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The subject Diapason Combo, like the predicate OSS Combination Screw Ring/Blocker, are intended for use only with the components of the commercially available Osteonics "Spinal System/ Diapason System. The Rods from the Xia Spinal System are intended to be used with the components of the Osteonics® Spinal System. The uses for the legally marketed Osteonics® Spinal System/Diapason System are as follows:

As a posterior, non-pedicle screw system of the T4-S2 spine, the Osteonics® Spinal System is indicated for:

• Long and short curve scoliosis .
• Vertebral fracture or dislocation .
• Spondylolisthesis .
• Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the . disc confirmed by history and radiographic studies).
• Previously failed fusion
• Spinal tumor .

Pedicular Use:

• When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally . mature patients, the Osteonics® Spinal System is indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
• In addition, the Osteonics® Spinal System is indicated for pedicle screw fixation in skeletally . mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, having fusions with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass.

The design change involves modifying the ring height, blocker height and assembly process of the predicate OSS Combination Screw Ring/Blocker. In addition, the submission covers use of predicate Xia 6 mm diameter Rods with the Osteonics Spinal System. The submission involves no change to the Xia rods themselves.

The subject component, a design modification to the Osteonics® Spinal System Combination Screw Ring/Blocker, is a single-use device which is sold non-sterile and is intended for use only with the other components of the commercially available Osteonics® Spinal System. The Rods from the Xia Spinal System are intended to be used with the components of the Osteonics® Spinal System.

This document describes a Special 510(k) submission for a device modification to the Osteonics® Spinal System, specifically for the Diapason Combo and the use of Xia 6mm diameter rods with the system. The submission does not contain information typically found in studies for AI/ML-based medical devices. Instead, it focuses on the mechanical performance of modified spinal implant components. Therefore, many of the requested categories related to AI/ML device studies (such as sample sizes for test/training sets, expert adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI models) are not applicable to this submission.

The "study" referenced in this document is a series of mechanical tests designed to demonstrate the comparable performance of the modified components to their predicates.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a number of "cases" or "patients" as this is a mechanical engineering study. The "sample size" would refer to the number of individual test specimens of the device components. This detail is not provided in the summary.
• Data Provenance: Not applicable. This is a laboratory study involving physical testing of materials/components, not patient data from a specific country or retrospective/prospective collection.

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

Not applicable. "Ground truth" in this context refers to established mechanical engineering standards and measurements, not expert clinical interpretation of medical data. The "experts" would be the engineers and technicians performing and analyzing the mechanical tests, operating under established protocols.

4. Adjudication method for the test set

Not applicable. This is a mechanical testing study, not a clinical study requiring adjudication of expert opinions. The determination of "comparable" or "acceptable" performance would be based on engineering analysis and adherence to pre-defined test protocols and measurable criteria.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• MRMC Study: No.
• Effect Size of AI: Not applicable, as this is not an AI-based device.

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

Not applicable, as this is not an AI-based device.

7. The type of ground truth used

The "ground truth" for this engineering study is based on:

• Established Mechanical Engineering Principles and Standards: This includes accepted methods for static and fatigue testing of spinal implants.
• Performance of Predicate Devices: The key ground truth for comparison is the documented and accepted mechanical performance of the previously cleared Osteonics® Spinal System components (the OSS Screw Blocker and Cap) and the Xia 6mm diameter rods. The goal is to show "comparable" or "acceptable" properties relative to these established devices.

8. The sample size for the training set

Not applicable. This is a mechanical testing study, not a machine learning study that requires a training set.

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

Not applicable, as this is not a machine learning study.

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