MasterGraft™ Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MasterGraft™ Bone Void Filler is to be gently packed into bony voids of the skeletal system (e.g., the spine, pelvis, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MasterGraft™ provides a bone void filler that resorbs and is replaced with bone during the healing process.

Device Description

MasterGraff™ Bone Void Filler is made of medical grade combination of hydroxyapatite and ßtricalcium phosphate. MasterGraft™ is provided in a 60 percent hydroxyapatite and 40 percent ßtricalcium phosphate formulation. Alternatively, MasterGraft™ may be provided in a 15 percent hydroxyapatite and 85 percent ß-tricalcium phosphate formulation. The product is supplied sterile for single patient use. MasterGraft™ is an osteoconductive porous implant.

AI/ML Overview

This document is a 510(k) summary for the Medtronic Sofamor Danek MasterGraft™ Bone Void Filler. It focuses on establishing substantial equivalence to previously cleared devices rather than presenting a de novo study with specific performance acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and study details for an AI/device performance evaluation is not applicable or present in this document.

Here's an breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable. This document does not describe specific performance acceptance criteria or report on performance metrics in the way one would for an AI or novel device study. The core of this 510(k) summary is to demonstrate "substantial equivalence" of the MasterGraft™ Bone Void Filler to existing, legally marketed bone void fillers.

The "performance" described is the product's intended function based on its composition and mechanism of action, which is assumed to be similar to its predicates.

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

Not Applicable. No test set for performance evaluation is described. The document pertains to regulatory clearance based on substantial equivalence, not a clinical performance study with a test set.

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

Not Applicable. No test set or ground truth establishment by experts is described.

4. Adjudication Method for the Test Set

Not Applicable. No test set or adjudication method 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 document concerns a physical medical device (bone void filler), not an AI algorithm. Therefore, an MRMC study and AI assistance are not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable. This document concerns a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

Not Applicable. No ground truth for performance evaluation is mentioned as this is a substantial equivalence submission. The closest concept might be the established safety and efficacy of the predicate devices.

8. The Sample Size for the Training Set

Not Applicable. No training set is mentioned as this is a physical medical device, not an AI algorithm.

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

Not Applicable. No training set or ground truth establishment is described.

Summary of the Document's Content:

The document is a 510(k) summary for the Medtronic Sofamor Danek MasterGraft™ Bone Void Filler. It outlines:

Product Description: A medical-grade combination of hydroxyapatite and β-tricalcium phosphate, supplied sterile, in two formulations (60% HA/40% β-TCP or 15% HA/85% β-TCP). It is described as an osteoconductive porous implant.
Indications for Use: For bony voids or gaps not intrinsic to the stability of the bony structure, to be gently packed into skeletal voids (spine, pelvis, extremities). These defects can be surgically created or from traumatic injury. The product resorbs and is replaced by bone during healing.
Substantial Equivalence: The primary assertion is that the MasterGraft™ Bone Void Filler is substantially equivalent to other previously cleared bone void fillers. This means the device is considered as safe and effective as a legally marketed predicate device, and thus does not require a de novo premarket approval application. The FDA letter confirms this finding of substantial equivalence (K012506).

Summary

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KOI2506

7 2002 MAR

Medtronic Sofamor Danek MasterGraft™ Bone Void Filler 510(K) Summary March 2002

Medtronic Sofamor Danek USA I. Company: 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133

Proposed Proprietary Trade Name: MasterGraft™ Bone Void Filler II.

Product Description III.

IV. Indications

MasterGraft™ Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MasterGraft™ Bone Void Filler is to be gently packed into bony voids of the skeletal system (e.g., the spine, pelvis, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MasterGraf™ provides a bone void filler that resorbs and is replaced with bone during the healing process.

V. Substantial Equivalence

Documentation was provided which demonstrated the MasterGraft™ Bone Void Filler to be substantially equivalent to other previously cleared bone void fillers.

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Image /page/1/Picture/1 description: The image is a logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing strength and protection. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

7 2002 MAR

Richard W. Treharne, Ph.D. Sr. Vice President, Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132

Re: K012506

MasterGraft™ Bone Void Filler Regulatory Class: unclassified Product Code: MQV Dated: December 5, 2001 Received: December 7, 2001

Dear Dr. Treharne:

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.

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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if

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Page 2 - Richard W. Treharne, Ph.D.

applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,

Mark N Milbersen

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Devices Evaluation Center for Devices and Radiological Devices

Enclosure

for Mark N Millerson

al, Restorative

510(k) Number

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510(k) Number (if known):

MasterGraft Bone Void Filler Device Name:

Indications for Use:

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

Concurrence of CDRH, Office of Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)(Optional 1-2-96)
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Over-the-counter Use	____________________
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for Mark A. Mellema
Division Sign-Off

, Restorative and Neurologica

510(k) Number K012506

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.