WMT Composite DBM resultant paste is intended for use as a bone graft substitute to be injected or digitally packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities and pelvis) to cure in-situ. These open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process.

The WMT Composite DBM 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.

The WMT Composite DBM Core Decompression Procedure Kit, consisting of a bone void filler and manual surgical instruments, is intended to be used during core decompression procedures. The bone void filler component resorbs and is replaced by bone during the healing process. The bone void filler included in the WMT Composite DBM Core Decompression Kit is not intended to be used as a load bearing device.

WMT Composite DBM is provided sterile for single use.

Device Description

WMT Composite DBM consists of a calcium sulfate, calcium phosphate, and demineralized bone matrix bone void filler consisting of a powder component and an aqueous mixing solution. When the two components are mixed, according to directions, an injectable paste is formed which subsequently hardens via hydration reactions.

AI/ML Overview

The provided text is a 510(k) summary for the WMT Composite DBM device, a bone void filler. It describes the device's intended use, composition, and claims about its performance, primarily in comparison to other bone graft materials. However, the document does not describe a study involving "acceptance criteria" for device performance in the typical sense of a pre-defined threshold that the device needs to meet for regulatory approval.

Instead, the document details "Non-Clinical Performance/Marketing Claims" which are based on comparative studies. These studies aim to demonstrate the device's effectiveness and safety, primarily by showing it is comparable to or, in some aspects, superior to, existing predicate devices or autograft. The document does not contain information about:

A table of acceptance criteria and reported device performance against those criteria.
Sample sizes used for a test set in the context of typical AI/software performance evaluation.
Data provenance for a test set.
Number of experts or their qualifications, adjudication methods, MRMC studies, or standalone performance for an algorithm.
The type of ground truth used in an AI/software context.
Training set sample size or how ground truth was established for a training set.

The document discusses biological and mechanical performance metrics from animal studies, which are used to support the claim of substantial equivalence to predicate devices and to justify its intended use. Here's a breakdown of the information that is available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: The document does not define explicit "acceptance criteria" in the form of numerical thresholds for device performance to be met for regulatory approval. Instead, the performance claims are comparative, aiming to show non-inferiority or superiority to predicate devices or autograft.

Reported Device Performance:

Performance Claim / Comparison	Reported Device Performance (WMT Composite DBM)
Accelerated healing vs. PRO-DENSE®	At 6 weeks, similar percentage of new bone formation, but less residual material in WMT Composite DBM defects. Showed accelerated and more complete healing as evidenced by new bone formation across the width of the defect.
Accelerated healing vs. Autograft	At 13 and 26 weeks, showed accelerated new bone formation (slightly higher stiffness, greater amount of newly formed bone, statistically significantly greater compressive strength). At 26 weeks, no statistically significant differences in percentage of new bone, compressive strength, and modulus of elasticity compared to autograft. Clinical, contact radiographs, and gross/histological images showed little to no apparent differences between WMT Composite DBM and autograft at 26 weeks.
Bone remodeling to normal bone at 13 weeks	From 6 to 13 weeks, increased new bone formation; material had substantially remodeled. From 13 to 26 weeks, sustained new bone formation, continued decrease in residual material. At every time point, WMT Composite DBM compared to normal bone showed no significant differences for percentage new bone, compressive strength, and modulus of elasticity.
Osteoinductivity	Confirmed to be osteoinductive, following the same test design as the predicate ALLOMATRIX®.

Note: All of these claims are based on a "critically sized canine proximal humerus defect model." The document explicitly states: "It is unknown how results from the canine model compare with clinical results in humans."

2. Sample size used for the test set and the data provenance

The studies described are animal studies.

Sample Size for Test Set: Not explicitly stated in the provided text. The claims refer generally to "WMT Composite DBM defects," "PRO-DENSE® treated defects," "autograft," and "normal bone" within a canine model, implying groups of animals were used, but specific numbers are not given.
Data Provenance: Critically sized canine proximal humerus defect model (animal study, prospective in design for the purpose of evaluating the device). Country of origin is not specified, but the submission is to the US FDA.

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 in the document. The evaluation of bone formation, residual material, stiffness, and compressive strength would typically be performed by veterinary pathologists, histologists, and biomechanical engineers, but their specific numbers or qualifications are not detailed.

4. Adjudication method for the test set

This information is not provided. The objective nature of some measurements (e.g., compressive strength, modulus of elasticity) might not require complex adjudication, while histological assessments might involve consensus or reviews, but no details are given.

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

No such study was conducted or described. This type of study is relevant for AI or imaging interpretation devices, not for a bone void filler product.

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

Not applicable. This is not an AI/software device.

7. The type of ground truth used

The ground truth was established through histological analysis, biomechanical testing (stiffness, compressive strength, modulus of elasticity), and possibly radiographic imaging (clinical and contact radiographs, gross cross-sectional images). This is a combination of direct biological and mechanical measurements on the animal model.

8. The sample size for the training set

Not applicable. This is not an AI/software device relying on a training set.

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

Not applicable.

Summary

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KOR3270

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

AUG 2 7 2009

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 WMT Composite DBM.

Submitted By:

Date:

Contact Person:

Proprietary Name:

Common Name:

Classification Name and Reference:

Wright Medical Technology, Inc.

September 24, 2008

Ryan M. Belaney

Sr. Regulatory Affairs Specialist/Product Development Engineer (as of 2/10/09)

WMT Composite DBM

Bone Void Filler

Orthopedic/87/MOV

21 CFR 888.3045 - Resorbable Calcium Salt Bone Void Filler Device - Class II

Device Product Code and Panel Code:

DEVICE INFORMATION

A. INTENDED USE

WMT Composite DBM is provided sterile for single use.

B. DEVICE DESCRIPTION

The design features of the WMT Composite DBM Kit are substantially equivalent to the design features of the predicate devices. A brief description of the WMT Composite DBM implant and a summary of additional performance/marketing claims are provided below.

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IMPLANT DESCRIPTION

NON-CLINICAL PERFORMANCE/MARKETING CLAIMS

Accelerated healing compared to PRO-DENSE®*: At 6 weeks, the percentage of new bone formation within the WMT Composite DBM defects was approximately the same as for PRO-DENSE® treated defects although there was less residual material in the WMT Composite DBM defects at this time point compared to PRO-DENSE®. Compared to PRO-DENSE®, WMT Composite DBM showed accelerated and more complete healing as evidenced by new bone formation across the width of the defect.

Accelerated healing compared to autograft*: Compared to autograft and normal bone, WMT Composite DBM showed accelerated new bone formation at 13 and 26 weeks. This was evident by the slightly higher stiffness, the greater amount of newly formed bone, and statistically significantly greater compressive strength shown for WMT Composite DBM. By comparing the 26-week clinical and contact radiographs and gross cross-sectional images and histological images, there appeared to be little to no apparent differences between defects filled with either WMT Composite DBM or autograft. Comparison of percentage of new bone, compressive strength, and modulus of elasticity showed no statistically significant differences between the materials at 26 weeks.

Bone remodeling to normal bone at 13 weeks *: From 6 to 13 weeks, the amount of new bone formation in the WMT Composite DBM defects increased. At 13 weeks, the WMT Composite DBM material had substantially remodeled compared to the 6-week time point. From 13 to 26 weeks, the amount of new bone formation for WMT Composite DBM was sustained and the amount of residual material continued to decrease. Further, at every time point, a comparison of WMT Composite DBM to normal bone shows no significant differences for percentage new bone, compressive strength, and modulus of elasticity.

Following the same test design as the predicate, ALLOMATRIX®, the osteoinductive property of WMT Composite DBM was confirmed.

All claims are based on a critically sized canine proximal humerus defect model. It is unknown how results from the canine model compare with clinical results in humans.

C. SUBSTANTIAL EQUIVALENCE INFORMATION

The intended use, type of interface, operating principles, shelf life, and design features of the WMT Composite DBM are substantially equivalent to the previously cleared predicates. Additionally, the safety and effectiveness of the WMT Composite DBM is adequately supported by the substantial equivalent information, materials data, and testing results provided within this Premarket Notification.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features an eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The seal is black and white.

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

AUG 2 7 2009

Wright Medical Technology, Inc. % Mr. Ryan Belaney Sr. Regulatory Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002

Re: K083270

Trade Name: WMT Composite DBM Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MOV, MBP Dated: August 3, 2009 Received: August 11, 2009

Dear Mr. Belaney:

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. Ilsting of devices, good manufacturing 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 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 - Mr. Ryan Belaney

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/CDRHOffices/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/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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Houbare Bruckner

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: K083270

Device Name: WMT Composite DBM

Indications For Use:

WMT Composite DBM is provided sterile for single use only.

Henneth C. Fager

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K083270

Prescription Use ブ (Per21 CFR 801.109)

(Division Sign-Off)

Division of General Restorative Devices

510(k) Number

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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.