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510(k) Data Aggregation
(113 days)
FIBERGRAFT BG Putty Bone Graft Substitute
FIBERGRAFT® BG Putty - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT® BG Putty 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 Putty must be used with autograft in the posterolateral spine.
FIBERGRAFT® BG Putty is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.
The FIBERGRAFT®BG Putty is an osteoconductive, resorbable, biocompatible bone graft substitute to be gently packed into defect sites and to be used as non-structural scaffolds. The FIBERGRATT® BG putty is made from 45S5 bioactive glass, where the bioactive glass components are mixed with an absorbable binder to form a cohesive material.
The provided text does not contain information about acceptance criteria or a study that proves a device meets specific performance criteria in terms of accuracy, sensitivity, or specificity, as would be relevant for an AI/ML device.
Instead, the document is a 510(k) premarket notification for a medical device called "FIBERGRAFT® BG Putty Bone Graft Substitute". The 510(k) clearance process focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific quantitative accuracy metrics for software.
The performance data discussed relates to:
- Physical and chemical property evaluation studies: These confirmed in vitro functionality and bioactivity, but it explicitly states, "The in vitro bioactivity test results have not been correlated to clinical performance."
- Biocompatibility tests (ISO 10993 testing): This demonstrates the material's safety for biological contact.
- Packaging evaluations, shelf life testing, and real-time aging testing.
- Bacterial endotoxin testing.
- Functional performance animal studies:
- Ovine model: Evaluated in critical size defects in skeletally mature sheep (total of 58 tested samples). This study demonstrated evidence of new bone formation with "substantially equivalent performance compared to the predicate device."
- Rabbit posterolateral spine fusion model: Compared to predicate devices and positive controls in 71 skeletally mature rabbits. This study also showed "substantially equivalently to the predicate devices."
The animal studies used radiographic, histomorphometric, and biomechanical data to evaluate performance, which are methods for assessing bone formation and structural integrity. However, the document does not present specific acceptance criteria in a table format with corresponding device performance metrics (e.g., bone volume percentages, fusion rates above a certain threshold) that could be definitively extracted and formatted as requested. The conclusion is based on "substantial equivalence" to predicate devices, meaning it performs as safely and effectively without raising new safety or effectiveness concerns, rather than meeting a predefined quantitative performance target.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor details about sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not addressed in the provided 510(k) summary for this type of device.
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(103 days)
FIBERGRAFT BG PUTTY BONE GRAFT SUBSTITUTE
FIBERGRAFT™ BG Putty - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT™ BG Putty 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.
FIBERGRAFT™ BG Putty is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.
The FIBERGRAFT™ BG Putty is a osteoconductive, resorbable, biocompatible bone graff substitute to be gently packed into defect sites and to be used as non-structural scaffolds. The FIBERGRAFT™ BG putty is made from 45S5 bioactive glass, where the bioactive glass components are mixed with an absorbable binder to form a cohesive material.
The provided document is a 510(k) Summary for the FIBERGRAFT™ BG Putty Bone Graft Substitute. It describes the device, its intended use, and demonstrates substantial equivalence to predicate devices. However, this document does not contain a table of acceptance criteria or details of a study that directly proves the device meets specific performance acceptance criteria in the format requested.
Instead, it evaluates the device against predicate devices and relies on animal studies and biocompatibility testing. I will extract the available information as best as possible to answer your questions, but many points will be marked as "Not provided" or inferred from the context of a 510(k) submission.
Here's the breakdown of the information based on your request:
1. A table of acceptance criteria and the reported device performance
A specific table of acceptance criteria with numerical targets and corresponding device performance is not provided in the document. The document states that performance was evaluated and found "substantially equivalent" to predicate devices, and that the device "performs as safely and as effectively as the predicate device."
The closest statements to performance attributes are:
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Physical and Chemical Properties: In vitro functionality and bioactivity. | Confirmed in vitro functionality and bioactivity. (No specific numerical results provided). |
| Biocompatibility: Meets ISO 10993 standards. | Demonstrated by ISO 10993 testing and the long history of clinical use of the bioactive glass material for the same intended use. |
| Functional Performance (In vivo): Evidence of new bone formation in critical size defects, substantially equivalent to predicate device. | "Animal testing demonstrated evidence of new bone formation in critical size defects, with substantially equivalent performance compared to the predicate device... The results of the study demonstrated that the BG Putty device performs as safely and as effectively as the predicate device, and any differences between the results of the device groups do not raise new types of safety or effectiveness concerns." (No specific quantitative metrics for bone formation or equivalence provided). |
| Packaging, Shelf Life, Aging: Passing results. | Packaging evaluations, shelf life testing and real-time aging testing were performed with passing results. |
| Safety and Effectiveness: Functions as intended without raising new safety or effectiveness concerns compared to predicate. | "Performance testing demonstrated that the BG Putty device functions as intended and meets the requirements of class II bone void fillers as compared to the predicate devices." "The minor technological differences between BG Putty and its predicate devices do not raise any new issues of safety or effectiveness. Performance data demonstrate that BG Putty is equivalent to the predicate devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: The document mentions a functional performance animal study: "A total of 58 tested samples were evaluated in the study from skeletally mature sheep." This refers to samples within the study, not necessarily individual animals.
- Data provenance:
- Country of origin: Not provided.
- Retrospective or prospective: The animal study described is a prospective study by its nature, designed to evaluate the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. This device is a bone graft substitute, and its performance is evaluated in an animal model using objective measures (radiographic, histological, histomorphometric, and biomechanical data), not by expert interpretation of images or clinical assessments in a human study that would typically require independent expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided. As noted above, this is an animal study with objective measurements, not a human clinical trial requiring adjudication of interpretations.
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/Not provided. This is not an AI/imaging device. It's a bone graft substitute.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable/Not provided. See above.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the animal study, the "ground truth" equivalent would be the objective measurements obtained from the ovine model:
- Radiographic data
- Histological data
- Histomorphometric data
- Biomechanical data
These are direct measurements of biological and mechanical responses to the implant.
8. The sample size for the training set
Not applicable/Not provided. As this is a material science and biological response evaluation for a bone graft substitute, there is no "training set" in the context of machine learning algorithms. The development of the material itself would involve R&D and iterative testing, but not a "training set" in the requested sense.
9. How the ground truth for the training set was established
Not applicable/Not provided. See above.
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