NanoBone® SBX Putty is intended for use as bone void fillers for voids or gaps that are not intrinsic to the stability of the bony structure. NanoBone® SBX Putty is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. NanoBone® SBX Putty is intended to be packed into bony voids or gaps of the skeletal system as a bone void filler (i.e., extremities and pelvis). This product provides a bone void filler that resorbs and is replaced by bone during the healing process.

Device Description

NanoBone® SBX Putty consists of NanoBone granulate embedded in an aqueous gel. NanoBone granulate consists of phase-pure non-sintered nanocrystalline osteoconductive hydroxyapatite (HA) embedded in a highly porous silica gel matrix. The high porosity of the product includes nano pores, micro pores, and macro pores. The interconnected and open porous structure of the macro pores of the NanoBone® is similar to human cancellous bone.

AI/ML Overview

The provided text is a 510(k) summary for the medical device NanoBone® SBX Putty. It details the device's characteristics, intended use, and equivalence to predicate devices, and includes a section on performance data.

However, the provided text does not contain the information requested to answer the specific questions about acceptance criteria and a study proving a device meets these criteria in the context of an AI/human-in-the-loop study for medical imaging. The document describes a traditional medical device (bone void filler) and its testing, which involves:

Bench testing: Chemical/elemental analysis, phase purity/XRD, dissolution testing, sterilization validation, pyrogenicity testing.
Biocompatibility assessment/testing.
Animal testing: Using a critical-sized femoral condyle defect model in New Zealand white rabbits, with analysis via histology, histomorphometry, micro CT, and image analysis for new bone formation and product resorption.

This type of testing is characteristic of a substance or implantable material, not an AI-powered diagnostic device or a system that requires human-in-the-loop performance evaluation through MRMC studies. Therefore, I cannot extract the requested information regarding acceptance criteria, AI/human performance improvement, ground truth establishment for a test or training set, or expert qualifications and adjudication methods as these concepts are not applicable to the described device and its testing in the provided document.

To answer your question, information about AI-specific acceptance criteria, test set sizes, expert ground truth establishment, MRMC studies, and training set details would need to be present, which it is not in this document.

Summary

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

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around a central emblem. The emblem consists of a stylized design of three human profiles facing right, with flowing lines beneath them, resembling a bird or abstract form.

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

October 26, 2016

ARTOSS GmbH Dr. Walter Gerike Managing Partner Friedrich-Barnewitz-Strasse 3 Rostock 18119 GERMANY

Re: K161351

Trade/Device Name: NanoBone® SBX Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: September 18, 2016 Received: September 20, 2016

Dear Dr. Gerike:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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

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 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,

Mark N. Melkerson -S

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

Enclosure

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

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

Indications for Use

510(k) Number (if known) K161351

Device Name NanoBone® SBX Putty

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Exemptions Under Part 286.801 Subpart J	Own Use Consumption (Part 286.801 Subpart A)

|× | 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}------------------------------------------------

NanoBone®

510(k) Summary

(as required by 21 CFR 807.92)

NanoBone® SBX Putty

510(k) K161351

Submitter	ARTOSS GmbHFriedrich-Barnewitz-Staße 318119 Rostock, GermanyTelephone: +49 (0) 381 5 43 45 - 701Fax: +49 (0) 381 5 43 45 – 702
Contact Person	Walter GerikeManaging PartnerARTOSS GmbHgerike@artoss.com
Date Prepared	10/25/2016

Trade Name	NanoBone® SBX Putty
Common Name	Bone Void Filler
ClassificationRegulation	Resorbable calcium salt bone void filler21 CFR 888.3045, Product Code MQV
Class	Class II Special Controls
Panel code	Orthopedic / 888
Predicate Devices	ARTOSS NanoBone® granulate (K141189)ApaTech Actifuse ™ ABX E-Z-fil (K071206)
Intended Use andIndications	NanoBone® SBX Putty is intended for use as bone void fillers for voids or gaps thatare not intrinsic to the stability of the bony structure. NanoBone® SBX Putty isindicated for use in the treatment of surgically created osseous defects or osseousdefects resulting from traumatic injury to the bone. NanoBone® SBX Putty isintended to be packed into bony voids or gaps of the skeletal system as a bone voidfiller (i.e., extremities and pelvis). This product provides a bone void filler thatresorbs and is replaced by bone during the healing process.
TechnologicalCharacteristics-Comparison toPredicate Devices	pores. The interconnected and open porous structure of the macro pores of theNanoBone® is similar to human cancellous bone.NanoBone® SBX Putty is composed of the same porous calcium phosphate asused in the NanoBone® predicate (K141189), with the same aqueous gel as thepredicate Actifuse ABX E-Z-fil (K071206).The NanoBone® SBX Putty and the predicate NanoBone granulate (K141189) havethe same intended use, to fill bony voids and gaps that are not intrinsic to thestability of the bony structure. These defects may be surgically created osseousdefects or those created from traumatic injury to the bone.NanoBone® SBX Putty has the same indications, contraindications, risks, basictechnology, equivalent materials, and potential adverse events as the NanoBone®granulate predicate (K141189). The only difference between the predicate ARTOSSNanoBone® granulate and the Subject device is the addition of an aqueous carrierand primary packaging in an applicator.The Subject devices are therefore substantially equivalent to its predicates.
Performance Data	Bench testing has shown the NanoBone® SBX Putty meets the requirements of allrelevant requirements for calcium salt bone void filler devices, including ASTMF1185.Testing was performed to characterize and evaluate the performance of theNanoBone® products. The testing included:• Chemical / elemental analysis• Phase purity / XRD• Dissolution testing• Biocompatibility assessment / testing• Sterilization validation• Pyrogenicity testing• Animal testingPerformance testing was undertaken to demonstrate that NanoBone® SBXPutty is capable of healing a critically-sized defect in a clinically relevantimplantation site. A well-established critical-sized femoral condyle defectmodel in the mature New Zealand white rabbit was used. Thirty rabbitswere divided into two groups of fifteen. Test articles were implantedbilaterally in 5mm diameter and 10mm deep defects in the lateral aspect ofthe femoral condyles. Fifteen experimental defects were implanted withNanoBone® SBX Putty. Fifteen control defects were implanted withNanoBone® granulate and another fifteen control defects were implantedwith Actifuse® ABX Putty. Five rabbits from each group were sacrificed at 4,8, and 12 weeks after implantation.The safety and performance of each test article were evaluated usinghistology, histomorphometry, micro CT, and image analysis. Outcomemeasures were new bone formation and product resorption. Based uponthe results of this testing, NanoBone SBX Putty performs satisfactorily as abone void filler and in a manner substantially equivalent to the predicatesNanoBone granulate (K141189) and Actifuse ABX Putty (K071206)

Description NanoBone® SBX Putty consists of NanoBone granulate embedded in an aqueous gel. NanoBone granulate consists of phase-pure non-sintered nanocrystalline osteoconductive hydroxyapatite (HA) embedded in a highly porous silica gel matrix. The high porosity of the product includes nano pores, micro pores, and macro

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

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

Conclusions	NanoBone® SBX Putty has the same intended use and similar technological characteristics as the predicate devices. Performance data demonstrates that the product performs as intended, and is substantially equivalent to its predicates.
-------------	-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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.