(90 days)
The REUNION SI Joint System is indicated for skeletally mature patients for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
The Reunion Sacroiliac (SI) Joint Fusion System is a screw system designed to provide fixation across the sacroiliac joint to promote fusion. The screws are accompanied by a modular screw head that provides additional fixation points to the bone. A secondary screw option is a compression screw that does not affix to the modular heads. The system is supported by a comprehensive set of instruments to install the screw implants within the system.
The provided text is a 510(k) summary for the REUNION Sacroiliac Joint Fusion System. This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing, rather than presenting a study proving a device meets specific performance acceptance criteria for an AI/algorithm-based diagnostic or screening tool.
Therefore, the requested information regarding acceptance criteria, linked study designs, ground truth establishment, expert adjudication, or MRMC studies for an AI device is not applicable to this document.
Here's why and what information is available in the provided text:
- Device Type: The REUNION Sacroiliac Joint Fusion System is a physical medical device (a screw system for bone fixation), not an AI/algorithm.
- Approval Pathway: It's being approved via a 510(k) pathway, which primarily requires demonstrating substantial equivalence to a legally marketed predicate device, often through mechanical and material testing, rather than clinical performance trials to prove a specific numerical measure of diagnostic accuracy.
- "Clinical Test Summary": The document explicitly states "No clinical studies were performed" (page 5), reinforcing that the evaluation was not based on human clinical performance data against a specific acceptance criterion.
Based on the provided text, I cannot answer the questions regarding acceptance criteria and a study proving the device meets those criteria, as these concepts, in the context described (e.g., AI/algorithm performance), are not present or relevant to this 510(k) submission.
The acceptance criteria for this type of device (a physical implant) would typically be met through:
- Material compatibility and strength: Demonstrated by tests like those listed (Torsional Properties, Driving Torque, Axial Pullout Strength, Static/Dynamic Cantilever Bending) according to relevant ASTM standards. The "acceptance criteria" here would be meeting the specified mechanical property ranges or failure modes outlined in those standards, and showing equivalence to the predicate devices.
- Design and manufacturing controls: Adherence to Quality System (QS) regulation (21 CFR Part 820).
- Labeling requirements.
The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical tests summarized on page 5:
- Torsional Properties (ASTM F543)
- Driving Torque (ASTM F543)
- Axial Pullout Strength (ASTM F543)
- Static Cantilever Bending (ASTM F2193)
- Dynamic Cantilever Bending (ASTM F2193)
These tests are designed to show that the device performs mechanically as intended and is substantially equivalent to predicate devices. However, the document does not enumerate specific numerical acceptance criteria for these tests or explicitly state the reported device performance against those numerical criteria in a table within the provided text. It merely states that "The REUNION Sacroiliac Joint Fusion System is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performances."
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.