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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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The Xia® Spinal System and Xia® 4.5 Spinal System are 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); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The 6 mm diameter rods from the DIAPASONTM Spinal System and OPUS™ Spinal System are intended to be used with the other components of the Xia® Titanium Spinal System. The Titanium Multi-Axial Cross Connectors are intended to be used with the other components of the Xia® Titanium Spinal System.

The Stryker Spine Xia Spinal System consists of Ø6mm rods, Monoaxial and Polyaxial screws, Hooks, Blockers, and Monoaxial and Polyaxial Cross Connectors. The Xia® 4.5 Spinal System is comprised of Ø 4.5 mm rods, Polyaxial and Monoaxial bone screws, Blockers, Hooks, Dual Staples, and Connectors. The components of both systems are available in a variety of diameters and lengths in order to accommodate patient anatomy and are fabricated from titanium alloy. The implants are provided non-sterile and are used for either posterior or anterior/anteral non-cervical spinal fixation.

This submission is intended to address a line extension to both the Xia® Titanium and Xia® 4.5 Spinal Systems (K060361). The line extension for the Xia® Titanium Spinal System includes:

• . A new Ø6mm spinal rod fabricated from Cobalt-Chromium-Molybdenum Alloy (Vitallium®).
  The line extension for the Xia® 4.5 Spinal System includes:
• New Ø4mm monoaxial titanium alloy screw in lengths of 20mm to 40mm in five 미 millimeter increments,
• 트 New Ø4mm polyaxial titanium alloy screw in lengths of 20mm to 40mm in five millimeter increments, and
• New Ø 4.5mm spinal rod fabricated from Cobalt-Chromium-Molybdenum Alloy . (Vitallium®).

The provided text describes a 510(k) submission for a line extension to the Xia® Titanium Spinal System and Xia® 4.5 Spinal System. It does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of typical AI/ML device performance studies (e.g., sensitivity, specificity, AUC, etc.).

Instead, this submission is for a medical device (spinal system components), and the "study" mentioned refers to mechanical testing to demonstrate comparable mechanical properties to predicate devices. The acceptance criteria for such a device would typically involve satisfying specific mechanical and material properties as stipulated by relevant ISO standards or FDA guidance for spinal implants.

Based on the provided text, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance:
   The document states: "Mechanical testing also demonstrated comparable mechanical properties to the predicate devices." This implies that the acceptance criterion was "comparable mechanical properties" to the predicate devices, and the reported performance was that this comparison was met. However, no specific quantitative criteria (e.g., minimum bending strength, fatigue life, etc.) or specific performance values are provided in this summary.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
   This information is not available in the provided text. Mechanical testing typically involves material samples or prototypes, not patient-derived data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
   This information is not applicable and not available in the provided text. "Ground truth" in the context of this device's mechanical testing refers to established engineering standards and material science principles, not expert clinical interpretation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   This information is not applicable and not available in the provided text, as it pertains to clinical data adjudication, not mechanical testing.

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:
   This information is not applicable and not available in the provided text. This device is a physical spinal implant, not an AI/ML-assisted diagnostic or therapeutic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   This information is not applicable and not available in the provided text. This device is a physical spinal implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   For mechanical testing, the "ground truth" is typically defined by established engineering standards and material specifications for spinal implants. The submission implies that the mechanical properties of the new components were compared against those of the predicate devices, which are presumed to meet such standards.

8. The sample size for the training set:
   This information is not applicable and not available in the provided text. "Training set" is relevant for AI/ML models, not for mechanical testing of physical implants.

9. How the ground truth for the training set was established:
   This information is not applicable and not available in the provided text. See point 8.

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