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The Liberty SI Lateral Implant System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The Liberty SI Lateral Implant System is a minimally invasive sacroliac joint fusion implantation across the joint space (i.e., the implant transfixes the Sl Lateral Implant System is composed of Ti-6Al-4V ELI titanium alloy per ASTM F136 and is partially coated with hydroxyapatite (HA) per ASTM F1185. To accommodate varying patient anatomy, the Liberty Sl Lateral Implants are available in multiple diameters and length offerings. The Liberty Sl Lateral Implants consist of a cannulated central threaded body that has deployable Wings and a Compressive Body. Using the designated instrument system, one or two implants may be inserted across the SI Joint to apply a compressive force across the joint and to provide stabilization and fusion. The Liberty SI Lateral Implants are single use devices that are provided sterile.

The provided text is a 510(k) summary for the Liberty SI Lateral Implant System. It describes the device, its intended use, and a comparison to a predicate device. However, it does not contain information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML powered device.

The document states: "Clinical performance testing was not performed for this submission." This explicitly indicates that no studies were conducted to assess the clinical performance of the device in a manner that would generate the kind of data typically associated with acceptance criteria for an AI/ML powered medical device.

Therefore, I cannot provide the requested information for the following reasons:

• No Acceptance Criteria: The document does not define any specific performance metrics or acceptance criteria for an AI/ML component.
• No Reported Device Performance for AI/ML: There is no reported performance for an AI/ML device, as the submission appears to be for a physical implant system.
• No Test Set Details: Information on sample size, data provenance, expert ground truth establishment, or adjudication methods for a test set is absent.
• No MRMC Study: There is no mention of a multi-reader multi-case comparative effectiveness study.
• No Standalone Performance: No standalone (algorithm-only) performance is discussed.
• No Ground Truth Type: No ground truth type for an AI/ML model is specified.
• No Training Set Details: There is no information regarding a training set or its ground truth establishment.

In summary, the provided document describes a medical device clearance for a sacroiliac joint implant system, not an AI/ML software device. Therefore, the requested information pertaining to AI/ML device acceptance criteria and performance studies is not available within this text.

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