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Bone Plus ™ BCP Eagle Eye is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

• Augmentation or reconstructive treatment of alveolar ridge .
• Filling of periodontal defects .
• Filling of defects after root resection, apicocectomy, and cystectomy .
• Filling of extraction sockets to enhance preservation of the alveolar ridge .
• Elevation of maxillary sinus floor .
• Filling of periodontal defects in conjunction with products intended for Guided Tissue . Regeneration (GTR) and Guided Bone Regeneration (GBR)
• Filling of peri-implant defects in conjunction with products intended for Guided Bone . Regeneration

Bone Plus™ BCP Eagle Eye is an osteocondective, synthetic bone graft material. Bone Plus™ BCP Eagle Eye is biphasic calcium phosphate (BCP) bioceramics that is composed of bioactive HA and bioresorbable beta-TCP. The ratio of HA to beta-TCP is 60:40. Bone Plus has interconnected porous structure that is made of macro-pores and/or micro-pores. Bone Plus™ BCP Eagle Eye is supplied in granules of different sizes and shapes.

Here's a breakdown of the acceptance criteria and study information based on the provided 510(k) submission for Bone Plus™ BCP Eagle Eye:

I. Acceptance Criteria and Reported Device Performance

II. Sample Size and Data Provenance for Test Set

• Sample Size: Not applicable. This submission describes non-clinical testing of material properties and biocompatibility, not performance in a human clinical "test set" in the context of AI/diagnostic devices. The testing is on the device material itself.
• Data Provenance: The document does not specify the country of origin for the non-clinical tests. It lists ISO standards, which are international standards. The tests are retrospective in the sense that they are conducted on manufactured samples of the device.

III. Number and Qualifications of Experts for Ground Truth

• Not applicable. The ground truth for the non-clinical tests is established by adherence to international standards (ISO) and laboratory measurements of material properties, not through expert consensus on cases.

IV. Adjudication Method

• Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for assessing visual data (e.g., medical images) by multiple human readers, not for objective material property tests.

V. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No such study was performed or is relevant to this 510(k) submission. This device is a bone grafting material, not an AI or diagnostic tool designed to assist human readers in interpreting data.

VI. Standalone (Algorithm Only) Performance Study

• No such study was performed or is relevant. This device is a physical bone grafting material, not an algorithm.

VII. Type of Ground Truth Used

• The ground truth used for this device is based on objective material property measurements and biocompatibility assessments performed according to established international standards (ISO 13779-1, ISO 13779-3, ISO 10993-14, ISO 10993-6).

VIII. Sample Size for Training Set

• Not applicable. There is no "training set" in the context of this traditional medical device submission. The device is manufactured according to a specified composition and process, and its properties are then tested.

IX. How Ground Truth for Training Set Was Established

• Not applicable. See VIII.

Summary of the Study:

The provided 510(k) summary for Bone Plus™ BCP Eagle Eye describes a series of non-clinical bench and in-vitro/in-vivo tests designed to demonstrate the device's material properties and biocompatibility. The primary method of demonstrating substantial equivalence to the predicate device (Bone Plus™ BCP, K090950) is through direct comparison of design, materials, indications, and performance, supported by these non-clinical tests.

The study did not involve human readers, clinical cases, AI algorithms, or the establishment of ground truth through expert consensus on medical images. Instead, the "study" comprises laboratory testing against defined ISO standards to characterize the synthetic bone graft material. The specific numerical results of these tests are not provided in this summary, but the submission states that they were performed according to the listed standards. The equivalence argument relies on the subject device being "identical and equivalent in design, materials, indications and intended use, and performance" to the predicate device, with the non-clinical tests serving as evidence for the performance aspect.

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