The intended use for the MIIG® SR resultant paste is to be injected, digitally packed into open bone voids/gaps to cure in-situ, or molded into solid pellets that are gently packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities, spine, and pelvis). These open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The paste/pellets provide a bone void filler that resorbs and is replaced with bone during the healing process.

The MIIG® SR paste cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K-Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.

MIIG® SR is provided sterile for single use only.

Device Description

MIIG SR" bone void filler is supplied in paste and powder forms. MIIG® SR consists of a calcium sulfate/calcium phosphate composite bone void filler along with instruments for mixing and delivering the graft to the defect site.

AI/ML Overview

The provided text is a 510(k) summary for the MIIG® SR bone void filler. It details the device's intended use, description, and the materials it's made from. However, it explicitly states that the safety and effectiveness are supported by "substantial equivalence information, materials data, compliance with the FDA guidance document), and biocompatibility testing results provided within this Premarket Notification."

This means the submission relies on demonstrating similarity to already cleared devices and general compliance, rather than presenting a comparative effectiveness study with specific performance metrics and acceptance criteria as would be found in a study designed to prove new performance claims.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in this document.

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

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly stated in terms of specific performance metrics (e.g., accuracy, sensitivity, specificity) for a clinical or in-vitro study. The acceptance criterion for this 510(k) submission is "substantial equivalence" to predicate devices.
Reported Device Performance: No specific device performance metrics (e.g., healing rates, resorption times, mechanical strength) from a dedicated study are reported. The document focuses on material composition and intended use being equivalent to already cleared devices.

2. Sample sized used for the test set and the data provenance:

Not applicable as no specific test set or clinical study data is presented to prove performance against acceptance criteria. The submission relies on "biocompatibility testing results" and "materials data" which are not detailed in terms of sample size or provenance in this summary.

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 as no specific test set requiring expert-established ground truth is described.

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

Not applicable as no specific test set 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:

Not applicable. This device is a bone void filler, not an AI-assisted diagnostic or therapeutic tool with human readers.

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

Not applicable. This is a medical device (bone void filler), not an algorithm.

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

Not applicable as no specific test set requiring a ground truth is outlined. The "safety and effectiveness" are supported by substantial equivalence to previously cleared devices, which implies that the predicate devices' established safety and effectiveness serve as the "ground truth" for the new device's regulatory pathway.

8. The sample size for the training set:

Not applicable as there is no mention of a training set for an algorithm or a clinical trial in the context of this 510(k) summary.

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

Not applicable as there is no mention of a training set.

Summary

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WRIGHT.

FEB 2 7 2006

Kotooll

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of MIIG® SR.

Submitted By:

Datc:

Contact Person:

Wright Medical Technology, Inc.

December 30, 2005

Brian J. Young Sr. Director, Regulatory Affairs Phone: 901-867-4120 901-867-4630 Fax:

Proprietary Name:	MIIG® SR
Common Name:	Bone Void Filler
Classification Name and Reference:	21 CFR 888.3045, Resorbable Calcium Salt BoneVoid Filler Device
Device Product Code and Panel Code:	Orthopedics/87/MQV

DEVICE INFORMATION

INTENDED USES/ INDICATIONS A.

The intended use for the MIG® SR resultant paste is to be injected, digitally packed into open bone voids/gaps to cure in-situ, or molded into solid pellets that are gently packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities, spine, and pelvis). These open bone voids may be surgically created osseous defects or osscous defects created from traumatic injury to the bone. The paste/pellets provide a bone void filler that resorbs and is replaced with bone during the healing process.

MIIG® SR is provided sterile for single use only.

headquarters

Wright Medical Technology, Inc.	5677 Airline Road Arlington, TN 38002
---------------------------------	---------------------------------------

Phone	901.867.9971
Website	www.wmt.com

international subsidiaries

011.32.2.378.3905	Belgium
011.39.0250.678.227	Italy
905.826.1600	Canada
011.81.3.3538.0474	Japan
011.33.1.45.13.24.40	France
011.44.1483.721.404	UK
011.49.4161.745130	Germany

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DEVICE DESCRIPTION B.

C. MATERIALS

MIIG® SR bone void filler is comprised of calcium sulfate and calcium phosphate. As such, MIIG® SR bone void filler is substantially equivalent to other predicate 510(k) cleared Wright Medical Technology products. The resultant powder is diluted with an aqueous solution comprised of the same USP sterile water used in a predicate WMT bone void filler and combined with high purity glycolic acid titrated with sodium hydroxide to a neutral pH.

SUBSTANTIAL EQUIVALENCE INFORMATION D.

The intended use, material composition, and design features of the MIIG® SR are substantially equivalent to previously cleared 510(k) WMT bone void fillers. The safety and effectiveness of MIG® SR is adequately supported by the substantial equivalence information, materials data, compliance with the FDA guidance document), and biocompatibility testing results provided within this Premarket Notification.

1 Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.

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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 is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a bird with three wing-like shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 7 2006

Mr. Brain J. Young Sr. Director, Regulatory Affairs Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002

Re: K060011 Trade/Device Name: MIIG®SR Regulation Number: 21 CFR 888.3045 Regulation Name: Bone Void Filler Regulatory Class: II Product Code: MQV Dated: December 30, 2005 Received: January 03, 2006

Dear Mr. Young:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your becally be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encrosure) to regars) in the Medical Device Amendments, or to conninered proc to may 20, 1978, the eccordance with the provisions of the Federal Food, Drug, devices mat nave been recuire approval of a premarket approval application (PMA). and Cosmetic rice (110) that do novice, subject to the general controls provisions of the Act. The Act. The r ou may, dicrolore, mainer are as act include requirements for annual registration, listing of general controls providions practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device It may be subject to same additions, Title 21, Parts 800 to 898. In addition, FDA can oc found in the Oous of concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oc acrisou that I Dr one in that your device complies with other requirements of the Act that I Dri has made a asnd regulations administered by other Federal agencies. You must or any I cacraf statutes and registments, including, but not limited to: registration and listing (21 Comply with an the Free S requirements, new and 801); good manufacturing practice requirements as set OI IN Furt 007), idoomig (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic forul in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Brian J. Young

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Herbert Lewin Co

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number: Not yet assigned.

MIIG® SR Device Name:

Indications For Use:

The intended use for the MIIG® SR resultant paste is to be injected, digitally packed into open bone voids/gaps to cure in-situ, or molded into solid pellets that are gently packed into open bonc voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities, spine, and pelvis). These open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The paste/pellets provide a bone void filler that resorbs and is replaced with bone during the healing process.

The MIIG® SR paste cured in situ provides an open void/gap filler that can augment provisiona hardware (e.g. K-Wires) to help support bone fragments during the surgical procedure. The curec paste acts only as a temporary support media and is not intended to provide structural support during the healing process.

MIIG® SR is provided sterile for single use only.

(Division Sign-Off)

Division of General Restorative Devices

510(k) Number

Prescription Use _/
(Per21 CFR 801.109)

Over-The Counter Use (Optional Format 1-2-96)

(Division Sign-Off)

Store - Continue on another page if needed)

and Neurological Device CDRH, Office of Device Evaluation (ODE)

Kobooll 510(k) Number

headquarters

Wright Medical Technology, Inc. 5677 Airline Road Arlinaton, TN 38002 www.urmt.com 901.867.9971 ohone international subsidiones 011.32.2.378.3905 Belgium 11.49.4161.745130 Germany 011.39.0250.678.227 Italy 011.81.3.3538.0474 Japan 011.44.1483.721.404 UK

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.