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The Spinal Alignment Solutions Pelvic Incidence (PI) Rod System is indicated for the use with Medtronic CD Horizon™ SOLERA™ Spinal System which is intended for posterior, lumbar and sacral fixation in skeletally mature patients as an adjunct to fusion 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, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

The Spinal Alignment Solutions Pelvic Incidence (PI) Rod System consists of pre-bent spinal rods compatible for use with the Medtronic CD Horizon™ SOLERA™ Spinal System. The SAS PI Rod System is manufactured from either titanium alloy or cobalt chrome.

The CD Horizon™ Spinal System consists of a variety of shapes and size of rods, screws, CROSSLINK® Plates, and connecting components which can be rigidly locked into avariety of configurations, with each construct being tailor-made for the individual case.

This looks like a 510(k) clearance letter for a medical device, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study of the device's performance against specific acceptance criteria for AI/software-as-a-medical-device (SaMD).

The provided text discusses a "Spinal Alignment Solutions Pelvic Incidence (PI) Rod System," which appears to be a physical medical device (pre-bent spinal rods) intended for use with an existing spinal system (Medtronic CD Horizon™ SOLERA™ Spinal System). It is not a software-based or AI-driven device.

Therefore, the prompt's request for:
1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth
4. Adjudication method
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

...are not applicable to the content provided. The document describes a traditional medical device submission, where "Performance Testing" refers to mechanical testing (or the absence thereof, as noted in this case, due to substantial equivalence) rather than clinical performance or AI algorithm validation.

The key statement in the document regarding "Performance Testing" is:

"When used with the Medtronic CD Horizon™ SOLERA™ Spinal System the subject SAS PI Rods have the same fundamental scientific technology, indications for use, intended use, materials, manufacturing processes, and levels of attachment as the predicate CD Horizon™ SOLERA™ Spinal System devices. The subject device does not introduce a new worst case condition and therefore, no additional mechanical testing was performed."

This indicates that the clearance was based on the substantial equivalence principle, asserting that the new device is so similar to an already cleared device that no new performance studies (mechanical or otherwise) were deemed necessary by the FDA. The "acceptance criteria" for a traditional mechanical device would typically involve meeting specific mechanical strength or fatigue standards, but these are not detailed here because the pre-bent rods are considered equivalent to the existing predicate rods.

In summary, as the provided text pertains to a physical medical device (spinal rods) and a 510(k) submission based on substantial equivalence, it does not contain the information requested about acceptance criteria, study design, ground truth, or expert involvement typically associated with the validation of AI/SaMD devices.

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