MASTERGRAFT® Resorbable Ceramic Granules may be used alone or in combination with autograft to provide a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process. MASTERGRAFT® Resorbable Ceramic Granules 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® Resorbable Ceramic Granules may be used with or without internal fixation, and may be mixed with autograft as a bone graft extender.

Device Description

MASTERGRAFT® Resorbable Ceramic Granules is made of medical grade combination of hydroxyapatite and b-tricalcium phosphate. MASTERGRAFT® is provided in a 60 percent hydroxyapatite and 40 percent b-tricalcium phosphate formulation. Alternatively, MASTERGRAFT® may be provided in a 15 percent hydroxyapatite and 85 percent b-tricalcium phosphate formulation. The product is supplied sterile for single patient use. MASTERGRAFT® Resorbable Ceramic Granules is an osteoconductive porous implant.

AI/ML Overview

This 510(k) premarket notification for Medtronic Sofamor Danek MASTERGRAFT® Resorbable Ceramic Granules primarily focuses on expanding the indications for use to the oral and maxillofacial region, based on substantial equivalence to previously cleared devices. Therefore, the traditional "acceptance criteria" and detailed "study that proves the device meets the acceptance criteria" in terms of performance metrics like sensitivity, specificity, accuracy, and confidence intervals, which are common in AI/Diagnostic device submissions, are not applicable here.

Instead, the "acceptance criteria" for this type of submission revolve around demonstrating substantial equivalence to predicate devices for the new indications. The "study" proving this involves a comparison of the device's characteristics (material composition, intended use, technological characteristics) to the predicate devices.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, for this 510(k) application, the acceptance criteria are not performance metrics but rather a demonstration of substantial equivalence.

Acceptance Criteria (for Substantial Equivalence)	Reported Device Performance (Demonstration)
Material Composition Equivalence: Device material is equivalent to predicate devices.	MASTERGRAFT® Resorbable Ceramic Granules is made of a medical-grade combination of hydroxyapatite and b-tricalcium phosphate (60% HA, 40% b-TCP or 15% HA, 85% b-TCP). This composition falls within the established parameters of the predicate devices.
Intended Use Equivalence (for expanded indications): Device's intended use for oral and maxillofacial applications is equivalent to predicate devices.	The device is intended for use alone or combined with autograft as a bone void filler for bony voids or gaps that are not intrinsic to the stability of the bony structure in the oral and maxillofacial region (e.g., periodontal defects, extraction sockets, cystic defects, sinus lifts, alveolar ridge augmentation, oral/maxillofacial augmentation or reconstruction). This expanded indication is argued to be substantially equivalent to the existing indications of the predicate devices.
Technological Characteristics Equivalence: Device shares similar technological characteristics with predicate devices.	The document states "Documentation is provided that demonstrates MASTERGRAFT® Resorbable Ceramic Granules to be substantially equivalent to the previously cleared MASTERGRAFT® Resorbable Ceramic Granules (K020986, SE 07/22/2002) and MBCP™ (K051885, SE 09/16/2005)." This implies that the design, manufacturing, and operational principles are similar.
Performance Data (if applicable for substantial equivalence): Any relevant performance data (e.g., biocompatibility) supports equivalence.	While not explicitly detailed as performance studies in this summary, the substantial equivalence claim inherently relies on the understanding that the device performs similarly to the predicates in terms of osteoconductivity and resorption characteristics, given the similar composition. The 510(k) process typically assumes that if a new device has similar technological characteristics and intended uses to a predicate, it will function similarly.

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

The provided document does not describe a "test set" in the context of clinical performance or algorithm evaluation. This submission is for substantial equivalence based on material composition and intended use expansion, not for demonstrating clinical efficacy through a new trial with a distinct test set.

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. There was no clinical "test set" requiring expert ground truth establishment for this 510(k) submission.

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

Not applicable. There was no clinical "test set" requiring adjudication for this 510(k) submission.

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/diagnostic device, and no MRMC study was conducted or referenced in this summary.

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

Not applicable. This is a medical device (bone graft material), not an algorithm or AI system.

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

Not applicable in the conventional sense of a clinical study for a diagnostic or AI device. The "ground truth" for this submission is embedded in the regulatory precedent set by the predicate devices (K020986 and K051885) and their established safety and effectiveness. The "truth" being established is that the new device is substantially equivalent to these already-approved devices.

8. The sample size for the training set

Not applicable. There was no "training set" as this is not an AI/machine learning device.

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

Not applicable. There was no "training set."

Summary of the Study for Substantial Equivalence:

The "study" for this 510(k) submission is a comparison to predicate devices (MASTERGRAFT® Resorbable Ceramic Granules K020986 and MBCP™ K051885). The manufacturer provided documentation demonstrating that the subject device shares the same material composition (hydroxyapatite and b-tricalcium phosphate) and similar technological characteristics, and that its expanded oral and maxillofacial indications are substantially equivalent to the existing indications of the predicate devices. The FDA reviewed this documentation and concurred with the substantial equivalence claim, allowing the device to be marketed for the specified expanded indications. This process does not involve new clinical trials or performance studies to establish "acceptance criteria" through statistical metrics.

Summary

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K082917

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Medtronic Sofamor Danek MASTERGRAFT® Resorbable Ceramic Granules 510(K) Summary September 2008

Company:

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

Contact: Ryan Massev Regulatory Affairs Specialist

Classification Name:

Product Code:

Requlation No .:

MASTERGRAFT Resorbable Ceramic Granules Bone grafting material NUN 872.3930

JAN - 9 2009

. Product Description/Purpose of Application

II.Proposed Proprietary Trade Name:

The purpose of this 510(k) application is to expand the indications for the MASTERGRAFT® Resorbable Ceramic Granules device so that it may be used in the oral and maxillofacial region. Like the previously cleared predicates, MASTERGRAFT® Resorbable Ceramic Granules (K020986. SE 07/22/2002) and MBCP™ (K051885, SE 09/16/2005), the subject system is intended to be used alone or combined with autograft as a bone void filler for bony voids or gaps that are not intrinsic to the stability of the bony

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K082917

structure. In addition, MASTERGRAFT® Resorbable Ceramic Granules can

be mixed with autograft and used as a bone graft extender.

IV. Indications

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

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

V. Substantial Equivalence

Documentation is provided that demonstrates MASTERGRAFT® Resorbable

Ceramic Granules to be substantially equivalent to the previously cleared

MASTERGRAFT® Resorbable Ceramic Granules (K020986, SE 07/22/2002) and MBCP™ (K051885, SE 09/16/2005).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged in a circle around the eagle. The eagle is black, and the text is also black.

Public Health Service

FEB 26 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr.Ryan Massey Regulatory Affairs Specialist Medtronic Sofamor Danek 1800 Pyramid Place Memphis. Tennessee 38132

Re: K082917/A001

Trade/Device Name: Mastercraft Resorbable Ceramic Granules Regulation Number: 21 CFR 872.3930 Regulation Name: Bone grafting material Regulatory Class: II Product Code: LYC Dated: January 27, 2009 Received: January 28, 2009

Dear Mr. Massey:

This letter corrects our substantially equivalent letter of January 9, 2009.

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 (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 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.

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Page 2 - Mr. Massey

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.

This letter will allow you to continue 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 Office of Compliance at (240) 276-Jsee OC organization structure below for correct phone extension]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). 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/dsma/dsmamain.html

Sincerely vours.

Suite H. Michie MD.

Ginette Y. Michaud, M. D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known): K082917

Device Name: MASTERGRAFT® Resorbable Ceramic Granules

Indications for Use:

Procedures specific to MASTERGRAFT® Granules include:

. Filling of dental extraction sockets
Filling of cystic defects
. Oral/maxillofacial auqmentation or reconstruction.

Procedures specific to MASTERGRAFT® Mini Granules include:

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X	OR	Over-The-Counter Use
Per 21 CFR 801.109

Robert J. Betz DDS for Dr. Susan Renner

(Division Sign-Off)

11 Division of Anesthesiclogy, General Hospital Infection Control, Lental Dental Devices

510(k) Number: K082917

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.