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BoneSource® is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial skeleton.

The packaging contains the following: BoneSource® powder in a plastic bowl with a foil lid, sodium phosphate sterile solution in a syringe or vial, and a polycarbonate mixing spatula packaged in a Polyethylene Terephthalate Glycol Modified (PETG) tray. The kit is terminally sterilized by gamma irradiation. Kits may be provided in several different sizes.

This document is a 510(k) premarket notification for a medical device called Bonesource® HAC Fast Setting Cement. It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML device.

The provided text describes a traditional medical device (hydroxyapatite cement) and its substantial equivalence to previously marketed devices. There are no mentions of an algorithm, AI, machine learning, or any performance metrics like sensitivity, specificity, or AUC, nor any study conducted on such a system.

Therefore, I cannot fulfill the request to provide information regarding acceptance criteria and a study proving an AI/ML device meets them, as the provided input does not pertain to an AI/ML device.

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BoneSource® is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial skeleton.

The packaging contains the following: BoneSource® powder in a plastic bowl with a foil lid. Sodium phosphate sterile solution in a glass syringe with a plastic cap. A polycarbonate mixing spatula, and an instruction for use card packed in a Polyethylene Terephthalate Glycol Modified (PETG) tray. The kit is terminally sterilized by gamma irradiation. Packages are being provided in sizes ranging from 5g to 50g.

This document is a 510(k) summary for the Bonesource® HAC, a self-setting calcium phosphate cement. It seeks to establish substantial equivalence to previously cleared predicate devices. The information provided does not describe a study involving device performance through testing against acceptance criteria in the context of an AI/algorithm-driven medical device. Instead, it details a regulatory submission for a physical medical device (hydroxyapatite cement).

Therefore, I cannot fulfill your request for information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the provided document. The 510(k) summary focuses on demonstrating that the Bonesource® HAC is substantially equivalent to predicate devices based on its intended use, technological characteristics, and safety/effectiveness profile, as determined by the FDA's regulatory process for physical medical devices.

Ask a specific question about this device