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Intended for use in reconstruction of natural or surgical periodontal defects of the oral and maxillofacial region, including sinus floor elevation and augmentation of the alveolar crest.

Intended for filling into the site of a bony defect in combination with patient blood, autologous bone, membranes or sterile saline after removal of cysts or surgical removal of retained teeth.

ArrowBone-B consists of high purity Tricalcium Phosphate Ceramics of which the Ca/P ratio is 1.50. It is manufactured by a validated manufacturing process which guarantees pure-phase materials depending on the sintering temperature. This process is illustrated in Appendix I. Basically, it involves the well-established methods of wet synthesis from phosphoric acid and calcium hydroxide in dilute solution, spray drying to make spherical aggregates, calcination of the aggregates, x-ray diffraction analysis/identification of impurities, removal of fines by sieving, and molding of the particles into porous granules. These are then sintered at the selected temperature for the product which incinerates and removes the binder, hydroxypropyl cellulose, for which the specifications are shown in Appendix 1.6.

The chemical composition of this material is shown. It can be identified by x-ray powder diffraction analysis as pure-phase beta-Tricalcium Phosphate Ceramic in ArrowBone-B. The diffraction analysis is provided.. The identifying peaks as shown on these patterns for ßtricalcium phosphate are indicated by open circles. These data show that the crystalline structure of ArrowBone-B is pure-phase beta-Tricalcium Phosphate

No acceptance criteria or study demonstrating that the device meets acceptance criteria are described in the provided text. The document is a 510(k) summary for ArrowBone-B, focusing on substantial equivalence to predicate devices, and details about its composition, manufacturing, and general compliance with performance standards and regulations.

The document does mention an "extensive animal implantation study of ArrowBone-B was recently conducted by independent scientists at the Tokyo Medical and Dental University" (Section VIII, not fully provided, but mentioned in Section VII. Substantial Equivalence). This study observed "biocompatibility and biodegradation of TCP, which was absorbed by new bone." However, this is presented as evidence for substantial equivalence and biocompatibility, not as a study proving specific performance criteria against a set of defined acceptance criteria for device function in humans.

Therefore, I cannot provide the requested table or information because the input text does not contain acceptance criteria for device performance nor a study designed to prove the device meets such criteria.

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