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The Radius® Spinal System is intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinaly stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed nrevious fusion.

The Radius® Spinal System can also be linked to the Xia® Titanium Spinal System via the Ø5.5 mm to Ø6.0 mm Radius® rod-to-rod connector.

This 510(k) is intended to introduce an extension to the existing Radius® Spinal System. The proposed line extension includes the addition of a Vitallium rod.

This document is a 510(k) premarket notification for a medical device (Radius Spinal System Line Extension – Vitallium Rod). It does not contain information about acceptance criteria or a study proving device performance in the way typically associated with AI/software devices.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices for a physical implantable device (spinal system with a Vitallium rod). Therefore, the questions related to AI/software performance metrics, training sets, and expert adjudication are not applicable to the content provided.

Here's an analysis based on the provided text, addressing the relevant aspects:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: The document implies that the "acceptance criteria" for this 510(k) revolve around demonstrating substantial equivalence to legally marketed predicate devices. This is achieved through:
  • Material comparability.
  • Design comparability.
  • Indications for Use comparability.
  • Compliance with FDA's "Guidance for Spinal System 510(k)'s May 3, 2004."
• Reported Device Performance:

  Aspect	Performance/Demonstration
  Material	"Documentation is provided which demonstrates the new components of the Stryker Spine Radius® Spinal System to be substantially equivalent to the predicate devices in terms of material..." (Vitallium rod being the new material).
  Design	"...substantially equivalent to the predicate devices in terms of... design..."
  Indications for Use	"The Radius® Spinal System is intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DDD)... spondylolisthesis; trauma... spinal stenosis; curvatures... tumor; pseudoarthrosis; and failed previous fusion." (This is identical to predicate devices).
  Engineering Analysis & Testing	"Engineering analysis and testing to demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 was completed for the Stryker Spine Radius® Spinal System, including the subject components."

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

• Not applicable. This submission is for a physical medical device, not a software/AI device that would use a "test set" in the context of performance evaluation with patient data. The "testing" mentioned refers to engineering and material testing, not clinical studies with patient data to establish performance metrics like sensitivity/specificity.

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

• Not applicable. See point 2.

4. Adjudication method for the test set

• Not applicable. See point 2.

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, not done. This is not an AI-assisted diagnostic or therapeutic device. It is a spinal implant.

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

• Not applicable. This device does not involve an algorithm.

7. The type of ground truth used

• Not applicable for AI/software devices requiring ground truth from patient data. For this physical device, the "ground truth" relates to established engineering standards, material properties, and the established safety and efficacy of the predicate devices. The "truth" is that the new Vitallium rod is comparable in function, safety, and effectiveness to existing, legally marketed spinal rods.

8. The sample size for the training set

• Not applicable. See point 2.

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

• Not applicable. See point 2.

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