(189 days)
BG Morsels - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. BG Morsels 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.
BG Morsels is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.
BG Morsels provides an osteoconductive, resorbable, biocompatible bone graft substitute made from crystalline 45S5 bioactive glass. Each granule of BG Morsels is created from a matrix of bioactive glass fibers and microspheres. Bioactive glass is defined as a group of glasses which has a compositional range that allows the formation of hydroxyapatite (HA) as a surface laver when exposed to an aqueous phosphate-containing solution such as simulated body fluid. The HA layer that forms in an aqueous phosphate-containing solution plays a significant role in forming a strong bond with natural bone. The granules provide an ultra-porous scaffold for desired biological response and improved handling characteristics, while optimizing radiopacity and resorption. BG Morsels are generally spherical in appearance and provided in granular form. The matrix is flash sintered to form a porous shell at its surface, which creates the generally spherical structure of the granules, while maintaining a level of porosity within each granule.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Prosidyan, Inc.'s BG Morsels - Bone Graft Substitute:
Acceptance Criteria and Device Performance for BG Morsels - Bone Graft Substitute
The acceptance criteria for the BG Morsels device are implicitly defined by its substantial equivalence claim to predicate devices (NovaBone Resorbable Bone Graft Substitute (K052494) and NovaBone Putty (K112773)) and its ability to function as intended for Class II bone void fillers. The performance data provided focuses on demonstrating safety and effectiveness comparable to these predicates.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission, explicit quantitative acceptance criteria (e.g., "must achieve X% new bone formation") are not directly stated in the summary. Instead, the acceptance is based on demonstrating comparable performance to legally marketed predicate devices.
| Acceptance Criteria Category | Benchmark/Implicit Criteria | Reported Device Performance (BG Morsels) |
|---|---|---|
| Material Properties | Osteoconductive | Osteoconductive (made from 45S5 bioactive glass) |
| Resorbable | Resorbable (replaced with bone during healing) | |
| Biocompatible | Biocompatible (demonstrated by ISO 10993 testing and clinical history of bioactive glass) | |
| Bioactivity | Bioactive (in vitro studies show apatite layer formation in SBF) | |
| Mechanical/Physical | Functional as bone void filler | Provides ultra-porous scaffold, optimized radiopacity and resorption. Flash sintered for porous shell. |
| Packaging integrity | Passed simulated distribution, whole package integrity, seal strength, accelerated and real-time aging tests. | |
| Biological Performance (In Vivo) | New bone formation in critical size defects, comparable to predicate. | Demonstrated evidence of new bone formation in critical size defects. Performs as safely and effectively as predicate device (NovaBone Putty). No new safety or effectiveness concerns. |
| Resorption and replacement by bone | Resorbs and is replaced with bone during healing process (as per intended use statement). | |
| Safety | Safe for intended use | ISO 10993 biocompatibility, same chemical composition as predicate (long history of use), no new safety concerns raised by animal study. |
| Effectiveness | Effective as a bone void filler | Performs as effectively as predicate device, consistent with FDA recommendations for Class II synthetic bone graft substitutes. |
2. Sample Size Used for the Test Set and Data Provenance
- Animal Study (In Vivo Test Set):
- Sample Size: "58 skeletally mature sheep"
- Data Provenance: "ovine model" (sheep), suggesting a prospective animal study. The country of origin of the study is not specified, but the submission is to the US FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The text doesn't explicitly state the number of experts used for ground truth or their exact qualifications. However, the animal study involved "radiographic, histological, histomorphometric, and biomechanical data" analysis. This implies that experts in veterinary radiology, histology, histomorphometry, and biomechanics would have been involved in evaluating the outcomes. Common qualifications would include DVM/PhD with specialization in these areas, or relevant scientific/medical degrees and experience.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method like 2+1 or 3+1 for the animal study data. It merely states that various types of data (radiographic, histological, histomorphometric, biomechanical) were collected and analyzed. It's common in animal studies for principal investigators and study pathologists to interpret results collectively or independently.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The study described is an animal model comparing the device to a predicate and a sham control, not a human reader study evaluating improved performance with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the BG Morsels is a physical medical device (bone graft substitute), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant. The performance evaluated is that of the physical device.
7. The Type of Ground Truth Used
- For the animal study (in vivo performance): The ground truth was established by direct experimental observation and quantitative measurements from the ovine model, including:
- Radiographic findings (imaging evidence of bone healing)
- Histological analysis (microscopic examination of tissue structure)
- Histomorphometric analysis (quantitative measurements from histology, e.g., new bone volume, defect fill)
- Biomechanical data (measurements of bone strength or stiffness).
- Comparison to a positive control (predicate device) and a negative control (untreated defect).
8. The Sample Size for the Training Set
This question is not applicable for this type of device. The BG Morsels is a physical medical device, not an AI or machine learning model that requires a "training set." The development process would involve material science, engineering, and preclinical testing, rather than data training.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no "training set" in the context of this physical device.
§ 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.