Search Results
Found 1 results
510(k) Data Aggregation
(86 days)
FIBERGRAFT® BG Matrix - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT® BG Matrix is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, 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. FIBERGRAFT® BG Matrix must be used with autogenous bone marrow aspirate and autograft in posterolateral spine.
FIBERGRAFT® BG Matrix product is composed of 45S5 bioactive glass components (M-45 granules, MS-45 microspheres) and bovine type I collagen. The BG Matrix after hydration with saline or blood can be applied to the defect site or can be molded into the desired shape and gently packed into the defect site as a non-setting putty. In the posterolateral spine fusion applications, the product is intended to be hydrated with bone marrow aspirate (BMA) and mixed with autograft in a 1:1 ratio.
The FIBERGRAFT® BG Matrix product was previously cleared in K171284. There has not been any change to the device since the last clearance.
The provided text describes the FIBERGRAFT® BG Matrix Bone Graft Substitute but does not contain a discrete table of acceptance criteria and reported device performance. It also lacks specific details on sample sizes, ground truth establishment, expert involvement, or comparative effectiveness studies in the format requested.
However, based on the information provided, here's an attempt to structure the answer, highlighting what is available and noting the missing information:
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria for FIBERGRAFT® BG Matrix Bone Graft Substitute
The performance of the FIBERGRAFT® BG Matrix was established through physical and chemical property evaluation studies, functional performance animal studies, and biocompatibility tests. The device's substantial equivalence to predicate devices for its intended use as a synthetic bone void filler was the primary goal, demonstrating that it functions as intended without raising new safety or effectiveness concerns.
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| In Vitro Functionality & Bioactivity | Confirmed by physical and chemical property studies. (Note: "The in vitro bioactivity test results have not been correlated to clinical performance.") |
| Biocompatibility | Demonstrated by ISO 10993 testing. Long history of clinical use of the bioactive glass material for the same intended use. Composed of the same bioactive glass material and the same type and duration of patient contact as the predicates. |
| Packaging & Shelf Life | Evaluations and real-time aging testing performed with passing results. |
| Bacterial Endotoxin Limits | Testing performed using the limulus amebocyte lysate (LAL) method, showing the device meets established endotoxin limits. |
| In Vivo Performance (Posterolateral Spine) | Demonstrated performance at 26-week follow-up in a rabbit posterolateral spine fusion study. Evaluated using radiographic, histological, histomorphometric, and biomechanical data. Compared favorably to a predicate device and controls. |
| In Vivo Performance (Extremities & Pelvis) | Demonstrated substantial equivalence to the predicate device and positive control at 26-week follow-up in a critical size distal femur defects study in rabbits. Evaluated using radiographic, histomorphometric, and biomechanical data. "Minor technological differences between the device groups do not raise new types of safety or effectiveness concerns." |
| Overall Safety and Effectiveness Concerns | Performance testing demonstrated that the device functions as intended and meets the requirements of Class II bone void fillers as compared to the predicate device. Minor technological differences do not raise any new issues of safety or effectiveness, supporting substantial equivalence. |
2. Sample size used for the test set and the data provenance
- Rabbit Posterolateral Spine Fusion Study:
- Sample Size: 53 skeletally mature rabbits.
- Data Provenance: Animal study (specifically, rabbit model). The text implies prospective data collection within the study design. Country of origin not specified.
- Rabbit Critical Size Distal Femur Defects Study:
- Sample Size: 42 skeletally mature rabbits.
- Data Provenance: Animal study (specifically, rabbit model). The text implies prospective data collection within the study design. Country of origin not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The provided text describes animal studies with data evaluated using radiographic, histological, histomorphometric, and biomechanical data. It does not mention human experts establishing ground truth for the test set in the context of clinical images or diagnostic performance. Instead, ground truth is inferred from the scientific measurements and observations made in the animal models.
4. Adjudication method for the test set
Not applicable, as the clinical adjudication of diagnostic assessments by human readers is not the focus of these animal performance studies. The evaluation methods (radiographic, histological, histomorphometric, biomechanical data) are objective measurements.
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. The studies described are animal studies evaluating the performance of a bone graft substitute, not a diagnostic AI device requiring human reader assessment.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a bone graft substitute, not an algorithm.
7. The type of ground truth used
The ground truth in these animal studies was established through:
- Histology: Microscopic examination of tissue.
- Histomorphometry: Quantitative analysis of tissue structure.
- Radiography: X-ray imaging for bone formation/healing.
- Biomechanical data: Measurements of mechanical properties of the bone.
These are direct scientific measurements of material integration and functional outcomes in a living organism.
8. The sample size for the training set
Not applicable. As this is a medical device (bone graft substitute) and not an AI/algorithm, there is no concept of a "training set" in the context of machine learning. The studies described are performance evaluations of the physical product.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for this type of medical device.
Ask a specific question about this device
Page 1 of 1