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BonAlive™ Granules and BonAlive™ Plate are intended for the augmentation or reconstruction of the cranio-maxillofacial skeleton.

BonAlive™ products are sterile medical devices made of S53P4 bioactive glass. Bioactive glasses are characterised by their ability to attach firmly to living tissue. Other properties include being able to guide tissue growth, bond chemically with surrounding bone in an implantation bed and promote new bone formation in the implanted area. It has been shown that tissue bonds to bioactive glass due to formation of a silica-gel layer on the glass. The silica-rich layer acts as a template for a calcium phosphate precipitation, which then bonds the bioactive glass to the surrounding bone. This makes the bioactive glass a unique material for filling defects and replacing damaged bony tissue. The composition of this synthetic, osteoconductive and bacterialgrowth inhibiting material is, by weight, SiO2 53%, Na2O 23%, CaO 20% and P>O5 4%. BonAlive™ products are supplied as granules and plates. Both are bone grafting materials intended to fill, augment, or reconstruct bony defects of the cranial and maxillofacial region. BonAlive™ granules and plates are sterilized in hot dry air. The granules are available as different granule and unit sizes. The plates are available in different shapes and sizes.

The provided text describes a 510(k) premarket notification for BonAlive™ Granules and BonAlive™ Plates. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific, quantitative acceptance criteria through a formal statistically powered study. Therefore, the information typically requested in your prompt (e.g., acceptance criteria, test set sample size, expert ground truth, MRMC study, standalone performance) is largely not applicable in this context.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The submission does not provide explicit acceptance criteria. Instead, it compares the new device to predicate devices based on descriptive information and summarizes preclinical (biocompatibility, solubility, surface structure, dissolution, animal studies) and clinical observations.

Summary of Performance Testing (Observations, not quantitative criteria fulfillment):

• Preclinical: Biocompatibility tests showed the device was safe. Solubility, surface structure, and dissolution tests indicated low release of Si and P, suggesting good stability. Ca release created a suitable environment for calcium phosphate layer formation and new bone.
• Animal Studies: BAG produced more and faster new bone than hydroxyl apatite (control). Proper blood circulation in the periosted flap was important for healing with both materials.
• Clinical Observations:
  • Frontal Sinus Obliteration: BAG is well-functioning, stable, safe, and well-tolerated. Remnants of glass particles maintained bone formation. The healing process and stability were assessed using ROI assessments.
  • Orbital Floor Fractures, Septum Perforations, Nasal Cavity Narrowing: Well-functioning and well-tolerated, no harmful reactions observed.

2. Sample size used for the test set and the data provenance

Not applicable. This is not a study designed to meet specific performance metrics with a defined test set sample. The preclinical and clinical observations are summarized without specific sample sizes for particular "test sets." The "data provenance" is implied as preclinical (lab/animal studies) and clinical observations (human patients), but specific countries or retrospective/prospective details are not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth, in the typical sense of a diagnostic agreement for a fixed test set, is not described. Clinical observations were likely made by treating physicians.

4. Adjudication method for the test set

Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a biomaterial, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a biomaterial.

7. The type of ground truth used

For animal studies, the "ground truth" for bone formation would likely be histological analysis of tissue samples. For human clinical observations, the "ground truth" for healing and stability would be clinical assessment, imaging (e.g., "ROI assessments" for frontal sinus obliteration), and patient outcomes. There is no mention of pathology reports or external outcome data as a primary "ground truth" for a specific test set.

8. The sample size for the training set

Not applicable. This is a biomaterial, not a machine learning model.

9. How the ground truth for the training set was established

Not applicable.

Ask a specific question about this device

BonAlive™ Granules are sterile medical devices consisting of bioactive glass. Bioactive glass is a bone grafting material that is intended to fill, augment or reconstruct periodontal or bony defects. BonAlive™ Granules are indicated for use in the craniomaxillofacial area including jaws.

BonAlive™ products are sterile medical devices made of S53P4 bioactive glass. Bioactive glasses are characterised by their ability to attach firmly to living tissue. Other properties include being able to bond chemically with surrounding bone in an implantation bed and promote new bone formation in the implanted area. Bone bonding is a physico-chemical process leading to continuity between an implant and bone matrix. It has been shown that tissue bonds to bioactive glass due to formation of a silica-gel layer on the glass. The silica-rich layer acts as a template for a calcium phosphate precipitation, which then bonds the bioactive glass to the surrounding bone. This makes the bioactive glass a unique material for filling defects and replacing damaged bony tissue. The composition of this synthetic, osteoconductive material is, by weight, SiO2 53%, Na2O 23%, CaO 20% and P2O5 4%.

BonAlive™ products are supplied as granules are bone grafting materials intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. BonAlive™ granules are sterilized in hot dry air. The granules are available as different granule and unit sizes.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics. This 510(k) submission primarily focuses on establishing substantial equivalence to a predicate device based on its composition, intended use, and device description, rather than presenting performance data against defined acceptance criteria.

The document is a 510(k) summary for BonAlive™ Granules, a bone grafting material. It describes the device, its intended use, and its equivalence to a predicate device (NovaBone Perioglas®, NovaBone-C/M®). The FDA letter confirms the substantial equivalence determination.

Therefore, I cannot provide the requested information as it is not present in the given text.

Ask a specific question about this device