(85 days)
Rafugen™ DBM is intended for use as a bone void filler in bony voids or gaps of the skeletal system (i.e., 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. Rafugen™ DBM is resorbed/remodeled and is replaced by host bone during the healing process.
Rafugen™ DBM is a human bone allograft product containing human DBM (demineralized bone matrix), CMC (carboxymethyl cellulose), Starch and Glycerol. It is intended for use in filling bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure. Rafugen™ DBM is a ready-to use moldable gel formulation provided pre-filled in syringes of various volumes and is intended for single patient use. It is offered in six volumes: 0.25, 0.5, 1.0, 3.0, 5.0, and 10.0 cc. The Rafugen™ DBM can be either directly applied into the defect from the syringe, using the cap tip, or extruded for molding and insertion into the defect by hand.
The provided text is a 510(k) summary for the device Rafugen™ DBM, which is a resorbable calcium salt bone void filler. This document is a regulatory submission for market clearance and not a detailed clinical study report. Therefore, it does not contain the typical information one would find in a clinical trial publication regarding acceptance criteria and performance of a device based on clinical endpoints or reader studies for AI.
However, based on the non-clinical performance data section, I can extract information related to the device's technical acceptance criteria and the studies performed to meet them.
Here's a breakdown of the requested information based on the provided text, recognizing the limitations of the document type for certain aspects:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Biocompatibility | Biocompatibility testing | "The final composition of Rafugen™ DBM was found to be biocompatible and to meet its design specifications." |
| Sterility | Sterility testing | Performed (mentioned as a conducted test, but specific results or acceptance criteria are not detailed beyond the implication that it passed). |
| Chemical/Physical Properties | Chemical and physical properties testing | Performed (mentioned as a conducted test, but specific results or acceptance criteria are not detailed beyond the implication that it passed and the product being "substantially equivalent to the predicate device with respect to materials... and an inert resorbable nontissue additive or carrier"). |
| Material Mediated Pyrogenicity | Endotoxin level below 0.5 EU/mL | "Under the conditions of this study, no endotoxin level showed above 0.5 EU/mL in all five batches. The test extract was judged as non-pyrogenic, and the test sample satisfied the requirements for the absence of pyrogens." |
| Osteoinductive Potential | Positive result in athymic rat assay (ectopic pouch model) | "Yes, per athymic rat assay." "The testing for osteoinductive potential of both devices was demonstrated using a validated athymic rat assay." |
| Inactivation of Model Viruses | Validation of processing to demonstrate inactivation of a panel of model viruses | "Validation was performed for the Rafugen™ DBM processing to demonstrate inactivation of a panel of model viruses." (Implied successful validation, but specific inactivation levels or acceptance criteria are not provided). |
| Performance (Bone Growth/Remodeling) | Equivalent bone growth and remodeling to predicate in a rabbit femoral defect model | "Bone growth and remodeling in a rabbit femoral defect model"; "comparison performance testing conducted in a rabbit critical size femoral defect model demonstrated equivalent bone formation and remodeling." |
| Overall Design/Labeling | Meets all requirements for overall design, sterilization, biocompatibility, labeling, and performance. | "Rafugen™ DBM meets all the requirements for overall design, sterilization, biocompatibility, labeling, and performance." (This is a summary statement, not a specific performance metric). |
| Shelf Life | Shelf life testing | Performed (mentioned as a conducted test, but specific results or acceptance criteria are not detailed beyond the implication that it passed). |
| Design Specifications | Meets design specifications and does not raise new questions of safety and effectiveness compared to predicate. | "The final composition of Rafugen™ DBM was found to be biocompatible and to meet its design specifications." "It has been shown in this 510(k) submission that the minor differences between the Rafugen™ DBM and the Grafton® DBM predicate device do not raise new questions regarding its safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions a "rabbit femoral condyle model" and a "rabbit critical size femoral defect model" for performance testing, and an "athymic rat assay (ectopic pouch model)" for osteoinductive potential. However, specific sample sizes (number of animals) for these animal studies are not provided in this 510(k) summary. The data provenance is pre-clinical animal studies, likely conducted by the manufacturer or contracted labs. There is no information about country of origin of the data provided. These are prospective studies in the sense that they were designed and executed to support the regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the document describes non-clinical (animal) studies, not studies involving human experts establishing ground truth for a diagnostic AI device.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3.
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 information is not applicable as the device is a bone void filler, not an AI diagnostic tool that would involve multi-reader studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable as the device is a medical implant, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the animal studies:
- Osteoinductive potential: The ground truth would be based on histological and/or imaging analysis of the ectopic bone formation in the athymic rat model, likely interpreted by scientific experts in the field.
- Bone growth and remodeling: The ground truth would be based on histological, radiography, and/or micro-CT analysis of bone formation and remodeling within the rabbit femoral defect model, again interpreted by experts.
8. The sample size for the training set
This information is not applicable. The device is a manufactured medical product, not an AI algorithm that requires a training set. The "design specifications" and manufacturing processes are validated, not "trained."
9. How the ground truth for the training set was established
This information is not applicable for the same reasons as 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.