MicroFuse® Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MicroFuse® Bone Void Filler may be combined with autogenous bone marrow aspirate or autograft. MicroFuse® Putty is a bone graft extender to be used with autogenous bone marrow aspirate and autograft. MicroFuse® is intended to be gently packed into bony voids or gaps of the skeletal system (e.g. the spine, pelvis, and extremities). These osseous defects may be surgically created or created from traumatic injury to the bone. MicroFuse® provides a bone void filler that resorbs and is replaced with bone during the healing process.

Device Description

MicroFuse® Bone Void Filler is a porous bone graft scaffold composed of bonded poly (lactide-co-glycolide) or poly(lactic acid) microspheres. MicroFuse® is available with and without a combination of barium sulfate and calcium sulfate. MicroFuse® is provided in a variety of shapes and sizes, in the form of granules, sheets, pre-formed blocks, putty and ST MIS implants. MicroFuse® ST Granules and putty are designed to be gently packed into contained voids or defects. MicroFuse® Sheets are designed to be used with shallow bony defects, or as a bone graft onlay to cover a defect. MicroFuse® Blocks and ST MIS implants are designed to fill an entire defect. MicroFuse® Putty is composed of MicroFuse® ST Granules combined with an inert biodegradable carrier. MicroFuse® implants are available in short-term (ST), mid-term (MT), or long-term (LT) composition.

AI/ML Overview

The provided 510(k) summary for the MicroFuse® additional implants (Putty and ST MIS) does not describe a study involving an AI/Machine Learning device or software. Therefore, many of the requested elements for an AI/ML study (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable or cannot be extracted from this document.

Instead, this submission pertains to a medical device (bone void filler) and its acceptance criteria are based on traditional medical device testing and comparison to predicate devices, rather than AI/ML performance metrics.

Here's a breakdown of the information that can be extracted, and the reasons why other information is not present:

Description of Acceptance Criteria and Device Performance (for a Medical Device, not AI/ML)

The acceptance criteria for the MicroFuse® additional implants are centered on demonstrating that the new implants are substantially equivalent to existing predicate devices and meet established performance and safety standards for their device type.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Reported Device Performance
Material Properties/Formulation	Meets requirements for molecular weight testing.
Biocompatibility	Satisfies biocompatibility testing standards.
Degradation Characteristics	Meets requirements for carrier degradation testing.
pH Stability	Satisfies pH testing.
Shelf Life	Meets shelf life testing standards.
In Vivo Performance/Safety	Satisfies animal testing requirements.
Special Controls Compliance	Complies with special controls provided in the "Guidance for Industry and FDA, Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device, Issued June 2, 2003."
Substantial Equivalence to Predicates	The MicroFuse® additional implants are similar to the predicate device(s) with respect to design, indications for use, and principles of operation. The information provided within this premarket notification supports substantial equivalence to the predicate device(s) (MicroFuse® Bone Void Filler K071187, K082442, and K083232).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable for an AI/ML context. This document doesn't describe a "test set" in the sense of a dataset for an algorithm. The testing described (molecular weight, biocompatibility, etc.) would involve specific samples of the device material, but the sample sizes for these specific lab tests are not detailed in this summary. Data provenance is not mentioned as it's a device manufacturing and performance claim, not a data-driven diagnostic.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable for an AI/ML context. No "ground truth" establishment by human experts is mentioned for this device submission, as it's not an AI diagnostic or image analysis tool.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable for an AI/ML context. This concept is irrelevant for the type of device and testing 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:

Not applicable. This pertains to AI-assisted diagnostic tools, which this device is not.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a physical bone void filler, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable in the AI/ML sense. For this device, "ground truth" would relate to accepted scientific methods for evaluating material properties, biological response (e.g., animal models), and adherence to established regulatory standards for bone void fillers. The ground truth for its performance is derived from these standardized tests, not human expert interpretation of data.

8. The sample size for the training set:

Not applicable. This summary does not describe an AI/ML device with a "training set."

9. How the ground truth for the training set was established:

Not applicable. This summary does not describe an AI/ML device.

In summary: The provided document is a 510(k) summary for a physical medical device (bone void filler) and its substantial equivalence to predicate devices, based on standard engineering, chemical, and biological testing, rather than an AI/Machine Learning diagnostic or assistive software. Therefore, the questions formulated for an AI/ML device are largely inapplicable.

Summary

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K102392

510(k) Summary: MicroFuse® Additional Implants

Company:	Globus Medical Inc.2560 General Armistead Ave.Audubon, PA 19403(610) 415-9000
Contact:	Kelly J. Baker, Ph.D.Director, Clinical Affairs & Regulatory
Date Prepared:	August 20, 2010
Device Name(s):	MicroFuse® Putty and MicroFuse® ST MIS
Classification:	Per 21 CFR as follows:§888.3045: Resorbable Calcium Salt Bone Void FillerProduct Code is MQVRegulatory Class II Panel Code 87.
Predicate(s):	MicroFuse® Bone Void Filler (K071187, K082442 andK083232)

Purpose:

The purpose of this submission is to add MicroFuse® additional implants (Putty and ST MIS) to the MicroFuse® product line.

DEVICE DESCRIPTION:

Indications for Use:

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bone. MicroFuse® provides a bone void filler that resorbs and is replaced with bone during the healing process.

Performance Data:

MicroFuse® additional implants satisfy molecular weight testing, carrier degradation testing, biocompatibility testing, shelf life testing, pH testing, and animal testing, and special controls provided in the Guidance for Industry and FDA, Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device, Issued June 2, 2003,

Basis of Substantial Equivalence:

The MicroFuse® additional implants are similar to the predicate device(s) with respect to design, indications for use and principles of operation. The information provided within this premarket notification supports substantial equivalence to the predicate device(s).

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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an image of an eagle with its wings spread.

DEC 2 2 2010

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

Globus Medical Inc. % Kelly J. Baker, Ph.D. Director, Clinical Affairs and Regulatory 2560 General Armistead Avenue Audubon, Pennsylvania 19403

Re: K102392

Trade/Device Name: MicroFuse® Putty and MicroFuse® ST MIS Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: November 24, 2010 Received: November 26, 2010

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

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Page 2 - Kelly J. Baker, Ph.D.

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/CDRHQffices/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.

Sincerely vours.

A. B. Rute
for.

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

Enclosure

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Indications for Use Statement

510(k) Number: K102392

MicroFuse® Putty and MicroFuse® ST MIS Device Name:

Indications:

MicroFuse® Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MicroFuse® Bone Void Filler may be combined with autogenous bone marrow aspirate or autograft. MicroFuse Putty is a bone graft extender to be used with autogenous bone marrow aspirate and autograft. MicroFuse® is intended to be gently packed into bony voids or gaps of the skeletal system (e.g. the spine, pelvis, and extremities). These osseous defects may be surgically created or created from traumatic injury to the bone. MicroFuse® provides a bone void filler that resorbs and is replaced with bone during the healing process.

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)

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102392

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.