(277 days)
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.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Material Composition | S53P4 bioactive glass (SiO2 53%, Na2O 23%, CaO 20%, P2O5 4%) - Similar to predicate device's bioactive glass composition. |
| Intended Use | Bony voids/gaps in extremities and pelvis, not load-bearing. Resorbs and replaced with bone. - Identical to or highly similar to predicate device's intended use. |
| Mechanism of Action | Forms silica-gel layer, acts as template for calcium phosphate precipitation, bonds to surrounding bone. Promotes new bone formation. - Functions the same as predicate device. |
| Biocompatibility | Device is safe for intended uses. - Confirmed by biocompatibility tests as stated. |
| Safety and Effectiveness | Well-functioning, safe, and well-tolerated material that creates a suitable local environment for filling bone cavities. - Confirmed by animal and clinical studies as stated, and comparison to predicate. |
| Sterilization Method | Sterilized in hot dry air. - Standard and safe method. |
| Non-Inferiority to Predicate | "BonAlive® granules functions the same as NovaBone products in similar clinical applications and do not introduce any new issues of safety or effectiveness." - This is the core of the substantial equivalence claim. |
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.
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.