(384 days)
Grafton Plus® DBM Paste is intended for use as a bone graft extender, bone graft substitute, and bone void filler in bony voids or gaps of the skeletal system (i.e., spine, pelvis and extremities) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. Grafton Plus® DBM Paste is resorbed/remodeled and is replaced by host bone during the healing process.
GRAFTON PLUS® DBM Paste is a human bone allograft product consisting of human demineralized bone matrix (DBM) to which an inert starch-based carrier has been added. It is intended for use in filling bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure. GRAFTON PLUS® DBM Paste is provided in a ready-to-use paste-like, malleable form that can be molded or manipulated by the user into various shapes. It is provided in various package sizes by volume. GRAFTON PLUS® DBM Paste is a demineralized bone product that is osteoconductive as well as osteoinductive in an athymic rat assay.
The provided text describes the GRAFTON PLUS® DBM Paste, a demineralized bone matrix allograft. The study supporting its safety and effectiveness is primarily based on animal bone formation studies and the product's osteoinductive properties.
Here's an analysis of the acceptance criteria and study in relation to your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (as implied) | Reported Device Performance |
|---|---|---|
| Osteoinductivity | Consistent osteoinductivity in an athymic rat assay, using a 5-point linear scale (0-4) for bone formation at 28 days. | "validated to consistently produce DBM that is osteoinductive in an athymic rat assay." Achieved scores on a 5-point linear scale (0,1,2,3,4) for bone formation at 28 days. |
| Performance vs. Autograft | Comparable performance to autograft in bone formation. | "The results of bone formation studies in animals showed that GRAFTON PLUS® DBM Paste performed comparably to autograft." |
| Viral Inactivation | Validated inactivation of specified viruses (HIV-1, HBV, HCV, CMV, Polio virus) by the production process. | "proprietary production process that has been validated to inactivate viruses including: HIV-1; hepatitis B virus (duck hepatitis virus as model); hepatitis C virus (bovine diarrhea virus as model), CMV; and Polio virus." |
| Substantial Equivalence | Equivalence to predicate devices in material, form, and intended use. | Grafton Plus® DBM Paste is stated to be "substantially equivalent to one or more of the predicate devices with respect to materials in that it consists of human demineralized bone matrix (DBM) and an inert resorbable non-tissue additive or carrier. It is provided in a ready-to-use paste-like, malleable form that can be molded or manipulated by the user into various shapes." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not explicitly stated numbers for animals used in the bone formation studies. It mentions "ongoing testing" but not specific sample sizes for the "test set" in a traditional sense. The athymic rat assay is used for ongoing product and process consistency confirmation.
- Data Provenance: Animal studies (athymic rat assay). No country of origin is specified for the animals. The studies are retrospective in the sense that the results are being reported after completion, but the "ongoing testing" suggests continuous evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Experts: Not explicitly stated within the provided text. The osteoinductivity assay uses a "five-point linear scale (0,1,2,3,4) to score bone formation." This implies expert scoring, but the number and qualifications are not detailed. The referenced publication (Edwards, J.T., PhD, Diegmann, M.H., MS, Scarborough, N.L., PhD) suggests that experts with relevant scientific backgrounds (PhD, MS) were involved in developing or executing the method.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated. The use of a "five-point linear scale" suggests a standardized scoring method, but details on inter-rater reliability or adjudication of discrepancies are not provided.
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
- MRMC Study: No. This device is a biomaterial (demineralized bone matrix paste), not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Study: Yes, in an analogous sense for a device of this type. The performance of the GRAFTON PLUS® DBM Paste itself (e.g., its osteoinductive capacity, comparable performance to autograft) was evaluated directly in animal studies, without human intervention in the "performance" aspect of the paste. The scoring of the results (e.g., bone formation) would involve human observation and assessment, but the device's action is independent of a human-in-the-loop directly influencing its biological outcome.
7. The Type of Ground Truth Used
- Ground Truth: In the context of bone formation:
- Expert Scoring/Histological Evaluation: The five-point linear scale for bone formation in the athymic rat assay heavily relies on expert assessment of tissue samples (histology).
- Comparative Performance: Comparison to "autograft" performance serves as a ground truth benchmark for effective bone healing. Autograft is often considered the gold standard for bone regeneration.
8. The Sample Size for the Training Set
- Sample Size (Training Set): Not explicitly stated. The product is described as being prepared via a "proprietary processing method... that has been validated to consistently produce DBM that is osteoinductive." This validation process would implicitly involve a "training" or development phase to achieve consistency, but specific sample sizes for this phase are not provided in this summary.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth (Training Set): Implied through the "validation" of the proprietary processing method. The ground truth for the processing would be established by demonstrating that the resulting DBM consistently exhibits osteoinductivity as measured by the athymic rat assay (i.e., achieving specific scores on the 5-point scale). This would involve iterative testing and refinement of the processing method until the desired osteoinductive outcome is reliably achieved.
§ 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.