SIGNIFY™ Bioactive is intended for use as a bone void filler 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. SIGNIFY™ Crunch is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and posterolateral spine). SIGNIFY™ Putty and Gel are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). SIGNIFY™ resorbs and is replaced with bone during the healing process.

Device Description

SIGNIFY™ Bioactive is a resorbable bone void filler for the repair of bony defects. It is an osteoconductive and osteostimulative material that guides bone regeneration. When SIGNIFY™ is placed in direct contact with host bone, new bone grows in apposition to the implant. As the implant resorbs, bone and other connective tissues grow into the space previously occupied by SIGNIFY™. SIGNIFY™ consists of Bioglass (per ASTM F1538), polyethylene glycol, and glycerol, and is available in putty, gel, and crunch forms to accommodate surgical and anatomical needs.

AI/ML Overview

The provided text describes the SIGNIFY™ Bioactive device, a resorbable bone void filler. The submission is a 510(k) premarket notification, indicating that the device aims to demonstrate "substantial equivalence" to legally marketed predicate devices.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Demonstrate substantial equivalence to predicate devices.	"Performance data demonstrates substantial equivalence to the predicate devices."
As safe as predicate devices.	"SIGNIFY™ implants are as safe...as the predicate devices."
As effective as predicate devices.	"SIGNIFY™ implants are as...effective...as the predicate devices."
Perform as well as or better than predicate devices.	"SIGNIFY™ implants...perform as well as or better than the predicate devices."
In vivo performance in tibia defect model.	"In vivo performance testing (tibia defect model...) were conducted"
In vivo performance in posterolateral spine fusion model.	"In vivo performance testing (...and posterolateral spine fusion model) were conducted"
Biocompatibility testing in accordance with "Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device," June 2, 2003.	"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."

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

The document does not explicitly state the numerical sample size for the "in vivo performance testing" (test set). It only mentions that a "tibia defect model and posterolateral spine fusion model" were used.

The data provenance (country of origin, retrospective/prospective) is also not specified.

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

This information is not provided in the document. The studies mentioned are "in vivo performance testing" which typically involve animal models or clinical trials, not expert review of retrospective data for ground truth establishment in the way it might be for an AI diagnostic device.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. The performance testing described is direct product performance in biological models, not an assessment requiring adjudication of human interpretations.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or mentioned. This type of study is typically relevant for diagnostic imaging AI systems where AI-assisted human performance is compared to human-only performance. The given device is a bone void filler, and its performance is assessed directly through in vivo models and biocompatibility, not through human interpretation of diagnostic images.

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

Yes, the studies described can be considered "standalone" in the sense that they are evaluating the device's intrinsic biological performance directly, independently of human interaction beyond surgical implantation. The "in vivo performance testing" and "biocompatibility testing" assess the material's properties and interaction with biological systems without a human-in-the-loop component for evaluating the device's performance.

7. Type of Ground Truth Used

The "ground truth" for this device's performance would be established through the direct outcomes and biological responses observed in the "in vivo performance testing" and "biocompatibility testing." This would include:

Histological evaluation: To assess new bone formation, integration with host bone, and resorption rates.
Imaging (e.g., X-ray, micro-CT): To visualize bone fill and structural integrity.
Biomechanical testing: To evaluate the strength of the repaired bone.
Clinical observation: In the case of animal models, observation of healing and any adverse reactions.
Biocompatibility assays: To determine cytotoxicity, sensitization, irritation, etc., as per the specified guidance document.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable to the assessment of this device. A bone void filler is a physical implant, not an AI or machine learning model that requires training data. Its performance is evaluated through direct experimental testing.

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

As established in point 8, a "training set" is not relevant for this device.

Summary

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K130977 Page 1 of 2

DEC 2 4 2013

510(k) Summary: SIGNIFY™ Bioactive

Company:	Globus Medical Inc.2560 General Armistead Ave.Audubon, PA 19403610-930-1800
Contact:	Christina KichulaGroup Manager, Regulatory Affairs
Date Prepared:	April 5, 2013
Device Name:	SIGNIFY™ Bioactive
Classification:	Per 21 CFR as follows:§888.3045 Resorbable Calcium Salt Bone Void FillerDeviceProduct Codes: MQVRegulatory Class: II, Panel Code 87
Predicate(s):	KINEX® Bioactive (K130392)Vitoss® BA Bioactive Bone Graft Substitute (K103173,K994337)NovaBone® Bioactive Bone Graft (K080009)

Purpose:

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

Device Description:

SIGNIFY™ consists of Bioglass (per ASTM F1538), polyethylene glycol, and glycerol, and is available in putty, gel, and crunch forms to accommodate surgical and anatomical needs.

Indication for Use:

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gaps of the skeletal system (i.e., the extremities and pelvis). SIGNIFY™ 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 devices.

Basis of Substantial Equivalence:

SIGNIFY™ 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). SIGNIFY™ implants are as safe, as effective, and perform as well as or better than the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure.

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

December 24, 2013

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

Re: K130977

Trade/Device Name: SIGNIFY™ Bioactive Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: November 14, 2013 Received: November 15, 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, 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 Iisting (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

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Page 2 - Ms. Christina Kichula

requirements as set forth in 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 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/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 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.

Lori A. Wiggins

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

K130977 510(k) Number:

Device Name: SIGNIFY™ Bioactive

INDICATIONS:

..............................................................................................................................................................................

OR Prescription Use X (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: K130977

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.