MCS Bone Graft is a bone graft substitute intended for use in bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or result from traumatic injury to the bone. MCS Bone Graft is indicated to be hydrated with autologous bone marrow aspirate and packed into osseous defects of the extremities, pelvis and posterolateral spine. When used in the posterolateral spine, MCS Bone Graft is to be used as an autograft extender. Following implantation, the graft resorbs and is replaced by host bone during the healing process.

Device Description

MCS Bone Graft is a bone graft substitute comprising biphasic mineral granules suspended in a porous, bovine type I collagen matrix. The biphasic granules are 60% hydroxyapatite (HA) and 40% beta tri-calcium phosphate (betaTCP). The device is provided in a strip form and is supplied terminally sterile for single patent use. The device is designed to be combined with autologous bone marrow aspirate prior to facilitate packing into bony defects and is used with autologous bone in the posterolateral spine. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process.

AI/ML Overview

The provided document is a 510(k) summary for the MCS Bone Graft device. It describes the device, its intended use, and provides a summary of performance testing and substantial equivalence. However, it does not contain specific acceptance criteria, a detailed study description with sample sizes, or information on human reader studies (MRMC or standalone), which are typically associated with artificial intelligence/machine learning devices. The MCS Bone Graft is a medical device, specifically a bone graft substitute, and its evaluation focuses on biocompatibility, material properties, and in-vivo animal studies, not AI performance.

Therefore, the requested information cannot be fully extracted from the provided text in the context of an AI/ML device. I will answer based on the information that is present about the MCS Bone Graft as a physical medical device.

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria in a table format, nor does it present device performance in terms of metrics like sensitivity, specificity, or accuracy that are typical for AI/ML devices. Instead, it refers to compliance with standards and successful outcomes in animal studies.

Acceptance Criteria (Inferred/Compliance)	Reported Device Performance
Compliance with FDA guidance documents and recognized consensus standards.	Non-clinical testing performed in accordance with FDA guidance documents and recognized consensus standards.
Meet relevant requirements of ASTM F1185-03, F1088-04a, and F2212-11.	Physical and chemical characterization of implant raw materials and finished device meet these requirements.
Collagen raw materials meet essential safety requirements of ISO 22442.	Collagen raw materials meet essential safety requirements for medical devices utilizing animal tissues according to ISO 22442.
Meet biocompatibility requirements for permanent tissue/bone implants.	Met biocompatibility requirements as per "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
Successful viral inactivation, sterilization, packaging, and shelf-life stability	Viral inactivation, sterilization, packaging, and shelf-life stability evaluations performed with passing results.
Demonstrates safety and performance compared to predicate devices (animal study).	In prior 510(k) (K142276), MCS Bone Graft was deemed substantially equivalent to Vitoss Scaffold Foam in a critical-size rabbit femoral defect study. In the current submission, it demonstrated substantially equivalent spine fusion performance compared to the predicate device and control group (iliac crest bone graft) in a rabbit posterolateral spine fusion study.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document mentions a "critical-size rabbit femoral defect study" and a "rabbit posterolateral spine fusion study." It does not specify the exact number of animals used in these studies.
Data Provenance: The studies are animal studies (rabbits), specifically in vivo performance testing. There is no information on the country of origin of the data or whether it was retrospective or prospective, though animal studies are typically prospective by nature.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to this device submission. The MCS Bone Graft is a physical medical device, not an AI/ML diagnostic tool. Ground truth was established through scientific methods such as radiographic, microCT, biomechanical, and histological endpoints in animal models, not by human expert assessment of AI output.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. The device is a bone graft substitute, and its performance evaluation does not involve human adjudication of diagnostic outputs.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic devices where human readers interpret medical images with or without AI assistance. The MCS Bone Graft is a therapeutic bone graft substitute.

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

No, a standalone performance study (algorithm only) was not done. This is not relevant for a physical bone graft device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the animal in vivo performance testing, the ground truth was established using:

Radiographic endpoints
MicroCT (micro-computed tomography) endpoints
Biomechanical endpoints
Histological endpoints (examination of tissue microstructure)

8. The sample size for the training set

This information is not applicable. The MCS Bone Graft is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable, as there is no training set for this type of medical device.

Summary

{0}------------------------------------------------

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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is rendered in black, and the text is also in black.

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

February 13, 2017

Bioventus, LLC % Patsy Trisler, J.D., R.A.C. Regulatory Consultant Trisler Consulting 5600 Wisconsin Avenue Chevy Chase, Maryland 20815

Re: K162860

Trade/Device Name: MCS Bone Graft Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: December 28, 2016 Received: December 28, 2016

Dear Ms. Trisler:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{1}------------------------------------------------

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/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/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,

Mark N. Melkerson -S

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

Enclosure

{2}------------------------------------------------

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K162860

Device Name

MCS Bone Graft

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

Submitter Information:

Name:	Bioventus, LLC
Address:	4721 Emperor Boulevard, Suite 100Durham, NC 27703
Contact Person:	John Brunelle, PhDChief Technology Officer – Surgical
Telephone:	(949) 553-1717
Date Prepared:	February 6, 2017

Device Information:

Trade Name: MCS Bone Graft Common Name: Bone graft substitute Classification: Class 2 Regulation: 888.3045, Resorbable calcium salt bone void filler device Product Code: MQV

Predicate Device(s):

K142276: MCS Bone Graft (BioStructures, LLC) K071813: Mastergraft® Putty (Medtronic Sofamor Danek)

Background:

MSC Bone Graft has been previously cleared as a bone filler device under 510(k) submission K142276 with indications for use in osseous defects of the extremities and pelvis when mixed with bone marrow aspirate. The purpose of the current submission is to obtain clearance for an additional indication for use in the posterolateral spine when mixed with bone marrow aspirate and combined with autologous bone.

Indications for Use:

{4}------------------------------------------------

Device Description:

MCS Bone Graft is a bone graft substitute comprising biphasic mineral granules suspended in a porous, bovine type I collagen matrix. The biphasic granules are 60% hydroxyapatite (HA) and 40% beta tri-calcium phosphate (βTCP). The device is provided in a strip form and is supplied terminally sterile for single patent use. The device is designed to be combined with autologous bone marrow aspirate prior to facilitate packing into bony defects and is used with autologous bone in the posterolateral spine. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process.

Performance Testing:

Non-Clinical Testing:

Non-clinical testing was performed in accordance with FDA guidance documents and recognized consensus standards as applicable. Physical and chemical characterization of the implant raw materials and finished device was conducted as recommended in the FDA class II bone void filler guidance document and meet relevant requirements of ASTM F1185-03, F1088-04a and F2212-11. The collagen raw materials meet essential safety requirements for medical devices utilizing animal tissues according to ISO 22442. The device has met biocompatibility requirements for permanent tissue/bone implants according to FDA's Guidance for Industry and Food and Drug Administration Staff: "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Viral inactivation, sterilization, packaging and shelf life stability evaluations have been performed with passing results.

In Vivo Performance Testing:

Animal performance testing was conducted to demonstrate the safety and performance of the MCS Bone Graft as directly compared to the predicate devices. In the prior 510(k) submission (K142276), the MCS Bone Graft was evaluated in a critical-size rabbit femoral defect study and deemed substantially equivalent to Vitoss Scaffold Foam. In the current submission, the MCS Bone Graft was evaluated in a rabbit posterolateral spine fusion study, which demonstrates substantially equivalent spine fusion performance compared to the predicate device and control group (iliac crest bone graft). Outcomes were determined using radiographic, microCT, biomechanical and histological endpoints, measured at 4, 8 and 12 weeks after surgery.

Substantial Equivalence:

MCS Bone Graft has the same intended use, and the same or similar technological characteristics, principles of operation and indications as the predicate devices. The material composition of the MCS Bone Graft is identical to the previously cleared MCS Bone Graft and similar to the Mastergraft Putty. All devices comprise biphasic granules (mixture of hydroxyapatite and beta-tricalcium phosphate) and bovine type I collagen. MCS Bone Graft is provided in strip form and has >90% implant porosity, same as the previously cleared MCS Bone Graft. MCS Bone Graft is supplied sterile and is combined with bone marrow aspirate prior to use, same as both predicates. MCS Bone Graff is to be used with autologous bone in the posterolateral spine, same as Mastergraft Putty. Any technological differences presented by the MCS Bone Graft do not raise new issues of safety or effectiveness.

{5}------------------------------------------------

Conclusion:

Performance testing and technological comparisons presented in this 510(k) indicate MCS Bone Graft is substantially equivalent to the predicate devices.

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.