KINEX™ Bioactive is intended for use as a bone void filler and autograft extender for voids or gaps that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or created from traumatic injury to the bone. KINEX™ Plus Putty and KINEX™ Plus Gel are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and spine) and should be combined with bone marrow aspirate. KINEX™ Strip, KINEX™ Plus Strip, KINEX™ Putty and KINEX™ Gel are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis) and should be combined with bone marrow aspirate. KINEX™ resorbs and is replaced with bone during the healing process.

Device Description

KINEX™ Bigactive is a resorbable bone void filler for the repair of bony defects. It is an osteoconductive and osteostimulative material that guides bone regeneration. When KINEX™ is placed in direct contact with host bone, new bone grows in apposition to the surfaces of the implant. As the implant resorbs, bone and other connective tissues grow into the space previously occupied by KINEX™.

KINEX™ implants consist of bioglass (per ASTM F1538), collagen (per ASTM F2212), and hyaluronic acid, and are available in putty, gel, and strip forms to accommodate surgical and anatomical needs.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (KINEX™ Bioactive), which primarily focuses on establishing substantial equivalence to predicate devices for regulatory clearance. It describes the device, its intended use, and states that performance data supported its equivalence. However, it does not contain the detailed information required to answer many of your specific questions about acceptance criteria, a specific study's methodology, or a statistical comparison of performance.

Here's a breakdown of what can and cannot be answered based on the provided text:

What can be extracted/inferred:

Device Performance (General): The document states "Performance data demonstrates substantial equivalence to the predicate device." and "KINEX™ implants are as safe, as effective, and perform as well as or better than the predicate devices."
Type of Testing: "In vivo performance testing (tibia defect model and posterolateral spine fusion model) and biocompatibility testing were conducted..."
Guidance Followed: "...in accordance with the 'Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device,' June 2, 2003." This guidance would contain acceptance criteria, but they are not explicitly listed in this document.
Ground Truth Type (Inferred for in vivo studies): For in vivo animal models, ground truth is typically assessed through histological analysis, micro-CT, or other imaging techniques to evaluate bone formation, resorption, and integration.

What cannot be extracted from the provided text:

A table of acceptance criteria and reported device performance: This document only provides a high-level statement about meeting acceptance criteria (via substantial equivalence). It does not list specific numerical performance metrics or acceptance thresholds.
Sample size used for the test set and data provenance: The document mentions "tibia defect model and posterolateral spine fusion model" but does not give sample sizes, animal species, or country of origin.
Number of experts used to establish the ground truth for the test set and their qualifications: This information is not present.
Adjudication method for the test set: Not mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: This is highly unlikely for a bone void filler device and is not mentioned. MRMC studies are typical for diagnostic imaging AI.
If a standalone performance study was done: The provided text indicates in vivo testing but doesn't differentiate between standalone performance vs. comparison to a predicate in a statistically rigorous way described for AI. The "substantial equivalence" framework means the device is compared to existing devices, not necessarily tested in isolation against absolute performance metrics in the same way an AI model might be.
The sample size for the training set: Not applicable for this type of device and study. There's no AI model being "trained."
How the ground truth for the training set was established: Not applicable for this type of device either.

Based on the available information, here is a summary without the specific details that are not present:

The KINEX™ Bioactive device underwent in vivo performance testing in both a tibia defect model and a posterolateral spine fusion model, in addition to biocompatibility testing. These studies were conducted in accordance with the "Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device," issued June 2, 2003.

Acceptance Criteria and Device Performance:

Acceptance Criteria (Inferred from Guidance)	Reported Device Performance
Specific criteria not explicitly listed in this document, but would typically relate to:Osteoconductivity: Evidence of new bone formation at the implant-bone interface.Resorption Profile: Evidence of appropriate material degradation and replacement by bone over time.Biocompatibility: Absence of adverse tissue reactions, inflammation, or toxicity.Mechanical Performance (In vivo): Stability within the defect site, contribution to fusion (if applicable).Equivalence to Predicate: Performance "as safe, as effective, and perform as well as or better than the predicate devices."	The device "demonstrates substantial equivalence to the predicate device."KINEX™ implants are stated to be "as safe, as effective, and perform as well as or better than the predicate devices."

Acceptance Criteria (Inferred from Guidance)

Reported Device Performance

*Specific criteria not explicitly listed in this document, but would typically relate to:*Osteoconductivity: Evidence of new bone formation at the implant-bone interface.Resorption Profile: Evidence of appropriate material degradation and replacement by bone over time.Biocompatibility: Absence of adverse tissue reactions, inflammation, or toxicity.Mechanical Performance (In vivo): Stability within the defect site, contribution to fusion (if applicable).Equivalence to Predicate: Performance "as safe, as effective, and perform as well as or better than the predicate devices."

The device "demonstrates substantial equivalence to the predicate device."KINEX™ implants are stated to be "as safe, as effective, and perform as well as or better than the predicate devices."

Study Details (Limited Information):

Sample size for the test set and data provenance: Not specified in the provided text. The studies were in vivo animal models (tibia defect and posterolateral spine fusion models).
Number of experts and qualifications for ground truth: Not specified. For in vivo animal studies, experts would typically be veterinary pathologists, histologists, or orthopedic surgeons.
Adjudication method: Not specified.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable for this type of device submission and no such study was performed or mentioned.
Standalone performance study: The in vivo performance testing evaluates the device's biological response in an animal model. The core claim is substantial equivalence to predicates, implying a comparative context, but the animal studies themselves would characterize the device's fundamental performance.
Type of ground truth used: Inferred to be animal in vivo outcomes, likely assessed through histological analysis, imaging (e.g., micro-CT, radiography), and macroscopic evaluation of bone repair/fusion.
Sample size for the training set: Not applicable; this device is not an AI algorithm requiring a training set.
How the ground truth for the training set was established: Not applicable.

In essence, this 510(k) summary provides a regulatory overview of a traditional medical device, not a detailed technical report of an AI-powered diagnostic system, which is what most of your questions are geared towards. The "performance data" mentioned refers to standard biological, and possibly biomechanical, testing for bone void fillers, demonstrating its functional equivalence to existing products on the market.

Summary

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510(k) Summary: KINEX™ Bioactive

Company:Contact:	Globus Medical Inc.2560 General Armistead Ave.Audubon, PA 19403610-930-1800Christina Kichula
	AU6 1 5 201?Group Manager, Regulatory Affairs
Date Prepared:	February 12, 2013
Device Name:	KINEX™ Bioactive
Classification:	Per 21 CFR as follows:§888.3045 Resorbable Calcium Salt Bone Void FillerProduct Codes: MQVRequlatory Class: II, Panel Code 87
Predicate(s):	Vitoss® BA Bioactive BGS K103173 & K994337NovaBone® Bioactive Bone Graft K080009InQu® (Bone Void Filler) K103799

Purpose:

The purpose of this submission is to request clearance of the KINEX™ Bioactive.

Device Description:

KINEX™ implants consist of bioglass (per ASTM F1538), collagen (per ASTM F2212), and hyaluronic acid, and are available in putty, gel, and strip forms to accommodate surgical and anatomical needs.

Indication for Use:

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(i.e., the extremities, pelvis) and should be combined with bone marrow aspirate. KINEX™ resorbs and is replaced with bone during the healing process.

Performance Data:

In vivo performance testing (tibia defect model and posterolateral spine fusion model) and biocompatibility testing were conducted in accordance with the "Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device," June 2, 2003. Performance data demonstrates substantial equivalence to the predicate device.

Basis of Substantial Equivalence:

KINEX™ Bioactive is similar to the predicate devices with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence to the predicate device(s). KINEX™ implants are as safe, as effective, and perform as well as or better than the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, a common symbol associated with the U.S. government.

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

August 15, 2013

Ms. Christina Kichula Group Manager. Regulatory Affairs Globus Medical Incorporated 2560 General Armistead Avenue Audubon, Pennsylvania 19403

Re: K130392

Trade/Device Name: KINEX™ Bjoactive Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV Dated: June 28, 2013 Received: July 1, 2013

Dear Ms. Kichula:

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. Ilisting 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

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Page 2 – Ms. Christina Kichula

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" (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,

Ering Seith

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: K130392

Device Name: KINEX™ Bioactive

INDICATIONS:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR §801.109)

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Laurence D. Coyne -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K130392

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.