(181 days)
Vivorté BVF™ is a moldable, self-setting, gradually resorbable, calcium phosphate bone void filler with shaped particles of human bone that contain osteoinductive demineralized bone matrix (DBM). Vivorté BVF™ 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™ may be manually applied to the bony defect or applied to the defect through a cannula. Vivorté BVF™ is gradually resorbed and remodeled by the body as new bone formation occurs during the healing process.
Vivorté BVF™ is a moldable, self-setting, gradually resorbable, calcium phosphate bone void filler with shaped particles of human bone that contain osteoinductive demineralized bone matrix (DBM). Vivorté BVF™ 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™ may be manually applied to the bony defect or applied to the defect through a cannula. Vivorté BVF™ isothermically hardens in vivo to form a composite of a carbonated apatite (hydroxyapatite) and shaped particles of human bone that contain DBM. Vivorté BVF™ 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 and the shaped particles of human bone contain osteoinductive demineralized bone matrix (DBM). The composite device is gradually resorbed and remodeled by the body as new bone formation occurs during the healing process. Vivorté BVF™ is provided in various kit sizes corresponding to the amount of bone void filler produced when the components of the kit are mixed together.
Each lot of allograft human bone in the Vivorté BVF™ is assayed for osteoinductive potential using an athymic mouse or rat model. The results of the osteoinductive potential testing may or may not be indicative of the osteoinductivity of Vivorté BVF™ in humans.
The provided document describes a 510(k) premarket notification for a medical device called Vivorté BVF™. A 510(k) submission generally aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, rather than proving its safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval). Therefore, the concept of "acceptance criteria" as applied to a device's performance in a standalone clinical efficacy study might not directly align with the information typically found in a 510(k) summary.
Based on the provided text, the Vivorté BVF™ device is claiming substantial equivalence to two predicate devices: ETEX EquivaBone® Osteoinductive Bone Graft Substitute (K090855) and Synthes® Norian® SRS® Bone Void Filler (K011897). The "study" demonstrating this substantial equivalence is primarily focused on non-clinical testing.
Here's an analysis of the provided information in response to your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission focused on substantial equivalence, specific "acceptance criteria" for clinical performance are not explicitly detailed in the document in the way one might expect for a PMA or a de novo submission. Instead, the acceptance criteria are implicitly met by demonstrating comparable characteristics to the predicate devices through non-clinical testing.
| Acceptance Criteria Category (Implied by Substantial Equivalence Basis) | Reported Device Performance (Vivorté BVF™ vs. Predicates) |
|---|---|
| Chemical Composition | Chemically substantially equivalent to ETEX EquivaBone® and Synthes® Norian® SRS®. Vivorté BVF™ and ETEX EquivaBone® are synthetic calcium phosphate based bone void fillers containing osteoinductive demineralized bone matrix (DBM). Vivorté BVF™ and Synthes® Norian® SRS® are composed of virtually identical synthetic calcium phosphate materials (Synthes® Norian® SRS® does not contain DBM). |
| Physical Properties | Physically substantially equivalent to ETEX EquivaBone® and Synthes® Norian® SRS®. Both Vivorté BVF™ and predicate devices are intraoperatively prepared by mixing components to produce self-hardening calcium phosphate bone void fillers. Both devices have comparable mixing, handling/working, and setting times. When fully hardened, both are composed primarily of apatites with similar physical characteristics. |
| Mechanical Properties | Mechanically substantially equivalent to ETEX EquivaBone® and Synthes® Norian® SRS®. Vivorté BVF™ has compressive and bending strength greater than that of human cancellous bone. When fully hardened, both are composed primarily of apatites with similar mechanical characteristics and properties. |
| Resorption and Remodeling | Vivorté BVF™ is gradually resorbed and remodeled by the body as new bone formation occurs, similar to the predicate devices. |
| Biocompatibility & Toxicity | Passed testing according to ISO 10993, ASTM, and USP standards. |
| Sterility | Provided packaged sterile, similar to predicate devices. |
| Indications for Use | Similar indications for use to the predicate devices. |
| Osteoinductivity Testing (of Allograft component) | Each lot of allograft human bone in Vivorté BVF™ is assayed for osteoinductive potential using an athymic mouse or rat model. (Note: The document states these results may or may not be indicative of human osteoinductivity.) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of a clinical test set for performance. The "test set" here refers to materials and animal models used for non-clinical and animal testing. Specific sample sizes for the chemical, physical, mechanical, biocompatibility, and animal testing are not provided in this summary.
- Data Provenance: The testing was performed by Vivorté, Inc. and its contractors. The country of origin for the data is implicitly the United States, where Vivorté, Inc. is located and operates. The testing is prospective in the sense that it was conducted specifically to support this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. Ground truth, in the clinical sense, would be established by medical experts for patient outcomes or diagnoses. No such clinical "ground truth" establishment is mentioned as part of this 510(k) submission. For the non-clinical and animal testing, the "ground truth" is defined by established scientific and regulatory standards (e.g., ISO, ASTM, USP) and laboratory protocols.
- Qualifications of Experts: Not specified. Testers performing the non-clinical and animal studies would be qualified scientists, engineers, and veterinarians/animal technicians relevant to their fields, but their specific qualifications are not detailed.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Adjudication methods (like 2+1 or 3+1) are used in clinical trials to resolve discrepancies in expert judgments for ground truth establishment. Since no clinical trials are described, this is not relevant. The "adjudication" for non-clinical tests typically involves adherence to validated methods and review by internal quality control or regulatory bodies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. An MRMC comparative effectiveness study is used to assess the impact of a device (often AI-assisted) on human reader performance in diagnostic tasks. Vivorté BVF™ is a bone void filler, not a diagnostic imaging device, and its 510(k) submission explicitly states: "Clinical testing was not necessary to determine substantial equivalence between Vivorté BVF™ and the predicate devices." Therefore, no MRMC study was conducted or is relevant.
- Effect Size of Human Readers with/without AI assistance: Not applicable.
6. Standalone Performance Study (Algorithm Only)
- Standalone Study Done: Not applicable. This question concerns the performance of an algorithm without human intervention, typically for AI/ML diagnostic devices. Vivorté BVF™ is a physical medical device, and the concept of "standalone performance" for an algorithm is not relevant. The performance of the physical device is established through the non-clinical (chemical, physical, mechanical, biocompatibility) and animal testing to show substantial equivalence.
7. Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" here is based on established scientific and regulatory standards and measurement techniques for material properties (chemical composition, physical properties, mechanical strength), biocompatibility, and animal responses (for osteoinductive potential of the DBM component). It is not pathology, expert consensus on patient outcomes, or human-specific clinical outcomes data, as clinical testing was not performed.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. A "training set" refers to data used to train an algorithm, typically in AI/ML applications. Vivorté BVF™ is not an AI/ML device. The non-clinical and animal testing involved samples of the device and biological models for evaluation, but these are not "training sets" in the AI/ML context.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not applicable, as there is no training set for an AI/ML 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.