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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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Bone Plus™ BCP 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 is a synthetic resorbable osteo-conductive bone graft substitute composed of Hydroxyapatite (HA) and beta-Tricalcium Phosphate (beta-TCP). Bone Plus™ BCP presents a interconnected porosity structure, similar to that of human cancellous bone. It is supplied sterile and it is dedicated for single use.

Here's the breakdown of the acceptance criteria and the study information for the Bone Plus™ BCP device, based on the provided text:

Important Note: The provided text is a 510(k) summary for a medical device seeking substantial equivalence, not a detailed scientific paper on a clinical trial. Therefore, much of the information typically found in a study proving device performance (like specific statistical metrics, detailed ground truth establishment for a test set, expert qualifications, or MRMC studies) is not present. The purpose of a 510(k) summary is to demonstrate equivalence to a predicate device, often through non-clinical testing and comparison.

1. Table of Acceptance Criteria and Reported Device Performance

• Histomorphometric Evaluation
• Chemical and Physical Analysis
• Porosity assessment
• Solubility | "Testing and other comparisons have established that the subject of Bone Plus™ BCP substantially equivalent in design, materials, indications and intended use, and performance to other predicate devices of the type currently marketed in the U.S."
  Studies performed:
• Histomorphometric Evaluation of Bone Plus™ BCP
• Chemical and Physical Analysis of Bone Plus™ BCP
• Porosity assessment of Bone Plus™ BCP
• Solubility Test of Bone Plus™ BCP
• Clinical Study of Bone Plus™ BCP |

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified. The document mentions a "Clinical Study of Bone Plus™ BCP" but does not provide details on its sample size, methodology, or results. Given the context of a 510(k), this study was likely supportive evidence for substantial equivalence rather than a full-scale clinical trial with a defined test set for performance metrics.
• Data Provenance: Not specified for the "Clinical Study." The manufacturer is MegaGen Implant Co., Ltd. from South Korea, so it's possible the clinical data originated there, but this is not confirmed. It's also not specified if it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Not specified. The 510(k) summary does not provide details on how "ground truth" was established for any clinical or performance studies, nor does it mention the involvement of experts in that capacity.

4. Adjudication Method for the Test Set

• Not specified. No information is provided regarding adjudication methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study is not mentioned or implied. The document focuses on demonstrating substantial equivalence to predicate devices through various technical and likely non-clinical evaluations, along with a mention of a "Clinical Study," the details of which are not provided.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• This question is not applicable. The device is a bone grafting material, not a software algorithm or AI-powered diagnostic tool. Performance is assessed through material properties, biological interaction, and clinical outcomes, not an "algorithm-only" evaluation.

7. The Type of Ground Truth Used

• For the technical and material characterization studies (histomorphometric, chemical, physical, porosity, solubility), the "ground truth" would be established by standard analytical methodologies, laboratory measurements, and histological examination by qualified personnel (e.g., histologists, materials scientists).
• For the "Clinical Study," the nature of the ground truth is not specified, but it would typically involve clinical assessments, radiographic evidence, and potentially histological analysis of biopsies from the implantation sites, interpreted by clinicians or pathologists. The document implies comparison to clinical outcomes of the predicate devices.

8. The Sample Size for the Training Set

• This question is not applicable. The device is a physical medical implant (bone graft material), not a machine learning model or algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• This question is not applicable, as there is no training set for this type of device.

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