MasterGraft® Putty combined with either autogenous bone marrow, and/or sterile water, and/or autograft is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MasterGraft® Matrix is to be combined with autogenous bone marrow and like MasterGraft® Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Both devices are to be gently packed into bony voids or gaps of the skeletal system (e.g., the posterolateral spine, pelvis, ileum, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Both devices provide a bone void filler that resorbs and is replaced with bone during the healing process.

Device Description

MasterGraft® Putty is made of medical grade combination of purified Type 1 bovine collagen and hydroxyapatite and ß-tricalcium phosphate ceramic. The ceramic portion of MasterGraft® Putty is provided in a 15 percent hydroxyapatite and 85 percent ß-tricalcium phosphate formulation. When mixed with either autogenous bone marrow, and/or sterile water, and/or autograft the product forms into a putty, which is moldable. The product is supplied sterile for single patient use. MasterGrati® Putty is an osteoconductive, porous implant that allows for bony ingrowth across the graft site while resorbing at a rate consistent with bone healing. The product is blocompatible.

MasterGraft™ Matrix is made of medical grade combination of purified collagen and hydroxyapatite and ß-tricalcium phosphate ceramic. The collagen is a highly purified bioresorbable lyophilized bovine tendon that is primarily Type I collagen. The ceramic portion of MasterGrafi™ Matrix is provided in a 15 percent hydroxyapatite and 85 percent ß-tricalcium phosphate formulation. The product is supplied sterile in a premixed strip form for single patient use. MasterGraft™ Matrix is a 3-dimensional, ostcoconductive, porous implant that allows for bony ingrowth across the graft site while resorbing at a rate consistent with bone healing. The product is biocompatible.

The purpose of this 510(k) application is to add the MasterGraft® Putty device to the previously cleared MasterGraft® product family.

AI/ML Overview

This 510(k) premarket notification for Medtronic Sofamor Danek's MasterGraft® Putty and MasterGraft® Matrix provides information primarily focused on establishing substantial equivalence to previously cleared devices. It does not contain a study demonstrating the device's performance against specific acceptance criteria in the manner requested (e.g., clinical trial with quantitative performance metrics).

Therefore, I cannot populate the table or answer the questions related to acceptance criteria, sample sizes, expert ground truth, adjudication, or MRMC studies because the provided document does not contain this type of information.

The document states:

"Documentation was provided which demonstrated MasterGraft® Putty to be substantially equivalent to the previously cleared MasterGraft® Matrix Resorbable Ceramic (K020986 and K012506), and to Orthovita's Vitoss Scaffold Foam Flow Bone Graft Material (K032288) and DePuy's HEALOS® Bone Graft Material (K043308 and K012751)."

This indicates that the regulatory pathway chosen was a substantial equivalence determination, not a clinical study to prove performance against pre-defined acceptance criteria for a new, novel device. The FDA's letter (K051386/S2) confirms this in its approval, stating, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent to legally marketed devices..."

However, I can extract the following relevant information based on the request:

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

Acceptance Criteria	Reported Device Performance
Not applicable.	The device demonstrated substantial equivalence to predicate devices (MasterGraft® Matrix Resorbable Ceramic, Vitoss Scaffold Foam Flow, HEALOS® Bone Graft Material). The basis for this equivalence is not explicitly detailed in terms of performance metrics against specific criteria within this document, but rather implies similar intended use, technological characteristics, and safety/effectiveness profile as the predicate devices.

Acceptance Criteria

Reported Device Performance

Not applicable.

The device demonstrated substantial equivalence to predicate devices (MasterGraft® Matrix Resorbable Ceramic, Vitoss Scaffold Foam Flow, HEALOS® Bone Graft Material). The basis for this equivalence is not explicitly detailed in terms of performance metrics against specific criteria within this document, but rather implies similar intended use, technological characteristics, and safety/effectiveness profile as the predicate devices.

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

This document does not describe a "test set" or a study with a defined sample size for evaluating the device against acceptance criteria. The submission is based on demonstrating substantial equivalence to existing predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This document does not describe a study involving expert-established ground truth for a test set.

4. Adjudication method for the test set

This document does not describe a study involving adjudication of a test set.

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 MRMC study was conducted or reported in this document. The device is a bone void filler, not an AI-assisted diagnostic tool.

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

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

7. The type of ground truth used

Not applicable in the context of a performance study against acceptance criteria. The "ground truth" for this submission was the demonstration of substantial equivalence to legally marketed predicate devices based on a comparison of intended use, technological characteristics, and safety/effectiveness.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning algorithm requiring a training set.

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

Not applicable as there is no training set for this type of device.

Summary

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K051386 DEC 16 2005

Medtronic Sofamor Danck MasterGraft® Putty and MasterGraft® Matrix 510(K) Summary May 2005

!. Company: Medtronic Sofamor Danek USA 1800 Pyramid Place Memphis, TN 38132

Contact: Richard W. Treharne Sr. Vice President Regulatory Affairs (901) 396-3133

II.
Proposed Proprietary Trade Name:	MasterGraft® Putty
Classification Name:	Bone Void Filler
Product Code:	MQV
Regulation No.:	888.3045

lll. Product Description/Purpose of Application

The purpose of this 510(k) application is to add the MasterGraft® Putty device to the previously cleared MasterGraft® product family.

0000005

{1}------------------------------------------------

IV. Indications

V. Substantial Equivalence

Documentation was provided which demonstrated MasterGrafi®Putty to be substantially equivalent to the previously cleared MasterGraft® Matrix Resorbable Ceramic (K020986 and K012506), and to Orthovita's Vitoss Scaffold Foam Flow Bonc Graft Matcrial (K032288) and DePuy's HEALOS® Bone Graft Material (K043308 and K012751).

0000000

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of several curved lines.

OFC 16 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K051386/S2

Trade/Device Name: MasterGraft® Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: December 7, 2005 Received: December 9, 2005

Dear Mr. Treharne:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(x) premained institution in the indications
referenced above and have determined the device is substantially interstale referenced above and nave determined the devices marketed in interstate for use stated in the enclosure) to regary manked producal Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Enderel Food. Drug commerce prior to May 28, 1970, the charment with the provisions of the Federal Food, Drug.
devices that have been reclassified in accordance with the provision (PMA) devices that have been reclassified in accordance with as proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premisions of the Act . The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the general controls provisions of You may, therefore, market the device, subject to the gentration, listing of
general controls provisions of the Act include requirements wishesading and general controls provisions of the Fect morade requirement of the management misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), p If your device is classified (Scc above) into entrols. Existing major regulations affecting your device. FDA it may be subject to such additional confrols: "Existing major via.
can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA can be found in the Code of Feactar cogential concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination and mean Please be advised that I DA s issuance of a backannal with other requirements of the Act
that FDA has made a determination that your device complies with other requirements o that FDA has made a decemination administered by other Federal agencies. You must or any reactal statures and regulations daministered of not limited to: registration and listing (21 comply with all the Act s requirements, mentalians practice requirements as set CFK Part 807); labeling (21 CFR Fart 801); good manated in applicable, the elcettronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, 1960 forul in the quality systems (Q5) regalisms (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

Page 2 -Richard W. Treharne

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin marketing your workence of your device to a legally premarket notification. "The PDF Intuing of basistants of "
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 If you desire specific advice for your de rice of via Also, please note the regulation intitled, and Contact the Office of Comphalloo at (216) 276 - 178 - 178 Part 807.97). You may obtain "Misoranding by relective to premance nonlineanon on the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Consumer Plocious.cov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

ﺮ ﮐﮯ Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name:

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(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 General, Restorative, and Neurological Devices ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

510(k) Number_ KOST 386

0000004

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.