CONFIRM™ 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 from traumatic injury to the bone. CONFIRM™ Crunch is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and posterolateral spine) and must be combined with bone marrow aspirate and autogenous bone graft. CONFIRM™ Putty, Gel, Plus Gel, and Plus Crunch are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis) and must be combined with bone marrow aspirate and autogenous bone graft. CONFIRM™ resorbs and is replaced with bone during the healing process.

Device Description

CONFIRM™ 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 CONFIRM™ 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 CONFIRM™.

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

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called CONFIRM™ Bioactive. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain the detailed study information typically associated with acceptance criteria and device performance as might be found in a clinical trial report or a more comprehensive validation study.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor can I answer many of your specific questions about study design, ground truth, or expert involvement. The document primarily makes claims of substantial equivalence based on types of testing rather than presenting results against specific criteria.

Here's what can be extracted and what cannot:

Information that can be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: This detailed information is not provided in the document. The document states "Performance data demonstrates substantial equivalence to the predicate devices" and that in vivo and biocompatibility testing were conducted in accordance with a specific guidance document, but it does not present specific acceptance criteria or quantitative performance metrics against those criteria.
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not specified. The document mentions "in vivo performance testing (tibial defect model and posterolateral spine fusion model)" but does not give sample sizes for these animal models.
- Data provenance: The performance data comes from "in vivo performance testing" and "biocompatibility testing." These are likely pre-clinical (animal) studies, not human clinical trials. The country of origin is not specified, but the submission is to the U.S. FDA, suggesting the studies were likely conducted to U.S. or international standards acceptable by the FDA. The studies are prospective in nature as they involve testing the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided. Given the nature of the in vivo animal studies mentioned, "ground truth" would likely be established by veterinary pathologists or other scientific experts evaluating histological sections, imaging, or gross observations, but specifics are absent.
4. Adjudication method for the test set: This information is not provided.
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: This is not applicable and not mentioned. This device is a bone void filler, not an AI-powered diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not applicable as it's not an AI algorithm. Its performance as a standalone material is inherently what in vivo testing would evaluate.
7. The type of ground truth used:
- Based on the mention of "in vivo performance testing (tibial defect model and posterolateral spine fusion model)" and the nature of bone void fillers, the ground truth would likely involve:
  - Histopathology: Microscopic examination of tissue samples from the defect sites to assess new bone formation, integration, and resorption of the material.
  - Radiographic imaging: X-rays or CT scans to observe bone healing and density.
  - Gross observation: Visual assessment of the healing site.
  - Biomechanical testing: To assess the strength of the healed bone.
- The document implies that these methods were used to demonstrate "substantial equivalence to the predicate devices."
8. The sample size for the training set: This is not applicable as there is no "training set" for an AI device. The document describes in vivo studies, which are typically for performance evaluation.
9. How the ground truth for the training set was established: This is not applicable as there is no training set mentioned.

Summary of what the document does provide:

Device Name: CONFIRM™ Bioactive
Intended Use: Bone void filler and autograft extender for voids or gaps in the skeletal system (extremities, pelvis, posterolateral spine) that are not intrinsic to its stability. Must be combined with bone marrow aspirate and autogenous bone graft. Resorbs and is replaced with bone during healing.
Device Description: Resorbable bone void filler, osteoconductive and osteostimulative. Consists of Bioglass (per ASTM F1538), hyaluronic acid, and glycerol. Available in putty, gel, and crunch forms.
Performance Data Basis: "In vivo performance testing (tibial 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."
Conclusion: "Performance data demonstrates substantial equivalence to the predicate devices." CONFIRM™ Bioactive is similar to predicates in technical characteristics, performance, and intended use, and is as safe, effective, and performs as well as or better than the predicate devices.
Predicates: KINEX™ Bioactive Bone Void Filler (K130392), Vitoss® BA Bioactive Bone Graft Substitute (K103173 & K994337), NovaBone® Bioactive Bone Graft (K080009).

This document is a regulatory submission focused on demonstrating substantial equivalence, not a detailed scientific publication of study results.

Summary

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

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often used as a symbol of medicine. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol.

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

August 26, 2014

Globus Medical, Incorporated Kelly J. Baker, Ph.D. Senior Vice President, Regulatory and Clinical Affairs 2560 General Armistead Avenue Audubon, Pennsylvania 19403

Re: K133678

Trade/Device Name: CONFIRM™ Bioactive Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV Dated: August 19, 2014 Received: August 20, 2014

Dear Dr. Baker:

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

{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/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 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 yours.

Ronald和Aean -S for

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 on last page.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K133678

Device Name CONFIRM™ Bioactive

Indications for Use (Describe)

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

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

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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

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."

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

510(k) Summary: CONFIRM™ Bioactive

Company:	Globus Medical Inc.2560 General Armistead Ave.Audubon, PA 19403610-930-1800
Contact:	Kelly J. Baker, Ph.D.Senior Vice President, Regulatory and Clinical Affairs
Date Prepared:	August 25, 2014
Device Name:	CONFIRM™ 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 Bone Void Filler, K130392Vitoss® BA Bioactive Bone Graft Substitute, K103173 &K994337NovaBone® Bioactive Bone Graft, K080009

Purpose:

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

Device Description:

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

Indications for Use:

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

posterolateral spine) and must be combined with bone marrow aspirate and autogenous bone graft. CONFIRM™ Putty, Plus Putty, Gel, Plus Gel, and Plus Crunch are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis) and must be combined with bone marrow aspirate and autogenous bone graft. CONFIRM™ resorbs and is replaced with bone during the healing process.

Performance Data:

In vivo performance testing (tibial 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:

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

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.