(111 days)
Vivorté BVF™ Lite™ is a moldable, self-setting, gradually resorbable, calcium phosphate bone void filler. Vivorte BVF™ Lite™ is indicated for use to fill bony voids or defects of the skeletal system (i.e., extremities, pelvis) that may be surgically created or osseous defects created from traumatic injury to the bone and only for bony voids or defects that are not intrinsic to the stability of the bony structure. Vivorté BVF™ Lite™ may be manually applied to the bony defect or applied to the defect through a cannula. Vivorté BVF™ Lite™ is gradually resorbed and remodeled by the body as new bone formation occurs during the healing process.
Vivorté BVF™ Lite™ is a moldable, self-setting, gradually resorbable, biocompatible, calcium phosphate bone void filler. Vivorté BVF™ Lite™ is indicated for use to fill bony voids or defects of the skeletal system (i.e., extremities, pelvis) that may be surgically created or osseous defects created from traumatic injury to the bone and only for bony voids or defects that are not intrinsic to the stability of the bony structure. Vivorté BVF™ Lite™ may be manually applied to the bony defect or applied to the defect through a cannula. Vivorté BVF™ Lite™ isothermally hardens in vivo to form a carbonated apatite (hydroxyapatite). Vivorté BVF™ Lite™ has a compressive and bending strength that is greater than that of human cancellous bone. The carbonated apatite (hydroxyapatite), which closely resembles the mineral phase of bone, provides an osteoconductive scaffold for bone healing. The device is gradually resorbed and remodeled by the body as new bone formation occurs during the healing process. Vivorté BVF™ Lite™ is provided in various kit sizes corresponding to the amount of bone void filler produced when the components of the kit are mixed together.
The provided text describes a 510(k) submission for the Vivorté BVF™ Lite™ bone void filler, asserting its substantial equivalence to a predicate device, Synthes® Norian® SRS® Bone Void Filler. The basis for this determination is non-clinical testing, as explicitly stated that no clinical testing was performed or required. Therefore, the acceptance criteria and the study proving the device meets them are solely based on these non-clinical evaluations.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list acceptance criteria as numerical thresholds but rather states that the device is "substantially equivalent" to the predicate device in various aspects. The reported performance is therefore framed in terms of similarity to the predicate.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (Vivorté BVF™ Lite™) |
|---|---|
| Material Composition | Composed of synthetic calcium phosphate materials that are "virtually identical" to the predicate. Primarily composed of hydroxyapatite when fully hardened. |
| Preparation and Hardening Process | Intraoperatively prepared by mixing similar components to produce a self-hardening calcium phosphate bone void filler. Isothermally hardens in vivo to form carbonated apatite (hydroxyapatite). |
| Resorption and Remodeling Characteristics | Resorbed and remodeled by the body as new bone formation occurs during the healing process, similar to the predicate. Gradually resorbable. |
| Mixing, Handling/Working, and Setting Times | Comparable to the predicate device. |
| Chemical, Physical, and Mechanical Characteristics | Similar to the predicate device's when fully hardened (primarily hydroxyapatite). Compressive and bending strength greater than human cancellous bone. Osteoconductive scaffold for bone healing. |
| Biocompatibility and Toxicity | Meets ISO 10993, ASTM, and USP standards for permanent implants, as demonstrated by testing. |
| Animal Testing Performance | Demonstrated substantial equivalency to the predicate device in animal testing. (Specific outcomes not detailed, but implied to be comparable to predicate's known performance) |
| Intended Use and Indications for Use | Similar to the predicate device, for filling bony voids or defects of the skeletal system (extremities, pelvis) that may be surgically created or osseous defects from traumatic injury, only for bony voids or defects not intrinsic to the stability of the bony structure. |
| Sterility and Prescription Use | Provided packaged sterile and intended as prescription use only single use devices, consistent with the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated for any of the non-clinical tests (chemical, physical, mechanical, biocompatibility, animal testing). The nature of these tests often involves specific numbers of samples per test type (e.g., a certain number of specimens for mechanical strength tests, a certain number of animals for animal studies), but these numbers are not detailed in the summary.
- Data Provenance: The data provenance is internal to Vivorté, Inc. or its contracted laboratories that performed the non-clinical tests. The document does not specify the country of origin for the data, but since the submission is to the U.S. FDA, it is presumed to be conducted under U.S. or internationally recognized standards for and applicable to the U.S. market. All testing described is non-clinical.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This question is not applicable as the submission relies solely on non-clinical testing for substantial equivalence, not on human expert evaluation of clinical data or images. Ground truth, in this context, would be established by validated laboratory assays, animal observations, and engineering measurements, not by expert consensus on patient data.
4. Adjudication Method for the Test Set
This question is not applicable for the same reasons as #3. There was no clinical test set requiring human adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not necessary to determine substantial equivalence between Vivorté BVF™ Lite™ and the predicate device" and "No clinical tests were conducted or submitted in support of substantial equivalency." Therefore, there is no effect size of how much human readers improve with AI vs without AI assistance to report, as there was no clinical study involving human readers or AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. Vivorté BVF™ Lite™ is a physical medical device (bone void filler), not an algorithm or AI software, so standalone performance in the context of AI is irrelevant.
7. The Type of Ground Truth Used
The ground truth for the non-clinical testing would be derived from:
- Reference Standards/Validated Methods: For chemical composition, physical properties (e.g., density, porosity), and mechanical properties (e.g., compressive strength, bending strength), performance is measured against established scientific and engineering reference standards and/or the known properties of the predicate device.
- Biocompatibility Benchmarks: For biocompatibility and toxicity, the ground truth is established by adherence to recognized international standards (ISO 10993) and national standards (ASTM, USP).
- Animal Study Observations: For animal testing, the ground truth would be based on histological examination, imaging, and gross observations of bone formation, resorption, and overall tissue response in a controlled biological environment, compared to either (or both) untreated controls or the predicate device.
8. The Sample Size for the Training Set
This question is not applicable. As a physical medical device and not an AI/ML algorithm, there is no "training set" in the computational sense. The "knowledge base" for developing the device would stem from scientific literature, material science research, and established medical device development practices.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reasons as #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.