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BonAlive® granules is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. BonAlive® granules is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities and pelvis). These defects may be surgically created osseous defects created from traumatic injury to the bone. The product contains a bone void filler that resorbs and is replaced with bone during the healing process. When used in the extremities and pelvis, BonAlive® granules is intended to be used alone.

BonAlive® granules is composed of osteostimulative calcium-phosphorous-sodium-silicate (glass 553P4) granules (size 0.5-0.8 mm or 1.0-2.0 mm) and is a sterile medical device. This synthetic, osteoconductive material is comprised of SiO2, Na2O, CaO and P2O5. Bioactive glass is characterized by its ability to attach firmly to living tissue. Other properties include its ability to facilitate bone tissue growth, bond chemically with surrounding bone, and promote new bone formation in the implanted area. In aqueous solution (e.g. body fluids), bioactive glass works by leaching out ions and developing a silica-gel layer which acts as a template for a calcium phosphate (CaP) precipitation. The CaP crystallizes to hydroxyapatite, which resembles the mineral phase of natural bone in its chemical composition and structure, thus enabling bonding of the bioactive glass to the surrounding bone. The BonAlive® granules resorb and are replaced with bone slowly over a period of years. The bioactive glass in the BonAlive® granules is radiodense thus enabling postoperative radiologic evaluation. Best results are obtained by ensuring close contact of the device with surrounding bone tissue and by carefully following the Instructions for Use. BonAlive® granules is sterilized by irradiation and is available in different granule and unit sizes.

This document is a 510(k) Premarket Notification from the U.S. Food & Drug Administration (FDA) for the BonAlive® Granules device, a resorbable calcium salt bone void filler. It focuses on demonstrating substantial equivalence to a previously cleared predicate device (K071199 BonAlive Granules by Vivoxid Ltd.).

Therefore, the study design and associated information you're asking about (acceptance criteria, sample size, expert ground truth, MRMC studies, standalone performance, etc.) are not present in this document. This is because clinical performance data was not required to support the medical device's clearance.

The relevant section from the document is:

• {8} Section 12. Clinical Performance Data

  "There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device."

Instead of clinical studies, the submission relied on demonstrating substantial equivalence through:

• Comparison of intended use, technological characteristics, and principles of operation to the predicate device (as detailed in {5} and {6}).
• Non-Clinical Performance Data (Apatite, Composition Heavy Metals, Crystallinity, Particle Size Distribution, Surface Area, Manufacturing & Specifications Validation, all listed in {7}).
• Biocompatibility testing (ISO 10993-1, including cytotoxicity, sensitization, systemic toxicity, and muscle implantation, detailed in {7}).
• Sterility and Shelf Life testing (EN ISO 11137 and ISO 11607, detailed in {8}).

In summary, BigCo, the document does not contain the information you requested regarding acceptance criteria, training/test set details, expert ground truth, or clinical study specifics because such studies were not required for this 510(k) clearance based on substantial equivalence.

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BonAlive® granules is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. BonAlive® granules is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. When used in the extremities and pelvis, BonAlive® granules is intended to be used alone. The device is not intended for use in posterolateral spine applications.

BonAlive® granules is not indicated for use in load-bearing applications, therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.

BonAlive® granules is a sterile medical device made of S53P4 bioactive glass. Bioactive glass is characterized by its 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 material is, by weight, SiO2 53%, Na2O 23%, CaO 20% and P2O5 4%. BonAlive® granules functions in contact with body fluids allowing a progressive healing process which develops from the periphery to the central part of the obliteration mass. Best results are obtained by ensuring close contact of the device with surrounding tissue and by carefully following the instructions for clinical use.

When used in the extremities and pelvis, BonAlive® granules is intended to be used alone. BonAlive® granules is sterilized in hot dry air and available in different granule and unit sizes.

This document is a 510(k) Summary for the BonAlive® granules Bone Void Filler Device. It primarily focuses on demonstrating substantial equivalence to a predicate device (NovaBone - Resorbable Bone Graft Substitute) rather than presenting a detailed study with specific acceptance criteria and performance metrics typically found in clinical trials for novel devices.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert adjudication, MRMC studies, and ground truth establishment is not available in this summary. The assessment of the device largely relies on its similarity to existing, approved technology and general biocompatibility/safety testing.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) summary demonstrating substantial equivalence, explicit quantitative acceptance criteria for performance are not provided in the same way they would be for a de novo submission or clinical trial report. The "acceptance criteria" here are implied by successful comparability to the predicate device and safety.

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

• Test Sample Size: Not specified in the summary. The summary mentions "Animal and clinical studies" but does not provide details on their design, sample size, or specific outcomes.
• Data Provenance: The summary indicates "Animal and clinical studies showed the device is a well functioning, safe and well tolerated glass material". However, it does not specify the country of origin, whether they were retrospective or prospective, or detailed methodologies.

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

• This information is not provided in the 510(k) summary. Given the nature of a substantial equivalence submission relying on existing data and material properties, such detailed expert ground truth establishment for a specific test set is typically not part of the filing itself.

4. Adjudication method for the test set

• This information is not provided in the 510(k) summary.

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

• This is a medical device (bone void filler), not an AI diagnostic/imaging device. Therefore, an MRMC comparative effectiveness study involving "human readers" and "AI assistance" is not applicable and was not performed.

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

• This is a medical device (bone void filler), not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable and was not performed.

7. The type of ground truth used

• The "ground truth" for this type of device relates to its biological performance:
  • Histological evidence: Formation of a silica-gel layer and subsequent calcium phosphate precipitation, indicating chemical bonding with bone.
  • Radiographic evidence: Evidence of bone ingrowth and resorption of the material over time.
  • Clinical outcomes: Patient recovery, lack of adverse events, and functional improvement (though not explicitly detailed in this summary).
  • These are inferred from the statement: "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." and "Animal and clinical studies showed the device is a well functioning, safe and well tolerated glass material that creates suitable local environment filling of bone cavities."

8. The sample size for the training set

• Not applicable as this is a device submission focusing on substantial equivalence, not an AI model requiring a "training set."

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

• Not applicable as this is a device submission focusing on substantial equivalence, not an AI model requiring a "training set" and its ground truth establishment.

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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.

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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.

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