MASTERGRAFT® Contain is to be combined with autogenous bone marrow and is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure and can be used as a bone graft extender.

The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., the posterolateral spine, pelvis, ilium, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process. When used in the pelvis, ilium, or extremities, the device is to be used with bone marrow aspirate. When used in the posterolateral spine, the device must be mixed with bone marrow aspirate and autograft bone and used as a bone graft extender.

Device Description

MASTERGRAFT® Contain is made from a combination of medical grade purified collagen of bovine origin and biphasic calcium phosphate ceramic. In the MASTERGRAFT® Contain device, the collagen is a highly purified (>95%) Type I bioresorbable lyophilized collagen. The biphasic ceramic portion of the device is provided in a 15 percent hydroxyapatite and 85 percent ß- tricalcium phosphate formulation. The device is supplied sterile in a premixed form for single patient use. The device is a biocompatible, osteoconductive, porous implant that allows for bony ingrowth across the graft site while resorbing at a rate consistent with bone healing. The device readily absorbs bone marrow aspirate and has been shown to heal bone defects. The device is designed with a cavity (ies) to contain and deliver autologous bone to the surgical site when used as a bone graft extender.

AI/ML Overview

This document is a 510(k) premarket notification from the FDA, indicating that the device "MASTERGRAFT® Contain" is substantially equivalent to previously marketed predicate devices. This type of document does not contain acceptance criteria for device performance in the context of diagnostic or prognostic accuracy, nor does it describe a study to prove such criteria.

The acceptance criteria and study described in this document relate to the device meeting the requirements for substantial equivalence to predicate devices, focusing on material composition, intended use, manufacturing, and safety/biocompatibility.

Here's an analysis based on the provided text:

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

The document does not present quantitative performance metrics in a table. Instead, it asserts substantial equivalence based on qualitative comparisons of characteristics. The criteria for acceptance are implicitly that the new device (MASTERGRAFT® Contain) is "Similar" or "Identical" across various features to the predicate devices (MASTERGRAFT® Strip and MASTERGRAFT® Matrix EXT).

Acceptance Criteria Feature (Comparison to Predicate)	Reported Device Performance (MASTERGRAFT® Contain vs. Predicates)
Indication for Use	Similar
Fundamental Scientific Technology (Operating Principle, Mechanism of Action)	Identical
Sizes	Similar
Performance	Identical
Sterilization	Identical
Manufacturing principles	Identical
Shelf-Life	Identical
Packaging	Identical
Material Composition (Collagen, Granules)	Identical
Use of rigid fixation	Identical
Safety and Effectiveness profile	Identical
Geometry	Similar

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

The document explicitly states: "No new non-clinical testing was performed or submitted in support of this 510(k)." This means there was no specific "test set" of data generated for this particular submission. The data provenance would be tied to the previous submissions for the predicate devices (K082166 and K130335), which are not detailed here.

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. Since no new non-clinical testing was performed for this submission, there was no "test set" requiring ground truth establishment by experts in the context of device performance. The 510(k) review process involves FDA experts, but they are evaluating the submission rather than establishing ground truth for a test dataset.

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

Not applicable, as no new testing or test set was 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 device is a bone void filler/graft extender, not an AI-powered diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to this submission.

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

Not applicable. This is not an algorithm or AI device.

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

Not applicable, as no new testing or test set was described in this submission. The "ground truth" for the substantial equivalence claim relies on the previously established safety and effectiveness of the predicate devices based on their original testing, which would have adhered to various standards (e.g., biocompatibility standards listed) rather than a clinical ground truth like pathology for a diagnostic device.

8. The sample size for the training set

Not applicable. This device is a physical medical device, not a machine learning model, so there is no concept of 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 of the "Study" (or rather, "Evidence for Substantial Equivalence"):

The "study" that proves the device meets the acceptance criteria is actually the comparison study for substantial equivalence to previously cleared predicate devices (MASTERGRAFT® Strip K082166 and MASTERGRAFT® Matrix EXT K130335).

Evidence: The submission leverages non-clinical testing performed for the predicate devices.
Methodology: The sponsor asserted that MASTERGRAFT® Contain has "Identical" or "Similar" technological characteristics to the predicate devices across several categories, including material composition, intended use, mechanism of action, performance, sterilization, manufacturing, shelf-life, packaging, and safety/effectiveness profile. The key difference, the addition of a cavity, was deemed not to present a new worst-case scenario.
Standards: The non-clinical testing for the predicate devices was performed in accordance with recognized consensus standards (e.g., ASTM, ISO standards for ceramic composition, animal tissues, and biocompatibility - ISO 10993 series). This serves as the basis for the "Performance" and "Safety and Effectiveness profile" claims of "Identical" to the predicates.

In essence, for this 510(k) submission, the "study" was a lack of new significant differences analysis, asserting that because the new device is fundamentally the same as already cleared devices, it meets the same safety and effectiveness standards, rather than proving a specific diagnostic accuracy or clinical outcome in a new trial.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Medtronic Sofamor Danek USA, Incorporated Mr. Gregory Maschek Senior Regulatory Affairs Manager 1800 Pyramid Place Memphis, Tennessee 38132

August 14, 2015

Re: K151172

Trade/Device Name: Mastergraft® Contain Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: July 8, 2015 Received: July 9, 2015

Dear Mr. Mascheck:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the

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Page 2 - Mr. Gregory Maschek

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K151172

Device Name MASTERGRAFT® Contain

Indications for Use (Describe)

The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., the posterolateral spine, pelvis, ilium, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process. When used in the pelvis, illium, or extremittes, the device is to be used with bone marrow aspirate. When used in the posterolateral spine, the device must be mixed with bone marrow aspirate and autograft bone and used as a bone graft extender.

Type of Use (Select one or both, as applicable)	Authorization to Use EPA SET-2021 Interim Strategy Other	Authorization to Use EPA SET-2021 Interim Strategy	Other
Authorization to Use EPA SET-2021 Interim Strategy
Other

|X | Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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I. SUBMITTER NAME & ADDRESSS:	Medtronic Sofamor Danek USA, Inc
	1800 Pyramid Place
	Memphis, Tennessee 38132
	Telephone: (901) 396-3133
	Fax: (901) 346-9738
	Establishment Registration: 1030489
CONTACT PERSON:	Gregory Maschek
	Sr. Regulatory Affairs Specialist
DATE PREPARED:	July 7, 2015

II. PROPOSED PROPRIETARY TRADE NAME: MASTERGRAFT® Contain

DEVICE CLASSIFICATION NAME:	Resorbable Calcium Salt Bone Void Filler
REGULATION NUMBER:	21 CFR 888.3045
CLASSIFICATION PRODUCT CODE:	MQV
CLASS:	II

III. IDENTIFICATION OF LEGALLY MARKETED DEVICES:

Table 1. Legally Marketed Devices
Device name	510(k) number	Substantial Equivalence date
MASTERGRAFT® Strip	K082166	06/02/2009
MASTERGRAFT® MATRIXEXT	K130335	04/19/2013

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IV. DEVICE DESCRIPTION:

The purpose of this Traditional 510(k) application is to add MASTERGRAFT® Contain to the MASTERGRAFT® product family. The material composition of MASTERGRAFT® Contain is identical to that of predicate devices MASTERGRAFT® Strip and MASTERGRAFT® Matrix EXT. The intended use (i.e., bone void filler and posterolateral spine bone graft extender) of MASTERGRAFT® Contain are similar to that of predicate devices MASTERGRAFT® Strip and MASTERGRAFT® Matrix EXT. The overall dimensions of the MASTERGRAFT® Contain devices are similar to MASTERGRAFT® Strip and MASTERGRAFT® Matrix EXT, with the addition of a cavity to contain and deliver autogenous bone to the implant site when used as bone graft extender. Compared to the predicate devices, the inclusion of the cavity in the design of MASTERGRAFT® Contain does not present a new worst case for safety or effectiveness of the device for its intended use.

V. INDICATIONS FOR USE:

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Table 2. Summary of the technological Characteristics
Comparison Feature	SubjectMASTERGRAFT® Contain	PredicateMASTERGRAFT® StripK082166S.E. 06/02/2009	PredicateMASTERGRAFT®Matrix EXTK130335 S.E.04/19/2013
Indication for Use	Similar	S.E. 06/02/2009	S.E. 04/19/2013
Fundamental ScientificTechnology• Operating Principle• Mechanism of Action	Identical	S.E. 06/02/2009	S.E. 04/19/2013
Sizes	Similar	S.E. 06/02/2009	S.E. 04/19/2013
Performance	Identical	S.E. 06/02/2009	S.E. 04/19/2013
Sterilization	Identical	S.E. 06/02/2009	S.E. 04/19/2013
Manufacturing principles	Identical	S.E. 06/02/2009	S.E. 04/19/2013
Shelf-Life	Identical	S.E. 06/02/2009	S.E. 04/19/2013
Packaging	Identical	S.E. 06/02/2009	S.E. 04/19/2013
Material Composition• Collagen• Granules	Identical	S.E. 06/02/2009	S.E. 04/19/2013
Use of rigid fixation	Identical	S.E. 06/02/2009	S.E. 04/19/2013
Safety and Effectivenessprofile	Identical	S.E. 06/02/2009	S.E. 04/19/2013
Geometry	Similar	S.E. 06/02/2009	S.E. 04/19/2013

VI. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS:

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VII. DISCUSSION OF NON-CLINICAL TESTING:

Non-clinical testing was performed in support of substantial equivalence for the cited predicate K082166 [S.E. 06/02/2009] in accordance with FDA Recognized Consensus Standards and FDA Guidelines, where applicable. No new non-clinical testing was performed or submitted in support of this 510(k).

Previously submitted non-clinical testing was performed in accordance with the following standards:

· ASTM F1185-03: 2009 Specification for Composition of Ceramic Hydroxyapatite for Surgical Implants
ASTM F1088-04a: 2010, Specification for ß-tricalcium Phosphate for Surgical . Implantation
ISO 22442-1: 2007 Animal Tissues and Their Derivatives Utilized in the . Manufacture of Medical Devices -- Part 1 Analysis and Risk Management
. ISO 22442-2: 2007 Animal Tissues and Their Derivatives Utilized in the Manufacture of Medical Devices -- Part 2 Controls on Sourcing, Collection, and Handling
ISO 22442-3: 2007 Animal Tissues and Their Derivatives Utilized in the . Manufacture of Medical Devices -- Part 3 Validation of the Elimination and/or Inactivation of Virus and Transmissible Agents
ISO 10993-3: 2003/(R) 2009, Biological evaluation of medical devices -- Part 3 . Tests for genotoxicity, carcinogenicity, and reproductive toxicity. (Biocompatibility)
ISO10993-4: 2009, Biological evaluation of medical devices -- Part 4: Selection . of tests for interactions with blood
ISO 10993-5: 2009, Biological evaluation of medical devices -- Part 5: Tests for 0 In Vitro cytotoxicity. (Biocompatibility)
ISO 10993-6: 2009, Biological evaluation of medical devices -- Part 6: Tests for ● local effects after implantation. (Biocompatibility)

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ISO 10993-10: 2009, Biological evaluation of medical devices -- Part 10: Tests for ● irritation and skin sensitization. (Biocompatibility)
ISO 10993-11: 2009, Biological evaluation of medical devices -- Part 11: Tests for ● systemic toxicity. (Biocompatibility)
ISO 10993-12: 2009, Biological evaluation of medical devices -- Part 12: Sample . preparation and reference materials. (Biocompatibility)

VIII. CONCLUSION:

Documentation provided in this submission demonstrates that the subject device is substantially equivalent to the previously cleared bone void filler MASTERGRAFT® Strip [K082166 S.E. 06/02/2009] and MASTERGRAFT® Matrix EXT [K130335 S.E. 04/19/2013.]

The subject device is substantially equivalent to predicates MASTERGRAFT® Strip and MASTERGRAFT® Matrix EXT in several categories including: indication, material composition (including biphasic calcium phosphate granules and collagen), sterility, shelf-life, biocompatibility and the ability to resorb during the healing process.

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.