(30 days)
Vivorté Trabexus™ EB" 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 Trabexus™ EB™ 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 Trabexus™ EB" may be manually applied to the bony defect or applied to the defect through a cannula. Vivorté Trabexus " EB" is gradually resorbed and remodeled by the body as new bone formation occurs during the healing process.
Vivorté Trabexus™ EB™ is a moldable, self-setting, gradually resorbable, biocompatible, calcium phosphate bone void filler with shaped particles of human bone that contain osteoinductive demineralized bone matrix (DBM). The device is provided in kit sizes of 3 cc. 5 cc. and 10 cc. corresponding to the amount of bone void filler produced when the components of the kit are mixed together.
This document describes a 510(k) premarket notification for the Vivorté Trabexus™ EB™ device. The submission primarily focuses on establishing substantial equivalence to a predicate device, the Vivorté BVF™. The core of the submission emphasizes that the only difference in the subject device is the inclusion of an additional accessory (a delivery cannula). As such, the presented information does not detail a study proving the device meets clinical acceptance criteria in the way one might expect for a novel therapeutic or diagnostic device. Instead, the "acceptance criteria" and "study" are primarily focused on non-clinical performance and equivalence to the predicate device.
Here's an analysis based on the provided text, addressing your points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Extrudability | Acceptable extrudability | Not applicable (see note) |
| Biocompatibility | Biocompatible | Pass |
| Bubble leak test | No leaks | Pass |
| Heat seal strength of primary packaging | Adequate seal strength | Pass |
Note on Extrudability: The "Not applicable" result for extrudability is unusual for a bone void filler that is "applied to the defect through a cannula." This likely implies that the predicate device already demonstrated acceptable extrudability, and since the subject device is essentially the same formulation with just an added cannula, the company may have argued that the existing extrudability data on the formulation itself, or the new testing was not deemed necessary for the new device because it was simply an accessory. However, it is a significant omission if the new cannula itself was not tested for extrudability with the material.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for the non-clinical tests (Biocompatibility, Bubble leak test, Heat seal strength). It also does not specify dates or countries of origin for these non-clinical tests, nor whether they were retrospective or prospective. This information would typically be detailed in a more comprehensive test report, not necessarily summarized in the 510(k) summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This question is not applicable to this submission. The "test set" described here relates to non-clinical engineering and material properties, not clinical diagnostic or therapeutic outcomes requiring expert ground truth establishment.
4. Adjudication Method for the Test Set
This question is not applicable to this submission. Adjudication methods are used in clinical studies, typically for establishing ground truth or resolving discrepancies in readings. The tests performed are objective laboratory measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with vs. without AI Assistance
This question is not applicable to this submission. The Vivorté Trabexus™ EB™ is a medical device (bone void filler) and not an AI-powered diagnostic or therapeutic system. Therefore, an MRMC study related to AI assistance is not relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
This question is not applicable to this submission. As stated above, this is a medical device, not an algorithm.
7. Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
For the non-clinical tests, the "ground truth" is established by the predefined acceptance criteria for each test method (e.g., specific thresholds for biocompatibility, absence of bubbles, minimum seal strength). These are objective physical or chemical standards, not clinical outcomes or expert consensus.
8. Sample Size for the Training Set
This question is not applicable to this submission. There is no mention of a "training set" as this device does not involve machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable to this submission. Since there is no training set, there is no ground truth establishment for it.
Summary of the Study and Acceptance Criteria (from the provided text's perspective):
The "study" described in the 510(k) Summary is primarily a non-clinical performance testing exercise aimed at demonstrating that the Vivorté Trabexus™ EB™ device, particularly with its new cannula accessory, maintains the safety and effectiveness characteristics of its predicate device, Vivorté BVF™.
The acceptance criteria are implied to be the successful completion ("Pass") of standard engineering and biocompatibility tests. The submission hinges on the argument that the subject device is "essentially the same as the predicate device" with only an added cannula accessory. The non-clinical testing was conducted "according to the design verification test methods indicated by the risk analysis." The successful passing of these tests forms the basis for demonstrating substantial equivalence and, by extension, that the device meets its core acceptance criteria for safety and performance in the context of this 510(k) submission. No clinical efficacy or safety studies were presented in this summary section, as substantial equivalence to a legally marketed predicate device often relies heavily on non-clinical data if the changes are minor.
§ 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.