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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

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.

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Vivorté Trabexus" is a moldable, self-setting, gradually resorbable, calcium phosphate bone void filler. Vivorté Trabexus" 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™ may be manually applied to the bony defect or applied to the defect through a cannula. Vivorté Trabexus" is resorbed and remodeled by the body as new bone formation occurs during the healing process.

Vivorté Trabexus™ is a moldable, self-setting, gradually resorbable, biocompatible, calcium phosphate bone void filler. 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 is a 510(k) premarket notification for the Vivorté Trabexus™ device. It doesn't contain a detailed clinical study with acceptance criteria and device performance results in the format requested. The document focuses on demonstrating substantial equivalence to a predicate device based on bench testing.

Therefore, many of the requested sections regarding acceptance criteria, study details, ground truth, experts, and human reader performance cannot be fully extracted from this document.

However, I can extract the available information regarding non-clinical testing and the comparison to the predicate device.

Key Findings from the Document:

The Vivorté Trabexus™ is a new version of an existing device (Vivorté BVF™ Lite™). The primary difference is the inclusion of an additional accessory: a delivery cannula. The substantial equivalence is based on the argument that this accessory does not impact the safety and effectiveness of the device.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide specific quantitative acceptance criteria or detailed device performance metrics beyond "Pass" for the non-clinical tests.

Note: The document states "Performance testing according to the design verification test methods indicated by the risk analysis was conducted." However, it does not detail these test methods or specific quantitative acceptance criteria. The "Not applicable" for Extrudability suggests that this test might have been relevant for the predicate device but perhaps less so for the new device given the cannula accessory.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not specified for any of the non-clinical tests.
• Data Provenance: Not explicitly stated, but these are likely in-house (Vivorté, Inc.) non-clinical bench tests. The country of origin for the data is not mentioned. The tests are retrospective in the sense that they were conducted for this 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not applicable. This document describes non-clinical bench testing, not a clinical study requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

• Not applicable. This was non-clinical bench testing, not a study requiring adjudication of expert interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. This was not a clinical study involving human readers or AI.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done

• No. This document does not describe an algorithm or AI.

7. The Type of Ground Truth Used

• For the non-clinical tests, the "ground truth" would be the established scientific and engineering principles and standards for evaluating the properties of medical devices (e.g., biocompatibility standards, packaging integrity standards).

8. The Sample Size for the Training Set

• Not applicable. This document does not describe an AI/ML algorithm or a training set.

9. How the Ground Truth for the Training Set was Established

• Not applicable. This document does not describe an AI/ML algorithm or a training set.

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