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When used as a nonpedicle posterior system, the SCS system is indicated for patients with:

degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies spondylolisthesis fracture spinal stenosls deformities (i.e., scoliosis, kyphosis, lordosis) lumors pseudarthrosis failed previous fusion (pseudarthrosis)

When used as an anterolaterallanterior system the SCS system is indicated for patients with:

degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studios spondylolisthesis fracture spinal stenosls deformities (i.e., scoliosis, kyphosis, lordosis) tumors pseudarthrosis failed previous fusion (pseudarthrosls)

When used as a posterior pedicle svstem. the device is indicated for use in skeletally mature patients L3 & below who are:

having severe spondylollsthesis (Grades 3 and 4) at the L5-S1 joint

receiving fusions using autogenous bone graft only having the device fixed or attached to the lumbar and sacral spine

having the device removed after the development of a solid fusion mass.

Posterior pedicle systems are 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:

degenerative spondylolisthesis with objective evidence of neurologic impairment fracture dislocation scoliosis kyphosis spinal turnor failed previous fusion (pseudarthrosis)

This new connector is called the “Omni Axial Connector.” The part number is 7T20-CO04. It is made from titanium alloy as defined by the ASTM and ISO standards indicated below, TA6V ELI ASTM F136-92 ISO 5832-3. The Omniaxial Connector facilitates pedicle screw insertion by providing a range of adaptability of the screw path in the three axist, axial, sagittal and coronal. The OmntAxtal Connector is intended to be a "standard" component of the SCS Spinal System. The OmniAxtal Connector attaches to the spinal rods using the same connecting screw (2TD1-VS53) as used in the existing SCS Spinal System.

Here's a breakdown of the acceptance criteria and study information for the ORTHOTEC, LLC. OmniAxial Connector, based on the provided document:

This document is a 510(k) premarket notification for a medical device connector. The acceptance criteria and the study presented are focused on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving absolute clinical effectiveness or diagnostic accuracy as seen in AI/CADe devices. Therefore, many of the typical questions for AI/CADe will not be directly applicable (e.g., ground truth for training set, MRMC studies, effect size of AI assistance).

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: The document does not specify a numerical sample size for the mechanical and fatigue testing in terms of individual devices or components tested. It generally states that "Samples were tested."
• Data Provenance: Not applicable in the context of clinical data. The data provenance refers to mechanical and fatigue testing conducted by the manufacturer, ORTHOTEC, LLC. The testing is internal to the manufacturer for engineering validation.

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

• Not applicable. For this type of device (spinal implant connector), "ground truth" is established through engineering specifications, material standards, and benchmark testing against a predicate device, rather than expert clinical consensus on patient data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. Adjudication methods are relevant for studies involving human interpretation or clinical endpoints. This submission concerns mechanical performance. The "adjudication" is essentially the manufacturer's testing and a regulatory body's (FDA) review of that testing against established standards and predicate device data.

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:

• No. This is not an AI/CADe device. No MRMC study was conducted.

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

• Not applicable. This is not an algorithm or AI device. The "standalone performance" is the mechanical performance of the component itself, which was tested.

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

• For this device, the "ground truth" is defined by:
  • Engineering Standards: ASTM F-1717-96 guidance document for mechanical and fatigue testing.
  • Material Specifications: ASTM F136-92 and ISO 5832-3 for TA6V ELI titanium alloy.
  • Predicate Device Performance: The mechanical and functional characteristics of the previously cleared SCS Spinal System connector (K983353).

8. The sample size for the training set:

• Not applicable. This device does not involve a "training set" in the context of machine learning or algorithms. It is a physical medical device.

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

• Not applicable. As there is no training set for an algorithm, there is no ground truth to establish for it.

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