MASTERGRAFT® Matrix EXT 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 created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process.

Device Description

MASTERGRAFT® Matrix EXT is made from a combination of medical grade purified collagen of bovine origin and biphasic calcium phosphate ceramic. In the devices, 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. MASTERGRAFT® Matrix EXT is supplied sterile in a premixed strip 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.

AI/ML Overview

This FDA 510(k) summary for Medtronic's MASTERGRAFT® Matrix EXT bone void filler does not contain information about acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML powered medical device.

Instead, this document is a Traditional 510(k) application focused on demonstrating substantial equivalence to previously cleared predicate devices. The primary purpose of this specific submission is the addition of a new contraindication to the Instructions for Use (IFU) for the MASTERGRAFT® Matrix EXT.

Therefore, many of the requested points regarding AI/ML device testing are not applicable to this document. The document describes a traditional medical device (bioresorbable collagen and calcium phosphate ceramic) and its non-clinical testing for substantial equivalence, not an AI/ML algorithm's performance.

Here's an analysis based on the provided text, highlighting what's available and what's not:

1. Table of acceptance criteria and the reported device performance

Not Applicable. This document does not describe specific acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, or image analysis accuracy) for an AI/ML device. The "performance" mentioned refers to the general function and characteristics of the bone void filler, which are deemed "Identical" to the predicate devices.

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. No test set in the context of evaluating an AI/ML algorithm's performance is mentioned. The non-clinical testing refers to tests conducted on the physical device, not on data for algorithm evaluation.

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, is not established or discussed in this document.

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

Not Applicable. Adjudication methods for test sets are not relevant to this type of device 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. No MRMC study or AI assistance is mentioned.

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

Not Applicable. This is not an AI/ML algorithm.

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

Not Applicable. Ground truth in this context is not defined as there is no algorithm being evaluated against such a benchmark. The "ground truth" for this device would be its physical and chemical properties and its biological interaction with bone, evaluated through non-clinical (e.g., biocompatibility, dissolution rate) and potentially clinical studies (which are referenced as already having occurred for the predicate).

8. The sample size for the training set

Not Applicable. No training set for an AI/ML algorithm is mentioned.

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

Not Applicable.

Summary of Device and Substantial Equivalence Information Present in the Document:

The document describes the MASTERGRAFT® Matrix EXT, a resorbable calcium salt bone void filler device.

Device Description:
- Made from medical-grade purified collagen of bovine origin (Type I, >95%) and biphasic calcium phosphate ceramic (15% hydroxyapatite and 85% ß-tricalcium phosphate).
- Supplied sterile in a premixed strip form for single patient use.
- A biocompatible, osteoconductive, porous implant that supports bony ingrowth and resorbs at a rate consistent with bone healing.
- Absorbs bone marrow aspirate.
Indications for Use:
- To be combined with autogenous bone marrow.
- Indicated for bony voids or gaps not intrinsic to the stability of the bony structure.
- Can be used as a bone graft extender.
- Gently packed into bony voids or gaps of the skeletal system (posterolateral spine, pelvis, ilium, and/or extremities).
- For surgically created osseous defects or those from traumatic injury.
- Resorbs and is replaced with bone during healing.
Predicate Devices:
- MASTERGRAFT® UltraMatrix (K130335, S.E. 04/19/2013)
- MASTERGRAFT® Strip and MASTERGRAFT® Putty (K140375, S.E. 04/18/2014)
Basis for Substantial Equivalence (Non-Clinical Testing):
- The submission relies on non-clinical testing performed in support of MASTERGRAFT® Strip (K082166, S.E. 06/02/2009), which is considered relevant and supportive of the cited predicate K130335.
- No new non-clinical testing was performed or submitted for this specific 510(k) application.
- Testing was conducted in accordance with FDA Recognized Consensus Standards and FDA Guidelines.
- The subject device is deemed substantially equivalent to the predicate MASTERGRAFT® UltraMatrix due to identical:
  - Indication for Use
  - Fundamental Scientific Technology/Operating Principle/Mechanism of Action
  - Basic Design
  - Performance
  - Manufacturing principles
  - Sterilization
  - Shelf-Life
  - Packaging
  - Material Composition (collagen, granules)
  - Use of rigid fixation
  - Safety and Effectiveness profile
- It is also substantially equivalent to K140375 (MASTERGRAFT® Strip and MASTERGRAFT® Putty) regarding the additional contraindication identified in the labeling (which was the primary purpose of this specific 510(k)).

In essence, this document is a regulatory submission for a material-based medical device, not a software-based or AI/ML device, and thus the requested AI/ML specific information is not available within this text.

Summary

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

September 5, 2014

Medtronic Sofamor Danek USA Inc. Ms. Courtney N. Long Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

Re: K141824

Trade/Device Name: MASTERGRAFT® Matrix EXT Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: July 1, 2014 Received: July 7, 2014

Dear Ms. Long:

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

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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.

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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,

Laurence D/ Coyne -A

For Mark N. Melkerson

Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K141824

Device Name MASTERGRAFT® Matrix EXT

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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I. SUBMITTER NAME & ADDRESSS:	Medtronic Sofamor Danek USA, Inc1800 Pyramid PlaceMemphis, Tennessee 38132Telephone: (901) 396-3133Fax: (901) 346-9738Establishment Registration: 1030489
CONTACT PERSON:	Courtney N. LongRegulatory Affairs Specialist
DATE PREPARED:	July 1, 2014
II. PROPOSED PROPRIETARY TRADE NAME:	MASTERGRAFT® Matrix EXT
DEVICE CLASSIFICATION NAME:	Resorbable Calcium Salt Bone VoidFiller
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)	Substantial Equivalence Date
MASTERGRAFT® UltraMatrix	K130335	04/19/2013
MASTERGRAFT® Strip and	K140375	04/18/2014
MASTERGRAFT® Putty

IV. DEVICE DESCRIPTION:

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device is provided in a 15 percent hydroxyapatite and 85 percent ß-tricalcium phosphate formulation.

MASTERGRAFT® Matrix EXT is supplied sterile in a premixed strip 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.

The purpose of this Traditional 510(k) application is the addition of a new contraindication to the Instructions for Use (IFU) for MASTERGRAFT® Matrix EXT.

V. INDICATIONS FOR USE:

MASTERGRAFT® Matrix EXT is to be combined with autogenous bone marrow and is indicated for bony voids or gaps 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.

VI. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS:

Comparison Feature	SubjectMASTERGRAFT® MatrixEXT	PredicateMASTERGRAFT®UltraMatrix
Indication for Use	Identical	K130335 (S.E. 04/19/2013)
Fundamental ScientificTechnologyOperating Principle Mechanism of Action	Identical	K130335 (S.E. 04/19/2013)
Basic Design	Identical	K130335 (S.E. 04/19/2013)
Performance	Identical	K130335 (S.E. 04/19/2013)
Manufacturing principles	Identical	K130335 (S.E. 04/19/2013)

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Comparison Feature	SubjectMASTERGRAFT® MatrixEXT	PredicateMASTERGRAFT®UltraMatrix
Sterilization	Identical	K130335 (S.E. 04/19/2013)
Shelf-Life	Identical	K130335 (S.E. 04/19/2013)
Packaging	Identical	K130335 (S.E. 04/19/2013)
Material Composition• Collagen• Granules	Identical	K130335 (S.E. 04/19/2013)
Use of rigid fixation	Identical	K130335 (S.E. 04/19/2013)
Safety and Effectivenessprofile	Identical	K130335 (S.E. 04/19/2013)

VII. DISCUSSION OF NON-CLINICAL TESTING:

Non-clinical testing was performed in support of substantial equivalence for MASTERGRAFT® Strip cleared under K082166 (S.E. 06/02/2009). This data is considered relevant to and supportive of the cited predicate K130335 (S.E. 04/19/2013).

The non-clinical testing was conducted 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) application.

VIII. CONCLUSION:

Documentation provided in this submission demonstrates that the subject device is substantially equivalent to the previously cleared bone void filler MASTERGRAFT® UltraMatrix (K130335, SE 04/19/2013) and MASTERGRAFT® Strip and MASTERGRAFT® Putty K140375 (S.E. 04/18/2014).

The subject device is substantially equivalent to predicate MASTERGRAFT® UltraMatrix K130335 (04/19/2013) in several categories including: indication, material composition (including biphasic calcium phosphate granules and collagen), biodegradability, sterility, shelflife, need for rigid fixation, biocompatibility and the ability to resorb during the healing process. The subject device is also substantially equivalent to K140375 (S.E. 04/18/2014) MASTERGRAFT® Strip and MASTERGRAFT® Putty related to the additional contraindication identified in the labeling.

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.