not applicable. This device is a physical implant, not a software algorithm.

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

• The "ground truth" in this context is adherence to established engineering and material standards (e.g., specific ASTM and ANSI/AAMI standards for material composition, sterility, and mechanical performance). It is not based on expert clinical consensus, pathology, or patient outcomes data.

8. The sample size for the training set:

• Not applicable. There was no machine learning algorithm involved, and therefore no training set.

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

• Not applicable. There was no training set. The ground truth for the device's performance relies on its compliance with established industry standards and mechanical testing results.

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