(25 days)
Vitoss Scaffold Synthetic Cancellous Bone Void Filler 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 is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss Scaffold should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
Vitoss Scaffold is intended to be packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis) and may be combined with autogenous blood and/or bone marrow. Following placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.
Vitoss Scaffold is a porous calcium phosphate resorbable bone void filler 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 block and morsel forms.
Vitoss Scaffold guides the three-dimensional regeneration of bone in the defect site into which it is implanted. When Vitoss Scaffold is placed in direct contact with viable host bone, new bone grows in apposition to the calcium phosphate surfaces of the implant. As the implant resorbs, bone and other connective tissues grow into the space previously occupied by the scaffold. Results from animal studies demonstrate that eighty percent of Vitoss Scaffold is resorbed within twelve weeks.
The Vitoss® Scaffold Synthetic Cancellous Bone Void Filler is a resorbable bone void filler for repairing bony defects. The device underwent a 510(k) review (K032409), indicating that its substantial equivalence to predicate devices (WMT-TCP and chronOS) was demonstrated based on various performance characteristics rather than a clinical study with specific acceptance criteria and a detailed study design.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission for a medical device and not a diagnostic AI, the acceptance criteria are based on demonstrating substantial equivalence to predicate devices across several key performance and material characteristics, rather than specific accuracy metrics. The "reported device performance" reflects how Vitoss Scaffold compares to its predicates.
| Characteristic | Acceptance Criteria (Substantial Equivalence to Predicates) | Reported Vitoss Scaffold Performance |
|---|---|---|
| Intended Use | Same as predicate devices | Resorbable Synthetic Bone Void Filler (matches WMT-TCP, ChronOS) |
| Target Population | Individuals with bony defects from surgery/trauma | Individuals with bony defects resulting from surgery or trauma (matches WMT-TCP, ChronOS) |
| Anatomical Locations | Skeletal system (extremities, spine, pelvis) | Bony voids or gaps of the skeletal system, i.e., extremities, spine and pelvis (matches WMT-TCP, ChronOS) |
| Labeling | Same intended use as predicates | Labeling contains same intended use as predicate devices |
| Materials | β-Tricalcium Phosphate (satisfies ASTM F 1088) | β-Tricalcium Phosphate $Ca_3(PO_4)_2$ satisfies ASTM F 1088 (matches WMT-TCP, ChronOS) |
| Design: Physical Structure | Trabecular structure similar to cancellous bone | Trabecular structure similar to cancellous bone (matches WMT-TCP, ChronOS) |
| Design: Porosity | "Highly porous" (WMT-TCP) or 60-70% (ChronOS) | Approximately 90% |
| Design: Pore Size (range) | 100-500μm (ChronOS) | 1-1000μm |
| Performance: Osteoconductivity | Osteoconductive | Osteoconductive (matches WMT-TCP, ChronOS) |
| Performance: Resorption | "Resorbable" (WMT-TCP) or 6-12 months (ChronOS) | Demonstrated as 80% resorbed at twelve weeks |
| Performance: Mechanical Strength | Does not impart mechanical strength | Does not impart mechanical strength to surgical site (matches WMT-TCP, ChronOS) |
| Sterility | Gamma radiation, single use | Sterilized by gamma radiation, single use only (matches WMT-TCP, ChronOS) |
| Biocompatibility | Established | Established (matches WMT-TCP, ChronOS) |
| Dosage Form(s) | Granules/Blocks (WMT-TCP, ChronOS) | Morsels and Blocks |
The primary study mentioned proving the device's performance is an animal study demonstrating resorption.
2. Sample Size Used for the Test Set and Data Provenance
The provided document refers to "animal studies" as the basis for resorption performance.
- Sample Size: Not explicitly stated as "sample size" in the context of a clinical study; it refers to the number of animals used in the study. This number is not specified in the document.
- Data Provenance: Animal studies (implies pre-clinical, laboratory setting, potentially domestic, but country of origin is not specified).
- Retrospective or Prospective: Animal studies are typically prospective in design, where interventions are applied, and outcomes are observed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
N/A. This is a medical device for bone void filling, not a diagnostic AI device requiring expert-established ground truth for image interpretation or similar tasks. The "ground truth" for resorption would have been established through methods like histology, imaging, or biochemical assays in the animal model.
4. Adjudication Method for the Test Set
N/A. Not applicable to a non-diagnostic medical device study where ground truth is established through experimental measurements rather than human interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted for this device. This type of study is relevant for diagnostic devices (especially imaging-based AI) to assess the impact of AI assistance on human reader performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
N/A. This is a physical bone void filler, not an algorithm or AI system. Its performance is intrinsic to its material properties and biological interaction.
7. Type of Ground Truth Used
The document mentions "Results from animal studies demonstrate that eighty percent of Vitoss Scaffold is resorbed within twelve weeks." This indicates that the ground truth for resorption was likely established through observational data collected from animal models, using methods such as:
- Histology: Microscopic examination of tissue samples to assess material presence and bone ingrowth.
- Imaging: X-rays or micro-CT to quantify scaffold volume change over time.
- Gravimetric analysis: Measuring the remaining mass of the implant.
- Biochemical markers: Assessing bone remodeling.
The specific method(s) are not detailed, but it falls under experimental/outcomes data from animal models.
8. Sample Size for the Training Set
N/A. As this is not an AI/ML device, there is no "training set" in the conventional sense. The "training" for the device's design and manufacturing process would come from material science research, preclinical testing, and potentially predicate device data.
9. How the Ground Truth for the Training Set Was Established
N/A. No training set for an algorithm is applicable here. The development and validation of the device would rely on established scientific principles for biomaterials, in vitro testing, and the aforementioned animal studies, not on "ground truth" for a training set.
§ 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.