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The Spinal Elements Cerclage System is intended for use in cardiovascular surgery. The indications for use include cardiovascular surgery for closure of the sternotomy. The system is intended to provide temporary stabilization during the development of solid bony fusion.

The Spinal Elements Cerclage System is a temporary implant to be used in orthopedic surgery. The Spinal Elements Cerclage System is a bony anchor designed to provide temporary stabilization of the spine for bony fusion or consolidation of a fracture. The Spinal Elements Cerclage System is designed for a posterior approach. The indications for use include the following applications:

1. Spinal trauma surgery: The Spinal Elements Cerclage implants can be used in sublaminar wiring techniques;
2. Spinal degenerative surgery: The Spinal Elements Cerclage implants may be used as an adjunct to spinal fusions with bone graft (autograft or allograft) at level(s) of use.

The Spinal Elements Cerclage System consists of a strap manufactured from PEEK conforming to ASTM F2026 compounded with 7.5% barium sulphate for radiopacity. The leading tip of the device is comprised of a spherical feature followed by a tapered neck to allow for an instrument to assist in advancing the strap around the bony structures to be secured. The spherical tip contains a tantalum pin for visualization when fluoroscopic imaging is used. The device has teeth along its length that interact with a latching mechanism at the opposite end of the strap. The latch allows a loop created by feeding the strap through the latch to be made consecutively shorter or taught by continuing to pull the strap through the latch. Prior to creating the loop, the spherical tip of the device is cut off and discarded to allow for the strap to pass through the latch. The latch resists the lengthening of the loop due to forces that would pull the strap in the opposite direction, thereby securing the structures intended to be fixed. Once the desired loop length is reached, the unneeded portion of the strap may be cut off and discarded.

The provided text describes a 510(k) premarket notification for the "Spinal Elements Cerclage System," a medical device and does not contain information about an AI/ML device or a study involving acceptance criteria for an AI/ML product. The document is a regulatory submission for a physical medical implant, not a software algorithm. Therefore, I cannot extract the requested information related to AI/ML device performance, ground truth, sample sizes for test/training sets, expert adjudication, or MRMC studies.

The document discusses non-clinical testing to demonstrate mechanical strength and substantial equivalence to a predicate device, which are typical requirements for physical implants, but these are not related to AI/ML acceptance criteria.

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