(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 (p0.20 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.
§ 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.