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The iFuse Implant System is intended for sacroiliac joint fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruptions and degenerative sacroiliitis.

The iFuse Implant System® consists of porous plasma spray coated titanium implants and associated surgical instruments. The iFuse Implant lengths range from 30-90mm with a diameter of 4-7mm. Surgical treatment is accomplished using instrumentation similar to that previously described in K080398, K092375, K110838, K122074, K123850, K131405 and K141049.

The provided document does not contain any information about acceptance criteria or a study that proves the device meets acceptance criteria.

The document is a 510(k) premarket notification for the SI-BONE iFuse Implant System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance acceptance criteria through a de novo study.

Here's why the requested information cannot be extracted from this document:

• Acceptance Criteria and Reported Device Performance: This document states: "No performance data is required to support this Special 510(k)." This indicates that an explicit study with defined acceptance criteria and reported device performance was not part of this specific submission. The substantial equivalence argument relies on the predicate device's established performance, not new performance data for the current device.
• Sample Size, Data Provenance, Expert Ground Truth, Adjudication, MRMC Study, Standalone Performance, Ground Truth Type, Training Set Sample Size, and Training Set Ground Truth: All these items relate to the design and execution of a performance study. Since the document explicitly states "No performance data is required," none of this information is present.

Summary based on the provided document:

The device (SI-BONE iFuse Implant System) is considered substantially equivalent to its predicate devices (SI Joint Fusion System by SI-BONE, Inc. with various K numbers). The basis for this substantial equivalence is that "The iFuse Implant System has the same intended use, indications for use, and technological characteristics as the predicate device." Therefore, no new performance data or studies demonstrating specific acceptance criteria for the iFuse Implant System were provided or reviewed in this 510(k) submission.

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