Interface Bone Void Filler is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structures. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Interface Bone Void Filler is indicated to be gently packed into bony voids or gaps of the skeletal system (extremities and pelvis), or in the posterolateral spine when mixed with autograft. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

Device Description

Interface Bone Void Filler is a synthetic bioactive bone graft for use in the repair of osseous defects. It is supplied as irregular synthetic granules of bioactive glass, sized from 200 microns to 420 microns. The elemental composition of Interface Bone Void Filler granules is Si, Ca. Na, and P. Interface Bone Void Filler conforms to ASTM specification F1538 for 45S5 bioactive glass.

AI/ML Overview

Here's a breakdown of the requested information based on the provided text, focusing on the study and acceptance criteria for the Interface Bone Void Filler:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a comparative equivalency study rather than a study with pre-defined acceptance criteria against specific performance metrics for the subject device alone. The goal was to demonstrate equivalence to a predicate device. Therefore, the "acceptance criteria" here implicitly refers to the demonstration of equivalence.

Acceptance Criteria (Implicit)	Reported Device Performance
Chemical Composition Equivalence	The subject device (Interface Bone Void Filler) and predicate devices (Interface Bone Void Filler K092541 and NovaBone Resorbable Bone Graft Substitute K021336) were shown to have the same elemental composition (Si, Ca, Na, P). Chemical composition was analyzed by SEM/EDXA. Trace elemental analysis was performed by ICP/OES. Crystallinity was analyzed by FT-IR and XRD.
Physical Properties Equivalence	The subject device and predicate devices have similar particle sizes. Physical properties were evaluated by scanning electron microscopy, and particle size was determined by laser diffraction.
Performance Characteristics Equivalence (Dissolution)	Dissolution testing, monitoring calcium concentration with a calcium-specific electrode, demonstrated equivalent performance characteristics for the Interface Bone Void Filler and the NovaBone Resorbable Bone Graft Substitute devices.
Radiographic, Morphometric, and Histologic Performance	In a posterolateral spine fusion animal model, the radiographic, morphometric, and histologic performance of the subject Interface Bone Void Filler device was demonstrated to be equivalent to that of the predicate NovaBone device. (Note: Specific metrics for equivalence are not provided in this summary, only the general statement of equivalence)
Intended Use	The subject device has the same intended use as the predicate devices.
Operating Principle, Design, Materials, Packaging, and Sterilization	The subject device uses the same operating principle, incorporates the same basic design, incorporates the same or very similar materials, and has similar packaging and is sterilized using the same processes as the predicate devices.

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

Sample Size for Physical/Chemical Testing: Not explicitly stated as a numerical sample size. The document mentions "detailed side-by-side material characterization was performed" and lists analytical methods. This implies sufficient samples were tested for each method to ensure accurate characterization.
Sample Size for Animal Model: Not explicitly stated numerically. The text refers to "a posterolateral spine fusion animal model." More details (e.g., number of animals, number of implants per animal) would typically be in the full study report, but are absent in this summary.
Data Provenance: Not explicitly stated (e.g., country of origin for the animal study, if it was retrospective or prospective). The animal model description suggests it was a prospective animal study conducted to compare the devices.

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

This information is not provided in the given document extract. The summary mentions "radiographic, morphometric and histologic performance" in an animal model, which implies assessment by trained individuals (e.g., veterinary radiologists, pathologists), but their number or qualifications are not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the given document extract. For the animal study's assessment of radiographic, morphometric, and histologic performance, no adjudication method (e.g., 2+1, 3+1) is described.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The study described is a comparison of two medical devices (bone void fillers) against each other, and it does not involve human readers interpreting images with or without AI assistance. This type of study is typically done for diagnostic imaging devices.

6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) Was Done

This question is not applicable as the device is a bone void filler, not an AI algorithm. Therefore, an "algorithm only, without human-in-the-loop performance" study was not performed.

7. The Type of Ground Truth Used

For the animal model study, the "ground truth" was established by radiographic, morphometric, and histologic analyses. This implies:

Radiographic: Interpretation of X-rays or other imaging by experts.
Morphometric: Quantitative measurements of bone formation or other relevant structures from images or histological sections.
Histologic: Examination of tissue samples under a microscope by pathologists to assess bone ingrowth, material resorption, inflammation, etc.

8. The Sample Size for the Training Set

This question is not applicable. The device is a bone void filler, not an AI algorithm, so there is no concept of a "training set" in the context of machine learning.

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

This question is not applicable as there is no training set for an AI algorithm.

Summary

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PAGE 1 OF 3 KU2857

510(k) Summary

DEC 1 3 2011

Interface Bone Void Filler

510(k) Summary

BioStructures, LLC

Interface Bone Void Filler

September 29, 2011

Russell Cook, CEO

ADMINISTRATIVE INFORMATION

Manufacturer Name:

BioStructures, LLC 1201 Dove Street, Suite 470 Newport Beach, CA 92660 Telephone: +1 (949) 553-1717 Fax: +1 (949) 553-0407

Official Contact:

Representative/Consultant:

Kevin A. Thomas, PhD Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 +1 (858) 792-1235 Telephone: Fax: +1 (858) 792-1236 Email. kthomas@paxmed.com flarson@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Interface Bone Void Filler Common Name: Bone void filler Classification Regulations: 21 CFR 888.3045, Class II Product Code: MOV Filler, bone void, calcium compound Classification Name: Classification Panel: Orthopaedic and Rehabilitation Devices Panel Restorative Devices Branch Reviewing Branch:

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K112857

510(k) Summary

Interface Bone Void Filler

INTENDED USE

DEVICE DESCRIPTION

EQUIVALENCE TO MARKETED DEVICE

BioStructures, LLC submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices Interface Bone Void Filler is substantially equivalent in indications and design principles to the following predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices:

BioStructures LLC, Interface Bone Void Filler, cleared under K092541; and

NovaBone Products, L.L.C, NovaBone Resorbable Bone Graft Substitute, cleared under K021336.

The subject device and the predicate devices have the same intended use and have the same technological characteristics. The subject device and the predicate devices are synthetic bioactive glass with elemental composition of Si, Ca, Na, and P. The subject device and the predicate devices have similar particle sizes, and are packaged in similar materials and sterilized using similar methods.

To demonstrate equivalence detailed side-by-side material characterization was performed including chemical composition, physical properties and performance characteristics. Chemical composition was analyzed by scanning electron microscopy with energy dispersive x-ray analysis (SEM/EDXA). Trace elemental analysis was performed by inductively coupled plasma/optical emission spectroscopy (ICP/OES). Crystallinity was analyzed by Fourier Transform Infrared Spectroscopy (FT-IR) and X-ray Diffraction (XRD). Physical properties were evaluated by scanning electron microscopy and particle size was determined by laser diffraction. Dissolution testing was performed by monitoring the concentration of calcium in

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K112857

510(k) Summary

Interface Bone Void Filler

media by a calcium-specific electrode in an appropriate dissolution apparatus. The analytical characterization demonstrated equivalent chemical composition, physical properties and performance characteristics for the Interface Bone Void Filler and the NovaBone Resorbable Bone Graft Substitute devices.

The radiographic, morphometric and bistologic performance of the subject Interface Bone Void Filler device were compared to that of the predicate NovaBone device in a posterolateral spine fusion animal model. The results of the study demonstrated that the performance of the subject Interface Bone Void Filler device was equivalent to that of the predicate NovaBone device.

Interface Bone Void Filler has the following similarities to the predicate devices:

. has the same intended use,
uses the same operating principle,
. incorporates the same basic design,
. incorporates the same or very similar materials, and
. has similar packaging and is sterilized using the same processes.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font.

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

DEC 1 3 2011

BioStructures, LLC % PaxMed International, LLC Kevin A. Thomas, PhD 11234 El Camino Real, Suite 200 San Diego, California 92130

Re: K112857

Trade/Device Name: Interface Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV Dated: September 29, 2011 Received: September 30, 2011

Dear Dr. Thomas:

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

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Page 2 - Kevin A. Thomas, PhD

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 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/ReportalProblem/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.

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

Sincerely yours.

Fen
Mark N. Melkerson

Mark N. Melkerso Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Summary

Indications for Use

510(k) Number:

KII2857

Device Name: Interface Bone Void Filler

Indications for Use:

Interface Bone Void Filler is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structures. These defects may be surgically created osseous defects on osseous defects created from traumatic injury to the bone. Interface Bone Void Filler is indicated to be gently packed into bony voids or gaps of the skeletal system (extremities and pelvis), or in the posterolateral spine when mixed with autograft. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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)

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(Division Sign-Off)

(Division Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K112857

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.