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.

Device Description

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.

AI/ML Overview

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.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of three human profiles facing to the right, representing health and human services.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 14, 2015

Vivorté, Incorporated % Stephen J. Peoples, VMD, MS Peoples & Associates 5010 Lodge Pole Lane Fort Wayne, Indiana 46814

Re: K143547

Trade/Device Name: Vivorté Trabexus™ EBTM Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MBP, MQV Dated: December 12, 2014 Received: December 15, 2014

Dear Dr. Peoples:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number K143547

Device Name: Vivorté Trabexus™ EB™

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

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510(k) Summary

This 510(k) Summary is provided per the requirements of 21 CFR 807.92.

Submitter Information:

Name:	Vivorté, Inc.
Address:	1044 E. Chestnut StreetLouisville, KY 40204
Telephone:	(502) 693-2432
Fax:	(502) 714-7235

Contact Person:	Robert Burden
Date Prepared:	December 12, 2014

Device Information:

Trade Name: Vivorté Trabexus™ EB™ Common Name: Calcium bone void filler Classification: Class II Regulation Number and Description: 21 CFR 888.3045 - Resorbable calcium salt bone void filler device Product Code: MBP, MQV

Predicate Device:

The predicate device is Vivorté BVF™ that was cleared via 510(k) K130703 on September 12, 2013.

Device Description:

Indications for Use:

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

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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.

Comparison to Predicate Device:

The subject Vivorté Trabexus™ EB™is essentially the same as the predicate device. The only difference between the predicate and the subject device is that the subject device includes an additional accessory. a delivery cannula to deliver the calcium phosphate bone filler to the bone defect site as specified in the indications for use cleared in K130703. The primary packaging was modified to accommodate the additional accessory and the Instructions for Use were modified to instruct the physician how to use the additional delivery cannula accessory. The changes made to the Instructions for Use do not affect the intended use.

Non-Clinical Testing:

Performance testing according to the design verification test methods indicated by the risk analysis was conducted. A summary of the test results is included below.

Test Method	Subject Device Test
	Results
Extrudability	Not applicable
Biocompatibility	Pass
Bubble leak test	Pass
Heat seal strength of	Pass
primary packaging

Comparative Testing

Substantial Equivalence:

In establishing substantial equivalence to the predicate device. Vivorté evaluated the intended use and indications for use, materials, basic design, fundamental scientific technology, labeling, packaging materials and configuration, shelf life, and sterilization processes. The performance testing demonstrates that the subject device meets the acceptance criteria per the design verification test methods identified by the risk analysis. Based on the information presented, the proposed delivery cannula accessory does not impact the device safety and effectiveness and Vivorté Trabexus" EB" is substantially equivalent to the predicate Vivorté BVF™ cleared via K130703 on September 12, 2013.

Regulation Number and Section

§ 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.