(148 days)
Vitoss Scaffold Foam Bone Graft Material is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Vitoss Scaffold Foam is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss Scaffold Foam should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
Vitoss Scaffold Foam Bone Graft Material is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.
Vitoss Scaffold Foam is a porous calcium phosphate resorbable material admixed with Type I bovine collagen for the repair of bony defects. It is an osteoconductive porous implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. Pore diameters in the scaffold range from 1 um to 1000 um (1 mm). The implant is provided sterile in both cylinder and strip forms. Vitoss Scaffold Foam may be mixed with autogenous blood or bone marrow.
Vitoss Scaffold Foam guides the three-dimensional regeneration of bone in the defect site into which it is implanted. When Vitoss Scaffold Foam is placed in direct contact with viable host bone, new bone grows in apposition to the surfaces of the implant. As the implant resorbs, bone and other connective tissues grow into the space previously occupied by the scaffold.
The Vitoss® Scaffold Foam Bone Graft Material is intended as a bone void filler. The device's performance was established through non-clinical performance data, specifically pre-clinical animal studies, which demonstrated that the device supports bone growth and is resorbed concurrently with bone ingrowth and remodeling.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Criteria | New Device: Vitoss® Scaffold Foam Bone Graft Material | Predicate Device: Vitoss® Scaffold Synthetic Cancellous Bone Void Filler | Predicate Device: Healos® Bone Graft Material |
|---|---|---|---|
| Intended Use | Bone Void Filler | Bone Void Filler | Bone Void Filler |
| Target Population | Individuals with bony defects resulting from surgery or trauma | Individuals with bony defects resulting from surgery or trauma | Individuals with bony defects resulting from surgery or trauma |
| Anatomical Locations | Bony voids or gaps of the skeletal system (extremities, spine, pelvis) | Bony voids or gaps of the skeletal system (extremities, spine, pelvis) | Bony voids or gaps of the skeletal system (extremities, spine, pelvis) |
| Labeling | Substantially equivalent to Vitoss® Scaffold Synthetic, with additional collagen-related contraindications/adverse events from Healos® | - | - |
| Chemical Composition | Calcium salt with Type I bovine collagen | Calcium salt | Calcium salt with Type I bovine collagen |
| Mineral Phase(s) | β-Tricalcium phosphate (Ca₃(PO₄)₂) | β-Tricalcium phosphate (Ca₃(PO₄)₂) | Hydroxyapatite (Ca₁₀(PO₄)₆(OH)₂) |
| Physical Structure | Trabecular structure similar to cancellous bone | Trabecular structure similar to cancellous bone | Three-dimensional, open-cell matrix |
| Pore Size (range) | 1-1000 μm | 1-1000 μm | 4-200 μm |
| Osteoconductivity | Osteoconductive | Osteoconductive | Osteoconductive |
| Mechanical Strength | Does not impart mechanical strength to surgical site | Does not impart mechanical strength to surgical site | Does not impart mechanical strength to surgical site |
| Sterility | Sterilized by gamma irradiation, single use only | Sterilized by gamma irradiation, single use only | Sterilized by e-beam, single use only |
| Biocompatibility | Established | Established | Established |
| Dosage Form(s) | Cylinders (Blocks), Strips | Blocks, Morsels | Strips, Pads |
| Non-clinical Performance | Supports bone growth into metaphyseal defect, resorbed concurrently with bone ingrowth and remodeling | - | - |
2. Sample Size for Test Set and Data Provenance
The provided information does not specify a distinct "test set" in the context of human clinical trials. The performance data is derived from "pre-clinical animal data." Therefore, details regarding sample size, country of origin, or retrospective/prospective nature for human test sets are not applicable to the submitted information.
3. Number of Experts and Qualifications for Ground Truth
Given that the performance data relies on pre-clinical animal studies, there's no mention of human experts establishing ground truth for a test set in the traditional sense of a clinical study. The interpretation of animal study results would be conducted by researchers and possibly veterinarians specializing in bone biology and histology. Their specific number and qualifications are not detailed.
4. Adjudication Method
Not applicable, as the performance evaluation is based on animal study results, not human reader assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was conducted or reported in the provided documentation. The comparison is made against predicate devices based on material properties, intended use, and non-clinical animal data.
6. Standalone Performance (Algorithm Only)
The device is a physical bone graft material, not a software algorithm. Therefore, "standalone (i.e., algorithm only without human-in-the-loop performance)" is not applicable.
7. Type of Ground Truth Used
The ground truth for demonstrating the device's performance was established through histological and observational outcomes from pre-clinical animal studies. These studies assessed bone growth, resorption of the scaffold, and remodeling within metaphyseal defects.
8. Sample Size for Training Set
The concept of a "training set" typically applies to machine learning algorithms. As this is a medical device, the studies performed are for validation, not training an AI model. Therefore, a "training set" sample size is not applicable in this context. The animal data serves as the primary evidence for safety and effectiveness.
9. How Ground Truth for Training Set Was Established
Not applicable, as there is no training set in the context of an AI algorithm. The performance was established through the aforementioned pre-clinical animal studies, with their histological and observational findings serving as the evidence.
§ 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.