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The Stryker Spine XIA® III Spinal System is intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation system, the XIA®III Spinal System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: 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, kyphosis, and/or lordosis); Tumor; Pseudoarthrosis; and Failed previous fusion. The Ø5.5mm rods from the Stryker Spine Radius™ Spinal System and Ø6.0 mm Vitallium rods from XIA® Spinal System are intended to be used with the other components of Xia® III Spinal System.

The Stryker Spine Xia® III Spinal System is comprised of monoaxial & polyaxial bone screws, blocker (as a locking mechanism), rods, hooks, and connectors. The implants are manufactured from Ti6Al4V alloy, and CPTi. The subject system also offers MoCoCr alloy (Vitallium) rods.

The Stryker Spine Xia® III Spinal System is a spinal fixation system. The provided text indicates that its performance was assessed through testing in compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004. This testing demonstrated substantial equivalent performance characteristics to the predicate device systems.

However, the provided document does not contain detailed information regarding specific acceptance criteria, reported device performance metrics, sample sizes, data provenance, expert ground truth establishment, adjudication methods, or specific study types (MRMC or standalone AI studies).

Therefore, I can only provide the information that is explicitly stated or can be inferred from the text.

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

The document does not provide a specific table of acceptance criteria with numerical values or detailed reported device performance. It generally states:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document.

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 provided in the document. It's important to note that this is a spinal implant, and "ground truth" may not be established by medical experts in the same way it would be for an AI diagnostic device. Instead, performance is typically assessed through mechanical and biocompatibility testing.

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

This information is not provided in the document.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done, nor would it be applicable for this type of medical device (a spinal implant). MRMC studies are typically performed for diagnostic imaging devices where human interpretation is involved, often with AI assistance. This device is an implant for surgical use.

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

This question is not applicable as the device is a spinal implant, not an algorithm or AI system. Its performance is assessed through various engineering and biocompatibility tests, not algorithmic output.

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

Given that this is a spinal implant, the "ground truth" for its performance would likely be based on engineering standards, materials testing results (e.g., strength, fatigue, biocompatibility), and potentially pre-clinical data on mechanical stability and integration. The document mentions "testing in compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004," which would involve these types of evaluations. Expert consensus, pathology, or outcomes data are not explicitly mentioned as the primary ground truth for its performance in this 510(k) summary for substantial equivalence.

8. The sample size for the training set

This information is not provided and is not applicable as this is not an AI or machine learning device requiring a training set.

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

This information is not provided and is not applicable as this is not an AI or machine learning device requiring a training set.

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