MAGNIFUSE® Bone Graft is intended for use as a bone graft substitute and bone void filler in bony voids or gaps of the skeletal system (i.e., posterolateral spine and pelvis) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. MAGNIFUSE Bone Graft is resorbed/ remodeled and is replaced by host bone during the healing process.

Device Description

MAGNIFUSE® Bone Graft is comprised of human demineralized cortical bone fibers mixed with non-demineralized cortical bone fibers sealed in an absorbable PGA mesh pouch to form the final product.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the MAGNIFUSE® Bone Graft device:

Important Note: The provided document is a 510(k) Summary for a medical device and a clearance letter from the FDA. 510(k) clearances typically establish "substantial equivalence" to a predicate device rather than setting explicit, quantifiable "acceptance criteria" and proving performance against them in the same way a de novo or PMA application might. Therefore, the "acceptance criteria" here are implicitly linked to demonstrating equivalence to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) submission, explicit numerical acceptance criteria are not stated in the document. Instead, the "acceptance criteria" are effectively demonstrating comparability or equivalence to the predicate device.

Acceptance Criteria (Implicit)	Reported Device Performance
Similar material composition to predicate device	The subject MAGNIFUSE® Bone Graft has similar material composition to the predicate, both consisting of human cortical bone allograft tissue in a PGA mesh pouch. The allograft bone component in both consists of DBM fibers (osteoinductive) and a cortical bone allograft component (osteoconductive).
Similar Indications for Use statement to predicate device	The Indications for Use for the subject device are identical to the predicate: "for use as a bone graft substitute and bone void filler in bony voids or gaps of the skeletal system (i.e., posterolateral spine and pelvis) not intrinsic to the stability of the bony structure."
Identical operating principles to predicate device	Explicitly stated: "identical operating principles"
Identical finished product specifications to predicate device	Explicitly stated: "identical finished product specifications"
Equivalent performance in an animal model (remodeling and fusion rates) compared to predicate device	In vivo studies in animals showed "remodeling and fusion rates comparable to each other [subject and predicate] and to autograft bone."
Comparable osteoinductivity scores to predicate device	Osteoinductivity studies in an athymic rat model showed "comparable osteoinductivity scores for the subject and predicate MAGNIFUSE® Bone Grafts."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Test Set): The document mentions "in vivo studies of both subject and predicate MAGNIFUSE® Bone Graft implants in animals" and "Osteoinductivity studies in an athymic rat model." However, the specific number of animals/samples used in these studies is not provided in the summary.
Data Provenance: The studies were preclinical/animal studies. The country of origin for the data is not specified, but it's implied to be part of the manufacturer's (Medtronic Sofamor Danek USA, Inc.) research given their location. The studies are prospective in nature, as they involve testing the device in animals to assess its performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This section is not applicable as the studies are animal models and do not involve human expert interpretation of data in the sense of radiological or pathological diagnosis for establishing ground truth. The "ground truth" would be the direct biological outcomes (remodeling, fusion, osteoinductivity scores) observed in the animal models, rather than expert consensus on a human dataset.

4. Adjudication Method for the Test Set

This is not applicable as the studies are animal models evaluating biological endpoints, not human data requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study assesses the impact of an AI algorithm on human reader performance, which is not relevant for this bone graft device submission.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

No, a standalone algorithm performance study was not done. This device is a bone graft, not a software algorithm.

7. Type of Ground Truth Used

The ground truth used in the performance studies was biological outcomes from animal models:

In vivo studies: Remodeling and fusion rates in animals.
Osteoinductivity studies: Osteoinductivity scores in an athymic rat model.

8. Sample Size for the Training Set

This is not applicable. The MAGNIFUSE® Bone Graft is a physical medical device. It does not involve a "training set" in the context of machine learning or AI algorithms. The performance studies mentioned are for biological evaluation of the device itself.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no "training set" for a physical bone graft device.

Summary

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K123691 PAGE 1 OF 3

JAN 3 1 2013

510(K) Summary - MAGNIFUSE® Bone Graft

A summary of Safety And Effectiveness Information (In accordance with the requirements of 21CFR 807.92)

November 12, 2012

Company: Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, Tennessee 38132 Telephone: (732)-578-6697 (732) 389-3095 Fax:

Establishment Registration: 1030489

Contact:

IV.

Muriel Ashie Principal Regulatory Affairs Specialist

II. Name of Product: Proprietary Trade Name: Common Name:

MAGNIFUSE® Bone Graft Demineralized Bone Matrix Allograft

Classification Name(s): Resorbable Bone Void Filler III. Device Classification Panel: Orthopedic Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV, MBP

Description and Purpose of Application: MAGNIFUSE® Bone Graft is comprised of human demineralized cortical bone fibers mixed with non-demineralized cortical bone fibers sealed in an absorbable PGA mesh pouch to form the final product.

The purpose of this 510(k) is to request a change in formulation in MAGNIFUSE® Bone Graft. The predicate device is a combination of demineralized bone matrix in a fiber form and partially demineralized cortical chips while the subject device is a combination of demineralized bone matrix in a fiber form and non-demineralized cortical fibers.

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V. Indications for Use:

Identification of the Legally Marketed Predicate Devices Use to Claim VI. roomfoal - 02- 11- 02-2008 - 02-2009 - 02-2008 - 02-2008 - 10/16/2008];

Predicate Devices:	MAGNIFUSE Bone Graft K082615, SE 10/16/200
	(Cleared as Grafton II eDBM)
	GRAFTON DBM [K051195, SE 12/16/2005]
Regulation Number: 21 CFR 888.3045
Regulation Name:	Resorbable calcium salt bone void filler device
Product Code:	MQV, MBP

The MAGNIFUSE Bone Graft that is the subject of this 510(k) is substantially equivalent to the previously cleared MAGNIFUSE Bone Graft referenced above.

Summary of Technical Characteristics of Subject Device Compared To VII. Predicate Device

The MAGNIFUSE® Bone Graft that is the subject of this 510(k) is substantially equivalent to the above mentioned predicate MAGNIFUSE Bone graft device with respect to the design features and materials. The predicate and subject MAGNIFUSE devices both consist of human cortical bone allograft tissue contained in a sealed poly(glycolic acid; PGA) mesh pouch. The allograft bone component in both the predicate and subject MAGNIFUSE consists of demineralized bone matrix (DBM) in a fiber form as an osteoinductive component, combined with an osteoconductive cortical bone allograft component, specifically, partially demineralized cortical chips in predicate MAGNIFUSE and non-demineralized cortical fibers in the subject MAGNIFUSE.

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K123691
PAGE 3 OF 3

Based on similar material composition, similar Indications for Use statement, identical operating principles, identical finished product specifications and equivalent performance in an animal model, the subject MAGNIFUSE Bone Graft, is substantially equivalent to the predicate MAGNIFUSE Bone Graft.

VIII. Performance Data

In vivo studies of both subject and predicate MAGNIFUSE Bone Graft implants in animals showed remodeling and fusion rates comparable to each other and to autograft bone. Osteoinductivity studies in an athymic rat model also showed comparable osteoinductivity scores for the subject and predicate MAGNIFUSE Bone Grafts.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract figures that are connected and appear to be in motion. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

Medtronic Sofamor Danek USA, Incorporated % Ms. Muriel Ashie Principal Regulatory Affairs Associate 1800 Pyramid Place Memphis, Tennessee 38132

Letter dated: January 31, 2013

Re: K123691

Trade/Device Name: MAGNIFUSE® Bone Graft Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV, MBP Dated: November 26, 2012 Received: December 3, 2012

Dear Ms. Ashie:

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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Page 2 - Ms. Muriel Ashie

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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

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 Statement

K123691 510(k) Number:

MAGNIFUSE® Bone Graft Device Name:

Indications for Use

MAGNIFUSE® Bone Graft (GRAFTON® II eDBM) is intended for use as a bone graft substitute and bone void filler in bony voids or gaps of the skeletal system (i.e., posterolateral spine and pelvis) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. MAGNIFUSE® Bone Graft is resorbed / remodeled and replaced by host bone during the healing process.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ Use (Per 21 CFR 801.109)

Over-The-Counter

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Melkerson 2013.01.31 17:21:00 -05'00'

Director, DOD - K123691

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.