(26 days)
Vitoss® Bioactive Foam Bone Graft Substitute 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® Bioactive Foam Bone Graft Substitute is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss® Bioactive Foam should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
Vitoss® Bioactive Foam Bone Graft Substitute 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 Bioactive Foam and Vitoss Bioactive Foam Pack are resorbable, osteoconductive implants with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone.
The provided text describes the 510(k) summary for the Vitoss® Bioactive Foam and Vitoss® Bioactive Foam Pack Bone Graft Substitutes. This document is a premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical study with specific acceptance criteria and detailed performance metrics as one might find for a novel device or a device specifically addressing an AI/software component.
Based on the provided text, here's an analysis of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not present a formal table of acceptance criteria with specific numerical targets and corresponding device performance data as would be expected for a typical performance study. Instead, it states:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Meet predetermined design specifications | "In all instances, Vitoss Bioactive Foam and Vitoss Bioactive Foam Pack functioned as intended." |
| Demonstrate osteostimulatory nature | "calcium phosphate growth was induced on the surface of the Vitoss Bioactive Foam and Vitoss Bioactive Foam Pack after exposure to simulated body fluid. This phenomenon was not observed in control samples in which there was no bioactive glass component." |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: Not specified. The document mentions "in-vitro studies" for demonstrating osteostimulatory properties but does not detail the number of samples or experimental replicates.
- Data Provenance: The osteostimulatory study was an "in-vitro" study, meaning it was conducted in a laboratory setting (e.g., using simulated body fluid), not with human or animal subjects. The country of origin is not specified, but the submitting company is Orthovita, Inc. based in Malvern, PA, USA. The study is not retrospective or prospective clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Not applicable. This type of submission does not involve clinical studies where expert consensus is used to establish ground truth for a test set. The performance data presented refers to in-vitro testing.
4. Adjudication Method for the Test Set
Not applicable. There is no human subjective evaluation of a test set described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is not an AI/software device, and therefore, no MRMC study or assessment of human reader improvement with or without AI assistance was conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is not an AI/software algorithm. The performance testing relates to the physical and chemical properties of the bone graft substitute and its functional behavior in an in-vitro environment.
7. Type of Ground Truth Used
The ground truth for the osteostimulatory property was established by in-vitro observation of calcium phosphate growth on the surface of the device compared to control samples. This is a scientific observation under controlled laboratory conditions, not expert consensus, pathology, or outcomes data in a clinical context.
8. Sample Size for the Training Set
Not applicable. As this is not an AI/software device, there is no "training set." The testing performed relates to the manufacturing and material properties of the bone graft substitute.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for an AI/software algorithm.
§ 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.