MASTERGRAFT® Putty combined with either autogenous bone marrow, and/or sterile water, and/or autograft is indicated as a bone void filler for bony voids or gaps that are not intrinsic to the stability of the bony structure. MASTERGRAFT® Putty can be used with autograft as a bone graft extender. MASTERGRAFT® Matrix is to be combined with autogenous bone marrow and 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 resorb 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. MASTERGRAFT® 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 biocompatible.

AI/ML Overview

This is a 510(k) summary for a medical device (MASTERGRAFT® Putty), not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and expert involvement for AI/ML performance evaluation is not applicable.

The document focuses on demonstrating substantial equivalence to previously cleared predicate devices, a regulatory pathway for medical devices that are similar to existing ones.

Here's a breakdown of what is provided in the document:

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

Not Applicable. This document does not define acceptance criteria in terms of performance metrics (like accuracy, sensitivity, specificity) for an AI/ML system. The "acceptance" here refers to the FDA's regulatory acceptance of substantial equivalence.

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

Not Applicable. There is no "test set" in the context of an AI/ML evaluation. The device is a bone void filler, and its equivalence is based on material composition, intended use, and similar design to existing products, not on data analysis for performance.

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. "Ground truth" in the AI/ML sense (e.g., expert-labeled data) is not relevant here. The evaluation relies on comparing the device's characteristics and indications to predicate devices.

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

Not Applicable. No adjudication method for a test set is mentioned or relevant.

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 is not an AI/ML device, so no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

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

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

Not Applicable. The "ground truth" for this regulatory submission is essentially established by the FDA's existing regulations for medical devices and the characteristics of legally marketed predicate devices.

8. The sample size for the training set

Not Applicable. There is no training set as this is not an AI/ML product.

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

Not Applicable. No training set exists.

Summary of what the document does provide regarding "acceptance criteria" and "study":

The "acceptance criteria" for this submission are the FDA's requirements for demonstrating substantial equivalence to legally marketed predicate devices. The "study" mentioned is the 510(k) premarket notification process itself, which involves providing documentation to the FDA to show this equivalence.

Key points from the document regarding substantial equivalence:

Product Description: MASTERGRAFT® Putty is a combination of purified Type 1 bovine collagen, hydroxyapatite, and ß-tricalcium phosphate ceramic. It forms into a moldable putty when mixed with autogenous bone marrow, sterile water, and/or autograft. It is designed as an osteoconductive, porous implant that resorbs and is replaced by bone.
Purpose of Application: To expand the indication for use with autograft as a bone graft extender.
Indications for Use: Bone void filler for bony voids or gaps not intrinsic to bony structure stability, including use with autograft as a bone graft extender. Applied gently into skeletal system voids (e.g., posterolateral spine, pelvis, ileum, extremities), which can be surgically created or from traumatic injury. The device resorbs and is replaced by bone.
Substantial Equivalence Documentation: The document states that "Documentation was provided which demonstrated MASTERGRAFT®Putty to be substantially equivalent to the previously cleared MASTERGRAFT® Putty (K051386), MBCP™ (K051774), 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)."

The "study" here is the regulatory review of this documentation by the FDA. The FDA's letter (pages 2-3) confirms they have reviewed the 510(k) and determined the device is substantially equivalent for the stated indications, allowing it to be marketed.

Summary

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Medtronic Sofamor Danek MASTERGRAFT® Putty 510(K) Summary June 2007

I. Company: Medtronic Sofamor Danek USA 1800 Pyramid Place Memphis, TN 38132 Telephone: (901) 396-3133 Fax: (901) 346-9738

Christine Scifert Contact: Director, Regulatory Affairs

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

III. Product Description/Purpose of Application

The purpose of this 510(k) application is to expand the indication for the MASTERGRAFT® Putty device so that it may be used with autograft as a bone graft extender.

IV. Indications

NOV 0 9 2007

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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 resorb and is replaced with bone during the healing process.

V. Substantial Equivalence

Documentation was provided which demonstrated MASTERGRAFT®Putty to be substantially equivalent to the previously cleared MASTERGRAFT® Putty (K051386), MBCP™ (K051774), 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).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an abstract eagle design, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the eagle. The eagle is stylized and composed of thick, curved lines, giving it a modern and symbolic appearance. The text is in uppercase and evenly spaced to follow the circular shape of the seal.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 9 2007

Medtronic Sofamor Danek % Ms. Michelle Obenauer Regulatory Affairs Supervisor 1800 Pyramid Place Memphis, Tennessee 31832

K071813 Re:

Trade/Device Name: MASTERGRAFT® Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler Regulatory Class: Class II Product Code: MQV Dated: October 4, 2007 Received: October 9, 2007

Dear Ms. Obenauer:

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

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Page 2 – Ms. Michelle Obenauer

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

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

Enclosure

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Ko71813 510(k) Number (if known):

MASTERGRAFT® Putty Device Name: --

Indications for Use:

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

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 K071813

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.