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510(k) Data Aggregation
(191 days)
InterGro DBM products (Putty, Paste, Plus) are to be used for filling bony voids or gaps in the extremities and pelvis that are not intrinsic to the bony stability of the structure, and as an autograft extender in the spine. InterGro Plus may also be used as a bone void filler in the spine (posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to bone. InterGro DBM may also be used for filling craniofacial defects and craniotomies that are no larger than 25cm². The amount of InterGro DBM products to be used should be based on the type of procedure and size of the graft site.
InterGro DBM is a resorbable, osteoconductive, and osteoinductive bone graft substitute that resorbs and is replaced with bone during the healing process. Its main component, demineralized cortical bone matrix (DBM), is derived from donor human tissue (allograft bone) and contains various growth factors including osteoinductive proteins. The DBM has been granulated, lyophilized and aseptically processed. In some versions of the product, calcium salt granules shall be incorporated to provide additional radiopacity, osteoconduction, and enhanced structural strength. The carrier for InterGro DBM is a resorbable, biocompatible, semi-viscous lipid. InterGro DBM is provided ready-to-use in various physical consistencies. It is packaged in various sizes by volume for single patient use.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the InterGro DBM device:
It is important to note that the provided text is a 510(k) summary for a medical device (bone graft substitute), not an AI/ML medical device. Therefore, the questions related to AI/ML specific criteria (like test set, ground truth, experts, adjudication, MRMC studies, standalone performance, training set) are not applicable in this context. The acceptance criteria and "study" described here pertain to the biological and performance characteristics of a traditional medical device.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria / Performance Aspect | Reported Device Performance | Comments |
|---|---|---|
| Viral Inactivation Potential | The methods for processing the DBM contained in InterGro DBM were evaluated. A select panel of viruses representing various viral types, sizes, shapes, and genomes were evaluated. The viral inactivation testing demonstrated suitable viral inactivation potential of the processing methods for a wide range of potential human viruses. | This outlines the evaluation of the manufacturing process's ability to inactivate viruses. The criteria are likely defined by the "suitable viral inactivation potential" against a panel of viruses, implying meeting established benchmarks for viral reduction. No specific log reduction values are provided, but the statement indicates the process was successful. |
| Osteoinductive Potential (In Vitro) | Each lot of DBM is assayed for its osteoinductive potential using a C2C12 myoblast cell line, measuring alkaline phosphatase production. Resulting osteoinductive index is compared to positive and negative controls. | This describes an in-vitro assay. The implied acceptance criterion is likely to demonstrate osteoinductive activity above a certain threshold and consistent with positive controls. The correlation with in vivo results is discussed below. |
| Osteoinductive Potential (Correlation to In Vivo) | In-vitro C2C12 assay results correlated with results from implantation of DBM into athymic rat muscle. Demonstrated a correlation coefficient of 0.88 (p<0.0005) and accurately predicted in vivo osteoinductivity in 20 donor lots. | This provides evidence that the in-vitro assay is predictive of in-vivo osteoinductive potential. The acceptance criteria for the correlation would have been set a priori (e.g., correlation coefficient > X and p-value < Y). The reported 0.88 correlation and p<0.0005 suggest strong correlation. |
| Product Performance Testing (In Vivo) | Performance of InterGro DBM was evaluated in an animal model by radiographic and histological methods. | This indicates that in-vivo performance was assessed. The acceptance criteria would likely involve demonstrating bone formation or integration as observed through radiology and histology, comparable to or better than a control, or meeting pre-defined histological scores. Specific results or quantitative criteria are not provided in this summary. |
| Substantial Equivalence | InterGro DBM was found to be substantially equivalent to predicate devices based on intended use, base materials, select performance properties, and use of a handling material. | This is an overarching regulatory acceptance criterion for 510(k) clearance. The device must demonstrate it is as safe and effective as a legally marketed predicate device. The specific performance properties evaluated for equivalence are not detailed beyond "select performance properties." |
| Biocompatibility | The carrier for InterGro DBM is described as "resorbable, biocompatible." | While no specific study is detailed here for biocompatibility, the statement implies previous testing or material history demonstrating biocompatibility, which is a fundamental acceptance criterion for implantable devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Viral Inactivation Validation: A "select panel of viruses" was used. The specific number of viruses is not stated. Data provenance is not specified but would be from laboratory experiments.
- Osteoinductive Potential (In Vitro): "Each lot of DBM" is assayed. This is an ongoing quality control process, not a single test set.
- Osteoinductive Potential (Correlation): 20 donor lots were used for the correlation study between the in-vitro C2C12 assay and in-vivo athymic rat muscle testing. The study was prospective in nature, demonstrating the predictive power of the in-vitro assay for future lots. Data provenance is not specified.
- Product Performance Testing (Animal Model): An "animal model" was used. The number of animals, their species, and the specific study design (prospective/retrospective) are not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable. This submission is for a traditional medical device (bone graft substitute) and does not involve AI/ML. "Ground truth" in this context refers to the biological and physical properties of the material and its performance in animal models, not expert interpretations of diagnostic images or data. The "ground truth" for the osteoinductive potential correlation was the in-vivo performance in rats.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable as it pertains to AI/ML diagnostic or prognostic devices. Adjudication methods are not used for validating the biological properties or in-vivo performance of a bone graft substitute in the manner described for AI.
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 section is not applicable. MRMC studies are specific to evaluating human reader performance with and without AI assistance for diagnostic tasks. This device is a bone graft substitute, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. This device is a physical product (bone graft substitute), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the areas where a "ground truth" equivalent can be interpreted:
- Viral Inactivation Validation: Laboratory-defined acceptable reduction levels (derived from industry standards/scientific understanding) for viral load.
- Osteoinductive Potential (Correlation): The in-vivo osteoinductivity demonstrated in the athymic rat muscle model. This is essentially a biological/histological "ground truth."
- Product Performance Testing (Animal Model): Radiographic and histological findings of bone formation and integration in the animal model. This is a biological/histological "ground truth."
8. The sample size for the training set
This section is not applicable. This device is not an AI/ML product that undergoes training on a data set.
9. How the ground truth for the training set was established
This section is not applicable for the same reasons as #8.
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(655 days)
InterGro DBM products are to be used for filling bony voids or gaps in the extremities, and pelvis that are not intrinsic to the bony stability of the structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to bone. The device may also be used for filling craniofacial defects and craniotomies that are no larger than 25cm². The amount of InterGro DBM products to be used should be based on the type of procedure and size of the graft site.
InterGro® DBM products contain human tissue (allograft bone) and are intended for transplantation. The allograft bone has been granulated, demineralized and provided in a lipid carrier. Some versions contain porous ceramic granules that are a composite of highly resorbable calcium carbonate with a slower resorbing 2 to 10 um outer layer of calcium phosphate.
InterGro DBM products have been processed aseptically and are ready to use. They do not require rehydration or any special preparation. InterGro DBM is intended for single patient use only.
The provided 510(k) summary for InterGro® DBM describes a bone graft substitute and its assessment for substantial equivalence. It does not contain information about an AI/ML powered medical device, therefore many of the requested categories related to such systems (e.g., AI assistance, MRMC studies, training set details) are not applicable.
Here's an analysis of the provided text based on your request, focusing on the available information:
Acceptance Criteria and Device Performance for InterGro® DBM (K031399)
This 510(k) pertains to a bone graft substitute. The acceptance criteria and "performance" are framed around biological equivalence and safety rather than diagnostic accuracy metrics typically associated with AI/ML devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance/Results |
|---|---|---|
| Biocompatibility/Safety | Viral Inactivation Potential: Evaluate processing methods for demineralized bone matrix (DBM) to inactivate viruses. | The viral inactivation testing demonstrated suitable viral inactivation potential of the processing methods for a wide range of potential human viruses (representing various virus types, sizes, shapes, and genomes). |
| Functional Equivalence | Osteoinductive Potential (In Vitro): Assay each lot of DBM for its ability to induce bone formation (measured as proliferation of SAOS human osteosarcoma cells). | Results of the SAOS assay have been correlated with results from implantation of DBM into athymic rat muscle, demonstrating a correlation coefficient of 0.850 (p<0.0005) and accurately predicting in vivo osteoinductivity in 25 donor lots. Clinical results using DBM with an osteoinductive index (OII) >0.20 showed 92% healing by radiography, while DBM with OII ≤0.20 showed 33% healing, indicating a significant difference. Note: The osteoinductivity of the combined formulation (DBM + carrier +/- ceramic granules) was not evaluated, and correlation with human clinical performance of the full product is unknown. |
| Product Performance | In Vivo Performance: Evaluate InterGro® DBM in animal models (rabbit and sheep). | Performance was evaluated using radiographic and histological methods in rabbit and sheep models. (Specific quantitative results or detailed criteria not provided in this summary for this section). |
2. Sample Size Used for the Test Set and Data Provenance
- Viral Inactivation Validation: "A select panel of viruses representing various virus types, sizes, shapes, and genomes were evaluated." (Specific number of viruses not provided). Data provenance is not specified but the nature of the test suggests laboratory-based validation.
- Osteoinductive Potential (In Vivo Correlation): 25 donor lots of DBM were used for correlation with athymic rat muscle implantation. Data provenance for these donor lots is not specified but implies human tissue.
- Osteoinductive Potential (Clinical Results): "Clinical results using DBM..." (Number of patients or specific studies not provided explicitly for this summary). The context implies human clinical data, but provenance (e.g., country, retrospective/prospective) is not given.
- Product Performance Testing (Animal Models): "evaluated in rabbit and sheep models." (Specific number of animals or studies not provided). This is prospective animal study data.
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable. This device is a material (bone graft substitute) not an AI diagnostic device. Ground truth is established through laboratory assays, animal studies, and clinical observations of healing, not expert interpretation of outputs.
4. Adjudication Method for the Test Set
- Not Applicable. See point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Applicable. This is not an AI-powered diagnostic device, so MRMC studies comparing human readers with and without AI assistance are irrelevant.
6. Standalone (Algorithm Only) Performance Study
- Not Applicable. This is not an algorithm. The in-vitro SAOS assay and in-vivo athymic rat model can be considered "standalone" in vitro/in vivo tests of the DBM's osteoinductivity, independent of human clinical application, but they are not algorithm performances.
7. Type of Ground Truth Used
- Viral Inactivation: Laboratory assay results demonstrating a reduction in viral titre.
- Osteoinductive Potential:
- In-vitro: Proliferation of SAOS human osteosarcoma cells (a cellular assay).
- In-vivo correlation: Histological evidence of bone formation in athymic rat muscle following DBM implantation.
- Clinical: Radiographic evaluation of healing in human patients following DBM implantation.
- Product Performance Testing: Radiographic and histological methods in animal models.
8. Sample Size for the Training Set
- Not Applicable. This device does not involve a "training set" in the context of AI/ML.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point 8.
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