MASTERGRAFT® Putty is combined with either sterile water and/or autograft to provide a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process. MASTERGRAFT® Putty is packed into bony voids or gaps to fill and/or augment dental oral/maxillofacial bony tissue. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Procedures include:

. Filling of periodontal defects
. Filling of dental extraction sockets
. Filling of cystic defects
. Sinus lifts
. Alveolar ridge augmentation
. Oral/maxillofacial augmentation or reconstruction.
MASTERGRAFT® Putty may be used with or without internal fixation, and may be mixed with autograft as a bone graft extender.

Device Description

MASTERGRAFT® Putty is made from a combination of medical grade purified collagen and biphasic calcium phosphate ceramic. The collagen component is Type I bovine collagen. The biphasic ceramic portion of MASTERGRAFT® Putty is provided in a 15 percent hydroxyapatite and 85 percent b-tricalcium phosphate formulation. MASTERGRAFT® Putty is supplied as a sterile, dry, solid, construct that is hydrated for single patient use and is a moldable form of bone void filler. The device 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. MASTERGRAFT® Putty has been shown to heal bone defects.

AI/ML Overview

This document is a 510(k) summary for Medtronic Sofamor Danek MASTERGRAFT® Putty, indicating its clearance for use in oral and oral/maxillofacial regions. It asserts substantial equivalence to previously cleared devices rather than presenting a study with specific acceptance criteria and performance metrics for a novel device. Therefore, a direct response to your request, which expects explicit acceptance criteria and study results, cannot be fully provided from the given text.

Based on the information provided in the 510(k) summary:

Acceptance Criteria and Reported Device Performance: This document does not specify quantitative acceptance criteria or provide a table of device performance against such criteria. The "acceptance" here refers to the FDA's determination of "substantial equivalence" to predicate devices, not meeting pre-defined performance metrics in a clinical study.
Study Details (for a device proving equivalence): The document claims substantial equivalence based on comparisons to predicate devices (K071813, K010701, K030682, K062834, K051885).
- Sample size used for the test set and data provenance: No specific test set sample size or data provenance is mentioned as this is a substantial equivalence claim, not a de novo clinical study with a test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment by experts for a test set is typically part of a clinical trial or performance study, which is not detailed here.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. The document does not describe MRMC studies or human reader improvement with AI assistance, as this device is a bone void filler, not an AI diagnostic tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a bone void filler product.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for "substantial equivalence" is the established safety and effectiveness of the predicate devices. The document implies that data from previous clearances (K071813, K010701, K030682, K062834, K051885) was used to support this claim.
- The sample size for the training set: Not applicable. This summary does not describe a training set for an algorithm.
- How the ground truth for the training set was established: Not applicable.

Summary based on the provided text:

The "study" in this context is the comparison demonstrating "substantial equivalence" to previously cleared predicate devices, not a clinical trial designed to establish specific performance metrics against acceptance criteria.

Acceptance Criterion	Reported Device Performance
Substantial Equivalence: Demonstrated to be substantially equivalent to previously cleared predicate devices for the expanded indications in oral/maxillofacial regions.	MASTERGRAFT® Putty was deemed substantially equivalent to: - MASTERGRAFT® Putty (K071813) - MSD Biphasic Calcium Bone Void Filler (K010701) - Calcium Hydroxylapatite Implant (K030682) - Osteon (K062834) - MBCP™ (K051885)

Summary

{0}------------------------------------------------

Medtronic Sofamor Danek MASTERGRAFT® Putty 510(k) Summary June 2008

SEP 1 7 2008

Medtronic Sofamor Danek USA l. Company: 1800 Pyramid Place Memphis, TN 38132 Telephone: (901) 396-3133 Fax: (901) 346-9738
Contact: Michelle Obenauer Regulatory Affairs Manager
Proposed Proprietary Trade Name: MASTERGRAFT® Putty ll. Classification Name: Bone Grafting Materials, Synthetic Product Code: LYC 872.3930 Regulation No .:

Product Description/Purpose of Application III.

The purpose of this 510(k) application is to expand the indication for the MASTERGRAFT® Putty device to include use in the oral and oral/maxillofacial regions.

IV. Indications

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

K08/784

. Filling of periodontal defects
. Filling of dental extraction sockets
. Filling of cystic defects
. Sinus lifts
. Alveolar ridge augmentation
. Oral/maxillofacial augmentation or reconstruction.

MASTERGRAFT® Putty may be used with or without internal fixation, and may be mixed with autograft as a bone graft extender.

Substantial Equivalence V.

Documentation was provided which demonstrated MASTERGRAFT® Putty to be substantially equivalent to the previously cleared MASTERGRAFT® Putty (K071813), MSD Biphasic Calcium Bone Void Filler (K010701), Calcium Hydroxylapatite Implant (K030682), Osteon (K062834) and MBCP™ (K051885).

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, facing to the right. 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

Ms. Michelle Obenauer Regulatory Affairs Manager Medtronic Sofamor Danek USA 1800 Pyramid Place Memphis, Tennessee 38132

SEP 1 7 2008

Re: K081784

Trade/Device Name: MASTERGRAFT® Putty Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: September 15, 2008 Received: September 15, 2008

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 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.

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

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 (OS) regulation (21 CFR Part 820); and if 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

J.H. Samuels-Vendor BCH

Chiu S. Lin. Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

K081784

510(k) Number (if known):

MASTERGRAFT® Putty Device Name:

Indications for Use:

Filling of periodontal defects .
. Filling of dental extraction sockets
. Filling of cystic defects
. Sinus lifts
Alveolar ridge augmentation .
♥ Oral/maxillofacial augmentation or reconstruction.

MASTERGRAFT® Putty may be used with or without internal fixation, and may be mixed with autograft as a bone graft extender.

Prescription Use X

AND/OR

Over-The-Counter Use

1 881

(Part 21 CFR 801 Subpart D) C)

(21 CFR 807 Subpart

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rums

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K081784

Regulation Number and Section

§ 872.3930 Bone grafting material.

(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.