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The Affix® Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1 - S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion in the following conditions:

• . Degenerative disc disease - 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)
• Tumor
  The Affix Spinous Process Plate System is not intended for stand-alone use.

The Affix® Spinous Process Plate is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion, and is not intended for stand-alone use. When the Affix Plate is used as supplemental fixation in interbody fusion procedures, its use is limited to the treatment of degenerative disc disease (DDD) of the lumbosacral spine (L2-S1).

This document is a 510(k) summary for the Affix® Spinous Process Plate System, seeking to modify the Surgical Technique. As such, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through new data generation. Instead, it relies on substantial equivalence to predicate devices.

Therefore, most of the requested information cannot be extracted from this document, as the submission states:

• "No new performance data was generated for the purpose of this submission."

Here's a breakdown of what can be answered and what cannot:

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

Explanation: This 510(k) submission focuses on a modification to the surgical technique and asserts substantial equivalence to predicate devices. It does not provide specific acceptance criteria or performance data for new testing.

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

• Sample Size: Not applicable. No test set was used for this specific submission as no new performance data was generated.
• Data Provenance: Not applicable.

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)

• Number of Experts: Not applicable.
• Qualifications of Experts: Not applicable.

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

• Adjudication method: Not applicable.

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

• MRMC Study: No. This is a medical implant, not an AI-assisted diagnostic device.

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

• Standalone Performance: No. This is a medical implant, not an algorithm.

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

• Ground Truth Type: Not applicable. No new study requiring ground truth was conducted for this submission.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not an AI/machine learning device.

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

• Ground Truth Establishment: Not applicable.

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