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.

AI/ML Overview

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.

Summary

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510(k) Summary

510(k) SPONSOR: Vivorté, Inc. 1044 E. Chestnut Street Louisville, KY 40204 Contact: Robert Burden Email: rburden@vivorte.com Telephone: (502) 693 - 2432 FAX: (502) 714 - 7235

SEP 12 2013

Vivorté BVFTM TRADE NAME:

Calcium phosphate bone void filler; bone void filler COMMON NAME:

Product	Regulation andDescription	Product Code	Device	Device Class
Vivorté BVF™	21 CFR 888.3045- Resorbablecalcium salt bonevoid filler device	MBP	Filler, bone void,osteoinductive(w/o humangrowth factor)	II
		MQV	Filler, bone void,calcium compound	II

ETEX EquivaBone® Osteoinductive Bone Graft Substitute PREDICATE DEVICES: (K090855)

Synthes® Norian® SRS® Bone Void Filler (K011897)

DEVICE DESCRIPTION:

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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.

INTENDED USE AND INDICATIONS FOR USE:

Vivorté BVF™ is a moldable, self-setting, 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 resorbed and remodeled by the body as new bone formation occurs during the healing process.

BASIS FOR SUBSTANTIAL EQUIVALENCE:

Vivorté BVF™ is chemically and physically substantially equivalent to the ETEX EquivaBone® Osteoinductive Bone Graft Substitute device. Both of these devices are synthetic calcium phosphate based bone void fillers containing osteoinductive demineralized bone matrix. The Vivorté BVF™ and the ETEX EquivaBone® Osteoinductive Bone Graft Substitute devices are both intraoperatively prepared by mixing similar components together to produce self-hardening calcium phosphate bone void fillers that, when implanted in a bony defect, are resorbed and remodeled by the body as new bone formation occurs during the healing process. Both devices have comparable mixing, handling/working, and setting times and, when fully hardened, are composed primarily of apatites that have similar chemical, physical, and mechanical characteristics and properties. The Vivorté BVF™ device and the ETEX EquivaBone® Osteoinductive Bone Graft Substitute device have similar indications for use.

Vivorté BVFTM is also chemically and physically substantially equivalent to the Synthes® Norian® SRS® Bone Void Filler. Both the Vivorté BVF™ and the Synthes® Norian® SRS® Bone Void Filler are composed of synthetic calcium phosphate materials that are virtually identical; however, the Synthes® Norian® SRS® Bone Void Filler does not contain any demineralized bone matrix. Both the Vivorté BVF™ and the Synthes® Norian® SRS® Bone Void Filler devices are intraoperatively prepared by mixing similar components together to produce self-hardening calcium phosphate bone void fillers that, when implanted in a bony defect, are resorbed and remodeled by the body as new bone formation occurs during the healing process. Both devices have comparable mixing, handling/working, and setting times; and both of these devices, when fully hardened, are composed primarily of hydroxyapatite that have similar chemical, physical, and mechanical characteristics and properties. The indications for use of the Vivorté BVF™ and the Synthes® Norian® SRS® Bone Void Filler are similar with the

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exception that the Synthes® Norian® SRS® Bone Void Filler does not contain DBM and therefore is not labeled as osteoinductive.

The Vivorté BVF™ and the ETEX and Synthes® predicate devices are provided packaged sterile and are intended as prescription use only single use devices.

Non-Clinical Testing

The following testing was performed to demonstrate substantial equivalency of Vivorté BVFTM to the predicate devices.

. Chemical, physical and mechanical testing
. Biocompatibility and toxicity (ISO 10993; ASTM; USP)
Animal testing .

Clinical Testing

Clinical testing was not necessary to determine substantial equivalence between Vivorté BVFTM and the predicate devices.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized symbol resembling a human figure with outstretched arms, accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged in a circular fashion around the symbol. The symbol is composed of three curved lines that form the shape of a person, and the text is written in a simple, sans-serif font.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

September 12. 2013

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

Re: K130703

Trade/Device Name: Vivorté I3VFTM Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MBP, MQV Dated: June 26, 2013 Received: July 10. 2013

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 10 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warrenties. We remind you. however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into cither class II (Special Controls) or class 111 (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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 -Stephen J. Peoples. VMD. MS

forth in the quality systems (QS) 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 Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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/Reportal?roblem/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 Small Manufacturers, International and Consumer Assistance 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.

Ronald P. Jean -S for

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: K130703

Device Name: Vivorté BVFTM

Indications for Use:

Vivorté BVFTM 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.

Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Laurence D. Coyne -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K130703

Page 1 of 1

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.