(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 X and p-value |
§ 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.