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The Biofusion Medical SI-Restore® Sacroiliac Joint Fixation Screw is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The SI-Restore® Sacroiliac Joint Fixation Screw consists of a cannulated, smooth or textured, titanium (Ti 6Al-4V ELI, per ATSM F136) screw with a titanium (Ti 6Al-4V ELI, per ATSM F136) washer affixed to the head of the screw for full cortex engagement. The implant is designed to prevent motion of the sacroiliac (SI) joint. The delivery system uses guide pins for accurate preparation and placement of the implant.

The provided document is a 510(k) Pre-market Notification from the FDA regarding a medical device, the SI-Restore® Sacroiliac Joint Fixation System. This type of document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with acceptance criteria for device performance (like an AI algorithm would need).

Therefore, the information requested in the prompt (acceptance criteria, details of a study proving the device meets them, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, and training set details) is NOT present in this document.

The document explicitly states:

• "Performance Data: Performance data is not included in this submission. The design changes being included for review do not present a new worst-case configuration that would require additional performance testing."

This indicates that clinical performance data of the type expected for an AI-powered diagnostic device, as outlined in your prompt, was not required or provided for this 510(k) submission because the changes to the device (a bone fixation screw) were considered minor and did not introduce new safety or effectiveness concerns requiring new performance data. The FDA's determination of substantial equivalence relies on comparison to existing, already cleared devices based on intended use, materials, and technological characteristics.

In summary, this document does not contain the information needed to answer your questions about acceptance criteria and a study proving device performance in the context of an AI/diagnostic device.

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The Biofusion Medical SI-Restore® Sacroiliac Joint Fixation System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The SI-Restore® Sacroiliac Joint Fixation System consists of a cannulated titanium (Ti 6AI4V ELI, per ATSM F136) screw with a titanium (Ti 6AI4V ELI, per ATSM F136) washer affixed to the head of the screw for full cortex engagement. The Implant is designed to prevent motion of the sacroiliac (SI) joint. The delivery system uses guide pins for accurate preparation for and placement of the implant.

The provided document is a 510(k) Premarket Notification for the Biofusion Medical SI-Restore® Sacroiliac Joint Fixation System. This document describes a medical device (a bone fixation system), not a software or AI/ML-based device. Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device, such as sample size for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable to this submission.

The document discusses the following types of performance data for this physical medical device:

• Static Axial Pull-out and Static Torque to Failure testing (per ASTM F543-13)
• Static Three-Point Bending and Dynamic Three-Point Bending (per ASTM F1264-14)

These tests confirmed that the device performed as intended and supported the claim of substantial equivalence to a legally marketed predicate device (SI-LOK™ Sacroiliac Joint Fixation System, K112028).

Since the request specifically asks about acceptance criteria and studies for an AI/ML device, and this document pertains to a physical orthopedic implant, I can only state that the requested information is not present in the provided text because the device in question is not an AI/ML product.

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