The MTF New Bone Void Filler is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. The MTF New Bone Void Filler is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. The MTF New Bone Void Filler must be used in the posterolateral spine with bone marrow aspirate or autograft.

The MTF New Bone Void Filler is for single patient use only.

Device Description

The MTF New Bone Void Filler (BVF) is processed human bone that has been demineralized and combined with gelatin and sodium hyaluronate, which are naturally derived materials that are biocompatible and biodegradable. The sodium hyaluronate used in the manufacturing of BVF is not of animal origin. BVF comes in the form of a mixture of demineralized bone with gelatin and sodium hyaluronate, and a spatula that is necessary to mix the components. A hydrating agent, such as blood and saline, can be used with BVF. Upon addition of a hydrating agent, BVF will achieve a flowable or moldable consistency. The resultant putty can then be manipulated by a surgeon into various shapes for ease and flexibility of use during surgical application.

AI/ML Overview

Here's an analysis of the provided text regarding the MTF New Bone Void Filler, focused on acceptance criteria and supporting studies:

It's important to note that this 510(k) submission is for a bone void filler, which is a medical device and not an AI/ML powered diagnostic or screening tool. Therefore, many of the typical acceptance criteria and study aspects related to AI (e.g., sensitivity, specificity, reader performance, ground truth establishment by experts, training set size, adjudication methods) are not applicable or described in this document.

The "acceptance criteria" for this device are focused on demonstrated substantive equivalence to predicate devices and meeting specific material properties and biological performance in animal models.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Substantial Equivalence	No new types of safety and effectiveness questions	Demonstrated in the animal study provided to be substantially equivalent to predicate devices.
Osteoinductive Potential	Positive osteoinductive potential in athymic mouse model.	Positive in athymic mouse model. (Every lot tested for release.)
Biocompatibility/Material Properties	Made from biocompatible, biodegradable materials (demineralized human bone, gelatin, sodium hyaluronate).	Described as such, sodium hyaluronate not of animal origin.
Sterility	Aseptically processed and passes USP <71> Sterility Tests.	Passes USP <71> Sterility Tests.
Donor Suitability	Compliant with 21 CFR Part 1271 (Human Cells, Tissues, and Cellular and Tissue Based Products).	Donor suitability criteria in compliance.
Viral Clearance and Inactivation	Demonstrated suitable viral inactivation potential for a wide spectrum of human viruses.	Testing demonstrated suitable viral inactivation potential.

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

Test Set Sample Size: Not explicitly stated as a numerical sample size in the context of typical "test sets" for AI/ML. The primary "test" to demonstrate substantial equivalence was an animal study. The document does not specify the number of animals or the design of this animal study.
Data Provenance: The animal study is the key performance data. The document does not specify the country of origin but implies it was conducted to support FDA submission in the USA. It is a prospective study (for the animal model) designed to evaluate the new device.

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

Not Applicable. For this bone void filler, "ground truth" as understood in AI/ML for image interpretation (e.g., disease presence/absence determined by human experts) is not relevant. The performance is assessed through biological outcomes in an animal model and adherence to material and processing standards.

4. Adjudication Method for the Test Set

Not Applicable. No human-expert adjudication is described, as the evaluation method is not dependent on subjective human interpretation of diagnostic data.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is not an AI/ML powered diagnostic or screening device that uses human readers for interpretation. Therefore, a MRMC study is not relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not Applicable. This is a physical medical device (bone void filler), not an algorithm or AI system.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established through:
- Biological Outcomes in an Animal Model: Specifically, osteoinductive potential in an athymic mouse model.
- Material Properties Testing: Sterility (USP <71>), viral clearance and inactivation.
- Compliance with Regulations: Donor suitability (21 CFR Part 1271).
- Comparison to Predicate Devices: Demonstrating no new safety or effectiveness concerns based on the animal study.

8. Sample Size for the Training Set

Not Applicable. This is not an AI/ML system that requires a "training set" in the computational sense.

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

Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

Study Summary:

The primary study referenced to demonstrate the MTF New Bone Void Filler meets its acceptance criteria for substantial equivalence is an animal study. This study showed the new device was substantially equivalent to its predicate devices, implying similar safety and effectiveness profiles in that model. Additionally, routine lot release testing confirms osteoinductive potential in an athymic mouse model. Other "studies" or testing involve laboratory analyses for sterility, viral clearance, and adherence to regulatory standards for donor tissue processing.

Summary

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

MTF New Bone Void Filler 510(k) Premarket Notification

510(k) SUMMARY (Per 21 CFR 807.92)

JAN 1 1 2013 1

ിമിടി പ

1/3

General Company Information

Name: Contact: Musculoskeletal Transplant Foundation Nancy Joy Senior Regulatory Affairs Submission Specialist

Address:

125 May Street Edison, NJ 08837 USA

Telephone: Fax:

Date Prepared

(732) 661-2381 (732) 661-2189

December 14, 2012

General Device Information

Product Name:

Classification:

Bone Void Filler Containing Human Bone 21 CFR §888.3045 - Product code: MBP, MQV. Class II

Predicate Devices

The MTF New Bone Void Filler Musculoskeletal Transplant Foundation 510(k) K110003, K113167

The MTF New Bone Void Filler

DBX® Demineralized Bone Matrix Musculoskeletal Transplant Foundation 510(k) K040262, K103784, K103795

DBX Strip® Musculoskeletal Transplant Foundation 510(k) K042829, K062205

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

Osteoinductive Potential

The MTF New Bone Void Filler is osteoconductive and has been shown to have osteoinductive potential in an athymic mouse model. Every lot of final product is tested to ensure the osteoinductive potential of the final product. Standard testing performed in an athymic mouse model must prove positive for lot release. It is unknown how the osteoinductive potential, measured in the athymic mouse model, will correlate with clinical performance in human subjects.

Description

Intended Use (Indications)

The MTF New Bone Void Filler is for single patient use only.

Viral Clearance and Inactivation

A panel of model potential human viruses representing various virus types, sizes, shapes and genomes were evaluated. The viral inactivation testing demonstrated suitable viral inactivation potential of the processing method for a wide spectrum of potential human viruses. The MTF New Bone Void Filler process further reduces the risk of viral contamination beyond donor testing and screening procedures.

Substantial Equivalence

This submission supports the position that the MTF New Bone Void Filler is substantially equivalent to a number of previously cleared devices, including:

The MTF New Bone Void Filler- Musculoskeletal Transplant Foundation [K110003, K113167]

DBX® Demineralized Bone Matrix - Musculoskeletal Transplant Foundation [K040262, K103784.K103795]

DBX Strip® - Musculoskeletal Transplant Foundation [K042829, K062205]

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

MTF New Bone Void Filler 510(k) Premarket Notification

Page 3

When comparing the MTF New Bone Void Filler to its predicate devices, there are no new types of safety and effectiveness questions. The MTF New Bone Void Filler has been demonstrated to be substantially equivalent to its predicate devices in the animal study provided within this submission.

Safety and Effectiveness Information

The MTF New Bone Void Filler is single-donor processed. The MTF New Bone Void Filler is aseptically processed and passes USP <71> Sterility Tests. The donor suitability criteria used to screen this donor are in compliance with the FDA regulations published in 21 CFR Part 1271 Human Cells, Tissues, and Cellular and Tissue Based Products.

Conclusion

MTF®

Musculoskeletal Transplant Foundation believes that the information provided in this 510(k) submission establishes that similar legally marketed devices have been used for the same clinical applications as the MTF New Bone Void Filler. The materials from which the MTF New Bone Void Filler is fabricated have an established history of use, and the device has been tested in accordance with applicable FDA guidelines.

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

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. In the center of the circle is a stylized symbol that resembles an abstract human figure embracing a bird or eagle. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Letter dated: January 11, 2013

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

Musculoskeletal Transplant Foundation % Ms. Nancy Joy Senior Regulatory Affairs Submission Specialist 125 May Street Edison. New Jersey 08837

Re: K121313

Trade/Device Name: MTF New Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV, MBP Dated: December 6, 2012 Received: December 10, 2012

Dear Ms. Joy:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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

Page 2 - Ms. Nancy Joy

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Mark N. Melkerson

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

Enclosure

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

INDICATIONS FOR USE

510(k) Number (if known): K121313

Device Name: MTF New Bone Void Filler

Indications for Use:

The MTF New Bone Void Filler is for single patient use only.

Prescription Use _ X (Per 21 CFR 801 Subpart D)

OR Over-The-Counter Use

(Per 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE------------------------------------------------------------------------------------------------------------------------------------------NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off

Division of Orthopedic Devices
510(k) Number K121313

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.